Trial Outcomes & Findings for Investigate Safety, Pharmacokinetics and Pharmacodynamics of GSK2118436 & GSK1120212 (NCT NCT01072175)
NCT ID: NCT01072175
Last Updated: 2019-07-05
Results Overview
For Clinical Chemistry parameters that were not graded according to NCI CTCAE criteria, changes above (High) and below (Low) the normal range were evaluated. Participants with missing Baseline were assumed to be within normal range. Participants were counted twice if the subject "Decreased to Low" and Increase to High" during the post-baseline period. Only descriptive analysis.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
430 participants
Primary outcome timeframe
From Baseline (Day 1) until Follow-up visit (up to approximately 8 years)
Results posted on
2019-07-05
Participant Flow
This study was conducted in 16 sites: Australia (2) and USA (14)
The study was comprised of Parts A, B, and D, which constitute the Phase I part of the study, and Part C, which constitutes the randomized Phase II part of the study. Participants did not enroll in all parts of the study sequentially. Each part of the study was comprised of a separate population of participants.
Participant milestones
| Measure |
Part A: Dabrafenib 75 mg + Trametinib 2 mg
Participants received a single dose of dabrafenib 75 mg gelatin capsules with repeat dose trametinib (Day 15).
|
Part B: Dabrafenib 75 mg + Trametinib 1 mg
Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 75 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available pharmacokinetic (PK), safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on dose-limiting toxicities (DLTs) occurring during the first 3 weeks of treatment.
|
Part B: Dabrafenib 150 mg + Trametinib 1 mg
Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors and participants who had salivary ductal cancer received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
|
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg
Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
|
Part B: Dabrafenib 150 mg + Trametinib 2 mg
Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
|
Part C (Randomized): Dabrafenib 150 mg
Participants received dabrafenib 150 mg gelatin capsules BID.
|
Part C (Randomized): Dabrafenib 150 mg + Trametinib 1 mg
Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD.
|
Part C (Randomized): Dabrafenib 150 mg + Trametinib 2 mg
Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD.
|
Part C (Crossover): Dabrafenib 150 mg + Trametinib 2 mg
Participants who received dabrafenib 150 mg capsules BID alone in the Randomized Phase were given the opportunity to receive combination dosing of dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD upon disease progression with approval of the GlaxoSmithKline (GSK) Medical Monitor.
|
Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg
Participants received dabrefinib 75 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 75 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
|
Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg
Participants received dabrefinib 150 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 150 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
|
Part D: Dabrafenib 75 mg + Trametinib 2 mg
Participants received dabrefinib 75 mg HPMC capsules BID and trametinib 2 mg tablets QD.
|
Part D: Dabrafenib 150 mg + Trametinib 2 mg
Participants received dabrefinib 150 mg HPMC capsules BID and trametinib 2 mg tablets QD.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part A (Drug-Drug Interaction)
STARTED
|
8
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part A (Drug-Drug Interaction)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part A (Drug-Drug Interaction)
NOT COMPLETED
|
8
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part B (Dose Escalation and Expansion)
STARTED
|
0
|
6
|
23
|
27
|
94
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part B (Dose Escalation and Expansion)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part B (Dose Escalation and Expansion)
NOT COMPLETED
|
0
|
6
|
23
|
27
|
94
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part C (Phase II: Randomized Phase)
STARTED
|
0
|
0
|
0
|
0
|
0
|
54
|
54
|
54
|
0
|
0
|
0
|
0
|
0
|
|
Part C (Phase II: Randomized Phase)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part C (Phase II: Randomized Phase)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
54
|
54
|
54
|
0
|
0
|
0
|
0
|
0
|
|
Part C (Phase II: Crossover Phase [CP])
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
45
|
0
|
0
|
0
|
0
|
|
Part C (Phase II: Crossover Phase [CP])
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part C (Phase II: Crossover Phase [CP])
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
45
|
0
|
0
|
0
|
0
|
|
Part D (HPMC Capsules)
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
12
|
16
|
43
|
39
|
|
Part D (HPMC Capsules)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part D (HPMC Capsules)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
12
|
16
|
43
|
39
|
Reasons for withdrawal
| Measure |
Part A: Dabrafenib 75 mg + Trametinib 2 mg
Participants received a single dose of dabrafenib 75 mg gelatin capsules with repeat dose trametinib (Day 15).
|
Part B: Dabrafenib 75 mg + Trametinib 1 mg
Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 75 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available pharmacokinetic (PK), safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on dose-limiting toxicities (DLTs) occurring during the first 3 weeks of treatment.
|
Part B: Dabrafenib 150 mg + Trametinib 1 mg
Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors and participants who had salivary ductal cancer received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
|
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg
Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
|
Part B: Dabrafenib 150 mg + Trametinib 2 mg
Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
|
Part C (Randomized): Dabrafenib 150 mg
Participants received dabrafenib 150 mg gelatin capsules BID.
|
Part C (Randomized): Dabrafenib 150 mg + Trametinib 1 mg
Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD.
|
Part C (Randomized): Dabrafenib 150 mg + Trametinib 2 mg
Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD.
|
Part C (Crossover): Dabrafenib 150 mg + Trametinib 2 mg
Participants who received dabrafenib 150 mg capsules BID alone in the Randomized Phase were given the opportunity to receive combination dosing of dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD upon disease progression with approval of the GlaxoSmithKline (GSK) Medical Monitor.
|
Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg
Participants received dabrefinib 75 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 75 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
|
Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg
Participants received dabrefinib 150 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 150 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
|
Part D: Dabrafenib 75 mg + Trametinib 2 mg
Participants received dabrefinib 75 mg HPMC capsules BID and trametinib 2 mg tablets QD.
|
Part D: Dabrafenib 150 mg + Trametinib 2 mg
Participants received dabrefinib 150 mg HPMC capsules BID and trametinib 2 mg tablets QD.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part A (Drug-Drug Interaction)
Death
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part A (Drug-Drug Interaction)
Physician Decision
|
6
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part A (Drug-Drug Interaction)
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part B (Dose Escalation and Expansion)
Death
|
0
|
4
|
18
|
21
|
68
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part B (Dose Escalation and Expansion)
Physician Decision
|
0
|
0
|
2
|
0
|
4
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part B (Dose Escalation and Expansion)
Lost to Follow-up
|
0
|
1
|
0
|
1
|
6
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part B (Dose Escalation and Expansion)
Study closed/terminated
|
0
|
0
|
3
|
2
|
10
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part B (Dose Escalation and Expansion)
Withdrawal by Subject
|
0
|
1
|
0
|
3
|
6
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part C (Phase II: Randomized Phase)
Death
|
0
|
0
|
0
|
0
|
0
|
44
|
34
|
39
|
0
|
0
|
0
|
0
|
0
|
|
Part C (Phase II: Randomized Phase)
Physician Decision
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Part C (Phase II: Randomized Phase)
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
3
|
0
|
0
|
0
|
0
|
0
|
|
Part C (Phase II: Randomized Phase)
Study closed/terminated
|
0
|
0
|
0
|
0
|
0
|
6
|
9
|
11
|
0
|
0
|
0
|
0
|
0
|
|
Part C (Phase II: Randomized Phase)
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
3
|
7
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part C (Phase II: Crossover Phase [CP])
Death
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
37
|
0
|
0
|
0
|
0
|
|
Part C (Phase II: Crossover Phase [CP])
Physician Decision
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Part C (Phase II: Crossover Phase [CP])
Study closed/terminated
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
4
|
0
|
0
|
0
|
0
|
|
Part C (Phase II: Crossover Phase [CP])
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
0
|
0
|
0
|
0
|
|
Part D (HPMC Capsules)
Death
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
10
|
12
|
28
|
26
|
|
Part D (HPMC Capsules)
Physician Decision
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
1
|
|
Part D (HPMC Capsules)
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
3
|
|
Part D (HPMC Capsules)
Study closed/terminated
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
1
|
10
|
9
|
|
Part D (HPMC Capsules)
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
3
|
0
|
Baseline Characteristics
Investigate Safety, Pharmacokinetics and Pharmacodynamics of GSK2118436 & GSK1120212
Baseline characteristics by cohort
| Measure |
Part A: Dabrafenib 75 mg + Trametinib 2 mg
n=8 Participants
Participants received a single dose of dabrafenib 75 mg gelatin capsules with repeat dose trametinib (Day 15).
|
Part B: Dabrafenib 75 mg + Trametinib 1 mg
n=6 Participants
Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 75 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available pharmacokinetic (PK), safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on dose-limiting toxicities (DLTs) occurring during the first 3 weeks of treatment.
|
Part B: Dabrafenib 150 mg + Trametinib 1 mg
n=23 Participants
Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors and participants who had salivary ductal cancer received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
|
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg
n=27 Participants
Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
|
Part B: Dabrafenib 150 mg + Trametinib 2 mg
n=94 Participants
Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
|
Part C: Dabrafenib 150 mg
n=54 Participants
Participants received dabrafenib 150 mg gelatin capsules BID.
|
Part C: Dabrafenib 150 mg + Trametinib 1 mg
n=54 Participants
Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD.
|
Part C: Dabrafenib 150 mg + Trametinib 2 mg
n=54 Participants
Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD.
|
Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg
n=12 Participants
Participants received dabrefinib 75 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 75 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
|
Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg
n=16 Participants
Participants received dabrefinib 150 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 150 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
|
Part D: Dabrafenib 75 mg + Trametinib 2 mg
n=43 Participants
Participants received dabrefinib 75 mg HPMC capsules BID and trametinib 2 mg tablets QD.
|
Part D: Dabrafenib 150 mg + Trametinib 2 mg
n=39 Participants
Participants received dabrefinib 150 mg HPMC capsules BID and trametinib 2 mg tablets QD.
|
Total
n=430 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
52.8 Years
STANDARD_DEVIATION 16.04 • n=5 Participants
|
48.2 Years
STANDARD_DEVIATION 7.28 • n=7 Participants
|
54.2 Years
STANDARD_DEVIATION 13.24 • n=5 Participants
|
52.2 Years
STANDARD_DEVIATION 12.09 • n=4 Participants
|
52.4 Years
STANDARD_DEVIATION 12.99 • n=21 Participants
|
51.8 Years
STANDARD_DEVIATION 15.19 • n=10 Participants
|
49.9 Years
STANDARD_DEVIATION 14.70 • n=115 Participants
|
55.9 Years
STANDARD_DEVIATION 11.85 • n=6 Participants
|
51.8 Years
STANDARD_DEVIATION 12.39 • n=6 Participants
|
53.1 Years
STANDARD_DEVIATION 17.04 • n=64 Participants
|
52.8 Years
STANDARD_DEVIATION 14.57 • n=17 Participants
|
56.7 Years
STANDARD_DEVIATION 14.08 • n=21 Participants
|
52.8 Years
STANDARD_DEVIATION 13.74 • n=22 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
56 Participants
n=21 Participants
|
25 Participants
n=10 Participants
|
24 Participants
n=115 Participants
|
20 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
8 Participants
n=64 Participants
|
18 Participants
n=17 Participants
|
14 Participants
n=21 Participants
|
197 Participants
n=22 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
38 Participants
n=21 Participants
|
29 Participants
n=10 Participants
|
30 Participants
n=115 Participants
|
34 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
8 Participants
n=64 Participants
|
25 Participants
n=17 Participants
|
25 Participants
n=21 Participants
|
233 Participants
n=22 Participants
|
|
Race/Ethnicity, Customized
White
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
92 Participants
n=21 Participants
|
52 Participants
n=10 Participants
|
54 Participants
n=115 Participants
|
53 Participants
n=6 Participants
|
12 Participants
n=6 Participants
|
16 Participants
n=64 Participants
|
43 Participants
n=17 Participants
|
39 Participants
n=21 Participants
|
407 Participants
n=22 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=22 Participants
|
|
Race/Ethnicity, Customized
African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=22 Participants
|
|
Race/Ethnicity, Customized
Missing
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=21 Participants
|
3 Participants
n=22 Participants
|
PRIMARY outcome
Timeframe: Day 15Population: Pharmacokinetic (PK) Population: all participants who received at least one dose of either dabrafenib or trametinib and for whom a PK sample was obtained and analyzed
Blood samples for PK analysis of dabrafenib and its the metabolites hydroxy-dabrafenib (GSK2285403), carboxy-dabrafenib (GSK2298683) and desmethyl-dabrafenib (GSK2167542) were obtained at pre-dose and at 1, 2, 3, 4, 6, 8, 10, and 24 hours after dabrafenib administration. From the plasma concentration-time curve, the PK parameter Cmax was determined by standard non-compartmental analysis using WinNonlin. Cmax data are reported as geometric least squares means.
Outcome measures
| Measure |
Part A: Dabrafenib 75 mg
n=8 Participants
Participants received a single dose of dabrafenib 75 mg gelatin capsules alone on Day 1.
|
Part A: Dabrafenib 75 mg + Trametinib 2 mg
n=8 Participants
Participants received a single dose of dabrafenib 75 mg gelatin capsules with repeat dose trametinib (Day 15).
|
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg
Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
|
Part B: Dabrafenib 150 mg + Trametinib 2 mg
Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
|
|---|---|---|---|---|
|
Part A: Maximum Plasma Concentration (Cmax) of a Single Dose of Dabrafenib Administered Alone and in Combination With Trametnib
GSK2285403
|
259 Nanograms per milliliter (ng/mL)
Interval 190.0 to 352.0
|
255 Nanograms per milliliter (ng/mL)
Interval 196.0 to 331.0
|
—
|
—
|
|
Part A: Maximum Plasma Concentration (Cmax) of a Single Dose of Dabrafenib Administered Alone and in Combination With Trametnib
GSK2298683
|
724 Nanograms per milliliter (ng/mL)
Interval 595.0 to 879.0
|
747 Nanograms per milliliter (ng/mL)
Interval 587.0 to 951.0
|
—
|
—
|
|
Part A: Maximum Plasma Concentration (Cmax) of a Single Dose of Dabrafenib Administered Alone and in Combination With Trametnib
GSK2118436
|
509 Nanograms per milliliter (ng/mL)
Interval 379.0 to 685.0
|
524 Nanograms per milliliter (ng/mL)
Interval 390.0 to 705.0
|
—
|
—
|
|
Part A: Maximum Plasma Concentration (Cmax) of a Single Dose of Dabrafenib Administered Alone and in Combination With Trametnib
GSK2167542
|
8.37 Nanograms per milliliter (ng/mL)
Interval 4.82 to 14.5
|
8.16 Nanograms per milliliter (ng/mL)
Interval 5.68 to 11.7
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 15Population: PK Population
Blood samples for PK analysis of dabrafenib and its metabolites hydroxy-dabrafenib (GSK2285403), carboxy-dabrafenib (GSK2298683) and desmethyl-dabrafenib (GSK2167542) were obtained at pre-dose and at 1, 2, 3, 4, 6, 8, 10, and 24 hours after dabrafenib administration. AUC is defined as the area under the dabrafenib concentration-time curve as a measure of drug exposure. AUC (0-inf) is defined as the area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time. AUC (0-t) is defined as area under the concentration-time curve from time zero (pre-dose) to the last time of quantifiable concentration. Date are reported as geometric least square means.
Outcome measures
| Measure |
Part A: Dabrafenib 75 mg
n=8 Participants
Participants received a single dose of dabrafenib 75 mg gelatin capsules alone on Day 1.
|
Part A: Dabrafenib 75 mg + Trametinib 2 mg
n=8 Participants
Participants received a single dose of dabrafenib 75 mg gelatin capsules with repeat dose trametinib (Day 15).
|
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg
Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
|
Part B: Dabrafenib 150 mg + Trametinib 2 mg
Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
|
|---|---|---|---|---|
|
Part A: AUC (0-t) and AUC (0-inf) of Dabrafenib and Its Metabolites
GSK2118436 AUC (0-t)
|
2734 ng*hour/mL (ng*hr/mL)
Interval 2205.0 to 3390.0
|
2751 ng*hour/mL (ng*hr/mL)
Interval 2219.0 to 3411.0
|
—
|
—
|
|
Part A: AUC (0-t) and AUC (0-inf) of Dabrafenib and Its Metabolites
GSK2118436 AUC (0-inf)
|
3128 ng*hour/mL (ng*hr/mL)
Interval 2578.0 to 3797.0
|
2949 ng*hour/mL (ng*hr/mL)
Interval 2445.0 to 3556.0
|
—
|
—
|
|
Part A: AUC (0-t) and AUC (0-inf) of Dabrafenib and Its Metabolites
GSK2285403 AUC (0-t)
|
2232 ng*hour/mL (ng*hr/mL)
Interval 1684.0 to 2959.0
|
2287 ng*hour/mL (ng*hr/mL)
Interval 1899.0 to 2753.0
|
—
|
—
|
|
Part A: AUC (0-t) and AUC (0-inf) of Dabrafenib and Its Metabolites
GSK2285403 AUC (0-inf)
|
2819 ng*hour/mL (ng*hr/mL)
Interval 2231.0 to 3562.0
|
2497 ng*hour/mL (ng*hr/mL)
Interval 2097.0 to 2974.0
|
—
|
—
|
|
Part A: AUC (0-t) and AUC (0-inf) of Dabrafenib and Its Metabolites
GSK2298683 AUC (0-t)
|
12761 ng*hour/mL (ng*hr/mL)
Interval 10347.0 to 15738.0
|
13053 ng*hour/mL (ng*hr/mL)
Interval 10475.0 to 16266.0
|
—
|
—
|
|
Part A: AUC (0-t) and AUC (0-inf) of Dabrafenib and Its Metabolites
GSK2167542 AUC (0-t)
|
270 ng*hour/mL (ng*hr/mL)
Interval 188.0 to 390.0
|
276 ng*hour/mL (ng*hr/mL)
Interval 230.0 to 332.0
|
—
|
—
|
PRIMARY outcome
Timeframe: From Baseline (Day 1) until Follow-up visit (up to approximately 8 years)Population: All Treated Participants (ATP) Population: all participants who received at least one dose of either dabrafenib or trametinib
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury.
Outcome measures
| Measure |
Part A: Dabrafenib 75 mg
n=6 Participants
Participants received a single dose of dabrafenib 75 mg gelatin capsules alone on Day 1.
|
Part A: Dabrafenib 75 mg + Trametinib 2 mg
n=23 Participants
Participants received a single dose of dabrafenib 75 mg gelatin capsules with repeat dose trametinib (Day 15).
|
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg
n=27 Participants
Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
|
Part B: Dabrafenib 150 mg + Trametinib 2 mg
n=94 Participants
Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
|
|---|---|---|---|---|
|
Part B: Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)
Any AE
|
6 Participants
|
23 Participants
|
27 Participants
|
93 Participants
|
|
Part B: Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)
Any SAE
|
1 Participants
|
15 Participants
|
14 Participants
|
55 Participants
|
PRIMARY outcome
Timeframe: From Baseline (Day 1) until Follow-up visit (up to approximately 8 years)Population: All Treated Participants (ATP) Population. Only participants with lab values at the specified planned time were considered.
Clinical Chemistry parameters were summarized according to National Cancer Institutes (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade, version 4.0. Grade 1, Mild; Grade 2, Moderate; Grade 3 (G3), Severe; Grade 4 (G4), Life-threatening or disabling; Grade 5, Death. Data are presented for only those parameters for which an increase to Grade 3 or Grade 4 occurred. Participants with missing Baseline Grade were assumed to have Baseline Grade of 0. All increases were an increase in grade from Baseline. Only descriptive analysis.
Outcome measures
| Measure |
Part A: Dabrafenib 75 mg
n=6 Participants
Participants received a single dose of dabrafenib 75 mg gelatin capsules alone on Day 1.
|
Part A: Dabrafenib 75 mg + Trametinib 2 mg
n=23 Participants
Participants received a single dose of dabrafenib 75 mg gelatin capsules with repeat dose trametinib (Day 15).
|
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg
n=27 Participants
Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
|
Part B: Dabrafenib 150 mg + Trametinib 2 mg
n=94 Participants
Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
|
|---|---|---|---|---|
|
Part B: Number of Participants With Worst-case Chemistry Toxicity Grade Change From Baseline
Albumin · Increase to Grade 3
|
0 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
|
Part B: Number of Participants With Worst-case Chemistry Toxicity Grade Change From Baseline
Albumin · Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part B: Number of Participants With Worst-case Chemistry Toxicity Grade Change From Baseline
Alkaline Phosphatase · Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part B: Number of Participants With Worst-case Chemistry Toxicity Grade Change From Baseline
Alanine Amino Transferase · Increase to Grade 3
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Part B: Number of Participants With Worst-case Chemistry Toxicity Grade Change From Baseline
Alanine Amino Transferase · Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part B: Number of Participants With Worst-case Chemistry Toxicity Grade Change From Baseline
Amylase · Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part B: Number of Participants With Worst-case Chemistry Toxicity Grade Change From Baseline
Amylase · Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part B: Number of Participants With Worst-case Chemistry Toxicity Grade Change From Baseline
Aspartate Amino Transferase · Increase to Grade 3
|
0 Participants
|
0 Participants
|
1 Participants
|
5 Participants
|
|
Part B: Number of Participants With Worst-case Chemistry Toxicity Grade Change From Baseline
Aspartate Amino Transferase · Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part B: Number of Participants With Worst-case Chemistry Toxicity Grade Change From Baseline
Total Bilirubin · Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Part B: Number of Participants With Worst-case Chemistry Toxicity Grade Change From Baseline
Total Bilirubin · Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part B: Number of Participants With Worst-case Chemistry Toxicity Grade Change From Baseline
Calcium (Hypercalcemia) · Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part B: Number of Participants With Worst-case Chemistry Toxicity Grade Change From Baseline
Calcium (Hypercalcemia) · Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part B: Number of Participants With Worst-case Chemistry Toxicity Grade Change From Baseline
Calcium (Hypocalcemia) · Increase to Grade 3
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Part B: Number of Participants With Worst-case Chemistry Toxicity Grade Change From Baseline
Calcium (Hypocalcemia) · Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Part B: Number of Participants With Worst-case Chemistry Toxicity Grade Change From Baseline
Creatine Kinase · Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part B: Number of Participants With Worst-case Chemistry Toxicity Grade Change From Baseline
Creatine Kinase · Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part B: Number of Participants With Worst-case Chemistry Toxicity Grade Change From Baseline
Creatinine · Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part B: Number of Participants With Worst-case Chemistry Toxicity Grade Change From Baseline
Creatinine · Increase to Grade 4
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Part B: Number of Participants With Worst-case Chemistry Toxicity Grade Change From Baseline
Gamma Glutamyl Transferase · Increase to Grade 3
|
1 Participants
|
0 Participants
|
3 Participants
|
13 Participants
|
|
Part B: Number of Participants With Worst-case Chemistry Toxicity Grade Change From Baseline
Gamma Glutamyl Transferase · Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part B: Number of Participants With Worst-case Chemistry Toxicity Grade Change From Baseline
Glucose (Hyperglycemia) · Increase to Grade 3
|
0 Participants
|
2 Participants
|
2 Participants
|
5 Participants
|
|
Part B: Number of Participants With Worst-case Chemistry Toxicity Grade Change From Baseline
Glucose (Hyperglycemia) · Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part B: Number of Participants With Worst-case Chemistry Toxicity Grade Change From Baseline
Glucose (Hypoglycemia) · Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Part B: Number of Participants With Worst-case Chemistry Toxicity Grade Change From Baseline
Glucose (Hypoglycemia) · Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part B: Number of Participants With Worst-case Chemistry Toxicity Grade Change From Baseline
Potassium (Hyperkalemia) · Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Part B: Number of Participants With Worst-case Chemistry Toxicity Grade Change From Baseline
Potassium (Hyperkalemia) · Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part B: Number of Participants With Worst-case Chemistry Toxicity Grade Change From Baseline
Potassium (Hypokalemia) · Increase to Grade 3
|
0 Participants
|
0 Participants
|
1 Participants
|
4 Participants
|
|
Part B: Number of Participants With Worst-case Chemistry Toxicity Grade Change From Baseline
Potassium (Hypokalemia) · Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part B: Number of Participants With Worst-case Chemistry Toxicity Grade Change From Baseline
Lipase · Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part B: Number of Participants With Worst-case Chemistry Toxicity Grade Change From Baseline
Lipase · Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part B: Number of Participants With Worst-case Chemistry Toxicity Grade Change From Baseline
Magnesium (Hypermagnesemia) · Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part B: Number of Participants With Worst-case Chemistry Toxicity Grade Change From Baseline
Magnesium (Hypermagnesemia) · Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part B: Number of Participants With Worst-case Chemistry Toxicity Grade Change From Baseline
Magnesium (Hypomagnesemia) · Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part B: Number of Participants With Worst-case Chemistry Toxicity Grade Change From Baseline
Magnesium (Hypomagnesemia) · Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part B: Number of Participants With Worst-case Chemistry Toxicity Grade Change From Baseline
Sodium (Hypernatremia) · Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part B: Number of Participants With Worst-case Chemistry Toxicity Grade Change From Baseline
Sodium (Hypernatremia) · Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part B: Number of Participants With Worst-case Chemistry Toxicity Grade Change From Baseline
Sodium (Hyponatremia) · Increase to Grade 3
|
0 Participants
|
2 Participants
|
7 Participants
|
12 Participants
|
|
Part B: Number of Participants With Worst-case Chemistry Toxicity Grade Change From Baseline
Sodium (Hyponatremia) · Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part B: Number of Participants With Worst-case Chemistry Toxicity Grade Change From Baseline
Blood pH · Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part B: Number of Participants With Worst-case Chemistry Toxicity Grade Change From Baseline
Blood pH · Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part B: Number of Participants With Worst-case Chemistry Toxicity Grade Change From Baseline
Phosphorus inorganic · Increase to Grade 3
|
0 Participants
|
2 Participants
|
6 Participants
|
4 Participants
|
|
Part B: Number of Participants With Worst-case Chemistry Toxicity Grade Change From Baseline
Phosphorus inorganic · Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part B: Number of Participants With Worst-case Chemistry Toxicity Grade Change From Baseline
Uric acid · Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part B: Number of Participants With Worst-case Chemistry Toxicity Grade Change From Baseline
Uric acid · Increase to Grade 4
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Part B: Number of Participants With Worst-case Chemistry Toxicity Grade Change From Baseline
Alkaline Phosphatase · Increase to Grade 3
|
1 Participants
|
2 Participants
|
1 Participants
|
10 Participants
|
PRIMARY outcome
Timeframe: From Baseline (Day 1) until Follow-up visit (up to approximately 8 years)Population: All Treated Participants (ATP) Population. Only participants with lab values at the specified planned time were considered.
For Clinical Chemistry parameters that were not graded according to NCI CTCAE criteria, changes above (High) and below (Low) the normal range were evaluated. Participants with missing Baseline were assumed to be within normal range. Participants were counted twice if the subject "Decreased to Low" and Increase to High" during the post-baseline period. Only descriptive analysis.
Outcome measures
| Measure |
Part A: Dabrafenib 75 mg
n=6 Participants
Participants received a single dose of dabrafenib 75 mg gelatin capsules alone on Day 1.
|
Part A: Dabrafenib 75 mg + Trametinib 2 mg
n=23 Participants
Participants received a single dose of dabrafenib 75 mg gelatin capsules with repeat dose trametinib (Day 15).
|
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg
n=27 Participants
Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
|
Part B: Dabrafenib 150 mg + Trametinib 2 mg
n=94 Participants
Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
|
|---|---|---|---|---|
|
Part B: Number of Participants With Worst-case Chemistry Change From Baseline With Respect to Normal Range
Chloride · Decrease to Low
|
0 Participants
|
4 Participants
|
10 Participants
|
39 Participants
|
|
Part B: Number of Participants With Worst-case Chemistry Change From Baseline With Respect to Normal Range
Chloride · Increase to High
|
2 Participants
|
11 Participants
|
8 Participants
|
16 Participants
|
|
Part B: Number of Participants With Worst-case Chemistry Change From Baseline With Respect to Normal Range
Carbon dioxide content/Bicarbonate · Decrease to Low
|
1 Participants
|
4 Participants
|
6 Participants
|
16 Participants
|
|
Part B: Number of Participants With Worst-case Chemistry Change From Baseline With Respect to Normal Range
Direct Bilirubin · Decrease to Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part B: Number of Participants With Worst-case Chemistry Change From Baseline With Respect to Normal Range
Direct Bilirubin · Increase to High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part B: Number of Participants With Worst-case Chemistry Change From Baseline With Respect to Normal Range
Indirect Bilirubin · Decrease to Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part B: Number of Participants With Worst-case Chemistry Change From Baseline With Respect to Normal Range
Indirect Bilirubin · Increase to High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part B: Number of Participants With Worst-case Chemistry Change From Baseline With Respect to Normal Range
Creatine Kinase MB mass · Decrease to Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part B: Number of Participants With Worst-case Chemistry Change From Baseline With Respect to Normal Range
Creatine Kinase MB mass · Increase to High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part B: Number of Participants With Worst-case Chemistry Change From Baseline With Respect to Normal Range
Carbon dioxide content/Bicarbonate · Increase to High
|
3 Participants
|
7 Participants
|
11 Participants
|
25 Participants
|
|
Part B: Number of Participants With Worst-case Chemistry Change From Baseline With Respect to Normal Range
Creatinine clearance · Decrease to Low
|
2 Participants
|
4 Participants
|
10 Participants
|
19 Participants
|
|
Part B: Number of Participants With Worst-case Chemistry Change From Baseline With Respect to Normal Range
Creatinine clearance · Increase to High
|
2 Participants
|
5 Participants
|
5 Participants
|
8 Participants
|
|
Part B: Number of Participants With Worst-case Chemistry Change From Baseline With Respect to Normal Range
Lactate dehydrogenase · Decrease to Low
|
1 Participants
|
2 Participants
|
1 Participants
|
4 Participants
|
|
Part B: Number of Participants With Worst-case Chemistry Change From Baseline With Respect to Normal Range
Lactate dehydrogenase · Increase to High
|
4 Participants
|
9 Participants
|
11 Participants
|
35 Participants
|
|
Part B: Number of Participants With Worst-case Chemistry Change From Baseline With Respect to Normal Range
Total protein · Decrease to Low
|
0 Participants
|
10 Participants
|
10 Participants
|
30 Participants
|
|
Part B: Number of Participants With Worst-case Chemistry Change From Baseline With Respect to Normal Range
Total protein · Increase to High
|
3 Participants
|
2 Participants
|
1 Participants
|
7 Participants
|
|
Part B: Number of Participants With Worst-case Chemistry Change From Baseline With Respect to Normal Range
Troponin I · Decrease to Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part B: Number of Participants With Worst-case Chemistry Change From Baseline With Respect to Normal Range
Troponin I · Increase to High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part B: Number of Participants With Worst-case Chemistry Change From Baseline With Respect to Normal Range
Trponin T · Decrease to Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part B: Number of Participants With Worst-case Chemistry Change From Baseline With Respect to Normal Range
Trponin T · Increase to High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part B: Number of Participants With Worst-case Chemistry Change From Baseline With Respect to Normal Range
Urea/BUN · Decrease to Low
|
2 Participants
|
4 Participants
|
3 Participants
|
17 Participants
|
|
Part B: Number of Participants With Worst-case Chemistry Change From Baseline With Respect to Normal Range
Urea/BUN · Increase to High
|
1 Participants
|
10 Participants
|
16 Participants
|
30 Participants
|
PRIMARY outcome
Timeframe: From Baseline (Day 1) until Follow-up visit (up to approximately 8 years)Population: All Treated Participants (ATP) Population. Only participants with lab values at the specified planned time were considered.
Hematology parameters were summarized according to National Cancer Institutes (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade, version 4.0. Grade 1, Mild; Grade 2, Moderate; Grade 3 (G3), Severe; Grade 4 (G4), Life-threatening or disabling; Grade 5, Death. Data are presented for only those parameters for which an increase to Grade 3 or Grade 4 occurred. Participants with missing Baseline Grade were assumed to have Baseline Grade of 0. All increases were an increase in grade from Baseline. Only descriptive analysis.
Outcome measures
| Measure |
Part A: Dabrafenib 75 mg
n=6 Participants
Participants received a single dose of dabrafenib 75 mg gelatin capsules alone on Day 1.
|
Part A: Dabrafenib 75 mg + Trametinib 2 mg
n=23 Participants
Participants received a single dose of dabrafenib 75 mg gelatin capsules with repeat dose trametinib (Day 15).
|
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg
n=27 Participants
Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
|
Part B: Dabrafenib 150 mg + Trametinib 2 mg
n=94 Participants
Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
|
|---|---|---|---|---|
|
Part B: Number of Participants With Worst-case Hematology Toxicity Grade Change From Baseline
Lymphocytes (Decreased) · Increase to Grade 3
|
0 Participants
|
7 Participants
|
4 Participants
|
19 Participants
|
|
Part B: Number of Participants With Worst-case Hematology Toxicity Grade Change From Baseline
Hemoglobin (Increased) · Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part B: Number of Participants With Worst-case Hematology Toxicity Grade Change From Baseline
Hemoglobin (Increased) · Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part B: Number of Participants With Worst-case Hematology Toxicity Grade Change From Baseline
Hemoglobin (Anemia) · Increase to Grade 3
|
0 Participants
|
0 Participants
|
3 Participants
|
10 Participants
|
|
Part B: Number of Participants With Worst-case Hematology Toxicity Grade Change From Baseline
Hemoglobin (Anemia) · Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part B: Number of Participants With Worst-case Hematology Toxicity Grade Change From Baseline
Lymphocytes (Increased) · Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part B: Number of Participants With Worst-case Hematology Toxicity Grade Change From Baseline
Lymphocytes (Increased) · Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part B: Number of Participants With Worst-case Hematology Toxicity Grade Change From Baseline
Lymphocytes (Decreased) · Increase to Grade 4
|
0 Participants
|
1 Participants
|
4 Participants
|
5 Participants
|
|
Part B: Number of Participants With Worst-case Hematology Toxicity Grade Change From Baseline
Total Neutrophils · Increase to Grade 3
|
1 Participants
|
3 Participants
|
3 Participants
|
10 Participants
|
|
Part B: Number of Participants With Worst-case Hematology Toxicity Grade Change From Baseline
Total Neutrophils · Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part B: Number of Participants With Worst-case Hematology Toxicity Grade Change From Baseline
Platelet Count · Increase to Grade 3
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Part B: Number of Participants With Worst-case Hematology Toxicity Grade Change From Baseline
Platelet Count · Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Part B: Number of Participants With Worst-case Hematology Toxicity Grade Change From Baseline
White Blood Cell Count · Increase to Grade 3
|
0 Participants
|
2 Participants
|
4 Participants
|
8 Participants
|
|
Part B: Number of Participants With Worst-case Hematology Toxicity Grade Change From Baseline
White Blood Cell Count · Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From Baseline (Day 1) until Follow-up visit (up to approximately 8 years)Population: All Treated Participants (ATP) Population. Only participants with lab values at the specified planned time were considered.
For Hematology parameters that were not graded according to NCI CTCAE criteria, changes above (High) and below (Low) the normal range were evaluated. Participants with missing Baseline were assumed to be within normal range. Participants were counted twice if the subject "Decreased to Low" and Increase to High" during the post-baseline period. Only descriptive analysis.
Outcome measures
| Measure |
Part A: Dabrafenib 75 mg
n=6 Participants
Participants received a single dose of dabrafenib 75 mg gelatin capsules alone on Day 1.
|
Part A: Dabrafenib 75 mg + Trametinib 2 mg
n=23 Participants
Participants received a single dose of dabrafenib 75 mg gelatin capsules with repeat dose trametinib (Day 15).
|
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg
n=27 Participants
Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
|
Part B: Dabrafenib 150 mg + Trametinib 2 mg
n=94 Participants
Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
|
|---|---|---|---|---|
|
Part B: Number of Participants With Worst-case Hematology Change From Baseline With Respect to Normal Range
Mean Corpuscle Hemoglobin concentration · Decrease to Low
|
0 Participants
|
6 Participants
|
11 Participants
|
21 Participants
|
|
Part B: Number of Participants With Worst-case Hematology Change From Baseline With Respect to Normal Range
Basophils · Decrease to Low
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Part B: Number of Participants With Worst-case Hematology Change From Baseline With Respect to Normal Range
Basophils · Increase to High
|
0 Participants
|
2 Participants
|
4 Participants
|
7 Participants
|
|
Part B: Number of Participants With Worst-case Hematology Change From Baseline With Respect to Normal Range
Eosinophils · Decrease to Low
|
1 Participants
|
5 Participants
|
6 Participants
|
28 Participants
|
|
Part B: Number of Participants With Worst-case Hematology Change From Baseline With Respect to Normal Range
Eosinophils · Increase to High
|
0 Participants
|
5 Participants
|
7 Participants
|
11 Participants
|
|
Part B: Number of Participants With Worst-case Hematology Change From Baseline With Respect to Normal Range
Hematocrit · Decrease to Low
|
1 Participants
|
5 Participants
|
7 Participants
|
24 Participants
|
|
Part B: Number of Participants With Worst-case Hematology Change From Baseline With Respect to Normal Range
Hematocrit · Increase to High
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
|
Part B: Number of Participants With Worst-case Hematology Change From Baseline With Respect to Normal Range
Mean Corpuscle Hemoglobin concentration · Increase to High
|
2 Participants
|
4 Participants
|
5 Participants
|
13 Participants
|
|
Part B: Number of Participants With Worst-case Hematology Change From Baseline With Respect to Normal Range
Mean Corpuscle Hemoglobin · Decrease to Low
|
0 Participants
|
6 Participants
|
8 Participants
|
12 Participants
|
|
Part B: Number of Participants With Worst-case Hematology Change From Baseline With Respect to Normal Range
Mean Corpuscle Hemoglobin · Increase to High
|
0 Participants
|
3 Participants
|
6 Participants
|
11 Participants
|
|
Part B: Number of Participants With Worst-case Hematology Change From Baseline With Respect to Normal Range
Mean Corpuscle Volume · Decrease to Low
|
1 Participants
|
5 Participants
|
6 Participants
|
13 Participants
|
|
Part B: Number of Participants With Worst-case Hematology Change From Baseline With Respect to Normal Range
Mean Corpuscle Volume · Increase to High
|
1 Participants
|
2 Participants
|
4 Participants
|
5 Participants
|
|
Part B: Number of Participants With Worst-case Hematology Change From Baseline With Respect to Normal Range
Monocytes · Decrease to Low
|
2 Participants
|
8 Participants
|
10 Participants
|
21 Participants
|
|
Part B: Number of Participants With Worst-case Hematology Change From Baseline With Respect to Normal Range
Monocytes · Increase to High
|
1 Participants
|
4 Participants
|
9 Participants
|
30 Participants
|
|
Part B: Number of Participants With Worst-case Hematology Change From Baseline With Respect to Normal Range
Red Blood Cell count · Decrease to Low
|
1 Participants
|
9 Participants
|
5 Participants
|
25 Participants
|
|
Part B: Number of Participants With Worst-case Hematology Change From Baseline With Respect to Normal Range
Red Blood Cell count · Increase to High
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Part B: Number of Participants With Worst-case Hematology Change From Baseline With Respect to Normal Range
Reticulocytes · Decrease to Low
|
2 Participants
|
1 Participants
|
5 Participants
|
3 Participants
|
|
Part B: Number of Participants With Worst-case Hematology Change From Baseline With Respect to Normal Range
Reticulocytes · Increase to High
|
2 Participants
|
7 Participants
|
6 Participants
|
6 Participants
|
PRIMARY outcome
Timeframe: From Baseline (Day 1) until Follow-up visit (up to approximately 8 years)Population: ATP Population
Blood pressure and heart rate were summarized according to NCI CTCAE grade, version 4.0. Grade 1, Mild; Grade 2, Moderate; Grade 3 (G3), Severe; Grade 4 (G4), Life-threatening or disabling; Grade 5, Death. Data are presented for only those parameters for which an increase to G3 or G4 occurred. Blood pressure measurement included systolic blood pressure (SBP, millimeters of mercury \[mmHg\]) and diastolic BP (DBP). Heart rate is the measure of heart beats per minute (bpm). Changes in heart rate, either decrease to \<60 bpm, change to normal or no change, or increase to \>100 bpm are presented.
Outcome measures
| Measure |
Part A: Dabrafenib 75 mg
n=6 Participants
Participants received a single dose of dabrafenib 75 mg gelatin capsules alone on Day 1.
|
Part A: Dabrafenib 75 mg + Trametinib 2 mg
n=23 Participants
Participants received a single dose of dabrafenib 75 mg gelatin capsules with repeat dose trametinib (Day 15).
|
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg
n=27 Participants
Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
|
Part B: Dabrafenib 150 mg + Trametinib 2 mg
n=78 Participants
Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
|
|---|---|---|---|---|
|
Part B: Number of Participants With the Indicated Worst-case Change From Baseline in Heart Rate and Blood Pressure
Heart rate, Decrease to <60 bpm
|
1 Participants
|
2 Participants
|
5 Participants
|
15 Participants
|
|
Part B: Number of Participants With the Indicated Worst-case Change From Baseline in Heart Rate and Blood Pressure
Heart rate, Change to normal or no change
|
3 Participants
|
14 Participants
|
15 Participants
|
37 Participants
|
|
Part B: Number of Participants With the Indicated Worst-case Change From Baseline in Heart Rate and Blood Pressure
Heart rate, Increase to >100 bpm
|
2 Participants
|
7 Participants
|
8 Participants
|
26 Participants
|
|
Part B: Number of Participants With the Indicated Worst-case Change From Baseline in Heart Rate and Blood Pressure
SBP, Increase to G3 or G4
|
0 Participants
|
2 Participants
|
3 Participants
|
8 Participants
|
|
Part B: Number of Participants With the Indicated Worst-case Change From Baseline in Heart Rate and Blood Pressure
DBP, Increase to G3 or G4
|
0 Participants
|
1 Participants
|
3 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: From the first dose of study medication to the first documented evidence of a confirmed complete response or partial response (up to approximately 7 years)Population: Intent-to-Treat (ITT) Population: all randomized participants regardless of whether or not treatment was administered
Best overall response is defined as complete response (CR: the disappearance of all target lesions. Any pathological lymph nodes must be \<10 millimeters \[mm\] in the short axis.) or partial reponse (PR: at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters \[e.g., percent change from Baseline\]). Participants with unknown or missing responses were considered as non-responders. To be assigned a status of PR or CR, a confirmatory disease assessment should have been performed no less than 28 days after the criteria for response were first met. Response was evaluated by an investigator as per Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1.
Outcome measures
| Measure |
Part A: Dabrafenib 75 mg
n=54 Participants
Participants received a single dose of dabrafenib 75 mg gelatin capsules alone on Day 1.
|
Part A: Dabrafenib 75 mg + Trametinib 2 mg
n=54 Participants
Participants received a single dose of dabrafenib 75 mg gelatin capsules with repeat dose trametinib (Day 15).
|
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg
n=54 Participants
Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
|
Part B: Dabrafenib 150 mg + Trametinib 2 mg
Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
|
|---|---|---|---|---|
|
Part C (Randomized): Number of Participants With BRAF Mutant Metastatic Melanoma With Best Overall Response as Assessed by the Investigator
CR
|
2 Participants
|
6 Participants
|
10 Participants
|
—
|
|
Part C (Randomized): Number of Participants With BRAF Mutant Metastatic Melanoma With Best Overall Response as Assessed by the Investigator
PR
|
27 Participants
|
21 Participants
|
31 Participants
|
—
|
PRIMARY outcome
Timeframe: From the first dose of study medication to the first documented evidence of a confirmed complete response or partial response (up to approximately 19 months)Population: ITT Population
Best overall response is defined as complete response (CR: the disappearance of all target lesions. Any pathological lymph nodes must be \<10 mm in the short axis.) or partial reponse (PR: at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters \[e.g., percent change from Baseline\]). Participants with unknown or missing responses were considered as non-responders. To be assigned a status of PR or CR, a confirmatory disease assessment should have been performed no less than 28 days after the criteria for response were first met. Response was evaluated by BICR as per RECIST, version 1.1.
Outcome measures
| Measure |
Part A: Dabrafenib 75 mg
n=54 Participants
Participants received a single dose of dabrafenib 75 mg gelatin capsules alone on Day 1.
|
Part A: Dabrafenib 75 mg + Trametinib 2 mg
n=54 Participants
Participants received a single dose of dabrafenib 75 mg gelatin capsules with repeat dose trametinib (Day 15).
|
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg
n=54 Participants
Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
|
Part B: Dabrafenib 150 mg + Trametinib 2 mg
Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
|
|---|---|---|---|---|
|
Part C (Randomized): Number of Participants With BRAF Mutant Metastatic Melanoma With Best Overall Response Assessed by Blinded Independent Central Review (BICR)
CR
|
4 Participants
|
4 Participants
|
7 Participants
|
—
|
|
Part C (Randomized): Number of Participants With BRAF Mutant Metastatic Melanoma With Best Overall Response Assessed by Blinded Independent Central Review (BICR)
PR
|
21 Participants
|
18 Participants
|
26 Participants
|
—
|
PRIMARY outcome
Timeframe: From the first dose of study medication to the first documented evidence of a confirmed complete response or partial response (up to approximately 7 years)Population: Crossover Population: participants who were randomized to and received at least one dose of dabrafenib monotherapy, and who elected to crossover to combination therapy following disease progression while on monotherapy
Best overall response is defined as complete response (CR: the disappearance of all target lesions. Any pathological lymph nodes must be \<10 mm in the short axis.) or partial reponse (PR: at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters \[e.g., percent change from Baseline\]). Participants with unknown or missing responses were considered as non-responders. To be assigned a status of PR or CR, a confirmatory disease assessment should have been performed no less than 28 days after the criteria for response were first met. Response was evaluated by an investigator as per RECIST, version 1.1.
Outcome measures
| Measure |
Part A: Dabrafenib 75 mg
n=45 Participants
Participants received a single dose of dabrafenib 75 mg gelatin capsules alone on Day 1.
|
Part A: Dabrafenib 75 mg + Trametinib 2 mg
Participants received a single dose of dabrafenib 75 mg gelatin capsules with repeat dose trametinib (Day 15).
|
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg
Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
|
Part B: Dabrafenib 150 mg + Trametinib 2 mg
Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
|
|---|---|---|---|---|
|
Part C (Crossover): Number of Participants With BRAF Mutant Metastatic Melanoma With Best Overall Response as Assessed by the Investigator
CR
|
1 Participants
|
—
|
—
|
—
|
|
Part C (Crossover): Number of Participants With BRAF Mutant Metastatic Melanoma With Best Overall Response as Assessed by the Investigator
PR
|
5 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From the date of randomization to the earliest date of disease progression (PD) or death due to any cause (up to approximately 7 years)Population: ITT Population
PFS is defined as the interval between the date of randomization and the earliest date of PD or death due to any cause. PD was based on radiographic or photographic evidence, and assessments were made by the investigator according to RECIST, version 1.1. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g., percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5 mm. Participants who received anti-cancer therapy prior to the date of documented events, were censored at the last adequate assessment prior to the initiation of therapy. If the participant did not had a documented date of events, PFS and survival were censored at the date of the last adequate assessment.
Outcome measures
| Measure |
Part A: Dabrafenib 75 mg
n=54 Participants
Participants received a single dose of dabrafenib 75 mg gelatin capsules alone on Day 1.
|
Part A: Dabrafenib 75 mg + Trametinib 2 mg
n=54 Participants
Participants received a single dose of dabrafenib 75 mg gelatin capsules with repeat dose trametinib (Day 15).
|
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg
n=54 Participants
Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
|
Part B: Dabrafenib 150 mg + Trametinib 2 mg
Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
|
|---|---|---|---|---|
|
Part C (Randomized): Progression-free Survival (PFS) as Assessed by the Investigator
|
5.8 Months
Interval 4.3 to 7.4
|
9.2 Months
Interval 5.7 to 11.0
|
9.4 Months
Interval 7.6 to 16.6
|
—
|
PRIMARY outcome
Timeframe: From the first dose of study medication to the earliest date of disease progression (PD) or death due to any cause (up to approximately 7 years)Population: Crossover Population
PFS is defined as the interval between the first dose of study medication and the earliest date of PD or death due to any cause. PD was based on radiographic or photographic evidence, and assessments were made by the investigator according to RECIST, version 1.1. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g., percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5 mm. Participants received anti-cancer therapy prior to the date of documented events, and censored at the last adequate assessment, prior to the initiation of therapy. If the participant did not have a documented date of events, PFS and survival were censored at the date of the last adequate assessment.
Outcome measures
| Measure |
Part A: Dabrafenib 75 mg
n=45 Participants
Participants received a single dose of dabrafenib 75 mg gelatin capsules alone on Day 1.
|
Part A: Dabrafenib 75 mg + Trametinib 2 mg
Participants received a single dose of dabrafenib 75 mg gelatin capsules with repeat dose trametinib (Day 15).
|
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg
Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
|
Part B: Dabrafenib 150 mg + Trametinib 2 mg
Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
|
|---|---|---|---|---|
|
Part C (Crossover): Progression-free Survival (PFS) as Assessed by the Investigator
|
3.6 Months
Interval 1.8 to 3.9
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From the date of randomization to the earliest date of disease progression (PD) or death due to any cause (up to approximately 19 months)Population: ITT Population
PFS is defined as the interval between the date of randomization and the earliest date of PD or death due to any cause. PD was based on radiographic or photographic evidence, and assessments were made by the BICR according to RECIST, version 1.1. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g., percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5 mm. Participants who received anti-cancer therapy prior to the date of documented events, were censored at the last adequate assessment prior to the initiation of therapy. If the participant did not had a documented date of events, PFS and survival were censored at the date of the last adequate assessment
Outcome measures
| Measure |
Part A: Dabrafenib 75 mg
n=54 Participants
Participants received a single dose of dabrafenib 75 mg gelatin capsules alone on Day 1.
|
Part A: Dabrafenib 75 mg + Trametinib 2 mg
n=54 Participants
Participants received a single dose of dabrafenib 75 mg gelatin capsules with repeat dose trametinib (Day 15).
|
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg
n=54 Participants
Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
|
Part B: Dabrafenib 150 mg + Trametinib 2 mg
Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
|
|---|---|---|---|---|
|
Part C (Randomized): Progression-free Survival (PFS) as Assessed by the Blinded Independent Central Review (BICR)
|
7.3 Months
Interval 5.5 to 9.4
|
8.3 Months
Interval 5.6 to 11.3
|
9.2 Months
Interval 7.6 to
NA: Not estimable due to insufficient number of participants with events
|
—
|
PRIMARY outcome
Timeframe: First documented evidence of PR or CR until the date of the first documented sign of disease progression or the date of death due to any cause (up to approximately 19 months)Population: ITT Population. Only those participants who had a CR or PR were analyzed for duration of response.
Duration of response for participants with either a CR (the disappearance of all target lesions. Any pathological lymph nodes must be \<10 mm in the short axis.) or PR (at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters \[e.g., percent change from Baseline\]) is defined as the time from the first documented evidence of a PR or CR until the first documented sign of disease progression (PD) or death due to any cause. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g., percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5 mm.
Outcome measures
| Measure |
Part A: Dabrafenib 75 mg
n=54 Participants
Participants received a single dose of dabrafenib 75 mg gelatin capsules alone on Day 1.
|
Part A: Dabrafenib 75 mg + Trametinib 2 mg
n=54 Participants
Participants received a single dose of dabrafenib 75 mg gelatin capsules with repeat dose trametinib (Day 15).
|
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg
n=54 Participants
Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
|
Part B: Dabrafenib 150 mg + Trametinib 2 mg
Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
|
|---|---|---|---|---|
|
Part C (Randomized): Duration of Response as Assessed by the Investigator and Blinded Independent Central Review (BICR)
Investigator assessed
|
5.6 Months
Interval 3.9 to 7.4
|
11.1 Months
Interval 7.4 to 13.2
|
10.5 Months
Interval 7.4 to 19.2
|
—
|
|
Part C (Randomized): Duration of Response as Assessed by the Investigator and Blinded Independent Central Review (BICR)
BICR assessed
|
7.6 Months
Interval 4.7 to
NA: Not estimable due to insufficient number of participants with events
|
9.5 Months
Interval 5.6 to
NA: Not estimable due to insufficient number of participants with events
|
NA Months
Interval 6.7 to
NA: Not estimable due to insufficient number of participants with events
|
—
|
PRIMARY outcome
Timeframe: From Baseline (Day 1) until Follow-up visit (up to approximately 7 years)Population: ATP Population
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury.
Outcome measures
| Measure |
Part A: Dabrafenib 75 mg
n=53 Participants
Participants received a single dose of dabrafenib 75 mg gelatin capsules alone on Day 1.
|
Part A: Dabrafenib 75 mg + Trametinib 2 mg
n=54 Participants
Participants received a single dose of dabrafenib 75 mg gelatin capsules with repeat dose trametinib (Day 15).
|
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg
n=55 Participants
Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
|
Part B: Dabrafenib 150 mg + Trametinib 2 mg
Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
|
|---|---|---|---|---|
|
Part C (Randomized): Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)
Any AE
|
53 Participants
|
53 Participants
|
55 Participants
|
—
|
|
Part C (Randomized): Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)
Any SAE
|
15 Participants
|
24 Participants
|
39 Participants
|
—
|
PRIMARY outcome
Timeframe: From Baseline (Day 1) until Follow-up visit (up to approximately 7 years)Population: All Treated Participants (ATP) Population. Only participants with lab values at the specified planned time were considered.
Clinical Chemistry parameters were summarized according to National Cancer Institutes (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade, version 4.0. Grade 1, Mild; Grade 2, Moderate; Grade 3 (G3), Severe; Grade 4 (G4), Life-threatening or disabling; Grade 5, Death. Data are presented for only those parameters for which an increase to Grade 3 or Grade 4 occurred. Participants with missing Baseline Grade were assumed to have Baseline Grade of 0. All increases were an increase in grade from Baseline. Only descriptive analysis.
Outcome measures
| Measure |
Part A: Dabrafenib 75 mg
n=53 Participants
Participants received a single dose of dabrafenib 75 mg gelatin capsules alone on Day 1.
|
Part A: Dabrafenib 75 mg + Trametinib 2 mg
n=54 Participants
Participants received a single dose of dabrafenib 75 mg gelatin capsules with repeat dose trametinib (Day 15).
|
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg
n=55 Participants
Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
|
Part B: Dabrafenib 150 mg + Trametinib 2 mg
Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
|
|---|---|---|---|---|
|
Part C (Randomized): Number of Participants With Worst-case Chemistry Toxicity Grade Change From Baseline
Albumin · Increase to Grade 3
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
|
Part C (Randomized): Number of Participants With Worst-case Chemistry Toxicity Grade Change From Baseline
Glucose (Hypoglycemia) · Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part C (Randomized): Number of Participants With Worst-case Chemistry Toxicity Grade Change From Baseline
Potassium (Hypokalemia) · Increase to Grade 3
|
3 Participants
|
1 Participants
|
1 Participants
|
—
|
|
Part C (Randomized): Number of Participants With Worst-case Chemistry Toxicity Grade Change From Baseline
Albumin · Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part C (Randomized): Number of Participants With Worst-case Chemistry Toxicity Grade Change From Baseline
Alkaline Phosphatase · Increase to Grade 3
|
0 Participants
|
3 Participants
|
2 Participants
|
—
|
|
Part C (Randomized): Number of Participants With Worst-case Chemistry Toxicity Grade Change From Baseline
Alkaline Phosphatase · Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part C (Randomized): Number of Participants With Worst-case Chemistry Toxicity Grade Change From Baseline
Alanine Amino Transferase · Increase to Grade 3
|
0 Participants
|
2 Participants
|
2 Participants
|
—
|
|
Part C (Randomized): Number of Participants With Worst-case Chemistry Toxicity Grade Change From Baseline
Alanine Amino Transferase · Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part C (Randomized): Number of Participants With Worst-case Chemistry Toxicity Grade Change From Baseline
Aspartate Amino Transferase · Increase to Grade 3
|
0 Participants
|
1 Participants
|
3 Participants
|
—
|
|
Part C (Randomized): Number of Participants With Worst-case Chemistry Toxicity Grade Change From Baseline
Aspartate Amino Transferase · Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part C (Randomized): Number of Participants With Worst-case Chemistry Toxicity Grade Change From Baseline
Total Bilirubin · Increase to Grade 3
|
0 Participants
|
2 Participants
|
0 Participants
|
—
|
|
Part C (Randomized): Number of Participants With Worst-case Chemistry Toxicity Grade Change From Baseline
Total Bilirubin · Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part C (Randomized): Number of Participants With Worst-case Chemistry Toxicity Grade Change From Baseline
Calcium (Hypercalcemia) · Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part C (Randomized): Number of Participants With Worst-case Chemistry Toxicity Grade Change From Baseline
Calcium (Hypercalcemia) · Increase to Grade 4
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Part C (Randomized): Number of Participants With Worst-case Chemistry Toxicity Grade Change From Baseline
Calcium (Hypocalcemia) · Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part C (Randomized): Number of Participants With Worst-case Chemistry Toxicity Grade Change From Baseline
Calcium (Hypocalcemia) · Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part C (Randomized): Number of Participants With Worst-case Chemistry Toxicity Grade Change From Baseline
Cholesterol · Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part C (Randomized): Number of Participants With Worst-case Chemistry Toxicity Grade Change From Baseline
Cholesterol · Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part C (Randomized): Number of Participants With Worst-case Chemistry Toxicity Grade Change From Baseline
Creatine Kinase · Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part C (Randomized): Number of Participants With Worst-case Chemistry Toxicity Grade Change From Baseline
Creatine Kinase · Increase to Grade 4
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Part C (Randomized): Number of Participants With Worst-case Chemistry Toxicity Grade Change From Baseline
Creatinine · Increase to Grade 3
|
0 Participants
|
1 Participants
|
2 Participants
|
—
|
|
Part C (Randomized): Number of Participants With Worst-case Chemistry Toxicity Grade Change From Baseline
Creatinine · Increase to Grade 4
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Part C (Randomized): Number of Participants With Worst-case Chemistry Toxicity Grade Change From Baseline
Gamma Glutamyl Transferase · Increase to Grade 3
|
1 Participants
|
11 Participants
|
7 Participants
|
—
|
|
Part C (Randomized): Number of Participants With Worst-case Chemistry Toxicity Grade Change From Baseline
Gamma Glutamyl Transferase · Increase to Grade 4
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Part C (Randomized): Number of Participants With Worst-case Chemistry Toxicity Grade Change From Baseline
Glucose (Hyperglycemia) · Increase to Grade 3
|
1 Participants
|
4 Participants
|
6 Participants
|
—
|
|
Part C (Randomized): Number of Participants With Worst-case Chemistry Toxicity Grade Change From Baseline
Glucose (Hyperglycemia) · Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part C (Randomized): Number of Participants With Worst-case Chemistry Toxicity Grade Change From Baseline
Glucose (Hypoglycemia) · Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part C (Randomized): Number of Participants With Worst-case Chemistry Toxicity Grade Change From Baseline
Potassium (Hyperkalemia) · Increase to Grade 3
|
2 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Part C (Randomized): Number of Participants With Worst-case Chemistry Toxicity Grade Change From Baseline
Potassium (Hyperkalemia) · Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part C (Randomized): Number of Participants With Worst-case Chemistry Toxicity Grade Change From Baseline
Potassium (Hypokalemia) · Increase to Grade 4
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Part C (Randomized): Number of Participants With Worst-case Chemistry Toxicity Grade Change From Baseline
Magnesium (Hypermagnesemia) · Increase to Grade 3
|
0 Participants
|
2 Participants
|
1 Participants
|
—
|
|
Part C (Randomized): Number of Participants With Worst-case Chemistry Toxicity Grade Change From Baseline
Magnesium (Hypermagnesemia) · Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part C (Randomized): Number of Participants With Worst-case Chemistry Toxicity Grade Change From Baseline
Magnesium (Hypomagnesemia) · Increase to Grade 3
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Part C (Randomized): Number of Participants With Worst-case Chemistry Toxicity Grade Change From Baseline
Magnesium (Hypomagnesemia) · Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part C (Randomized): Number of Participants With Worst-case Chemistry Toxicity Grade Change From Baseline
Sodium (Hypernatremia) · Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part C (Randomized): Number of Participants With Worst-case Chemistry Toxicity Grade Change From Baseline
Sodium (Hypernatremia) · Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part C (Randomized): Number of Participants With Worst-case Chemistry Toxicity Grade Change From Baseline
Sodium (Hyponatremia) · Increase to Grade 3
|
0 Participants
|
10 Participants
|
6 Participants
|
—
|
|
Part C (Randomized): Number of Participants With Worst-case Chemistry Toxicity Grade Change From Baseline
Sodium (Hyponatremia) · Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part C (Randomized): Number of Participants With Worst-case Chemistry Toxicity Grade Change From Baseline
Phosphorus inorganic · Increase to Grade 3
|
0 Participants
|
6 Participants
|
4 Participants
|
—
|
|
Part C (Randomized): Number of Participants With Worst-case Chemistry Toxicity Grade Change From Baseline
Phosphorus inorganic · Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part C (Randomized): Number of Participants With Worst-case Chemistry Toxicity Grade Change From Baseline
Triglycerides · Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part C (Randomized): Number of Participants With Worst-case Chemistry Toxicity Grade Change From Baseline
Triglycerides · Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: From Baseline (Day 1) until Follow-up visit (up to approximately 7 years)Population: ATP Population. Only those participants who were available at the indicated time points were analyzed.
For Clinical Chemistry parameters that were not graded according to NCI CTCAE criteria, changes above (High) and below (Low) the normal range were evaluated. Participants with missing Baseline were assumed to be within normal range. Participants were counted twice if the subject "Decreased to Low" and Increase to High" during the post-baseline period. Only descriptive analysis.
Outcome measures
| Measure |
Part A: Dabrafenib 75 mg
n=53 Participants
Participants received a single dose of dabrafenib 75 mg gelatin capsules alone on Day 1.
|
Part A: Dabrafenib 75 mg + Trametinib 2 mg
n=54 Participants
Participants received a single dose of dabrafenib 75 mg gelatin capsules with repeat dose trametinib (Day 15).
|
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg
n=55 Participants
Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
|
Part B: Dabrafenib 150 mg + Trametinib 2 mg
Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
|
|---|---|---|---|---|
|
Part C (Randomized): Number of Participants With Worst-case Chemistry Change From Baseline With Respect to Normal Range
Direct Bilirubin · Decrease to Low
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part C (Randomized): Number of Participants With Worst-case Chemistry Change From Baseline With Respect to Normal Range
Carbon dioxide content/Bicarbonate · Increase to High
|
8 Participants
|
14 Participants
|
16 Participants
|
—
|
|
Part C (Randomized): Number of Participants With Worst-case Chemistry Change From Baseline With Respect to Normal Range
High Density Lipids, Cholesterol · Decrease to Low
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part C (Randomized): Number of Participants With Worst-case Chemistry Change From Baseline With Respect to Normal Range
High Density Lipids, Cholesterol · Increase to High
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part C (Randomized): Number of Participants With Worst-case Chemistry Change From Baseline With Respect to Normal Range
Lactate Dehydrogenase · Decrease to Low
|
2 Participants
|
3 Participants
|
2 Participants
|
—
|
|
Part C (Randomized): Number of Participants With Worst-case Chemistry Change From Baseline With Respect to Normal Range
Direct Bilirubin · Increase to High
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part C (Randomized): Number of Participants With Worst-case Chemistry Change From Baseline With Respect to Normal Range
Creatine Kinase MB mass · Decrease to Low
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part C (Randomized): Number of Participants With Worst-case Chemistry Change From Baseline With Respect to Normal Range
Creatine Kinase MB mass · Increase to High
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Part C (Randomized): Number of Participants With Worst-case Chemistry Change From Baseline With Respect to Normal Range
Chloride · Decrease to Low
|
7 Participants
|
24 Participants
|
24 Participants
|
—
|
|
Part C (Randomized): Number of Participants With Worst-case Chemistry Change From Baseline With Respect to Normal Range
Chloride · Increase to High
|
11 Participants
|
14 Participants
|
12 Participants
|
—
|
|
Part C (Randomized): Number of Participants With Worst-case Chemistry Change From Baseline With Respect to Normal Range
Carbon dioxide content/Bicarbonate · Decrease to Low
|
5 Participants
|
8 Participants
|
12 Participants
|
—
|
|
Part C (Randomized): Number of Participants With Worst-case Chemistry Change From Baseline With Respect to Normal Range
C-Reactive protein · Decrease to Low
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part C (Randomized): Number of Participants With Worst-case Chemistry Change From Baseline With Respect to Normal Range
C-Reactive protein · Increase to High
|
0 Participants
|
0 Participants
|
3 Participants
|
—
|
|
Part C (Randomized): Number of Participants With Worst-case Chemistry Change From Baseline With Respect to Normal Range
Creatinine Clearance · Decrease to Low
|
7 Participants
|
16 Participants
|
10 Participants
|
—
|
|
Part C (Randomized): Number of Participants With Worst-case Chemistry Change From Baseline With Respect to Normal Range
Creatinine Clearance · Increase to High
|
7 Participants
|
11 Participants
|
10 Participants
|
—
|
|
Part C (Randomized): Number of Participants With Worst-case Chemistry Change From Baseline With Respect to Normal Range
Lactate Dehydrogenase · Increase to High
|
3 Participants
|
24 Participants
|
32 Participants
|
—
|
|
Part C (Randomized): Number of Participants With Worst-case Chemistry Change From Baseline With Respect to Normal Range
Low Density Lipids, Cholesterol · Decrease to Low
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part C (Randomized): Number of Participants With Worst-case Chemistry Change From Baseline With Respect to Normal Range
Low Density Lipids, Cholesterol · Increase to High
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part C (Randomized): Number of Participants With Worst-case Chemistry Change From Baseline With Respect to Normal Range
Total Protein · Decrease to Low
|
4 Participants
|
10 Participants
|
19 Participants
|
—
|
|
Part C (Randomized): Number of Participants With Worst-case Chemistry Change From Baseline With Respect to Normal Range
Total Protein · Increase to High
|
1 Participants
|
8 Participants
|
3 Participants
|
—
|
|
Part C (Randomized): Number of Participants With Worst-case Chemistry Change From Baseline With Respect to Normal Range
Troponin I · Decrease to Low
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part C (Randomized): Number of Participants With Worst-case Chemistry Change From Baseline With Respect to Normal Range
Troponin I · Increase to High
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part C (Randomized): Number of Participants With Worst-case Chemistry Change From Baseline With Respect to Normal Range
Urea/BUN · Decrease to Low
|
5 Participants
|
4 Participants
|
9 Participants
|
—
|
|
Part C (Randomized): Number of Participants With Worst-case Chemistry Change From Baseline With Respect to Normal Range
Urea/BUN · Increase to High
|
8 Participants
|
23 Participants
|
20 Participants
|
—
|
PRIMARY outcome
Timeframe: From Baseline (Day 1) until Follow-up visit (up to approximately 7 years)Population: All Treated Participants (ATP) Population. Only participants with lab values at the specified planned time were considered.
Hematology parameters were summarized according to National Cancer Institutes (NCI) CTCAE grade, version 4.0. Grade 1, Mild; Grade 2, Moderate; Grade 3, Severe; Grade 4, Life-threatening or disabling; Grade 5, Death. Data are presented for only those parameters for which an increase Grade 3 or Grade 4 occurred. Participants with missing Baseline Grade were assumed to have Baseline Grade of 0. All increases were an increase in grade from Baseline. Only descriptive analysis.
Outcome measures
| Measure |
Part A: Dabrafenib 75 mg
n=53 Participants
Participants received a single dose of dabrafenib 75 mg gelatin capsules alone on Day 1.
|
Part A: Dabrafenib 75 mg + Trametinib 2 mg
n=54 Participants
Participants received a single dose of dabrafenib 75 mg gelatin capsules with repeat dose trametinib (Day 15).
|
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg
n=55 Participants
Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
|
Part B: Dabrafenib 150 mg + Trametinib 2 mg
Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
|
|---|---|---|---|---|
|
Part C (Randomized): Number of Participants With Worst-case Hematology Toxicity Grade Change From Baseline
Hemoglobin (Increased) · Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part C (Randomized): Number of Participants With Worst-case Hematology Toxicity Grade Change From Baseline
Hemoglobin (Increased) · Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part C (Randomized): Number of Participants With Worst-case Hematology Toxicity Grade Change From Baseline
Hemoglobin (Anemia) · Increase to Grade 3
|
0 Participants
|
4 Participants
|
2 Participants
|
—
|
|
Part C (Randomized): Number of Participants With Worst-case Hematology Toxicity Grade Change From Baseline
Hemoglobin (Anemia) · Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part C (Randomized): Number of Participants With Worst-case Hematology Toxicity Grade Change From Baseline
Lymphocytes (Increased) · Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part C (Randomized): Number of Participants With Worst-case Hematology Toxicity Grade Change From Baseline
Lymphocytes (Increased) · Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part C (Randomized): Number of Participants With Worst-case Hematology Toxicity Grade Change From Baseline
Lymphocytes (Decreased) · Increase to Grade 3
|
3 Participants
|
10 Participants
|
12 Participants
|
—
|
|
Part C (Randomized): Number of Participants With Worst-case Hematology Toxicity Grade Change From Baseline
Lymphocytes (Decreased) · Increase to Grade 4
|
0 Participants
|
1 Participants
|
3 Participants
|
—
|
|
Part C (Randomized): Number of Participants With Worst-case Hematology Toxicity Grade Change From Baseline
Total Neutrophils · Increase to Grade 3
|
1 Participants
|
2 Participants
|
4 Participants
|
—
|
|
Part C (Randomized): Number of Participants With Worst-case Hematology Toxicity Grade Change From Baseline
Total Neutrophils · Increase to Grade 4
|
0 Participants
|
0 Participants
|
4 Participants
|
—
|
|
Part C (Randomized): Number of Participants With Worst-case Hematology Toxicity Grade Change From Baseline
Platelet Count · Increase to Grade 3
|
0 Participants
|
2 Participants
|
3 Participants
|
—
|
|
Part C (Randomized): Number of Participants With Worst-case Hematology Toxicity Grade Change From Baseline
Platelet Count · Increase to Grade 4
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Part C (Randomized): Number of Participants With Worst-case Hematology Toxicity Grade Change From Baseline
White Blood Cell count · Increase to Grade 3
|
0 Participants
|
3 Participants
|
5 Participants
|
—
|
|
Part C (Randomized): Number of Participants With Worst-case Hematology Toxicity Grade Change From Baseline
White Blood Cell count · Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: From Baseline (Day 1) until Follow-up visit (up to approximately 7 years)Population: All Treated Participants (ATP) Population. Only participants with lab values at the specified planned time were considered.
For Hematology parameters that were not graded according to NCI CTCAE criteria, changes above (High) and below (Low) the normal range were evaluated. Participants with missing Baseline were assumed to be within normal range. Participants were counted twice if the subject "Decreased to Low" and Increase to High" during the post-baseline period. Only descriptive analysis.
Outcome measures
| Measure |
Part A: Dabrafenib 75 mg
n=53 Participants
Participants received a single dose of dabrafenib 75 mg gelatin capsules alone on Day 1.
|
Part A: Dabrafenib 75 mg + Trametinib 2 mg
n=54 Participants
Participants received a single dose of dabrafenib 75 mg gelatin capsules with repeat dose trametinib (Day 15).
|
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg
n=55 Participants
Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
|
Part B: Dabrafenib 150 mg + Trametinib 2 mg
Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
|
|---|---|---|---|---|
|
Part C (Randomized): Number of Participants With Worst-case Hematology Change From Baseline With Respect to Normal Range
Basophils · Decrease to Low
|
1 Participants
|
1 Participants
|
3 Participants
|
—
|
|
Part C (Randomized): Number of Participants With Worst-case Hematology Change From Baseline With Respect to Normal Range
Basophils · Increase to High
|
3 Participants
|
6 Participants
|
10 Participants
|
—
|
|
Part C (Randomized): Number of Participants With Worst-case Hematology Change From Baseline With Respect to Normal Range
Eosinophils · Decrease to Low
|
3 Participants
|
11 Participants
|
8 Participants
|
—
|
|
Part C (Randomized): Number of Participants With Worst-case Hematology Change From Baseline With Respect to Normal Range
Eosinophils · Increase to High
|
2 Participants
|
11 Participants
|
9 Participants
|
—
|
|
Part C (Randomized): Number of Participants With Worst-case Hematology Change From Baseline With Respect to Normal Range
Hematocrit · Decrease to Low
|
15 Participants
|
23 Participants
|
27 Participants
|
—
|
|
Part C (Randomized): Number of Participants With Worst-case Hematology Change From Baseline With Respect to Normal Range
Hematocrit · Increase to High
|
2 Participants
|
1 Participants
|
2 Participants
|
—
|
|
Part C (Randomized): Number of Participants With Worst-case Hematology Change From Baseline With Respect to Normal Range
Mean Corpuscle Hemoglobin concentration · Decrease to Low
|
11 Participants
|
16 Participants
|
12 Participants
|
—
|
|
Part C (Randomized): Number of Participants With Worst-case Hematology Change From Baseline With Respect to Normal Range
Mean Corpuscle Hemoglobin concentration · Increase to High
|
2 Participants
|
8 Participants
|
9 Participants
|
—
|
|
Part C (Randomized): Number of Participants With Worst-case Hematology Change From Baseline With Respect to Normal Range
Mean Corpuscle Hemoglobin · Decrease to Low
|
6 Participants
|
11 Participants
|
8 Participants
|
—
|
|
Part C (Randomized): Number of Participants With Worst-case Hematology Change From Baseline With Respect to Normal Range
Mean Corpuscle Hemoglobin · Increase to High
|
4 Participants
|
6 Participants
|
8 Participants
|
—
|
|
Part C (Randomized): Number of Participants With Worst-case Hematology Change From Baseline With Respect to Normal Range
Mean Corpuscle Volume · Decrease to Low
|
8 Participants
|
5 Participants
|
7 Participants
|
—
|
|
Part C (Randomized): Number of Participants With Worst-case Hematology Change From Baseline With Respect to Normal Range
Mean Corpuscle Volume · Increase to High
|
1 Participants
|
5 Participants
|
4 Participants
|
—
|
|
Part C (Randomized): Number of Participants With Worst-case Hematology Change From Baseline With Respect to Normal Range
Monocytes · Decrease to Low
|
5 Participants
|
14 Participants
|
12 Participants
|
—
|
|
Part C (Randomized): Number of Participants With Worst-case Hematology Change From Baseline With Respect to Normal Range
Monocytes · Increase to High
|
17 Participants
|
20 Participants
|
14 Participants
|
—
|
|
Part C (Randomized): Number of Participants With Worst-case Hematology Change From Baseline With Respect to Normal Range
Red Blood Cell count · Decrease to Low
|
11 Participants
|
22 Participants
|
25 Participants
|
—
|
|
Part C (Randomized): Number of Participants With Worst-case Hematology Change From Baseline With Respect to Normal Range
Red Blood Cell count · Increase to High
|
1 Participants
|
4 Participants
|
4 Participants
|
—
|
|
Part C (Randomized): Number of Participants With Worst-case Hematology Change From Baseline With Respect to Normal Range
Reticulocytes · Decrease to Low
|
0 Participants
|
1 Participants
|
2 Participants
|
—
|
|
Part C (Randomized): Number of Participants With Worst-case Hematology Change From Baseline With Respect to Normal Range
Reticulocytes · Increase to High
|
0 Participants
|
0 Participants
|
5 Participants
|
—
|
PRIMARY outcome
Timeframe: From Baseline (Day 1) until Follow-up visit (up to approximately 7 years)Population: ATP Population
Blood pressure were summarized according to National Cancer Institutes (NCI) CTCAE grade, version 4.0. Grade 1, Mild; Grade 2, Moderate; Grade 3 (G3), Severe; Grade 4 (G4), Life-threatening or disabling; Grade 5, Death. Data are presented for only those parameters for which an increase to G3 or G4 occurred.lood pressure measurement included systolic blood pressure (BP, milimeter of mercury \[mmHg\]) and diastolic BP (DBP). Worst case change from Baseline was calculated as the post-Baseline value minus the Baseline value. Heart Rate is the measure of heart beats per minute (bpm). Changes in heart rate, either decrease to \<60 bpm, change to normal or no change, or increase to \>100 bpm are presented.
Outcome measures
| Measure |
Part A: Dabrafenib 75 mg
n=53 Participants
Participants received a single dose of dabrafenib 75 mg gelatin capsules alone on Day 1.
|
Part A: Dabrafenib 75 mg + Trametinib 2 mg
n=54 Participants
Participants received a single dose of dabrafenib 75 mg gelatin capsules with repeat dose trametinib (Day 15).
|
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg
n=55 Participants
Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
|
Part B: Dabrafenib 150 mg + Trametinib 2 mg
Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
|
|---|---|---|---|---|
|
Part C (Randomized): Number of Participants With the Indicated Worst-case Change From Baseline in Heart Rate and Blood Pressure
Systolic BP (mmHg) , G3 or G4
|
5 Participants
|
4 Participants
|
12 Participants
|
—
|
|
Part C (Randomized): Number of Participants With the Indicated Worst-case Change From Baseline in Heart Rate and Blood Pressure
Diastolic BP (mmHg), G3 or G4
|
4 Participants
|
4 Participants
|
4 Participants
|
—
|
|
Part C (Randomized): Number of Participants With the Indicated Worst-case Change From Baseline in Heart Rate and Blood Pressure
Heart rate, Decrease to <60 bpm
|
9 Participants
|
8 Participants
|
11 Participants
|
—
|
|
Part C (Randomized): Number of Participants With the Indicated Worst-case Change From Baseline in Heart Rate and Blood Pressure
Heart rate, Change to normal or no change
|
34 Participants
|
30 Participants
|
28 Participants
|
—
|
|
Part C (Randomized): Number of Participants With the Indicated Worst-case Change From Baseline in Heart Rate and Blood Pressure
Heart rate, Increase to >100 bpm
|
10 Participants
|
16 Participants
|
18 Participants
|
—
|
PRIMARY outcome
Timeframe: Day 1 and Day 21Population: PK Population: all participants who received at least one dose of either dabrafenib or trametinib and for whom a PK sample was obtained and analyzed
The PK parameter Cmax was assessed. Blood samples for PK analysis of dabrafenib were obtained at pre-dose Day 1 and Day 21 pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 hours (24 hour on Day 1 only) post-dose administration. From the plasma concentration-time curve, the PK parameter tmax was determined by standard non-compartmental analysis using WinNonlin. Cmax data are reported as geometric least squares means.
Outcome measures
| Measure |
Part A: Dabrafenib 75 mg
n=15 Participants
Participants received a single dose of dabrafenib 75 mg gelatin capsules alone on Day 1.
|
Part A: Dabrafenib 75 mg + Trametinib 2 mg
n=14 Participants
Participants received a single dose of dabrafenib 75 mg gelatin capsules with repeat dose trametinib (Day 15).
|
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg
n=15 Participants
Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
|
Part B: Dabrafenib 150 mg + Trametinib 2 mg
n=15 Participants
Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
|
|---|---|---|---|---|
|
Part D (Analyte=GSK2118436): Maximum Plasma Concentration (Cmax) of a Single and Repeat Dose of Dabrafenib Alone and in Combination With Trametinib
Day 1
|
1117 ng/mL
Interval 914.0 to 1365.0
|
1669 ng/mL
Interval 1059.0 to 2631.0
|
1227 ng/mL
Interval 924.0 to 1764.0
|
2289 ng/mL
Interval 1622.0 to 3231.0
|
|
Part D (Analyte=GSK2118436): Maximum Plasma Concentration (Cmax) of a Single and Repeat Dose of Dabrafenib Alone and in Combination With Trametinib
Day 21
|
1050 ng/mL
Interval 811.0 to 1358.0
|
1746 ng/mL
Interval 1344.0 to 2269.0
|
1217 ng/mL
Interval 895.0 to 1654.0
|
2052 ng/mL
Interval 1472.0 to 2860.0
|
PRIMARY outcome
Timeframe: Day 1 and Day 21Population: PK Population. Only participants available at the indicated timepoints were analyzed.
tmax is defined as the time of occurenceof Cmax. Blood samples for PK analysis of dabrafenib were obtained at Day 1 and Day 21 pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 24 hours (24 hour on Day 1 only) post-dose administration. From the plasma concentration-time curve, the PK parameter tmax was determined by standard non-compartmental analysis using WinNonlin.
Outcome measures
| Measure |
Part A: Dabrafenib 75 mg
n=15 Participants
Participants received a single dose of dabrafenib 75 mg gelatin capsules alone on Day 1.
|
Part A: Dabrafenib 75 mg + Trametinib 2 mg
n=14 Participants
Participants received a single dose of dabrafenib 75 mg gelatin capsules with repeat dose trametinib (Day 15).
|
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg
n=15 Participants
Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
|
Part B: Dabrafenib 150 mg + Trametinib 2 mg
n=15 Participants
Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
|
|---|---|---|---|---|
|
Part D (Analyte=GSK2118436): Tmax of a Single and Repeat Dose of Dabrafenib Alone and in Combination With Trametinib
Day 1
|
2.00 Hours
Interval 1.0 to 3.0
|
2.00 Hours
Interval 1.0 to 6.0
|
2.00 Hours
Interval 1.0 to 3.0
|
1.50 Hours
Interval 1.0 to 10.0
|
|
Part D (Analyte=GSK2118436): Tmax of a Single and Repeat Dose of Dabrafenib Alone and in Combination With Trametinib
Day 21
|
1.50 Hours
Interval 1.0 to 2.0
|
1.55 Hours
Interval 0.98 to 3.0
|
1.75 Hours
Interval 1.0 to 3.0
|
1.50 Hours
Interval 1.0 to 3.0
|
PRIMARY outcome
Timeframe: Day 1 and Day 21Population: PK Population. Only participants available at the indicated timepoints were analyzed.
The PK parameters were determined for area under the concentration-time curve from time zero (pre-dose) to last time of quantifiable concentration AUC (0-tau) and from time zero (pre-dose) extrapolated to infinite time AUC (0-inf). Blood samples for PK analysis of the metabolites of dabrafenib were obtained at Day 1 and Day 21 pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 hours (24 hour only on Day 1) post-dose administration.
Outcome measures
| Measure |
Part A: Dabrafenib 75 mg
n=15 Participants
Participants received a single dose of dabrafenib 75 mg gelatin capsules alone on Day 1.
|
Part A: Dabrafenib 75 mg + Trametinib 2 mg
n=14 Participants
Participants received a single dose of dabrafenib 75 mg gelatin capsules with repeat dose trametinib (Day 15).
|
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg
n=15 Participants
Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
|
Part B: Dabrafenib 150 mg + Trametinib 2 mg
n=15 Participants
Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
|
|---|---|---|---|---|
|
Part D (Analyte=GSK2118436): AUC (0-tau) and AUC (0-inf) of Single and Repeat Doses of Dabrafenib Alone and in Combination With Trametinib
AUC (0-tau), Day 1
|
3593 ng*hr/mL
Interval 3008.0 to 4293.0
|
6507 ng*hr/mL
Interval 4288.0 to 9872.0
|
4618 ng*hr/mL
Interval 3525.0 to 6051.0
|
7331 ng*hr/mL
Interval 5355.0 to 10037.0
|
|
Part D (Analyte=GSK2118436): AUC (0-tau) and AUC (0-inf) of Single and Repeat Doses of Dabrafenib Alone and in Combination With Trametinib
AUC (0-tau), Day 21
|
3020 ng*hr/mL
Interval 2390.0 to 3816.0
|
4663 ng*hr/mL
Interval 3511.0 to 6194.0
|
3434 ng*hr/mL
Interval 2679.0 to 4403.0
|
5886 ng*hr/mL
Interval 4608.0 to 7517.0
|
|
Part D (Analyte=GSK2118436): AUC (0-tau) and AUC (0-inf) of Single and Repeat Doses of Dabrafenib Alone and in Combination With Trametinib
AUC (0-inf), Day 1
|
3982 ng*hr/mL
Interval 3325.0 to 4770.0
|
7291 ng*hr/mL
Interval 4830.0 to 11005.0
|
5321 ng*hr/mL
Interval 4192.0 to 6755.0
|
8152 ng*hr/mL
Interval 5860.0 to 11341.0
|
PRIMARY outcome
Timeframe: From Baseline (Day 1) until Follow-up visit (up to approximately 7 years)Population: ATP Population
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event for possible drug-induced liver injury.
Outcome measures
| Measure |
Part A: Dabrafenib 75 mg
n=15 Participants
Participants received a single dose of dabrafenib 75 mg gelatin capsules alone on Day 1.
|
Part A: Dabrafenib 75 mg + Trametinib 2 mg
n=15 Participants
Participants received a single dose of dabrafenib 75 mg gelatin capsules with repeat dose trametinib (Day 15).
|
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg
n=41 Participants
Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
|
Part B: Dabrafenib 150 mg + Trametinib 2 mg
n=39 Participants
Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
|
|---|---|---|---|---|
|
Part D: Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)
Any AE
|
15 Participants
|
15 Participants
|
41 Participants
|
38 Participants
|
|
Part D: Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)
Any SAE
|
8 Participants
|
11 Participants
|
29 Participants
|
30 Participants
|
PRIMARY outcome
Timeframe: From Baseline (Day 1) until Follow-up visit (up to approximately 7 years)Population: All Treated Participants (ATP) Population. Only participants with lab values at the specified planned time were considered.
Clinical Chemistry parameters were summarized according to National Cancer Institutes (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade, version 4.0. Grade 1, Mild; Grade 2, Moderate; Grade 3 (G3), Severe; Grade 4 (G4), Life-threatening or disabling; Grade 5, Death. Data are presented for only those parameters for which an increase to Grade 3 or Grade 4 occurred. Participants with missing Baseline Grade were assumed to have Baseline Grade of 0. All increases were an increase in grade from Baseline. Only descriptive analysis.
Outcome measures
| Measure |
Part A: Dabrafenib 75 mg
n=15 Participants
Participants received a single dose of dabrafenib 75 mg gelatin capsules alone on Day 1.
|
Part A: Dabrafenib 75 mg + Trametinib 2 mg
n=15 Participants
Participants received a single dose of dabrafenib 75 mg gelatin capsules with repeat dose trametinib (Day 15).
|
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg
n=41 Participants
Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
|
Part B: Dabrafenib 150 mg + Trametinib 2 mg
n=39 Participants
Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
|
|---|---|---|---|---|
|
Part D: Number of Participants With Worst-case Chemistry Toxicity Grade Change From Baseline
Magnesium (Hypermagnesemia) · Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part D: Number of Participants With Worst-case Chemistry Toxicity Grade Change From Baseline
Total Bilirubin · Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part D: Number of Participants With Worst-case Chemistry Toxicity Grade Change From Baseline
Calcium (Hypercalcemia) · Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Part D: Number of Participants With Worst-case Chemistry Toxicity Grade Change From Baseline
Albumin · Increase to Grade 3
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Part D: Number of Participants With Worst-case Chemistry Toxicity Grade Change From Baseline
Albumin · Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part D: Number of Participants With Worst-case Chemistry Toxicity Grade Change From Baseline
Alkaline Phosphatase · Increase to Grade 3
|
1 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
|
Part D: Number of Participants With Worst-case Chemistry Toxicity Grade Change From Baseline
Alkaline Phosphatase · Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part D: Number of Participants With Worst-case Chemistry Toxicity Grade Change From Baseline
Alanine Amino Transferase · Increase to Grade 3
|
2 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Part D: Number of Participants With Worst-case Chemistry Toxicity Grade Change From Baseline
Alanine Amino Transferase · Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part D: Number of Participants With Worst-case Chemistry Toxicity Grade Change From Baseline
Amylase · Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part D: Number of Participants With Worst-case Chemistry Toxicity Grade Change From Baseline
Amylase · Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part D: Number of Participants With Worst-case Chemistry Toxicity Grade Change From Baseline
Aspartate Amino Transferase · Increase to Grade 3
|
2 Participants
|
0 Participants
|
3 Participants
|
3 Participants
|
|
Part D: Number of Participants With Worst-case Chemistry Toxicity Grade Change From Baseline
Aspartate Amino Transferase · Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part D: Number of Participants With Worst-case Chemistry Toxicity Grade Change From Baseline
Total Bilirubin · Increase to Grade 3
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Part D: Number of Participants With Worst-case Chemistry Toxicity Grade Change From Baseline
Calcium (Hypercalcemia) · Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part D: Number of Participants With Worst-case Chemistry Toxicity Grade Change From Baseline
Calcium (Hypocalcemia) · Increase to Grade 3
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Part D: Number of Participants With Worst-case Chemistry Toxicity Grade Change From Baseline
Calcium (Hypocalcemia) · Increase to Grade 4
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Part D: Number of Participants With Worst-case Chemistry Toxicity Grade Change From Baseline
Cholesterol · Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part D: Number of Participants With Worst-case Chemistry Toxicity Grade Change From Baseline
Cholesterol · Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part D: Number of Participants With Worst-case Chemistry Toxicity Grade Change From Baseline
Creatine Kinase · Increase to Grade 3
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Part D: Number of Participants With Worst-case Chemistry Toxicity Grade Change From Baseline
Creatine Kinase · Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part D: Number of Participants With Worst-case Chemistry Toxicity Grade Change From Baseline
Creatinine · Increase to Grade 3
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Part D: Number of Participants With Worst-case Chemistry Toxicity Grade Change From Baseline
Creatinine · Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part D: Number of Participants With Worst-case Chemistry Toxicity Grade Change From Baseline
Gamma Glutamyl Transferase · Increase to Grade 3
|
3 Participants
|
1 Participants
|
6 Participants
|
5 Participants
|
|
Part D: Number of Participants With Worst-case Chemistry Toxicity Grade Change From Baseline
Gamma Glutamyl Transferase · Increase to Grade 4
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Part D: Number of Participants With Worst-case Chemistry Toxicity Grade Change From Baseline
Glucose (Hyperglycemia) · Increase to Grade 3
|
1 Participants
|
2 Participants
|
4 Participants
|
1 Participants
|
|
Part D: Number of Participants With Worst-case Chemistry Toxicity Grade Change From Baseline
Glucose (Hyperglycemia) · Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part D: Number of Participants With Worst-case Chemistry Toxicity Grade Change From Baseline
Glucose (Hypoglycemia) · Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part D: Number of Participants With Worst-case Chemistry Toxicity Grade Change From Baseline
Glucose (Hypoglycemia) · Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part D: Number of Participants With Worst-case Chemistry Toxicity Grade Change From Baseline
Potassium (Hyperkalemia) · Increase to Grade 3
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Part D: Number of Participants With Worst-case Chemistry Toxicity Grade Change From Baseline
Potassium (Hyperkalemia) · Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part D: Number of Participants With Worst-case Chemistry Toxicity Grade Change From Baseline
Potassium (Hypokalemia) · Increase to Grade 3
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Part D: Number of Participants With Worst-case Chemistry Toxicity Grade Change From Baseline
Potassium (Hypokalemia) · Increase to Grade 4
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Part D: Number of Participants With Worst-case Chemistry Toxicity Grade Change From Baseline
Lipase · Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part D: Number of Participants With Worst-case Chemistry Toxicity Grade Change From Baseline
Lipase · Increase to Grade 4
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Part D: Number of Participants With Worst-case Chemistry Toxicity Grade Change From Baseline
Magnesium (Hypermagnesemia) · Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part D: Number of Participants With Worst-case Chemistry Toxicity Grade Change From Baseline
Magnesium (Hypomagnesemia) · Increase to Grade 3
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Part D: Number of Participants With Worst-case Chemistry Toxicity Grade Change From Baseline
Magnesium (Hypomagnesemia) · Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part D: Number of Participants With Worst-case Chemistry Toxicity Grade Change From Baseline
Sodium (Hypernatremia) · Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part D: Number of Participants With Worst-case Chemistry Toxicity Grade Change From Baseline
Sodium (Hypernatremia) · Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part D: Number of Participants With Worst-case Chemistry Toxicity Grade Change From Baseline
Sodium (Hyponatremia) · Increase to Grade 3
|
1 Participants
|
4 Participants
|
5 Participants
|
5 Participants
|
|
Part D: Number of Participants With Worst-case Chemistry Toxicity Grade Change From Baseline
Sodium (Hyponatremia) · Increase to Grade 4
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Part D: Number of Participants With Worst-case Chemistry Toxicity Grade Change From Baseline
Phosphorus inorganic · Increase to Grade 3
|
0 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
|
Part D: Number of Participants With Worst-case Chemistry Toxicity Grade Change From Baseline
Phosphorus inorganic · Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part D: Number of Participants With Worst-case Chemistry Toxicity Grade Change From Baseline
Triglycerides · Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part D: Number of Participants With Worst-case Chemistry Toxicity Grade Change From Baseline
Triglycerides · Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part D: Number of Participants With Worst-case Chemistry Toxicity Grade Change From Baseline
Uric acid · Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part D: Number of Participants With Worst-case Chemistry Toxicity Grade Change From Baseline
Uric acid · Increase to Grade 4
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From Baseline (Day 1) until Follow-up visit (up to approximately 7 years)Population: All Treated Participants (ATP) Population. Only participants with lab values at the specified planned time were considered.
For Clinical Chemistry parameters that were not graded according to NCI CTCAE criteria, changes above (High) and below (Low) the normal range were evaluated. Participants with missing Baseline were assumed to be within normal range. Participants were counted twice if the subject "Decreased to Low" and Increase to High" during the post-baseline period. Only descriptive analysis.
Outcome measures
| Measure |
Part A: Dabrafenib 75 mg
n=15 Participants
Participants received a single dose of dabrafenib 75 mg gelatin capsules alone on Day 1.
|
Part A: Dabrafenib 75 mg + Trametinib 2 mg
n=15 Participants
Participants received a single dose of dabrafenib 75 mg gelatin capsules with repeat dose trametinib (Day 15).
|
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg
n=41 Participants
Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
|
Part B: Dabrafenib 150 mg + Trametinib 2 mg
n=39 Participants
Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
|
|---|---|---|---|---|
|
Part D: Number of Participants With Worst-case Chemistry Change From Baseline With Respect to Normal Range
Chloride · Increase to High
|
2 Participants
|
2 Participants
|
7 Participants
|
9 Participants
|
|
Part D: Number of Participants With Worst-case Chemistry Change From Baseline With Respect to Normal Range
High Density Lipids cholesterol · Decrease Low
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Part D: Number of Participants With Worst-case Chemistry Change From Baseline With Respect to Normal Range
High Density Lipids cholesterol · Increase to High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part D: Number of Participants With Worst-case Chemistry Change From Baseline With Respect to Normal Range
Low Density Lipids cholesterol · Increase to High
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Part D: Number of Participants With Worst-case Chemistry Change From Baseline With Respect to Normal Range
Total Protein · Decrease Low
|
5 Participants
|
7 Participants
|
17 Participants
|
15 Participants
|
|
Part D: Number of Participants With Worst-case Chemistry Change From Baseline With Respect to Normal Range
Total Protein · Increase to High
|
2 Participants
|
1 Participants
|
6 Participants
|
7 Participants
|
|
Part D: Number of Participants With Worst-case Chemistry Change From Baseline With Respect to Normal Range
Troponin I · Decrease Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part D: Number of Participants With Worst-case Chemistry Change From Baseline With Respect to Normal Range
Troponin I · Increase to High
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Part D: Number of Participants With Worst-case Chemistry Change From Baseline With Respect to Normal Range
Troponin T · Decrease Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part D: Number of Participants With Worst-case Chemistry Change From Baseline With Respect to Normal Range
Troponin T · Increase to High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part D: Number of Participants With Worst-case Chemistry Change From Baseline With Respect to Normal Range
Urea/BUN · Decrease Low
|
2 Participants
|
2 Participants
|
10 Participants
|
5 Participants
|
|
Part D: Number of Participants With Worst-case Chemistry Change From Baseline With Respect to Normal Range
Urea/BUN · Increase to High
|
4 Participants
|
5 Participants
|
12 Participants
|
13 Participants
|
|
Part D: Number of Participants With Worst-case Chemistry Change From Baseline With Respect to Normal Range
Chloride · Decrease Low
|
7 Participants
|
9 Participants
|
18 Participants
|
25 Participants
|
|
Part D: Number of Participants With Worst-case Chemistry Change From Baseline With Respect to Normal Range
Direct Bilirubin · Decrease Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part D: Number of Participants With Worst-case Chemistry Change From Baseline With Respect to Normal Range
Direct Bilirubin · Increase to High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part D: Number of Participants With Worst-case Chemistry Change From Baseline With Respect to Normal Range
Creatine Kinase MB mass · Decrease Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part D: Number of Participants With Worst-case Chemistry Change From Baseline With Respect to Normal Range
Creatine Kinase MB mass · Increase to High
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Part D: Number of Participants With Worst-case Chemistry Change From Baseline With Respect to Normal Range
Carbon dioxide content/Bicarbonate · Decrease Low
|
3 Participants
|
5 Participants
|
12 Participants
|
8 Participants
|
|
Part D: Number of Participants With Worst-case Chemistry Change From Baseline With Respect to Normal Range
Carbon dioxide content/Bicarbonate · Increase to High
|
4 Participants
|
3 Participants
|
12 Participants
|
10 Participants
|
|
Part D: Number of Participants With Worst-case Chemistry Change From Baseline With Respect to Normal Range
C-Reactive protein · Decrease Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part D: Number of Participants With Worst-case Chemistry Change From Baseline With Respect to Normal Range
C-Reactive protein · Increase to High
|
2 Participants
|
0 Participants
|
3 Participants
|
3 Participants
|
|
Part D: Number of Participants With Worst-case Chemistry Change From Baseline With Respect to Normal Range
Creatinine Clearance · Decrease Low
|
5 Participants
|
5 Participants
|
7 Participants
|
7 Participants
|
|
Part D: Number of Participants With Worst-case Chemistry Change From Baseline With Respect to Normal Range
Creatinine Clearance · Increase to High
|
2 Participants
|
1 Participants
|
11 Participants
|
4 Participants
|
|
Part D: Number of Participants With Worst-case Chemistry Change From Baseline With Respect to Normal Range
Lactate Dehydrogenase · Decrease Low
|
2 Participants
|
3 Participants
|
1 Participants
|
4 Participants
|
|
Part D: Number of Participants With Worst-case Chemistry Change From Baseline With Respect to Normal Range
Lactate Dehydrogenase · Increase to High
|
7 Participants
|
7 Participants
|
20 Participants
|
20 Participants
|
|
Part D: Number of Participants With Worst-case Chemistry Change From Baseline With Respect to Normal Range
Low Density Lipids cholesterol · Decrease Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From Baseline (Day 1) until Follow-up visit (up to approximately 7 years)Population: All Treated Participants (ATP) Population. Only participants with lab values at the specified planned time were considered.
Hematology parameters were summarized according to National Cancer Institutes (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade, version 4.0. Grade 1, Mild; Grade 2, Moderate; Grade 3 (G3), Severe; Grade 4 (G4), Life-threatening or disabling; Grade 5, Death. Data are presented for only those parameters for which an increase to Grade 3 or Grade 4 occurred. Participants with missing Baseline Grade were assumed to have Baseline Grade of 0. All increases were an increase in grade from Baseline. Only descriptive analysis.
Outcome measures
| Measure |
Part A: Dabrafenib 75 mg
n=15 Participants
Participants received a single dose of dabrafenib 75 mg gelatin capsules alone on Day 1.
|
Part A: Dabrafenib 75 mg + Trametinib 2 mg
n=15 Participants
Participants received a single dose of dabrafenib 75 mg gelatin capsules with repeat dose trametinib (Day 15).
|
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg
n=41 Participants
Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
|
Part B: Dabrafenib 150 mg + Trametinib 2 mg
n=39 Participants
Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
|
|---|---|---|---|---|
|
Part D: Number of Participants With Worst-case Hematology Toxicity Grade Change From Baseline
Total Neutrophils · Increase to Grade 4
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Part D: Number of Participants With Worst-case Hematology Toxicity Grade Change From Baseline
Hemoglobin (Increased) · Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part D: Number of Participants With Worst-case Hematology Toxicity Grade Change From Baseline
Hemoglobin (Increased) · Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part D: Number of Participants With Worst-case Hematology Toxicity Grade Change From Baseline
Hemoglobin (Anemia) · Increase to Grade 3
|
1 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
|
Part D: Number of Participants With Worst-case Hematology Toxicity Grade Change From Baseline
Hemoglobin (Anemia) · Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part D: Number of Participants With Worst-case Hematology Toxicity Grade Change From Baseline
Lymphocytes (Increased) · Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part D: Number of Participants With Worst-case Hematology Toxicity Grade Change From Baseline
Lymphocytes (Increased) · Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part D: Number of Participants With Worst-case Hematology Toxicity Grade Change From Baseline
Lymphocytes (Decreased) · Increase to Grade 3
|
1 Participants
|
3 Participants
|
11 Participants
|
11 Participants
|
|
Part D: Number of Participants With Worst-case Hematology Toxicity Grade Change From Baseline
Lymphocytes (Decreased) · Increase to Grade 4
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Part D: Number of Participants With Worst-case Hematology Toxicity Grade Change From Baseline
Total Neutrophils · Increase to Grade 3
|
0 Participants
|
1 Participants
|
2 Participants
|
4 Participants
|
|
Part D: Number of Participants With Worst-case Hematology Toxicity Grade Change From Baseline
Platelet count · Increase to Grade 3
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part D: Number of Participants With Worst-case Hematology Toxicity Grade Change From Baseline
Platelet count · Increase to Grade 4
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Part D: Number of Participants With Worst-case Hematology Toxicity Grade Change From Baseline
White Blood Cell count · Increase to Grade 3
|
0 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
|
Part D: Number of Participants With Worst-case Hematology Toxicity Grade Change From Baseline
White Blood Cell count · Increase to Grade 4
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From Baseline (Day 1) until Follow-up visit (up to approximately 7 years)Population: All Treated Participants (ATP) Population. Only participants with lab values at the specified planned time were considered.
For Hematology parameters that were not graded according to NCI CTCAE criteria, changes above (High) and below (Low) the normal range were evaluated. Participants with missing Baseline were assumed to be within normal range. Participants were counted twice if the subject "Decreased to Low" and Increase to High" during the post-baseline period. Only descriptive analysis.
Outcome measures
| Measure |
Part A: Dabrafenib 75 mg
n=15 Participants
Participants received a single dose of dabrafenib 75 mg gelatin capsules alone on Day 1.
|
Part A: Dabrafenib 75 mg + Trametinib 2 mg
n=15 Participants
Participants received a single dose of dabrafenib 75 mg gelatin capsules with repeat dose trametinib (Day 15).
|
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg
n=41 Participants
Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
|
Part B: Dabrafenib 150 mg + Trametinib 2 mg
n=39 Participants
Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
|
|---|---|---|---|---|
|
Part D: Number of Participants With Worst-case Hematology Change From Baseline With Respect to Normal Range
Basophils · Decrease to Low
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Part D: Number of Participants With Worst-case Hematology Change From Baseline With Respect to Normal Range
Basophils · Increase to High
|
1 Participants
|
2 Participants
|
8 Participants
|
2 Participants
|
|
Part D: Number of Participants With Worst-case Hematology Change From Baseline With Respect to Normal Range
Eosinophils · Decrease to Low
|
1 Participants
|
2 Participants
|
3 Participants
|
4 Participants
|
|
Part D: Number of Participants With Worst-case Hematology Change From Baseline With Respect to Normal Range
Eosinophils · Increase to High
|
4 Participants
|
2 Participants
|
6 Participants
|
5 Participants
|
|
Part D: Number of Participants With Worst-case Hematology Change From Baseline With Respect to Normal Range
Erythrocyte Sedimentation Rate · Decrease to Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part D: Number of Participants With Worst-case Hematology Change From Baseline With Respect to Normal Range
Erythrocyte Sedimentation Rate · Increase to High
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Part D: Number of Participants With Worst-case Hematology Change From Baseline With Respect to Normal Range
Hematocrit · Decrease to Low
|
4 Participants
|
10 Participants
|
19 Participants
|
18 Participants
|
|
Part D: Number of Participants With Worst-case Hematology Change From Baseline With Respect to Normal Range
Hematocrit · Increase to High
|
1 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
|
Part D: Number of Participants With Worst-case Hematology Change From Baseline With Respect to Normal Range
Mean Corpuscle Hemoglobin concentration · Decrease to Low
|
3 Participants
|
4 Participants
|
10 Participants
|
6 Participants
|
|
Part D: Number of Participants With Worst-case Hematology Change From Baseline With Respect to Normal Range
Mean Corpuscle Hemoglobin concentration · Increase to High
|
6 Participants
|
3 Participants
|
8 Participants
|
6 Participants
|
|
Part D: Number of Participants With Worst-case Hematology Change From Baseline With Respect to Normal Range
Mean Corpuscle Hemoglobin · Decrease to Low
|
1 Participants
|
4 Participants
|
7 Participants
|
6 Participants
|
|
Part D: Number of Participants With Worst-case Hematology Change From Baseline With Respect to Normal Range
Mean Corpuscle Hemoglobin · Increase to High
|
1 Participants
|
1 Participants
|
8 Participants
|
3 Participants
|
|
Part D: Number of Participants With Worst-case Hematology Change From Baseline With Respect to Normal Range
Mean Corpuscle Volume · Decrease to Low
|
2 Participants
|
4 Participants
|
5 Participants
|
9 Participants
|
|
Part D: Number of Participants With Worst-case Hematology Change From Baseline With Respect to Normal Range
Mean Corpuscle Volume · Increase to High
|
2 Participants
|
0 Participants
|
5 Participants
|
2 Participants
|
|
Part D: Number of Participants With Worst-case Hematology Change From Baseline With Respect to Normal Range
Monocytes · Decrease to Low
|
4 Participants
|
2 Participants
|
12 Participants
|
12 Participants
|
|
Part D: Number of Participants With Worst-case Hematology Change From Baseline With Respect to Normal Range
Monocytes · Increase to High
|
7 Participants
|
8 Participants
|
17 Participants
|
13 Participants
|
|
Part D: Number of Participants With Worst-case Hematology Change From Baseline With Respect to Normal Range
Red Blood Cell count · Decrease to Low
|
5 Participants
|
8 Participants
|
26 Participants
|
17 Participants
|
|
Part D: Number of Participants With Worst-case Hematology Change From Baseline With Respect to Normal Range
Red Blood Cell count · Increase to High
|
0 Participants
|
0 Participants
|
5 Participants
|
1 Participants
|
|
Part D: Number of Participants With Worst-case Hematology Change From Baseline With Respect to Normal Range
Reticulocytes · Decrease to Low
|
0 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
|
Part D: Number of Participants With Worst-case Hematology Change From Baseline With Respect to Normal Range
Reticulocytes · Increase to High
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: From Baseline (Day 1) until Follow-up visit (up to approximately 7 years)Population: ATP Population
Blood pressure were summarized according to National Cancer Institutes (NCI) CTCAE grade, version 4.0. Grade 1, Mild; Grade 2, Moderate; Grade 3 (G3), Severe; Grade 4 (G4), Life-threatening or disabling; Grade 5, Death. Data are presented for only those parameters for which an increase to G3 or G4 occurred.lood pressure measurement included systolic blood pressure (BP, milimeter of mercury \[mmHg\]) and diastolic BP (DBP). Worst case change from Baseline was calculated as the post-Baseline value minus the Baseline value. Heart Rate is the measure of heartbeats per minute (bpm). Changes in heart rate, either decrease to \<60 bpm, change to normal or no change, or increase to \>100 bpm are presented
Outcome measures
| Measure |
Part A: Dabrafenib 75 mg
n=15 Participants
Participants received a single dose of dabrafenib 75 mg gelatin capsules alone on Day 1.
|
Part A: Dabrafenib 75 mg + Trametinib 2 mg
n=15 Participants
Participants received a single dose of dabrafenib 75 mg gelatin capsules with repeat dose trametinib (Day 15).
|
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg
n=40 Participants
Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
|
Part B: Dabrafenib 150 mg + Trametinib 2 mg
n=39 Participants
Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
|
|---|---|---|---|---|
|
Part D: Number of Participants With the Indicated Worst-case Change From Baseline in Heart Rate and Blood Pressure
Heart rate, Decrease to <60 bpm
|
2 Participants
|
3 Participants
|
12 Participants
|
14 Participants
|
|
Part D: Number of Participants With the Indicated Worst-case Change From Baseline in Heart Rate and Blood Pressure
Heart rate, Change to normal or no change
|
9 Participants
|
8 Participants
|
18 Participants
|
17 Participants
|
|
Part D: Number of Participants With the Indicated Worst-case Change From Baseline in Heart Rate and Blood Pressure
Heart rate, Increase to >100 bpm
|
5 Participants
|
5 Participants
|
12 Participants
|
12 Participants
|
|
Part D: Number of Participants With the Indicated Worst-case Change From Baseline in Heart Rate and Blood Pressure
Systolic BP (mmHg) , increase to G3 or G4
|
3 Participants
|
1 Participants
|
5 Participants
|
6 Participants
|
|
Part D: Number of Participants With the Indicated Worst-case Change From Baseline in Heart Rate and Blood Pressure
Diastolic BP (mmHg), increase to G3 or G4
|
4 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Day 15 and Day 16Population: PK Population
The steady state plasma concentration (Css) of trametinib with concomitant dabrafenib administration was assessed at Day 15 and Day 16. At steady state the amount of drug administered (in a given time period) is equal to the amount of drug eliminated.
Outcome measures
| Measure |
Part A: Dabrafenib 75 mg
n=7 Participants
Participants received a single dose of dabrafenib 75 mg gelatin capsules alone on Day 1.
|
Part A: Dabrafenib 75 mg + Trametinib 2 mg
Participants received a single dose of dabrafenib 75 mg gelatin capsules with repeat dose trametinib (Day 15).
|
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg
Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
|
Part B: Dabrafenib 150 mg + Trametinib 2 mg
Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
|
|---|---|---|---|---|
|
Part A: Steady State Concentration of Trametinib With Concomitant Administration of Dabrafenib
Day 15
|
9.7 ng/mL
Interval 6.0 to 18.0
|
—
|
—
|
—
|
|
Part A: Steady State Concentration of Trametinib With Concomitant Administration of Dabrafenib
Day 16
|
10.2 ng/mL
Interval 6.0 to 17.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 15 and Day 21Population: PK Population. Only those participants who were available at the indicated time point were analyzed.
Area under the concentration-time curve from time zero (predose) until the last time of quantifiable concentration (AUC \[0-tau\]) was assessed. Blood samples for PK analysis of dabrafenib and its the metabolites hydroxy-dabrafenib (GSK2285403), carboxy-dabrafenib (GSK2298683) and desmethyl-dabrafenib (GSK2167542) were obtained at Day 15 pre-dose and Day 21 pre-dose and at 1, 2, 4, 6, and 8 hours post-dose administration.
Outcome measures
| Measure |
Part A: Dabrafenib 75 mg
n=6 Participants
Participants received a single dose of dabrafenib 75 mg gelatin capsules alone on Day 1.
|
Part A: Dabrafenib 75 mg + Trametinib 2 mg
n=8 Participants
Participants received a single dose of dabrafenib 75 mg gelatin capsules with repeat dose trametinib (Day 15).
|
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg
n=12 Participants
Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
|
Part B: Dabrafenib 150 mg + Trametinib 2 mg
n=8 Participants
Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
|
|---|---|---|---|---|
|
Part B: AUC [0-tau] of Dabrafenib (DAB) and Its Metabolite in Combination With Trametinib
GSK2298683 , Day 21
|
—
|
47911 ng*hr/mL
Interval 30643.0 to 74909.0
|
49939 ng*hr/mL
Interval 39219.0 to 63589.0
|
59965 ng*hr/mL
Interval 45117.0 to 79699.0
|
|
Part B: AUC [0-tau] of Dabrafenib (DAB) and Its Metabolite in Combination With Trametinib
GSK2167542, Day 15
|
2859 ng*hr/mL
Interval 1568.0 to 5216.0
|
2961 ng*hr/mL
Interval 1206.0 to 7270.0
|
4156 ng*hr/mL
Interval 2802.0 to 6165.0
|
3746 ng*hr/mL
Interval 1992.0 to 7043.0
|
|
Part B: AUC [0-tau] of Dabrafenib (DAB) and Its Metabolite in Combination With Trametinib
GSK2167542, Day 21
|
—
|
3609 ng*hr/mL
Interval 2279.0 to 5714.0
|
2995 ng*hr/mL
Interval 1891.0 to 4743.0
|
3961 ng*hr/mL
Interval 2361.0 to 6645.0
|
|
Part B: AUC [0-tau] of Dabrafenib (DAB) and Its Metabolite in Combination With Trametinib
GSK2285403, Day 15
|
2120 ng*hr/mL
Interval 1366.0 to 3290.0
|
2163 ng*hr/mL
Interval 1267.0 to 3694.0
|
3136 ng*hr/mL
Interval 2501.0 to 3932.0
|
3180 ng*hr/mL
Interval 1389.0 to 7283.0
|
|
Part B: AUC [0-tau] of Dabrafenib (DAB) and Its Metabolite in Combination With Trametinib
GSK2285403, Day 21
|
—
|
3257 ng*hr/mL
Interval 2162.0 to 4907.0
|
2989 ng*hr/mL
Interval 2545.0 to 3510.0
|
3632 ng*hr/mL
Interval 2364.0 to 5581.0
|
|
Part B: AUC [0-tau] of Dabrafenib (DAB) and Its Metabolite in Combination With Trametinib
GSK2298683, Day 15
|
37159 ng*hr/mL
Interval 22389.0 to 61673.0
|
40634 ng*hr/mL
Interval 30329.0 to 54441.0
|
43727 ng*hr/mL
Interval 31486.0 to 60727.0
|
68528 ng*hr/mL
Interval 42444.0 to 110642.0
|
|
Part B: AUC [0-tau] of Dabrafenib (DAB) and Its Metabolite in Combination With Trametinib
DAB, Day 15
|
2466 ng*hr/mL
Interval 1458.0 to 4171.0
|
3539 ng*hr/mL
Interval 1634.0 to 7666.0
|
5187 ng*hr/mL
Interval 3737.0 to 7199.0
|
4114 ng*hr/mL
Interval 1560.0 to 10848.0
|
|
Part B: AUC [0-tau] of Dabrafenib (DAB) and Its Metabolite in Combination With Trametinib
DAB, Day 21
|
—
|
4656 ng*hr/mL
Interval 3901.0 to 5557.0
|
4528 ng*hr/mL
Interval 3602.0 to 5692.0
|
5518 ng*hr/mL
Interval 3732.0 to 8158.0
|
SECONDARY outcome
Timeframe: Day 15 and Day 21Population: PK Population. Only those participants who were available at the indicated time points were analyzed.
Pre-dose (trough) concentration at the end of the dosing interval (Ctau) and maximum plasma concentration (Cmax) were assessed for plasma dabrafenib (DAB) following repeat dosing of DAB administered in combination with trametinib (T). The trough concentration is defined as the plasma level of a pharmaceutical product measured just before the next dose. Blood samples for PK analysis of the metabolites hydroxy-dabrafenib (GSK2285403), carboxy-dabrafenib (GSK2298683) and desmethyl-dabrafenib (GSK2167542) of dabrafenib were obtained at Day 15 pre-dose and Day 21 pre-dose and at 1, 2, 4, 6, and 8 hours post-dose administration.
Outcome measures
| Measure |
Part A: Dabrafenib 75 mg
n=6 Participants
Participants received a single dose of dabrafenib 75 mg gelatin capsules alone on Day 1.
|
Part A: Dabrafenib 75 mg + Trametinib 2 mg
n=8 Participants
Participants received a single dose of dabrafenib 75 mg gelatin capsules with repeat dose trametinib (Day 15).
|
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg
n=12 Participants
Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
|
Part B: Dabrafenib 150 mg + Trametinib 2 mg
n=8 Participants
Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
|
|---|---|---|---|---|
|
Part B: Pre-dose (Trough) Concentration at the End of the Dosing Interval (Ctau) and Maximum Plasma Concentration (Cmax) of Dabrafenib and Its Metabolite in Combination With Trametinib
DAB Cmax, Day 21
|
—
|
1263 ng/mL
Interval 863.0 to 1848.0
|
1346 ng/mL
Interval 997.0 to 1817.0
|
1391 ng/mL
Interval 1002.0 to 1932.0
|
|
Part B: Pre-dose (Trough) Concentration at the End of the Dosing Interval (Ctau) and Maximum Plasma Concentration (Cmax) of Dabrafenib and Its Metabolite in Combination With Trametinib
DAB Ctau, Day 15
|
59.8 ng/mL
Interval 19.1 to 187.0
|
44.6 ng/mL
Interval 17.1 to 117.0
|
115 ng/mL
Interval 27.8 to 472.0
|
73.7 ng/mL
Interval 10.3 to 528.0
|
|
Part B: Pre-dose (Trough) Concentration at the End of the Dosing Interval (Ctau) and Maximum Plasma Concentration (Cmax) of Dabrafenib and Its Metabolite in Combination With Trametinib
DAB Ctau, Day 21
|
—
|
185 ng/mL
Interval 79.7 to 428.0
|
102 ng/mL
Interval 57.1 to 184.0
|
79.9 ng/mL
Interval 32.2 to 198.0
|
|
Part B: Pre-dose (Trough) Concentration at the End of the Dosing Interval (Ctau) and Maximum Plasma Concentration (Cmax) of Dabrafenib and Its Metabolite in Combination With Trametinib
DAB Cmax, Day 15
|
640 ng/mL
Interval 390.0 to 1048.0
|
906 ng/mL
Interval 221.0 to 3717.0
|
1306 ng/mL
Interval 700.0 to 2437.0
|
1046 ng/mL
Interval 545.0 to 2011.0
|
|
Part B: Pre-dose (Trough) Concentration at the End of the Dosing Interval (Ctau) and Maximum Plasma Concentration (Cmax) of Dabrafenib and Its Metabolite in Combination With Trametinib
GSK2285403 Ctau, Day 15
|
72.9 ng/mL
Interval 25.2 to 211.0
|
47.8 ng/mL
Interval 20.2 to 113.0
|
97.9 ng/mL
Interval 32.2 to 297.0
|
74.4 ng/mL
Interval 15.7 to 353.0
|
|
Part B: Pre-dose (Trough) Concentration at the End of the Dosing Interval (Ctau) and Maximum Plasma Concentration (Cmax) of Dabrafenib and Its Metabolite in Combination With Trametinib
GSK2285403 Ctau, Day 21
|
—
|
136 ng/mL
Interval 62.4 to 299.0
|
92.9 ng/mL
Interval 60.2 to 143.0
|
82.7 ng/mL
Interval 37.6 to 182.0
|
|
Part B: Pre-dose (Trough) Concentration at the End of the Dosing Interval (Ctau) and Maximum Plasma Concentration (Cmax) of Dabrafenib and Its Metabolite in Combination With Trametinib
GSK2285403 Cmax, Day 15
|
399 ng/mL
Interval 265.0 to 601.0
|
418 ng/mL
Interval 146.0 to 1201.0
|
597 ng/mL
Interval 300.0 to 1186.0
|
630 ng/mL
Interval 411.0 to 964.0
|
|
Part B: Pre-dose (Trough) Concentration at the End of the Dosing Interval (Ctau) and Maximum Plasma Concentration (Cmax) of Dabrafenib and Its Metabolite in Combination With Trametinib
GSK2285403 Cmax, Day 21
|
—
|
775 ng/mL
Interval 441.0 to 1364.0
|
668 ng/mL
Interval 507.0 to 882.0
|
722 ng/mL
Interval 502.0 to 1039.0
|
|
Part B: Pre-dose (Trough) Concentration at the End of the Dosing Interval (Ctau) and Maximum Plasma Concentration (Cmax) of Dabrafenib and Its Metabolite in Combination With Trametinib
GSK2298683 Ctau, Day 15
|
2345 ng/mL
Interval 1237.0 to 4447.0
|
2360 ng/mL
Interval 1134.0 to 4911.0
|
2792 ng/mL
Interval 2069.0 to 3768.0
|
4372 ng/mL
Interval 2589.0 to 7384.0
|
|
Part B: Pre-dose (Trough) Concentration at the End of the Dosing Interval (Ctau) and Maximum Plasma Concentration (Cmax) of Dabrafenib and Its Metabolite in Combination With Trametinib
GSK2298683 Ctau, Day 21
|
—
|
2920 ng/mL
Interval 1674.0 to 5095.0
|
3221 ng/mL
Interval 2619.0 to 3962.0
|
3740 ng/mL
Interval 2564.0 to 5455.0
|
|
Part B: Pre-dose (Trough) Concentration at the End of the Dosing Interval (Ctau) and Maximum Plasma Concentration (Cmax) of Dabrafenib and Its Metabolite in Combination With Trametinib
GSK2298683 Cmax, Day 15
|
3757 ng/mL
Interval 2385.0 to 5916.0
|
4545 ng/mL
Interval 3817.0 to 5411.0
|
4636 ng/mL
Interval 3258.0 to 6598.0
|
7098 ng/mL
Interval 4914.0 to 10254.0
|
|
Part B: Pre-dose (Trough) Concentration at the End of the Dosing Interval (Ctau) and Maximum Plasma Concentration (Cmax) of Dabrafenib and Its Metabolite in Combination With Trametinib
GSK2298683 Cmax, Day 21
|
—
|
5301 ng/mL
Interval 3392.0 to 8286.0
|
5416 ng/mL
Interval 4163.0 to 7048.0
|
6257 ng/mL
Interval 4937.0 to 7931.0
|
|
Part B: Pre-dose (Trough) Concentration at the End of the Dosing Interval (Ctau) and Maximum Plasma Concentration (Cmax) of Dabrafenib and Its Metabolite in Combination With Trametinib
GSK2167542 Ctau, Day 15
|
257 ng/mL
Interval 140.0 to 473.0
|
249 ng/mL
Interval 79.4 to 782.0
|
331 ng/mL
Interval 185.0 to 590.0
|
318 ng/mL
Interval 260.0 to 389.0
|
|
Part B: Pre-dose (Trough) Concentration at the End of the Dosing Interval (Ctau) and Maximum Plasma Concentration (Cmax) of Dabrafenib and Its Metabolite in Combination With Trametinib
GSK2167542 Ctau, Day 21
|
—
|
196 ng/mL
Interval 90.8 to 425.0
|
248 ng/mL
Interval 140.0 to 439.0
|
369 ng/mL
Interval 191.0 to 714.0
|
|
Part B: Pre-dose (Trough) Concentration at the End of the Dosing Interval (Ctau) and Maximum Plasma Concentration (Cmax) of Dabrafenib and Its Metabolite in Combination With Trametinib
GSK2167542 Cmax, Day 15
|
300 ng/mL
Interval 157.0 to 572.0
|
355 ng/mL
Interval 114.0 to 1108.0
|
523 ng/mL
Interval 251.0 to 1091.0
|
460 ng/mL
Interval 190.0 to 1113.0
|
|
Part B: Pre-dose (Trough) Concentration at the End of the Dosing Interval (Ctau) and Maximum Plasma Concentration (Cmax) of Dabrafenib and Its Metabolite in Combination With Trametinib
GSK2167542 Cmax, Day 21
|
—
|
543 ng/mL
Interval 298.0 to 989.0
|
373 ng/mL
Interval 248.0 to 562.0
|
430 ng/mL
Interval 226.0 to 818.0
|
SECONDARY outcome
Timeframe: Day 15 and Day 21Population: PK Population. Only those participants who were available at the indicated time points were analyzed.
The tmax is defined as the time of occurenceof Cmax. Tha tmax was assessed for plasma dabrafenib (DAB) following repeat dosing of dabrafenib 75 and 150 mg BID administered in combination with trametinib. Blood samples for PK analysis of the metabolites hydroxy-dabrafenib (GSK2285403), carboxy-dabrafenib (GSK2298683) and desmethyl-dabrafenib (GSK2167542) of dabrafenib were obtained at Day 15 pre-dose and Day 21 pre-dose and at 1, 2, 4, 6, and 8 hours post-dose administration.
Outcome measures
| Measure |
Part A: Dabrafenib 75 mg
n=6 Participants
Participants received a single dose of dabrafenib 75 mg gelatin capsules alone on Day 1.
|
Part A: Dabrafenib 75 mg + Trametinib 2 mg
n=8 Participants
Participants received a single dose of dabrafenib 75 mg gelatin capsules with repeat dose trametinib (Day 15).
|
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg
n=12 Participants
Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
|
Part B: Dabrafenib 150 mg + Trametinib 2 mg
n=8 Participants
Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
|
|---|---|---|---|---|
|
Part B: Tmax of Dabrafenib and Its Metabolite in Combination With Trametinib
DAB Day 15
|
2.00 Hours
Interval 1.03 to 2.0
|
2.00 Hours
Interval 1.03 to 6.0
|
2.00 Hours
Interval 1.0 to 2.1
|
1.50 Hours
Interval 1.0 to 2.0
|
|
Part B: Tmax of Dabrafenib and Its Metabolite in Combination With Trametinib
DAB Day 21
|
—
|
1.54 Hours
Interval 1.0 to 2.0
|
1.53 Hours
Interval 1.0 to 2.03
|
2.04 Hours
Interval 1.0 to 4.03
|
|
Part B: Tmax of Dabrafenib and Its Metabolite in Combination With Trametinib
GSK2285403 Day 15
|
2.00 Hours
Interval 2.0 to 2.03
|
2.00 Hours
Interval 1.03 to 8.0
|
2.00 Hours
Interval 2.0 to 4.03
|
2.00 Hours
Interval 2.0 to 2.0
|
|
Part B: Tmax of Dabrafenib and Its Metabolite in Combination With Trametinib
GSK2285403 Day 21
|
—
|
1.97 Hours
Interval 0.0 to 2.0
|
2.00 Hours
Interval 1.0 to 2.03
|
2.07 Hours
Interval 1.0 to 6.0
|
|
Part B: Tmax of Dabrafenib and Its Metabolite in Combination With Trametinib
GSK2298683 Day 15
|
6.00 Hours
Interval 4.0 to 8.0
|
4.96 Hours
Interval 0.0 to 6.3
|
4.17 Hours
Interval 1.0 to 8.02
|
4.10 Hours
Interval 4.0 to 8.0
|
|
Part B: Tmax of Dabrafenib and Its Metabolite in Combination With Trametinib
GSK2298683 Day 21
|
—
|
4.00 Hours
Interval 1.0 to 6.0
|
4.00 Hours
Interval 1.0 to 6.0
|
4.02 Hours
Interval 2.0 to 8.07
|
|
Part B: Tmax of Dabrafenib and Its Metabolite in Combination With Trametinib
GSK2167542 Day 15
|
0.00 Hours
Interval 0.0 to 4.17
|
2.94 Hours
Interval 0.0 to 8.0
|
4.17 Hours
Interval 1.0 to 8.02
|
1.52 Hours
Interval 0.0 to 2.0
|
|
Part B: Tmax of Dabrafenib and Its Metabolite in Combination With Trametinib
GSK2167542 Day 21
|
—
|
2.00 Hours
Interval 1.0 to 2.32
|
1.01 Hours
Interval 0.0 to 8.0
|
1.50 Hours
Interval 0.0 to 8.15
|
SECONDARY outcome
Timeframe: Day 15 and Day 21Population: PK Population. Only those participants who were available at the indicated time points were analyzed.
AUC (0-tau) is defined as area under the concentration-time curve from time zero (pre-dose) to last time of quantifiable concentration. AUC (0-tau) was assessed for plasma trametinib following repeat dosing of trametinib in combination with dabrafenib. Blood samples for PK analysis of the metabolites of dabrafenib were obtained at Day 15 pre-dose and Day 21 pre-dose and at 1, 2, 4, 6, and 8 hours post-dose administration.
Outcome measures
| Measure |
Part A: Dabrafenib 75 mg
n=6 Participants
Participants received a single dose of dabrafenib 75 mg gelatin capsules alone on Day 1.
|
Part A: Dabrafenib 75 mg + Trametinib 2 mg
n=8 Participants
Participants received a single dose of dabrafenib 75 mg gelatin capsules with repeat dose trametinib (Day 15).
|
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg
n=12 Participants
Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
|
Part B: Dabrafenib 150 mg + Trametinib 2 mg
n=8 Participants
Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
|
|---|---|---|---|---|
|
Part B (Analyte=GSK1120212): AUC (0-tau) Assessment of Trametinib in Combination With Dabrafenib
Day 15
|
169 ng*hr/mL
Interval 113.0 to 252.0
|
147 ng*hr/mL
Interval 101.0 to 212.0
|
217 ng*hr/mL
Interval 139.0 to 338.0
|
394 ng*hr/mL
Interval 229.0 to 679.0
|
|
Part B (Analyte=GSK1120212): AUC (0-tau) Assessment of Trametinib in Combination With Dabrafenib
Day 21
|
—
|
169 ng*hr/mL
Interval 146.0 to 194.0
|
269 ng*hr/mL
Interval 238.0 to 304.0
|
351 ng*hr/mL
Interval 284.0 to 432.0
|
SECONDARY outcome
Timeframe: Day 15 and Day 21Population: PK Population. Only those participants who were available at the indicated time point were analyzed.
Pre-dose (trough) concentration at the end of the dosing interval (Ctau) and maximum plasma concentration (Cmax) were assessed for plasma trametinib following repeat dosing of trametinib in combination with dabrafenib. Blood samples for PK analysis of the metabolites of dabrafenib were obtained at Day 15 pre-dose or Day 21 pre-dose and at 1, 2, 4, 6, and 8 hours post-dose administration.
Outcome measures
| Measure |
Part A: Dabrafenib 75 mg
n=6 Participants
Participants received a single dose of dabrafenib 75 mg gelatin capsules alone on Day 1.
|
Part A: Dabrafenib 75 mg + Trametinib 2 mg
n=8 Participants
Participants received a single dose of dabrafenib 75 mg gelatin capsules with repeat dose trametinib (Day 15).
|
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg
n=12 Participants
Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
|
Part B: Dabrafenib 150 mg + Trametinib 2 mg
n=8 Participants
Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
|
|---|---|---|---|---|
|
Part B (Analyte=GSK1120212): Ctau and Cmax Assessments of Trametinib in Combination With Dabrafenib
Ctau, Day 15
|
5.56 ng/mL
Interval 3.74 to 8.28
|
5.05 ng/mL
Interval 3.81 to 6.69
|
7.62 ng/mL
Interval 5.38 to 10.8
|
12.4 ng/mL
Interval 6.5 to 23.6
|
|
Part B (Analyte=GSK1120212): Ctau and Cmax Assessments of Trametinib in Combination With Dabrafenib
Ctau, Day 21
|
—
|
5.57 ng/mL
Interval 4.8 to 6.45
|
8.51 ng/mL
Interval 7.65 to 9.48
|
10.8 ng/mL
Interval 8.75 to 13.3
|
|
Part B (Analyte=GSK1120212): Ctau and Cmax Assessments of Trametinib in Combination With Dabrafenib
Cmax, Day 15
|
10.2 ng/mL
Interval 7.18 to 14.4
|
8.08 ng/mL
Interval 5.06 to 12.9
|
11.5 ng/mL
Interval 6.16 to 21.5
|
22.4 ng/mL
Interval 14.0 to 35.6
|
|
Part B (Analyte=GSK1120212): Ctau and Cmax Assessments of Trametinib in Combination With Dabrafenib
Cmax, Day 21
|
—
|
10.2 ng/mL
Interval 8.5 to 12.1
|
18.0 ng/mL
Interval 14.9 to 21.7
|
22.6 ng/mL
Interval 18.1 to 28.2
|
SECONDARY outcome
Timeframe: Day 15 and Day 21Population: PK Population. Only those participants who were available at the indicated time point were analyzed.
The tmax is defined as the time of occurrence of Cmax. The PK parameter for tmax was assessed for plasma trametinib following repeat dosing of trametinib in combination with dabrafenib. Blood samples for PK analysis of the metabolites of dabrafenib were obtained at Day 15 pre-dose or Day 21 pre-dose and at 1, 2, 4, 6, and 8 hours post-dose administration.
Outcome measures
| Measure |
Part A: Dabrafenib 75 mg
n=6 Participants
Participants received a single dose of dabrafenib 75 mg gelatin capsules alone on Day 1.
|
Part A: Dabrafenib 75 mg + Trametinib 2 mg
n=8 Participants
Participants received a single dose of dabrafenib 75 mg gelatin capsules with repeat dose trametinib (Day 15).
|
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg
n=12 Participants
Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
|
Part B: Dabrafenib 150 mg + Trametinib 2 mg
n=8 Participants
Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
|
|---|---|---|---|---|
|
Part B (Analyte=GSK1120212): Tmax Assessment of Trametinib in Combination With Dabrafenib
Day 15
|
2.00 Hours
Interval 1.03 to 4.0
|
2.00 Hours
Interval 1.0 to 8.0
|
2.00 Hours
Interval 1.0 to 8.0
|
1.52 Hours
Interval 1.0 to 2.0
|
|
Part B (Analyte=GSK1120212): Tmax Assessment of Trametinib in Combination With Dabrafenib
Day 21
|
—
|
2.00 Hours
Interval 0.93 to 8.0
|
2.00 Hours
Interval 1.0 to 2.0
|
2.00 Hours
Interval 1.0 to 8.15
|
SECONDARY outcome
Timeframe: From the first dose of study medication to the first documented evidence of a confirmed complete response or partial response (up to approximately 8 years)Population: All Treated Population
Best overall response is defined as complete response (CR: the disappearance of all target lesions. Any pathological lymph nodes must be \<10 milimeter \[mm\] in the short axis.) or partial reponse (PR: at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters \[e.g., percent change from Baseline\]). Participants with unknown or missing response were considered as non-responders. To be assigned a status of PR or CR, a confirmatory disease assessment should have been performed no less than 28 days after the criteria for response were first met. Response was evaluated by an investigator as per Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1. BRAFi-naïve participants were those with BRAF-mutation-positive melanoma who had not received prior therapy with a BRAF inhibitor.
Outcome measures
| Measure |
Part A: Dabrafenib 75 mg
n=6 Participants
Participants received a single dose of dabrafenib 75 mg gelatin capsules alone on Day 1.
|
Part A: Dabrafenib 75 mg + Trametinib 2 mg
n=22 Participants
Participants received a single dose of dabrafenib 75 mg gelatin capsules with repeat dose trametinib (Day 15).
|
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg
n=25 Participants
Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
|
Part B: Dabrafenib 150 mg + Trametinib 2 mg
n=24 Participants
Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
|
|---|---|---|---|---|
|
Part B: Number of Participants With BRAFi-naïve Mutant Metastatic Melanoma With the Best Overall Response as Assessed by Investigator
CR
|
0 Participants
|
4 Participants
|
3 Participants
|
4 Participants
|
|
Part B: Number of Participants With BRAFi-naïve Mutant Metastatic Melanoma With the Best Overall Response as Assessed by Investigator
PR
|
4 Participants
|
10 Participants
|
8 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: First documented evidence of PR or CR until the earlier of date of disease progression or date of death due to any cause (up to approximately 8 years)Population: All Treated Population. Only those participants who had a CR or PR were analyzed.
Duration of response for participants with either a CR (the disappearance of all target lesions. Any pathological lymph nodes must be \<10 mm in the short axis.) or PR (at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters \[e.g., percent change from Baseline\]) is defined as the time from the first documented evidence of a PR or CR until the first documented sign of disease progression (PD) or death due to any cause. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g., percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5 mm. BRAFi-naïve participants were those with BRAF-mutation-positive melanoma who had not received prior therapy with a BRAF inhibitor.
Outcome measures
| Measure |
Part A: Dabrafenib 75 mg
n=6 Participants
Participants received a single dose of dabrafenib 75 mg gelatin capsules alone on Day 1.
|
Part A: Dabrafenib 75 mg + Trametinib 2 mg
n=22 Participants
Participants received a single dose of dabrafenib 75 mg gelatin capsules with repeat dose trametinib (Day 15).
|
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg
n=25 Participants
Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
|
Part B: Dabrafenib 150 mg + Trametinib 2 mg
n=24 Participants
Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
|
|---|---|---|---|---|
|
Part B: Duration of Response as Assessed by the Investigator in Participants With BRAFi-naïve Mutant Metastatic Melanoma
|
12.4 Months
Interval 3.7 to
NA: Not estimable due to insufficient number of participants with events
|
8.4 Months
Interval 3.9 to 27.4
|
12.6 Months
Interval 5.1 to
NA: Not estimable due to insufficient number of participants with events
|
16.9 Months
Interval 7.4 to
NA: Not estimable due to insufficient number of participants with events
|
SECONDARY outcome
Timeframe: From the date of first dose to the earliest date of disease progression (PD) or death due to any cause (up to approximately 8 years)Population: All Treated Population.
PFS is defined as the interval between the first dose of study medication and the earliest date of PD or death due to any cause. PD was based on radiographic or photographic evidence, and assessments were made by the investigator according to RECIST, version 1.1. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g., percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5 mm. BRAFi-naïve were the participants with BRAF-mutation positive melanoma who had not received prior therapy with a BRAF-inhibitor..
Outcome measures
| Measure |
Part A: Dabrafenib 75 mg
n=6 Participants
Participants received a single dose of dabrafenib 75 mg gelatin capsules alone on Day 1.
|
Part A: Dabrafenib 75 mg + Trametinib 2 mg
n=22 Participants
Participants received a single dose of dabrafenib 75 mg gelatin capsules with repeat dose trametinib (Day 15).
|
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg
n=25 Participants
Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
|
Part B: Dabrafenib 150 mg + Trametinib 2 mg
n=24 Participants
Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
|
|---|---|---|---|---|
|
Part B: Progression-free Survival (PFS) as Assessed by the Investigator in Participants With BRAFi-naïve Mutant Metastatic Melanoma
|
8.7 Months
Interval 3.4 to
NA: Not estimable due to insufficient number of participants with events
|
8.2 Months
Interval 4.3 to 11.0
|
5.4 Months
Interval 3.5 to 12.8
|
10.8 Months
Interval 3.6 to 18.6
|
SECONDARY outcome
Timeframe: From the date of first dose until date of death due to any cause (up to approximately 8 years)Population: All Treated Population.
OS is defined as the interval of time between the first dose of study medication until the date of death due to any cause. For the participants who did not die, overall survival was censored at the date of last contact.
Outcome measures
| Measure |
Part A: Dabrafenib 75 mg
n=6 Participants
Participants received a single dose of dabrafenib 75 mg gelatin capsules alone on Day 1.
|
Part A: Dabrafenib 75 mg + Trametinib 2 mg
n=22 Participants
Participants received a single dose of dabrafenib 75 mg gelatin capsules with repeat dose trametinib (Day 15).
|
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg
n=25 Participants
Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
|
Part B: Dabrafenib 150 mg + Trametinib 2 mg
n=24 Participants
Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
|
|---|---|---|---|---|
|
Part B: Overall Survival (OS) in BRAFi Naïve Melanoma Participants
|
17.4 Months
Interval 8.0 to
NA: Not estimable due to insufficient number of participants with events
|
23.5 Months
Interval 12.9 to 33.7
|
13.3 Months
Interval 6.3 to 23.4
|
41.5 Months
Interval 12.9 to
NA: Not estimable due to insufficient number of participants with events
|
SECONDARY outcome
Timeframe: Screening and at disease progression (up to approximately 8 years)Population: Biomarker Population: participants with H-score data for pre- and post-biopsy pairs
p-ERK and p-AKT, biomarkers in tumor biopsies, were assessed for participants with BRAF mutant colorectal cancer. The H-score, which is a composite score that comprises intensity and percentage of staining, is a method of assessing the amount of protein or phospho-protein present in a biopsy sample. The score is obtained by the formula: (3 \* percentage of strongly staining nuclei) + (2 \* percentage of moderately staining nuclei) + (percentage of weakly staining nuclei). The H-score ranges from 0 to 300, with a score of 0 representing the absence of any of the target protein and an H-score of 300 representing maximum staining and intensity of the target protein.
Outcome measures
| Measure |
Part A: Dabrafenib 75 mg
n=10 Participants
Participants received a single dose of dabrafenib 75 mg gelatin capsules alone on Day 1.
|
Part A: Dabrafenib 75 mg + Trametinib 2 mg
Participants received a single dose of dabrafenib 75 mg gelatin capsules with repeat dose trametinib (Day 15).
|
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg
Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
|
Part B: Dabrafenib 150 mg + Trametinib 2 mg
Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
|
|---|---|---|---|---|
|
Part B: Pre- and Post-dose H-scores for Individual Participants
p-AKT: Participant 1, pre-dose score
|
130 scores on a scale
|
—
|
—
|
—
|
|
Part B: Pre- and Post-dose H-scores for Individual Participants
p-AKT: Participant 5, pre-dose score
|
55 scores on a scale
|
—
|
—
|
—
|
|
Part B: Pre- and Post-dose H-scores for Individual Participants
p-AKT: Participant 7, pre-dose score
|
22 scores on a scale
|
—
|
—
|
—
|
|
Part B: Pre- and Post-dose H-scores for Individual Participants
p-AKT, Participant 7, post-dose score
|
7 scores on a scale
|
—
|
—
|
—
|
|
Part B: Pre- and Post-dose H-scores for Individual Participants
p-AKT, Participant 8, post-dose score
|
123 scores on a scale
|
—
|
—
|
—
|
|
Part B: Pre- and Post-dose H-scores for Individual Participants
p-AKT, Participant 9, post-dose score
|
289 scores on a scale
|
—
|
—
|
—
|
|
Part B: Pre- and Post-dose H-scores for Individual Participants
p-AKT: Participant 10, pre-dose score
|
73 scores on a scale
|
—
|
—
|
—
|
|
Part B: Pre- and Post-dose H-scores for Individual Participants
p-AKT, Participant 10, post-dose score
|
0 scores on a scale
|
—
|
—
|
—
|
|
Part B: Pre- and Post-dose H-scores for Individual Participants
p-ERK: Participant 1, pre-dose score
|
135 scores on a scale
|
—
|
—
|
—
|
|
Part B: Pre- and Post-dose H-scores for Individual Participants
p-ERK: Participant 1, post-dose score
|
109 scores on a scale
|
—
|
—
|
—
|
|
Part B: Pre- and Post-dose H-scores for Individual Participants
p-ERK: Participant 2, pre-dose score
|
193 scores on a scale
|
—
|
—
|
—
|
|
Part B: Pre- and Post-dose H-scores for Individual Participants
p-ERK: Participant 2, post-dose score
|
138 scores on a scale
|
—
|
—
|
—
|
|
Part B: Pre- and Post-dose H-scores for Individual Participants
p-ERK: Participant 3, pre-dose score
|
148 scores on a scale
|
—
|
—
|
—
|
|
Part B: Pre- and Post-dose H-scores for Individual Participants
p-ERK: Participant 3, post-dose score
|
65 scores on a scale
|
—
|
—
|
—
|
|
Part B: Pre- and Post-dose H-scores for Individual Participants
p-ERK: Participant 4, pre-dose score
|
80 scores on a scale
|
—
|
—
|
—
|
|
Part B: Pre- and Post-dose H-scores for Individual Participants
p-ERK: Participant 4, post-dose score
|
20 scores on a scale
|
—
|
—
|
—
|
|
Part B: Pre- and Post-dose H-scores for Individual Participants
p-ERK: Participant 8, post-dose score
|
75 scores on a scale
|
—
|
—
|
—
|
|
Part B: Pre- and Post-dose H-scores for Individual Participants
p-ERK: Participant 9, pre-dose score
|
164 scores on a scale
|
—
|
—
|
—
|
|
Part B: Pre- and Post-dose H-scores for Individual Participants
p-ERK: Participant 9, post-dose score
|
109 scores on a scale
|
—
|
—
|
—
|
|
Part B: Pre- and Post-dose H-scores for Individual Participants
p-ERK: Participant 10, pre-dose score
|
239 scores on a scale
|
—
|
—
|
—
|
|
Part B: Pre- and Post-dose H-scores for Individual Participants
p-ERK: Participant 10, post-dose score
|
78 scores on a scale
|
—
|
—
|
—
|
|
Part B: Pre- and Post-dose H-scores for Individual Participants
p-AKT, Participant 1, post-dose score
|
180 scores on a scale
|
—
|
—
|
—
|
|
Part B: Pre- and Post-dose H-scores for Individual Participants
p-AKT: Participant 2, pre-dose score
|
76 scores on a scale
|
—
|
—
|
—
|
|
Part B: Pre- and Post-dose H-scores for Individual Participants
p-AKT, Participant 2, post-dose score
|
50 scores on a scale
|
—
|
—
|
—
|
|
Part B: Pre- and Post-dose H-scores for Individual Participants
p-AKT: Participant 3, pre-dose score
|
192 scores on a scale
|
—
|
—
|
—
|
|
Part B: Pre- and Post-dose H-scores for Individual Participants
p-AKT, Participant 3, post-dose score
|
277 scores on a scale
|
—
|
—
|
—
|
|
Part B: Pre- and Post-dose H-scores for Individual Participants
p-AKT: Participant 4, pre-dose score
|
25 scores on a scale
|
—
|
—
|
—
|
|
Part B: Pre- and Post-dose H-scores for Individual Participants
p-AKT, Participant 4, post-dose score
|
135 scores on a scale
|
—
|
—
|
—
|
|
Part B: Pre- and Post-dose H-scores for Individual Participants
p-AKT, Participant 5, post-dose score
|
2 scores on a scale
|
—
|
—
|
—
|
|
Part B: Pre- and Post-dose H-scores for Individual Participants
p-AKT: Participant 6, pre-dose score
|
145 scores on a scale
|
—
|
—
|
—
|
|
Part B: Pre- and Post-dose H-scores for Individual Participants
p-AKT, Participant 6, post-dose score
|
20 scores on a scale
|
—
|
—
|
—
|
|
Part B: Pre- and Post-dose H-scores for Individual Participants
p-AKT: Participant 8, pre-dose score
|
183 scores on a scale
|
—
|
—
|
—
|
|
Part B: Pre- and Post-dose H-scores for Individual Participants
p-AKT: Participant 9, pre-dose score
|
278 scores on a scale
|
—
|
—
|
—
|
|
Part B: Pre- and Post-dose H-scores for Individual Participants
p-ERK: Participant 5, pre-dose score
|
130 scores on a scale
|
—
|
—
|
—
|
|
Part B: Pre- and Post-dose H-scores for Individual Participants
p-ERK: Participant 5, post-dose score
|
99 scores on a scale
|
—
|
—
|
—
|
|
Part B: Pre- and Post-dose H-scores for Individual Participants
p-ERK: Participant 6, pre-dose score
|
68 scores on a scale
|
—
|
—
|
—
|
|
Part B: Pre- and Post-dose H-scores for Individual Participants
p-ERK: Participant 6, post-dose score
|
7 scores on a scale
|
—
|
—
|
—
|
|
Part B: Pre- and Post-dose H-scores for Individual Participants
p-ERK: Participant 7, pre-dose score
|
128 scores on a scale
|
—
|
—
|
—
|
|
Part B: Pre- and Post-dose H-scores for Individual Participants
p-ERK: Participant 7, post-dose score
|
81 scores on a scale
|
—
|
—
|
—
|
|
Part B: Pre- and Post-dose H-scores for Individual Participants
p-ERK: Participant 8, pre-dose score
|
196 scores on a scale
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From the date of randomization until date of death due to any cause (up to approximately 7 years)Population: ITT Population
OS is defined as the interval of time between the date of randomization until the date of death due to any cause. For the participants who did not die, overall survival was censored at the date of last contact. When calculating overall survival, deaths following crossover were included.
Outcome measures
| Measure |
Part A: Dabrafenib 75 mg
n=54 Participants
Participants received a single dose of dabrafenib 75 mg gelatin capsules alone on Day 1.
|
Part A: Dabrafenib 75 mg + Trametinib 2 mg
n=54 Participants
Participants received a single dose of dabrafenib 75 mg gelatin capsules with repeat dose trametinib (Day 15).
|
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg
n=54 Participants
Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
|
Part B: Dabrafenib 150 mg + Trametinib 2 mg
Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
|
|---|---|---|---|---|
|
Part C (Randomized): Overall Survival (OS)
|
20.2 Months
Interval 14.0 to 27.1
|
18.7 Months
Interval 13.7 to 35.3
|
25.0 Months
Interval 17.5 to 36.5
|
—
|
SECONDARY outcome
Timeframe: Day 15, Week 8, Week 16, Week 24, Week 32, Week 40, Week 48, and Week 56Population: PK Population. Only those participants who were available at the indicated time points were analyzed.
Plasma concentrations of dabrafenib and its metabolites hydroxy-dabrafenib (GSK2285403), carboxy-dabrafenib (GSK2298683) and desmethyl-dabrafenib (GSK2167542) were assesed following daily dose of dabrafenib and trametinib.
Outcome measures
| Measure |
Part A: Dabrafenib 75 mg
n=49 Participants
Participants received a single dose of dabrafenib 75 mg gelatin capsules alone on Day 1.
|
Part A: Dabrafenib 75 mg + Trametinib 2 mg
n=53 Participants
Participants received a single dose of dabrafenib 75 mg gelatin capsules with repeat dose trametinib (Day 15).
|
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg
n=50 Participants
Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
|
Part B: Dabrafenib 150 mg + Trametinib 2 mg
Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
|
|---|---|---|---|---|
|
Part C: Plasma Concentrations of Dabrafenib and Its Metabolites
Week 8, GSK2118436
|
45.6 ng/mL
Interval 3.0 to 1841.0
|
69.8 ng/mL
Interval 0.0 to 946.0
|
50.5 ng/mL
Interval 0.0 to 1696.0
|
—
|
|
Part C: Plasma Concentrations of Dabrafenib and Its Metabolites
Week 32, GSK2118436
|
40.6 ng/mL
Interval 1.0 to 500.0
|
57.1 ng/mL
Interval 0.0 to 1424.0
|
66.4 ng/mL
Interval 0.0 to 2042.0
|
—
|
|
Part C: Plasma Concentrations of Dabrafenib and Its Metabolites
Week 16, GSK2285403
|
113.4 ng/mL
Interval 0.0 to 2090.0
|
81.9 ng/mL
Interval 0.0 to 995.0
|
114.7 ng/mL
Interval 3.0 to 2563.0
|
—
|
|
Part C: Plasma Concentrations of Dabrafenib and Its Metabolites
Week 24, GSK2285403
|
95.0 ng/mL
Interval 4.0 to 616.0
|
88.1 ng/mL
Interval 0.0 to 1689.0
|
130.2 ng/mL
Interval 9.0 to 529.0
|
—
|
|
Part C: Plasma Concentrations of Dabrafenib and Its Metabolites
Week 40, GSK2285403
|
263.8 ng/mL
Interval 7.0 to 693.0
|
143.5 ng/mL
Interval 16.0 to 870.0
|
136.2 ng/mL
Interval 0.0 to 1665.0
|
—
|
|
Part C: Plasma Concentrations of Dabrafenib and Its Metabolites
Week 48, GSK2285403
|
43.3 ng/mL
Interval 32.0 to 241.0
|
93.6 ng/mL
Interval 0.0 to 898.0
|
146.4 ng/mL
Interval 2.0 to 418.0
|
—
|
|
Part C: Plasma Concentrations of Dabrafenib and Its Metabolites
Week 56, GSK2285403
|
48.3 ng/mL
Interval 45.0 to 51.0
|
92.9 ng/mL
Interval 0.0 to 1841.0
|
141.5 ng/mL
Interval 7.0 to 755.0
|
—
|
|
Part C: Plasma Concentrations of Dabrafenib and Its Metabolites
Day 15, GSK2298683
|
3493 ng/mL
Interval 1381.0 to 16820.0
|
3043.3 ng/mL
Interval 199.0 to 8562.0
|
3145.8 ng/mL
Interval 428.0 to 16240.0
|
—
|
|
Part C: Plasma Concentrations of Dabrafenib and Its Metabolites
Week 8, GSK2298683
|
3149.7 ng/mL
Interval 238.0 to 13330.0
|
3238.4 ng/mL
Interval 20.0 to 7686.0
|
3010 ng/mL
Interval 31.0 to 13130.0
|
—
|
|
Part C: Plasma Concentrations of Dabrafenib and Its Metabolites
Week 16, GSK2298683
|
3497.9 ng/mL
Interval 21.0 to 9952.0
|
2946.1 ng/mL
Interval 0.0 to 8782.0
|
2756.5 ng/mL
Interval 44.0 to 14004.0
|
—
|
|
Part C: Plasma Concentrations of Dabrafenib and Its Metabolites
Week 24, GSK2298683
|
2876.5 ng/mL
Interval 500.0 to 8635.0
|
3365.4 ng/mL
Interval 25.0 to 7482.0
|
3193.7 ng/mL
Interval 133.0 to 6531.0
|
—
|
|
Part C: Plasma Concentrations of Dabrafenib and Its Metabolites
Week 48, GSK2298683
|
3554.9 ng/mL
Interval 1889.0 to 7148.0
|
4146.9 ng/mL
Interval 0.0 to 8351.0
|
3936.1 ng/mL
Interval 464.0 to 12239.0
|
—
|
|
Part C: Plasma Concentrations of Dabrafenib and Its Metabolites
Week 56, GSK2298683
|
2032.2 ng/mL
Interval 1102.0 to 2963.0
|
3843.5 ng/mL
Interval 374.0 to 6866.0
|
2904.9 ng/mL
Interval 1305.0 to 4673.0
|
—
|
|
Part C: Plasma Concentrations of Dabrafenib and Its Metabolites
Day 15, GSK2167542
|
247.9 ng/mL
Interval 95.0 to 955.0
|
288 ng/mL
Interval 49.0 to 1164.0
|
289.3 ng/mL
Interval 72.0 to 1140.0
|
—
|
|
Part C: Plasma Concentrations of Dabrafenib and Its Metabolites
Week 8, GSK2167542
|
239.5 ng/mL
Interval 19.0 to 1092.0
|
275.2 ng/mL
Interval 3.0 to 983.0
|
262.4 ng/mL
Interval 0.0 to 9876.0
|
—
|
|
Part C: Plasma Concentrations of Dabrafenib and Its Metabolites
Week 24, GSK2167542
|
225.6 ng/mL
Interval 48.0 to 899.0
|
247.2 ng/mL
Interval 4.0 to 990.0
|
254.6 ng/mL
Interval 3.0 to 846.0
|
—
|
|
Part C: Plasma Concentrations of Dabrafenib and Its Metabolites
Week 40, GSK2167542
|
222.2 ng/mL
Interval 95.0 to 639.0
|
249.3 ng/mL
Interval 55.0 to 674.0
|
268.9 ng/mL
Interval 0.0 to 910.0
|
—
|
|
Part C: Plasma Concentrations of Dabrafenib and Its Metabolites
Week 48, GSK2167542
|
204.5 ng/mL
Interval 145.0 to 286.0
|
232 ng/mL
Interval 0.0 to 915.0
|
260.9 ng/mL
Interval 81.0 to 886.0
|
—
|
|
Part C: Plasma Concentrations of Dabrafenib and Its Metabolites
Week 56, GSK2167542
|
171.8 ng/mL
Interval 116.0 to 228.0
|
250 ng/mL
Interval 28.0 to 851.0
|
462.1 ng/mL
Interval 107.0 to 663.0
|
—
|
|
Part C: Plasma Concentrations of Dabrafenib and Its Metabolites
Day 15, GSK2118436
|
59.3 ng/mL
Interval 9.0 to 2420.0
|
68.2 ng/mL
Interval 0.0 to 1555.0
|
66.3 ng/mL
Interval 7.0 to 1804.0
|
—
|
|
Part C: Plasma Concentrations of Dabrafenib and Its Metabolites
Week 16, GSK2118436
|
84.4 ng/mL
Interval 0.0 to 1865.0
|
66.7 ng/mL
Interval 0.0 to 1774.0
|
82.9 ng/mL
Interval 2.0 to 3033.0
|
—
|
|
Part C: Plasma Concentrations of Dabrafenib and Its Metabolites
Week 24, GSK2118436
|
66.3 ng/mL
Interval 4.0 to 594.0
|
66.2 ng/mL
Interval 1.0 to 2684.0
|
93.3 ng/mL
Interval 7.0 to 741.0
|
—
|
|
Part C: Plasma Concentrations of Dabrafenib and Its Metabolites
Week 40, GSK2118436
|
229 ng/mL
Interval 5.0 to 714.0
|
97.6 ng/mL
Interval 19.0 to 2597.0
|
150.9 ng/mL
Interval 0.0 to 1624.0
|
—
|
|
Part C: Plasma Concentrations of Dabrafenib and Its Metabolites
Week 48, GSK2118436
|
44.7 ng/mL
Interval 13.0 to 132.0
|
105.6 ng/mL
Interval 0.0 to 1322.0
|
107.7 ng/mL
Interval 3.0 to 806.0
|
—
|
|
Part C: Plasma Concentrations of Dabrafenib and Its Metabolites
Week 56, GSK2118436
|
46.4 ng/mL
Interval 25.0 to 68.0
|
44.5 ng/mL
Interval 0.0 to 6646.0
|
193.8 ng/mL
Interval 3.0 to 413.0
|
—
|
|
Part C: Plasma Concentrations of Dabrafenib and Its Metabolites
Day 15, GSK2285403
|
92.7 ng/mL
Interval 14.0 to 1337.0
|
71.8 ng/mL
Interval 2.0 to 1220.0
|
90.5 ng/mL
Interval 10.0 to 995.0
|
—
|
|
Part C: Plasma Concentrations of Dabrafenib and Its Metabolites
Week 8, GSK2285403
|
65.2 ng/mL
Interval 3.0 to 2041.0
|
80.4 ng/mL
Interval 0.0 to 769.0
|
90.6 ng/mL
Interval 0.0 to 757.0
|
—
|
|
Part C: Plasma Concentrations of Dabrafenib and Its Metabolites
Week 32, GSK2285403
|
62.5 ng/mL
Interval 3.0 to 890.0
|
86.7 ng/mL
Interval 0.0 to 808.0
|
87.4 ng/mL
Interval 0.0 to 973.0
|
—
|
|
Part C: Plasma Concentrations of Dabrafenib and Its Metabolites
Week 32, GSK2298683
|
2699.9 ng/mL
Interval 447.0 to 14341.0
|
3267.1 ng/mL
Interval 0.0 to 9278.0
|
3046.8 ng/mL
Interval 50.0 to 9077.0
|
—
|
|
Part C: Plasma Concentrations of Dabrafenib and Its Metabolites
Week 40, GSK2298683
|
4410.6 ng/mL
Interval 1023.0 to 14258.0
|
3694.7 ng/mL
Interval 1900.0 to 7663.0
|
3492.8 ng/mL
Interval 0.0 to 12550.0
|
—
|
|
Part C: Plasma Concentrations of Dabrafenib and Its Metabolites
Week 16, GSK2167542
|
244 ng/mL
Interval 1.0 to 772.0
|
204.4 ng/mL
Interval 0.0 to 922.0
|
243.8 ng/mL
Interval 3.0 to 1049.0
|
—
|
|
Part C: Plasma Concentrations of Dabrafenib and Its Metabolites
Week 32, GSK2167542
|
171 ng/mL
Interval 19.0 to 544.0
|
255.4 ng/mL
Interval 0.0 to 698.0
|
289.3 ng/mL
Interval 2.0 to 962.0
|
—
|
SECONDARY outcome
Timeframe: Day 15, Week 8, Week 16, Week 24, Week 32, Week 40, Week 48, and Week 56Population: PK Population. Only those participants who were available at the indicated time points were analyzed.
Plasma concentrations of trametinib was assessed following daily dose of dabrafenib and trametinib.
Outcome measures
| Measure |
Part A: Dabrafenib 75 mg
n=59 Participants
Participants received a single dose of dabrafenib 75 mg gelatin capsules alone on Day 1.
|
Part A: Dabrafenib 75 mg + Trametinib 2 mg
n=53 Participants
Participants received a single dose of dabrafenib 75 mg gelatin capsules with repeat dose trametinib (Day 15).
|
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg
n=50 Participants
Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
|
Part B: Dabrafenib 150 mg + Trametinib 2 mg
Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
|
|---|---|---|---|---|
|
Part C: Plasma Concentrations of Trametinib
Week 24
|
0 ng/mL
Interval 0.0 to 19.7
|
5.99 ng/mL
Interval 0.0 to 11.2
|
9.54 ng/mL
Interval 0.5 to 27.4
|
—
|
|
Part C: Plasma Concentrations of Trametinib
Day 15
|
0 ng/mL
Interval 0.0 to 0.0
|
5.86 ng/mL
Interval 3.4 to 11.3
|
9.35 ng/mL
Interval 4.8 to 26.0
|
—
|
|
Part C: Plasma Concentrations of Trametinib
Week 8
|
0 ng/mL
Interval 0.0 to 13.9
|
6.70 ng/mL
Interval 2.0 to 9.6
|
10.3 ng/mL
Interval 0.0 to 25.8
|
—
|
|
Part C: Plasma Concentrations of Trametinib
Week 16
|
0 ng/mL
Interval 0.0 to 9.8
|
6.99 ng/mL
Interval 0.0 to 20.7
|
9.87 ng/mL
Interval 1.1 to 25.4
|
—
|
|
Part C: Plasma Concentrations of Trametinib
Week 32
|
0 ng/mL
Interval 0.0 to 0.0
|
5.77 ng/mL
Interval 0.7 to 11.6
|
9.74 ng/mL
Interval 0.0 to 51.5
|
—
|
|
Part C: Plasma Concentrations of Trametinib
Week 40
|
0 ng/mL
Interval 0.0 to 0.0
|
7.11 ng/mL
Interval 2.2 to 16.7
|
10.1 ng/mL
Interval 0.0 to 26.4
|
—
|
|
Part C: Plasma Concentrations of Trametinib
Week 48
|
0 ng/mL
Interval 0.0 to 0.0
|
5.62 ng/mL
Interval 0.0 to 14.3
|
10.3 ng/mL
Interval 0.0 to 35.6
|
—
|
|
Part C: Plasma Concentrations of Trametinib
Week 56
|
0 ng/mL
Interval 0.0 to 0.0
|
9.90 ng/mL
Interval 3.4 to 16.9
|
8.60 ng/mL
Interval 0.0 to 15.4
|
—
|
SECONDARY outcome
Timeframe: Day 15, Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48Population: PK Population
Oral clearance (CL/F) of dabrafenib and trametinib were assessed using a population approach. Oral clearance (CL/F) is defined as the apparent volume of plasma in the vascular compartment cleared of drug per unit time by the processes of metabolism and excretion. For dabrafenib, population CL/F is defined as inducible and non-inducible CL/F. As dabrafenib induces its own metabolism, total oral clearance at steady state includes a non-induced (Day 1) component and an induced component, as estimated by a population PK model.
Outcome measures
| Measure |
Part A: Dabrafenib 75 mg
n=53 Participants
Participants received a single dose of dabrafenib 75 mg gelatin capsules alone on Day 1.
|
Part A: Dabrafenib 75 mg + Trametinib 2 mg
n=109 Participants
Participants received a single dose of dabrafenib 75 mg gelatin capsules with repeat dose trametinib (Day 15).
|
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg
Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
|
Part B: Dabrafenib 150 mg + Trametinib 2 mg
Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
|
|---|---|---|---|---|
|
Part C: Oral Clearance (CL/F) of Dabrafenib and Trametinib
Non-inducible
|
19.4 Liters per hour (L/hr)
Interval 17.6 to 21.2
|
5.07 Liters per hour (L/hr)
Interval 4.83 to 5.31
|
—
|
—
|
|
Part C: Oral Clearance (CL/F) of Dabrafenib and Trametinib
Inducible
|
20.0 Liters per hour (L/hr)
Interval 19.2 to 20.8
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 15, Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48Population: PK Population
Oral volume of distribution (V/F) of dabrafenib and trametinib were assessed using a population approach. Oral volume of distribution (V/F) is defined as the apparent volume of distribution in the central compartment.
Outcome measures
| Measure |
Part A: Dabrafenib 75 mg
n=53 Participants
Participants received a single dose of dabrafenib 75 mg gelatin capsules alone on Day 1.
|
Part A: Dabrafenib 75 mg + Trametinib 2 mg
n=109 Participants
Participants received a single dose of dabrafenib 75 mg gelatin capsules with repeat dose trametinib (Day 15).
|
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg
Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
|
Part B: Dabrafenib 150 mg + Trametinib 2 mg
Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
|
|---|---|---|---|---|
|
Part C: Oral Volume of Distribution (V/F) of Dabrafenib and Trametinib
|
80.8 Liters (L)
Interval 73.9 to 87.7
|
184 Liters (L)
Interval 158.0 to 210.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: pre-dose, and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 24 hours post dose. Day 21: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 10 hours post-dosePopulation: PK Population. Only participants who were available at the indicated timepoints were analyzed.
The maximum concentration (Cmax) of dabrafenib metabolites hydroxy-dabrafenib (GSK2285403), carboxy-dabrafenib (GSK2298683) and desmethyl-dabrafenib (GSK2167542) after single and repeat doses of DAB alone and in combination with trametinib was measured at Day 1 and Day 21.
Outcome measures
| Measure |
Part A: Dabrafenib 75 mg
n=15 Participants
Participants received a single dose of dabrafenib 75 mg gelatin capsules alone on Day 1.
|
Part A: Dabrafenib 75 mg + Trametinib 2 mg
n=14 Participants
Participants received a single dose of dabrafenib 75 mg gelatin capsules with repeat dose trametinib (Day 15).
|
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg
n=15 Participants
Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
|
Part B: Dabrafenib 150 mg + Trametinib 2 mg
n=15 Participants
Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
|
|---|---|---|---|---|
|
Part D: Cmax of Dabrafenib Metabolites
GSK2285403, Day 1
|
525 ng/mL
Interval 429.0 to 643.0
|
1055 ng/mL
Interval 705.0 to 1579.0
|
597 ng/mL
Interval 474.0 to 752.0
|
1363 ng/mL
Interval 300.0 to 2066.0
|
|
Part D: Cmax of Dabrafenib Metabolites
GSK2285403, Day 21
|
596 ng/mL
Interval 501.0 to 709.0
|
1203 ng/mL
Interval 906.0 to 1599.0
|
696 ng/mL
Interval 551.0 to 880.0
|
1120 ng/mL
Interval 725.0 to 1730.0
|
|
Part D: Cmax of Dabrafenib Metabolites
GSK2298683, Day 1
|
1475 ng/mL
Interval 1249.0 to 1741.0
|
2268 ng/mL
Interval 1595.0 to 3223.0
|
1478 ng/mL
Interval 1197.0 to 1824.0
|
2551 ng/mL
Interval 1756.0 to 3707.0
|
|
Part D: Cmax of Dabrafenib Metabolites
GSK2298683, Day 21
|
3637 ng/mL
Interval 3119.0 to 4242.0
|
6743 ng/mL
Interval 5133.0 to 8859.0
|
4158 ng/mL
Interval 3136.0 to 5514.0
|
6319 ng/mL
Interval 4725.0 to 8450.0
|
|
Part D: Cmax of Dabrafenib Metabolites
GSK2167542, Day 1
|
50.1 ng/mL
Interval 30.0 to 84.0
|
68.6 ng/mL
Interval 36.0 to 129.0
|
61.2 ng/mL
Interval 41.0 to 91.0
|
86.3 ng/mL
Interval 48.0 to 155.0
|
|
Part D: Cmax of Dabrafenib Metabolites
GSK2167542, Day 21
|
210 ng/mL
Interval 154.0 to 285.0
|
355 ng/mL
Interval 268.0 to 470.0
|
289 ng/mL
Interval 201.0 to 416.0
|
440 ng/mL
Interval 303.0 to 637.0
|
SECONDARY outcome
Timeframe: Day 1: pre-dose, and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 24 hours post dose. Day 21: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 10 hours post-dosePopulation: PK Population. Only participants who were available at the indicated timepoints were analyzed.
The time to Cmax (tmax) of DAB metabolites hydroxy-dabrafenib (GSK2285403), carboxy-dabrafenib (GSK2298683) and desmethyl-dabrafenib (GSK2167542) after single and repeat doses of DAB alone and in combination with trametinib was measuered at Day 1 and Day 21.
Outcome measures
| Measure |
Part A: Dabrafenib 75 mg
n=15 Participants
Participants received a single dose of dabrafenib 75 mg gelatin capsules alone on Day 1.
|
Part A: Dabrafenib 75 mg + Trametinib 2 mg
n=14 Participants
Participants received a single dose of dabrafenib 75 mg gelatin capsules with repeat dose trametinib (Day 15).
|
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg
n=15 Participants
Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
|
Part B: Dabrafenib 150 mg + Trametinib 2 mg
n=15 Participants
Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
|
|---|---|---|---|---|
|
Part D: Tmax of Dabrafenib Metabolites
GSK2285403, Day 1
|
3.00 Hours
Interval 1.5 to 4.0
|
3.51 Hours
Interval 2.0 to 6.18
|
3.00 Hours
Interval 2.0 to 6.02
|
2.07 Hours
Interval 1.5 to 10.0
|
|
Part D: Tmax of Dabrafenib Metabolites
GSK2285403, Day 21
|
2.00 Hours
Interval 1.5 to 3.0
|
2.00 Hours
Interval 1.42 to 3.0
|
2.00 Hours
Interval 1.47 to 4.0
|
2.00 Hours
Interval 1.0 to 3.98
|
|
Part D: Tmax of Dabrafenib Metabolites
GSK2298683, Day 1
|
10.0 Hours
Interval 5.98 to 10.1
|
8.93 Hours
Interval 4.0 to 24.0
|
10.0 Hours
Interval 6.0 to 24.0
|
8.00 Hours
Interval 4.07 to 24.0
|
|
Part D: Tmax of Dabrafenib Metabolites
GSK2298683, Day 21
|
5.00 Hours
Interval 3.0 to 8.0
|
4.00 Hours
Interval 3.0 to 6.0
|
5.98 Hours
Interval 2.0 to 10.0
|
4.00 Hours
Interval 3.0 to 6.08
|
|
Part D: Tmax of Dabrafenib Metabolites
GSK2167542, Day 1
|
24.0 Hours
Interval 8.0 to 24.1
|
24.0 Hours
Interval 6.0 to 24.6
|
24.0 Hours
Interval 23.5 to 25.0
|
24.0 Hours
Interval 10.0 to 24.3
|
|
Part D: Tmax of Dabrafenib Metabolites
GSK2167542, Day 21
|
0.75 Hours
Interval 0.0 to 10.0
|
2.00 Hours
Interval 0.5 to 10.0
|
2.00 Hours
Interval 1.0 to 10.0
|
1.75 Hours
Interval 0.0 to 9.92
|
SECONDARY outcome
Timeframe: Day 1: pre-dose, and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 24 hours post dose. Day 21: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 10 hours post-dosePopulation: PK Population. Only participants who were available at the indicated timepoints were analyzed.
Area under the concentration-time curve (AUC) from pre-dose to dosing interval (AUC\[0-tau\]), from pre-dose to the last time of quantifable concentration (AUC\[0-tau\]), and from pre-dose extrapolated to infinity (AUC\[0-inf\]) of DAB metabolites hydroxy-dabrafenib (GSK2285403), carboxy-dabrafenib (GSK2298683) and desmethyl-dabrafenib (GSK2167542) after single and repeat doses of DAB alone and in combination with trametinib was measured at Day 1 and Day 21.
Outcome measures
| Measure |
Part A: Dabrafenib 75 mg
n=15 Participants
Participants received a single dose of dabrafenib 75 mg gelatin capsules alone on Day 1.
|
Part A: Dabrafenib 75 mg + Trametinib 2 mg
n=14 Participants
Participants received a single dose of dabrafenib 75 mg gelatin capsules with repeat dose trametinib (Day 15).
|
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg
n=15 Participants
Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
|
Part B: Dabrafenib 150 mg + Trametinib 2 mg
n=15 Participants
Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
|
|---|---|---|---|---|
|
Part D: Area Under the Concentration-time Curve (AUC) of Dabrafenib Metabolites
GSK2285403, AUC(0-tau), Day 1
|
3134 ng*hr/mL
Interval 2533.0 to 3877.0
|
5950 ng*hr/mL
Interval 4045.0 to 8753.0
|
3694 ng*hr/mL
Interval 2903.0 to 4700.0
|
6524 ng*hr/mL
Interval 4520.0 to 9416.0
|
|
Part D: Area Under the Concentration-time Curve (AUC) of Dabrafenib Metabolites
GSK2285403, AUC(0-inf), Day 1
|
3963 ng*hr/mL
Interval 3147.0 to 4990.0
|
7415 ng*hr/mL
Interval 4991.0 to 11015.0
|
5026 ng*hr/mL
Interval 3934.0 to 6422.0
|
7907 ng*hr/mL
Interval 5434.0 to 11506.0
|
|
Part D: Area Under the Concentration-time Curve (AUC) of Dabrafenib Metabolites
GSK2285403, AUC (0-tau), Day 21
|
2568 ng*hr/mL
Interval 2099.0 to 3143.0
|
4262 ng*hr/mL
Interval 3007.0 to 6040.0
|
2919 ng*hr/mL
Interval 2296.0 to 3711.0
|
4216 ng*hr/mL
Interval 2986.0 to 5951.0
|
|
Part D: Area Under the Concentration-time Curve (AUC) of Dabrafenib Metabolites
GSK2298683, AUC, (0-tau), Day 1
|
10396 ng*hr/mL
Interval 8388.0 to 12885.0
|
15952 ng*hr/mL
Interval 10532.0 to 24160.0
|
9575 ng*hr/mL
Interval 7143.0 to 12835.0
|
20935 ng*hr/mL
Interval 12430.0 to 35259.0
|
|
Part D: Area Under the Concentration-time Curve (AUC) of Dabrafenib Metabolites
GSK2298683, AUC (0-t), Day 1
|
20047 ng*hr/mL
Interval 15384.0 to 26125.0
|
35206 ng*hr/mL
Interval 24970.0 to 49639.0
|
22692 ng*hr/mL
Interval 18398.0 to 27988.0
|
31666 ng*hr/mL
Interval 18474.0 to 54277.0
|
|
Part D: Area Under the Concentration-time Curve (AUC) of Dabrafenib Metabolites
GSK2298683, AUC (0-tau), Day 21
|
34283 ng*hr/mL
Interval 29189.0 to 40266.0
|
59340 ng*hr/mL
Interval 44595.0 to 78960.0
|
39672 ng*hr/mL
Interval 29504.0 to 53343.0
|
52712 ng*hr/mL
Interval 40084.0 to 69318.0
|
|
Part D: Area Under the Concentration-time Curve (AUC) of Dabrafenib Metabolites
GSK2167542, AUC(0-tau), Day 1
|
132 ng*hr/mL
Interval 79.0 to 219.0
|
190 ng*hr/mL
Interval 101.0 to 356.0
|
88.8 ng*hr/mL
Interval 56.0 to 139.0
|
354 ng*hr/mL
Interval 228.0 to 549.0
|
|
Part D: Area Under the Concentration-time Curve (AUC) of Dabrafenib Metabolites
GSK2167542, AUC(0-t) Day 1
|
500 ng*hr/mL
Interval 271.0 to 925.0
|
737 ng*hr/mL
Interval 385.0 to 1410.0
|
614 ng*hr/mL
Interval 415.0 to 906.0
|
1316 ng*hr/mL
Interval 824.0 to 2103.0
|
|
Part D: Area Under the Concentration-time Curve (AUC) of Dabrafenib Metabolites
GSK2167542, AUC(0-tau), Day 21
|
1775 ng*hr/mL
Interval 1225.0 to 2570.0
|
2707 ng*hr/mL
Interval 2106.0 to 3481.0
|
2508 ng*hr/mL
Interval 1793.0 to 3507.0
|
3632 ng*hr/mL
Interval 2529.0 to 5216.0
|
SECONDARY outcome
Timeframe: Day 1: pre-dose, and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 24 hours post dose. Day 21: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 10 hours post-dosePopulation: PK Population. Only participants who were available at the indicated timepoints were analyzed.
Cmax of trametinib after single and repeat dose in combination with DAB was observed at Day 1 and Day 21. Blood samples for PK analysis of dabrafenib were obtained at pre-dose Day 1 and Day 21 pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 hours (Day 1 only) post-dose administration. From the plasma concentration-time curve, the PK parameter tmax was determined by standard non-compartmental analysis using WinNonlin.Participants receiving DAB 75 mg to DAB 75 mg + Trametinib 2 mg and those receiving DAB 150 mg to DAB 150 mg + Trametinib 2 mg did not receive Trametinib until Day 29; therefore, Cmax was not analyzed in these participants at Days 1 and 21.
Outcome measures
| Measure |
Part A: Dabrafenib 75 mg
Participants received a single dose of dabrafenib 75 mg gelatin capsules alone on Day 1.
|
Part A: Dabrafenib 75 mg + Trametinib 2 mg
Participants received a single dose of dabrafenib 75 mg gelatin capsules with repeat dose trametinib (Day 15).
|
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg
n=15 Participants
Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
|
Part B: Dabrafenib 150 mg + Trametinib 2 mg
n=14 Participants
Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
|
|---|---|---|---|---|
|
Part D: Cmax Assessment of Trametinib
Day 1
|
—
|
—
|
6.8 ng/mL
Interval 5.0 to 10.0
|
6.6 ng/mL
Interval 4.0 to 10.0
|
|
Part D: Cmax Assessment of Trametinib
Day 21
|
—
|
—
|
24.1 ng/mL
Interval 20.0 to 29.0
|
22.6 ng/mL
Interval 20.0 to 26.0
|
SECONDARY outcome
Timeframe: Day 1: pre-dose, and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 24 hours post dose. Day 21: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 10 hours post-dosePopulation: PK Population. Only participants who were available at the indicated timepoints were analyzed.
The tmax of trametinib after single and repeat dose in combination with dabrafenib (DAB) was observed at Day 1 and Day 21. Blood samples for PK analysis of dabrafenib were obtained at pre-dose Day 1 and Day 21 pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 hours (Day 1 only) post-dose administration. From the plasma concentration-time curve, the PK parameter tmax was determined by standard non-compartmental analysis using WinNonlin.Participants receiving DAB 75 mg to DAB 75 mg + Trametinib 2 mg and those receiving DAB 150 mg to DAB 150 mg + Trametinib 2 mg did not receive Trametinib until Day 29; therefore, tmax was not analyzed in these participants at Days 1 and 21.
Outcome measures
| Measure |
Part A: Dabrafenib 75 mg
Participants received a single dose of dabrafenib 75 mg gelatin capsules alone on Day 1.
|
Part A: Dabrafenib 75 mg + Trametinib 2 mg
Participants received a single dose of dabrafenib 75 mg gelatin capsules with repeat dose trametinib (Day 15).
|
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg
n=15 Participants
Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
|
Part B: Dabrafenib 150 mg + Trametinib 2 mg
n=14 Participants
Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
|
|---|---|---|---|---|
|
Part D: Tmax Assessment of Trametinib
Day 1
|
—
|
—
|
2.00 Hours
Interval 1.0 to 3.0
|
1.50 Hours
Interval 1.0 to 8.0
|
|
Part D: Tmax Assessment of Trametinib
Day 21
|
—
|
—
|
2.00 Hours
Interval 1.0 to 4.0
|
2.00 Hours
Interval 1.5 to 3.98
|
SECONDARY outcome
Timeframe: Day 1: pre-dose, and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 24 hours post dose. Day 21: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 10 hours post-dosePopulation: PK Population. Only participants who were available at the indicated timepoints were analyzed.
AUC(0-tau) after single and repeat dose of teametinib alone and in combination with dabrafenib was observed at Day 1 and Day 21. Blood samples for PK analysis of dabrafenib were obtained at pre-dose Day 1 and Day 21 pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 hours (Day 1 only) post-dose administration. From the plasma concentration-time curve, the PK parameter tmax was determined by standard non-compartmental analysis using WinNonlin.Participants receiving DAB 75 mg to DAB 75 mg + Trametinib 2 mg and those receiving DAB 150 mg to DAB 150 mg + Trametinib 2 mg did not receive Trametinib until Day 29; therefore, AUC(0-tau) was not analyzed in these participants at Days 1 and 21.
Outcome measures
| Measure |
Part A: Dabrafenib 75 mg
Participants received a single dose of dabrafenib 75 mg gelatin capsules alone on Day 1.
|
Part A: Dabrafenib 75 mg + Trametinib 2 mg
Participants received a single dose of dabrafenib 75 mg gelatin capsules with repeat dose trametinib (Day 15).
|
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg
n=15 Participants
Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
|
Part B: Dabrafenib 150 mg + Trametinib 2 mg
n=14 Participants
Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
|
|---|---|---|---|---|
|
Part D: Area Under the Concentration-time Curve Assessment of Trametinib
Day 21
|
—
|
—
|
366 ng*h/mL
Interval 305.0 to 439.0
|
356 ng*h/mL
Interval 318.0 to 400.0
|
|
Part D: Area Under the Concentration-time Curve Assessment of Trametinib
Day 1
|
—
|
—
|
53.4 ng*h/mL
Interval 40.0 to 72.0
|
50.7 ng*h/mL
Interval 39.0 to 66.0
|
SECONDARY outcome
Timeframe: From the date of first dose of study medication to the first documented evidence of a confirmed complete response or partial response (up to approximately 7 years)Population: ITT Population
Best overall response is defined as complete response (CR: the disappearance of all target lesions. Any pathological lymph nodes must be \<10 milimeter \[mm\] in the short axis.) or partial reponse (PR: at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters \[e.g., percent change from Baseline\]). To be assigned a status of PR or CR, a confirmatory disease assessment should be performed no less than 28 days after the criteria for response are first met. Response was evaluated by an investigator as per Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1.
Outcome measures
| Measure |
Part A: Dabrafenib 75 mg
n=12 Participants
Participants received a single dose of dabrafenib 75 mg gelatin capsules alone on Day 1.
|
Part A: Dabrafenib 75 mg + Trametinib 2 mg
n=16 Participants
Participants received a single dose of dabrafenib 75 mg gelatin capsules with repeat dose trametinib (Day 15).
|
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg
n=43 Participants
Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
|
Part B: Dabrafenib 150 mg + Trametinib 2 mg
n=39 Participants
Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
|
|---|---|---|---|---|
|
Part D: Number of Participants With the Best Overall Response as Assessed by the Investigator in Participants
CR
|
0 Participants
|
2 Participants
|
5 Participants
|
7 Participants
|
|
Part D: Number of Participants With the Best Overall Response as Assessed by the Investigator in Participants
PR
|
8 Participants
|
10 Participants
|
28 Participants
|
21 Participants
|
SECONDARY outcome
Timeframe: First documented evidence of PR or CR until the earlier of date of disease progression or date of death due to any cause (up to approximately 7 years)Population: ITT Population. Only those participants who had CR or PR were considered.
Duration of response for participants with either a CR (the disappearance of all target lesions. Any pathological lymph nodes must be \<10 mm in the short axis.) or PR (at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters \[e.g., percent change from Baseline\]) is defined as the time from the first documented evidence of a PR or CR until the first documented sign of disease progression (PD) or death due to any cause. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g., percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5 mm.
Outcome measures
| Measure |
Part A: Dabrafenib 75 mg
n=12 Participants
Participants received a single dose of dabrafenib 75 mg gelatin capsules alone on Day 1.
|
Part A: Dabrafenib 75 mg + Trametinib 2 mg
n=16 Participants
Participants received a single dose of dabrafenib 75 mg gelatin capsules with repeat dose trametinib (Day 15).
|
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg
n=43 Participants
Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
|
Part B: Dabrafenib 150 mg + Trametinib 2 mg
n=39 Participants
Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
|
|---|---|---|---|---|
|
Part D: Duration of Response as Assessed by the Investigator
|
8.2 Months
Interval 3.5 to 14.8
|
10.1 Months
Interval 5.6 to
NA: Not estimable due to insufficient number of participants with events
|
5.9 Months
Interval 3.7 to 9.0
|
14.3 Months
Interval 8.8 to 67.8
|
SECONDARY outcome
Timeframe: From the date of randomization to the earliest date of disease progression (PD) or death due to any cause (up to approximately 7 years)Population: ITT Population
PFS is defined as the interval between the date of randomization and the earliest date of PD or death due to any cause. PD was based on radiographic or photographic evidence, and assessments were made by the investigator according to RECIST, version 1.1. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g., percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5 mm.
Outcome measures
| Measure |
Part A: Dabrafenib 75 mg
n=12 Participants
Participants received a single dose of dabrafenib 75 mg gelatin capsules alone on Day 1.
|
Part A: Dabrafenib 75 mg + Trametinib 2 mg
n=16 Participants
Participants received a single dose of dabrafenib 75 mg gelatin capsules with repeat dose trametinib (Day 15).
|
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg
n=43 Participants
Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
|
Part B: Dabrafenib 150 mg + Trametinib 2 mg
n=39 Participants
Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
|
|---|---|---|---|---|
|
Part D: Progression-free Survival (PFS) as Assessed by the Investigator
|
7.9 Months
Interval 3.4 to 11.4
|
9.3 Months
Interval 3.7 to 28.6
|
7.4 Months
Interval 5.6 to 10.7
|
11.1 Months
Interval 7.0 to 28.5
|
SECONDARY outcome
Timeframe: From the date of first dose until date of death due to any cause (up to approximately 7 years)Population: ITT Population
OS is defined as the interval of time between the date of randomization until the date of death due to any cause. For the participants who did not die, overall survival was censored at the date of last contact.
Outcome measures
| Measure |
Part A: Dabrafenib 75 mg
n=12 Participants
Participants received a single dose of dabrafenib 75 mg gelatin capsules alone on Day 1.
|
Part A: Dabrafenib 75 mg + Trametinib 2 mg
n=16 Participants
Participants received a single dose of dabrafenib 75 mg gelatin capsules with repeat dose trametinib (Day 15).
|
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg
n=43 Participants
Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
|
Part B: Dabrafenib 150 mg + Trametinib 2 mg
n=39 Participants
Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
|
|---|---|---|---|---|
|
Part D: Overall Survival (OS)
|
19.5 Months
Interval 12.4 to 28.0
|
15.5 Months
Interval 10.4 to 60.0
|
15.3 Months
Interval 13.0 to 37.2
|
40.3 Months
Interval 15.7 to 69.6
|
Adverse Events
Part A: Dabrafenib 75 mg + Trametinib 2 mg
Serious events: 5 serious events
Other events: 8 other events
Deaths: 2 deaths
Part B: Dabrafenib 75 mg + Trametinib 1 mg
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Part B: Dabrafenib 150 mg + Trametinib 1 mg
Serious events: 15 serious events
Other events: 23 other events
Deaths: 1 deaths
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg
Serious events: 14 serious events
Other events: 27 other events
Deaths: 6 deaths
Part B: Dabrafenib 150 mg + Trametinib 2 mg
Serious events: 55 serious events
Other events: 91 other events
Deaths: 12 deaths
Part C (Randomized): Dabrafenib 150 mg
Serious events: 15 serious events
Other events: 53 other events
Deaths: 1 deaths
Part C (Randomized): Dabrafenib 150 mg + Trametinib 1 mg
Serious events: 24 serious events
Other events: 53 other events
Deaths: 4 deaths
Part C (Randomized): Dabrafenib 150 mg + Trametinib 2 mg
Serious events: 39 serious events
Other events: 55 other events
Deaths: 7 deaths
Part C (Crossover): Dabrafenib 150 mg + Trametinib 2 mg
Serious events: 24 serious events
Other events: 44 other events
Deaths: 7 deaths
Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg
Serious events: 8 serious events
Other events: 15 other events
Deaths: 1 deaths
Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg
Serious events: 11 serious events
Other events: 15 other events
Deaths: 4 deaths
Part D: Dabrafenib 75 mg + Trametinib 2 mg
Serious events: 29 serious events
Other events: 41 other events
Deaths: 7 deaths
Part D: Dabrafenib 150 mg + Trametinib 2 mg
Serious events: 30 serious events
Other events: 37 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Part A: Dabrafenib 75 mg + Trametinib 2 mg
n=8 participants at risk
Participants received a single dose of dabrafenib 75 mg gelatin capsules with repeat dose trametinib (Day 15).
|
Part B: Dabrafenib 75 mg + Trametinib 1 mg
n=6 participants at risk
Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 75 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available pharmacokinetic (PK), safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on dose-limiting toxicities (DLTs) occurring during the first 3 weeks of treatment.
|
Part B: Dabrafenib 150 mg + Trametinib 1 mg
n=23 participants at risk
Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors and participants who had salivary ductal cancer received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
|
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg
n=27 participants at risk
Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
|
Part B: Dabrafenib 150 mg + Trametinib 2 mg
n=94 participants at risk
Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
|
Part C (Randomized): Dabrafenib 150 mg
n=53 participants at risk
Participants received dabrafenib 150 mg gelatin capsules BID.
|
Part C (Randomized): Dabrafenib 150 mg + Trametinib 1 mg
n=54 participants at risk
Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD.
|
Part C (Randomized): Dabrafenib 150 mg + Trametinib 2 mg
n=55 participants at risk
Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD.
|
Part C (Crossover): Dabrafenib 150 mg + Trametinib 2 mg
n=45 participants at risk
Participants who received dabrafenib 150 mg capsules BID alone in the Randomized Phase were given the opportunity to receive combination dosing of dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD upon disease progression with approval of the GlaxoSmithKline (GSK) Medical Monitor.
|
Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg
n=15 participants at risk
Participants received dabrefinib 75 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 75 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
|
Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg
n=15 participants at risk
Participants received dabrefinib 150 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 150 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
|
Part D: Dabrafenib 75 mg + Trametinib 2 mg
n=41 participants at risk
Participants received dabrefinib 75 mg HPMC capsules BID and trametinib 2 mg tablets QD.
|
Part D: Dabrafenib 150 mg + Trametinib 2 mg
n=39 participants at risk
Participants received dabrefinib 150 mg HPMC capsules BID and trametinib 2 mg tablets QD.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Appendicitis
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.3%
1/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.7%
1/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.2%
1/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.8%
1/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.7%
1/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.1%
1/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.8%
1/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.4%
1/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.2%
1/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.1%
1/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Gastrointestinal disorders
Nausea
|
25.0%
2/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.3%
1/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.7%
1/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.2%
3/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
5.6%
3/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.8%
1/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.4%
2/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.9%
2/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.6%
1/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Gastrointestinal disorders
Obstructive pancreatitis
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.2%
1/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.6%
1/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
12.5%
1/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.1%
1/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Gastrointestinal disorders
Vomiting
|
12.5%
1/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.3%
1/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.2%
3/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.4%
4/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.2%
1/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.9%
2/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.6%
1/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
General disorders
Asthenia
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
8.7%
2/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.7%
1/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.1%
1/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.4%
1/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.6%
1/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
General disorders
Chills
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
13.0%
3/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.4%
2/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
19.1%
18/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
13.0%
7/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
21.8%
12/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
11.1%
5/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
40.0%
6/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
33.3%
5/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
34.1%
14/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
38.5%
15/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
General disorders
Fatigue
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.7%
1/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.4%
1/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.6%
1/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
General disorders
Hernia
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.1%
1/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
General disorders
Influenza like illness
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.3%
1/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.7%
1/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.1%
1/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
13.3%
2/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.6%
1/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.9%
2/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
General disorders
Oedema peripheral
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.2%
1/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
General disorders
Pain
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.1%
1/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.8%
1/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.6%
1/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
General disorders
Peripheral swelling
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.3%
1/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
General disorders
Pyrexia
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
26.1%
6/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
22.2%
6/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
26.6%
25/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
18.5%
10/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
29.1%
16/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
15.6%
7/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
40.0%
6/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
40.0%
6/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
39.0%
16/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
41.0%
16/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Hepatobiliary disorders
Gallbladder enlargement
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.4%
1/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.1%
2/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Immune system disorders
Allergy to immunoglobulin therapy
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Immune system disorders
Cytokine release syndrome
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.7%
1/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.1%
1/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.8%
1/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.2%
1/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.4%
1/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
12.8%
5/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Immune system disorders
Sarcoidosis
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.6%
1/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Infections and infestations
Abdominal abscess
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.2%
1/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Infections and infestations
Abscess neck
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.1%
1/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.4%
1/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.6%
1/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Infections and infestations
Bacterial sepsis
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.4%
1/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Infections and infestations
Cardiac infection
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.8%
1/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Infections and infestations
Cellulitis
|
12.5%
1/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.8%
1/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.2%
1/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.4%
1/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Infections and infestations
Device related infection
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.6%
1/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Infections and infestations
Device related sepsis
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.1%
1/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.3%
1/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Infections and infestations
Endocarditis bacterial
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.8%
1/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Infections and infestations
Escherichia sepsis
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.8%
1/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.6%
1/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Infections and infestations
Hepatic infection
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.7%
1/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Infections and infestations
Influenza
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.8%
1/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Infections and infestations
Kidney infection
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.4%
1/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.8%
1/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.6%
1/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Infections and infestations
Pelvic infection
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.8%
1/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Infections and infestations
Peritonitis
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.1%
1/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.7%
1/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.7%
1/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.1%
1/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
5.5%
3/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.2%
1/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.4%
1/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
5.1%
2/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Infections and infestations
Pneumonia necrotising
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Infections and infestations
Prostate infection
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.2%
1/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Infections and infestations
Pseudomonal sepsis
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.8%
1/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Infections and infestations
Sepsis
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.8%
1/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.2%
1/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.4%
1/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.6%
1/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Infections and infestations
Skin infection
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Infections and infestations
Staphylococcal sepsis
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.8%
1/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Infections and infestations
Streptococcal infection
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Infections and infestations
Streptococcal sepsis
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.8%
1/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Infections and infestations
Systemic infection
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.1%
1/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.3%
1/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.1%
1/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.2%
1/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.4%
1/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.2%
1/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Infections and infestations
Viral infection
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.8%
1/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.6%
1/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Infections and infestations
Wound infection
|
12.5%
1/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.8%
1/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Infections and infestations
Wound infection staphylococcal
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.8%
1/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.8%
1/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.4%
1/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.6%
1/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.8%
1/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.2%
1/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Injury, poisoning and procedural complications
Wound haemorrhage
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.8%
1/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.1%
1/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
20.0%
3/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.6%
1/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.1%
1/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
20.0%
3/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.6%
1/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
20.0%
3/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.6%
1/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
13.3%
2/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Investigations
Blood calcium increased
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.2%
1/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.4%
1/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.1%
1/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.8%
1/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.2%
1/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.4%
1/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Investigations
Ejection fraction
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.7%
1/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
8.5%
8/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
5.6%
3/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.3%
4/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
11.1%
5/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.3%
3/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.7%
3/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
5.1%
2/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.1%
1/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.6%
1/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Investigations
Liver function test increased
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.6%
1/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.3%
1/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.6%
1/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Investigations
White blood cell count increased
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.4%
1/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.3%
1/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.4%
2/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.3%
4/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.6%
2/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.9%
2/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.7%
3/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.1%
2/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.4%
1/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.6%
1/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.1%
1/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.4%
1/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.4%
2/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.1%
1/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.8%
1/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.2%
1/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.1%
1/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.4%
1/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
5.1%
2/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.8%
1/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.4%
1/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.6%
1/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
12.5%
1/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.2%
1/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma pancreas
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
5.3%
5/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.8%
1/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
8.9%
4/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.7%
3/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bowen's disease
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.7%
1/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.1%
2/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.8%
2/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.8%
1/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.2%
1/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.6%
1/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.6%
1/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Clear cell renal cell carcinoma
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.8%
1/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal adenocarcinoma
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.6%
1/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intracranial tumour haemorrhage
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.6%
1/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Keratoacanthoma
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.8%
2/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lentigo maligna
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.3%
1/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lip squamous cell carcinoma
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.7%
1/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.8%
1/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant ascites
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.3%
1/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma in situ
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.6%
1/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to meninges
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.2%
1/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to spine
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.1%
1/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic squamous cell carcinoma
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.6%
1/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pericardial neoplasm
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.8%
1/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.7%
1/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.1%
1/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.6%
2/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.2%
1/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.6%
1/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of head and neck
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.1%
1/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
12.5%
1/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
13.0%
3/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
11.1%
3/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.1%
2/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
11.3%
6/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.6%
2/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
8.9%
4/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.9%
2/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
10.3%
4/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of the tongue
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.3%
1/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Superficial spreading melanoma stage unspecified
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.3%
1/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.6%
1/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.2%
1/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.4%
1/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Nervous system disorders
Brain stem haemorrhage
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.8%
1/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.8%
1/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Nervous system disorders
Cerebrospinal fluid leakage
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.8%
1/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.8%
1/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Nervous system disorders
Cervical cord compression
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Nervous system disorders
Chronic inflammatory demyelinating polyradiculoneuropathy
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.4%
1/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.4%
2/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.1%
2/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.2%
1/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.9%
2/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
5.1%
2/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Nervous system disorders
Facial paralysis
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.1%
1/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Nervous system disorders
Facial paresis
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Nervous system disorders
Focal dyscognitive seizures
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.4%
1/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Nervous system disorders
Haemorrhage intracranial
|
12.5%
1/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.8%
1/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.2%
1/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Nervous system disorders
Head discomfort
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.2%
1/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Nervous system disorders
Headache
|
12.5%
1/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.7%
1/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.2%
1/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.6%
1/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.3%
1/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.7%
1/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.4%
1/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Nervous system disorders
Intracranial pressure increased
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
16.7%
1/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Nervous system disorders
Multiple sclerosis relapse
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.1%
1/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Nervous system disorders
Parkinson's disease
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.8%
1/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Nervous system disorders
Partial seizures
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.1%
1/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.4%
2/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Nervous system disorders
Seizure
|
12.5%
1/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
16.7%
1/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.7%
1/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.1%
2/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.8%
1/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.4%
2/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Nervous system disorders
Sensory ganglionitis
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.3%
1/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Nervous system disorders
Syncope
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.3%
1/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.1%
2/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.3%
3/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.6%
1/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Nervous system disorders
Tremor
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.4%
1/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Psychiatric disorders
Completed suicide
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.4%
2/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.1%
1/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.2%
1/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.3%
3/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Psychiatric disorders
Mania
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Psychiatric disorders
Mental disorder
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.4%
1/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.7%
1/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.6%
1/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.7%
1/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.1%
2/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.6%
2/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.9%
2/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Renal and urinary disorders
Renal disorder
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.8%
1/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.8%
1/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.1%
2/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.1%
1/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.8%
1/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.4%
1/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive airways disorder
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.1%
1/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.8%
1/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.2%
1/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.6%
1/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.2%
1/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.8%
1/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.7%
1/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.1%
2/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
5.5%
3/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.2%
1/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.9%
2/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.8%
1/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Respiratory, thoracic and mediastinal disorders
Upper airway obstruction
|
12.5%
1/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.2%
1/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Skin and subcutaneous tissue disorders
Granulomatous dermatitis
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.3%
1/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.8%
1/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.6%
1/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.4%
1/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.1%
1/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.6%
1/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.2%
1/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.3%
1/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.2%
1/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Vascular disorders
Hypotension
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.3%
1/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
11.1%
3/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.4%
7/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.8%
1/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.9%
2/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.7%
3/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.6%
1/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Vascular disorders
Vena cava thrombosis
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.1%
1/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.2%
3/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.7%
2/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.4%
1/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.1%
1/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.8%
1/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Blood and lymphatic system disorders
Immune thrombocytopenic purpura
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.4%
1/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.1%
1/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.7%
1/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.1%
1/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.8%
1/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.4%
2/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.1%
1/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.6%
2/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.4%
1/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.8%
1/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.4%
1/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.7%
1/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.1%
1/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.6%
1/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Cardiac disorders
Atrial thrombosis
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.8%
1/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.1%
1/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Cardiac disorders
Cardiogenic shock
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.1%
1/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.6%
1/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Cardiac disorders
Pericarditis
|
12.5%
1/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.2%
1/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.7%
1/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.1%
1/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Endocrine disorders
Addison's disease
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.1%
1/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.4%
1/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Eye disorders
Chorioretinopathy
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.8%
1/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Eye disorders
Diplopia
|
12.5%
1/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Eye disorders
Optic ischaemic neuropathy
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Eye disorders
Uveitis
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.6%
1/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Eye disorders
Vision blurred
|
12.5%
1/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.3%
1/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.3%
1/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.7%
1/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.8%
1/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.1%
1/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.6%
1/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Gastrointestinal disorders
Abdominal wall haematoma
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.4%
1/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.2%
1/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.2%
1/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.7%
1/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Gastrointestinal disorders
Duodenal stenosis
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.7%
1/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Gastrointestinal disorders
Dysphagia
|
12.5%
1/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.1%
1/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.3%
1/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.6%
2/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.6%
1/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.2%
1/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.8%
1/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.1%
2/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.8%
1/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.3%
1/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
Other adverse events
| Measure |
Part A: Dabrafenib 75 mg + Trametinib 2 mg
n=8 participants at risk
Participants received a single dose of dabrafenib 75 mg gelatin capsules with repeat dose trametinib (Day 15).
|
Part B: Dabrafenib 75 mg + Trametinib 1 mg
n=6 participants at risk
Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 75 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available pharmacokinetic (PK), safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on dose-limiting toxicities (DLTs) occurring during the first 3 weeks of treatment.
|
Part B: Dabrafenib 150 mg + Trametinib 1 mg
n=23 participants at risk
Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors and participants who had salivary ductal cancer received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
|
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg
n=27 participants at risk
Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
|
Part B: Dabrafenib 150 mg + Trametinib 2 mg
n=94 participants at risk
Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
|
Part C (Randomized): Dabrafenib 150 mg
n=53 participants at risk
Participants received dabrafenib 150 mg gelatin capsules BID.
|
Part C (Randomized): Dabrafenib 150 mg + Trametinib 1 mg
n=54 participants at risk
Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD.
|
Part C (Randomized): Dabrafenib 150 mg + Trametinib 2 mg
n=55 participants at risk
Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD.
|
Part C (Crossover): Dabrafenib 150 mg + Trametinib 2 mg
n=45 participants at risk
Participants who received dabrafenib 150 mg capsules BID alone in the Randomized Phase were given the opportunity to receive combination dosing of dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD upon disease progression with approval of the GlaxoSmithKline (GSK) Medical Monitor.
|
Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg
n=15 participants at risk
Participants received dabrefinib 75 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 75 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
|
Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg
n=15 participants at risk
Participants received dabrefinib 150 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 150 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
|
Part D: Dabrafenib 75 mg + Trametinib 2 mg
n=41 participants at risk
Participants received dabrefinib 75 mg HPMC capsules BID and trametinib 2 mg tablets QD.
|
Part D: Dabrafenib 150 mg + Trametinib 2 mg
n=39 participants at risk
Participants received dabrefinib 150 mg HPMC capsules BID and trametinib 2 mg tablets QD.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Nervous system disorders
Tremor
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.3%
1/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
5.3%
5/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.6%
2/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.2%
1/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
16.7%
1/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
21.7%
5/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.7%
1/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
10.6%
10/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
9.4%
5/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
9.3%
5/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.3%
4/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.4%
2/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
13.3%
2/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
5.1%
2/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
General disorders
Nodule
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.3%
1/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.4%
2/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.1%
1/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.9%
2/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.4%
2/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.2%
3/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.8%
2/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.7%
2/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
5.5%
3/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.2%
1/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
5.1%
2/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
General disorders
Oedema peripheral
|
12.5%
1/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
26.1%
6/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
18.5%
5/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
19.1%
18/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
17.0%
9/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
24.1%
13/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
25.5%
14/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
15.6%
7/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
20.0%
3/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
13.3%
2/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
24.4%
10/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
28.2%
11/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
General disorders
Pain
|
25.0%
2/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
33.3%
2/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
17.4%
4/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
14.8%
4/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
8.5%
8/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.5%
4/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
11.1%
6/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.3%
4/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
13.3%
2/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.3%
3/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.7%
3/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
General disorders
Peripheral swelling
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.3%
1/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.7%
1/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.3%
4/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.4%
4/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
5.5%
3/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.2%
1/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
13.3%
2/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.4%
1/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.6%
1/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
General disorders
Pyrexia
|
37.5%
3/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
66.7%
4/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
43.5%
10/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
48.1%
13/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
61.7%
58/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
24.5%
13/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
72.2%
39/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
67.3%
37/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
26.7%
12/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
46.7%
7/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
46.7%
7/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
46.3%
19/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
48.7%
19/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
General disorders
Swelling
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.3%
1/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.7%
1/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.1%
1/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.4%
1/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
General disorders
Systemic inflammatory response syndrome
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
General disorders
Tenderness
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.1%
2/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.7%
2/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
General disorders
Xerosis
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
8.7%
2/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.4%
2/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.1%
1/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.8%
2/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
5.6%
3/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.6%
2/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.2%
1/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.4%
1/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Investigations
Blood magnesium decreased
|
12.5%
1/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.1%
2/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.8%
1/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.6%
1/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.3%
1/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
5.3%
5/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
5.5%
3/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.6%
1/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
12.5%
1/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.1%
2/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Musculoskeletal and connective tissue disorders
Limb mass
|
12.5%
1/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.4%
1/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Blood and lymphatic system disorders
Anaemia
|
12.5%
1/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
16.7%
1/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
17.4%
4/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
11.1%
3/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
22.3%
21/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
5.7%
3/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
18.5%
10/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
21.8%
12/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
20.0%
9/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
40.0%
6/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
19.5%
8/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
20.5%
8/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Blood and lymphatic system disorders
Leukopenia
|
12.5%
1/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
21.7%
5/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
11.1%
3/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
8.5%
8/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.8%
2/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.7%
2/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.6%
2/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
3/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.4%
1/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.6%
1/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Blood and lymphatic system disorders
Lymph node pain
|
12.5%
1/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
12.5%
1/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
16.7%
1/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.8%
1/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.3%
1/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.2%
3/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
5.5%
3/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.9%
2/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.6%
1/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
13.0%
3/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
22.2%
6/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
11.7%
11/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
14.8%
8/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.3%
4/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.4%
2/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
13.3%
2/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.3%
3/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
10.3%
4/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
16.7%
1/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
11.1%
3/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
10.6%
10/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.7%
2/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
5.5%
3/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.2%
1/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Cardiac disorders
Intracardiac mass
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
16.7%
1/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.3%
1/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
5.7%
3/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
5.6%
3/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.8%
1/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.4%
2/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.3%
3/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.6%
1/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Cardiac disorders
Tachycardia
|
12.5%
1/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
16.7%
1/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.3%
1/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.4%
2/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.4%
7/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
5.5%
3/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.9%
2/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.6%
1/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Congenital, familial and genetic disorders
Dermoid cyst
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
16.7%
1/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Ear and labyrinth disorders
Ear congestion
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.1%
1/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
5.5%
3/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
16.7%
1/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.7%
1/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.1%
2/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.8%
1/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
8.7%
2/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.1%
1/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.7%
2/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.9%
2/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.6%
1/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.3%
1/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.1%
2/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.9%
2/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
5.1%
2/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Endocrine disorders
Hypothyroidism
|
12.5%
1/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.3%
1/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.3%
4/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.8%
1/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.4%
1/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Eye disorders
Asthenopia
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Eye disorders
Chalazion
|
12.5%
1/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Eye disorders
Chorioretinopathy
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.4%
2/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Eye disorders
Diplopia
|
12.5%
1/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.1%
1/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.8%
1/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.2%
1/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.9%
2/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.6%
1/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Eye disorders
Dry eye
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.3%
4/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.8%
2/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.4%
4/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
5.5%
3/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.4%
2/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
13.3%
2/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.9%
2/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
5.1%
2/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Eye disorders
Eye haemorrhage
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Eye disorders
Eye pain
|
12.5%
1/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.3%
1/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.1%
1/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.7%
2/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.6%
2/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.2%
1/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.4%
1/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.6%
1/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Eye disorders
Eye pruritus
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.7%
1/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Eye disorders
Keratopathy
|
12.5%
1/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Eye disorders
Lacrimation decreased
|
12.5%
1/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
8.7%
2/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.7%
2/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.8%
1/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.2%
1/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.4%
1/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.6%
1/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Eye disorders
Photophobia
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.7%
1/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.1%
1/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.8%
1/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.6%
1/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Eye disorders
Photopsia
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.3%
1/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.1%
1/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.7%
2/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.8%
1/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.4%
2/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Eye disorders
Retinal detachment
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Eye disorders
Vision blurred
|
12.5%
1/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
33.3%
2/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
13.0%
3/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.4%
2/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
5.3%
5/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
9.4%
5/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
18.5%
10/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
9.1%
5/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
8.9%
4/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
20.0%
3/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
26.7%
4/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
14.6%
6/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
12.8%
5/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.1%
1/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Eye disorders
Visual impairment
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.3%
1/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.7%
1/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
5.3%
5/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.8%
1/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.2%
1/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.4%
1/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Eye disorders
Vitreous detachment
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.1%
1/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.6%
1/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.7%
1/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.1%
1/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.8%
2/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
9.3%
5/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
3/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
20.0%
3/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
5.1%
2/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
16.7%
1/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
8.7%
2/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.1%
2/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.7%
2/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.6%
2/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.4%
1/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.6%
1/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.7%
1/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.3%
4/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
5.6%
3/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
5.5%
3/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.4%
2/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
13.3%
2/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.4%
1/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.6%
1/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Gastrointestinal disorders
Abdominal pain
|
12.5%
1/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
33.3%
2/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
17.4%
4/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.7%
1/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
16.0%
15/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
11.3%
6/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
20.4%
11/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
21.8%
12/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
8.9%
4/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
33.3%
5/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
33.3%
5/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
24.4%
10/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.6%
1/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
11.1%
3/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.4%
7/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.5%
4/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.4%
4/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
18.2%
10/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.2%
1/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.4%
1/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.6%
1/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Gastrointestinal disorders
Anal fissure
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.4%
1/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.7%
1/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.6%
1/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Gastrointestinal disorders
Cheilitis
|
12.5%
1/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Gastrointestinal disorders
Constipation
|
12.5%
1/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
16.7%
1/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
39.1%
9/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
22.2%
6/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
27.7%
26/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
11.3%
6/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
27.8%
15/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
27.3%
15/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
15.6%
7/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
40.0%
6/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
26.8%
11/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
17.9%
7/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Gastrointestinal disorders
Diarrhoea
|
37.5%
3/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
33.3%
2/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
39.1%
9/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
29.6%
8/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
34.0%
32/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
28.3%
15/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
33.3%
18/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
49.1%
27/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
22.2%
10/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
33.3%
5/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
40.0%
6/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
43.9%
18/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
30.8%
12/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Gastrointestinal disorders
Diverticulum
|
12.5%
1/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.4%
1/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.4%
2/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
9.6%
9/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
5.7%
3/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
14.8%
8/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
12.7%
7/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
13.3%
6/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
13.3%
2/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
14.6%
6/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
10.3%
4/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
16.7%
1/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
8.7%
2/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
14.8%
4/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
5.3%
5/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
5.7%
3/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
13.0%
7/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
12.7%
7/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.4%
2/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
14.6%
6/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.6%
1/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.4%
2/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.3%
4/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
5.7%
3/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.8%
1/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.2%
1/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.4%
1/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.7%
3/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
8.7%
2/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.6%
2/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.4%
1/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
12.5%
1/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.3%
1/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.7%
1/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.4%
6/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.4%
4/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.3%
4/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
10.3%
4/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.3%
1/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.2%
3/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.9%
2/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.6%
1/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Gastrointestinal disorders
Haemorrhoids
|
12.5%
1/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.3%
1/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.7%
1/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.1%
1/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.8%
2/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.6%
2/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.2%
1/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.4%
1/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.6%
1/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Gastrointestinal disorders
Mesenteric artery thrombosis
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.1%
2/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.8%
1/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
5.1%
2/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Gastrointestinal disorders
Nausea
|
50.0%
4/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
33.3%
2/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
47.8%
11/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
44.4%
12/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
52.1%
49/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
20.8%
11/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
55.6%
30/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
47.3%
26/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
24.4%
11/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
33.3%
5/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
66.7%
10/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
63.4%
26/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
53.8%
21/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Gastrointestinal disorders
Oral mucosa erosion
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Gastrointestinal disorders
Oral pain
|
12.5%
1/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.7%
1/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.2%
3/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.6%
1/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Gastrointestinal disorders
Retching
|
12.5%
1/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.3%
1/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.1%
1/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.8%
2/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.4%
1/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.1%
1/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Gastrointestinal disorders
Stomatitis
|
12.5%
1/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.7%
1/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.1%
1/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.7%
2/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.6%
2/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.2%
1/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.9%
2/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
5.1%
2/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Gastrointestinal disorders
Tongue ulceration
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.1%
1/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
5.1%
2/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.3%
1/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.8%
1/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.2%
1/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.4%
1/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
5.1%
2/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Gastrointestinal disorders
Vomiting
|
50.0%
4/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
33.3%
2/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
26.1%
6/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
44.4%
12/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
41.5%
39/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
15.1%
8/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
42.6%
23/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
47.3%
26/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
28.9%
13/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
20.0%
3/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
53.3%
8/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
48.8%
20/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
53.8%
21/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
General disorders
Asthenia
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
34.8%
8/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
11.1%
3/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
12.8%
12/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
5.7%
3/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.7%
2/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
10.9%
6/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.2%
1/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
14.6%
6/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.7%
3/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
General disorders
Axillary pain
|
12.5%
1/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.7%
1/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.1%
1/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.5%
4/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.7%
2/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.8%
1/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
General disorders
Chest discomfort
|
12.5%
1/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
13.0%
3/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.7%
1/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.1%
1/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.8%
1/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.4%
1/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
5.1%
2/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
General disorders
Chills
|
37.5%
3/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
50.0%
3/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
39.1%
9/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
40.7%
11/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
40.4%
38/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
15.1%
8/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
44.4%
24/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
52.7%
29/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
13.3%
6/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
13.3%
2/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
33.3%
5/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
36.6%
15/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
33.3%
13/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
General disorders
Face oedema
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.1%
1/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.2%
1/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.4%
1/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.7%
3/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
General disorders
Fatigue
|
62.5%
5/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
66.7%
4/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
56.5%
13/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
44.4%
12/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
53.2%
50/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
41.5%
22/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
64.8%
35/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
58.2%
32/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
26.7%
12/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
46.7%
7/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
26.7%
4/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
70.7%
29/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
41.0%
16/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
General disorders
Gait disturbance
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.3%
1/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.2%
3/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.7%
2/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.6%
2/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.9%
2/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.6%
1/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
General disorders
Influenza like illness
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
13.0%
3/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.4%
2/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.2%
3/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.5%
4/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
22.2%
12/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
10.9%
6/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
11.1%
5/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
13.3%
2/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
20.0%
3/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.3%
3/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
15.4%
6/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
General disorders
Malaise
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.4%
2/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.4%
7/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.7%
2/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.8%
1/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.9%
2/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.6%
1/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
General disorders
Mass
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
16.7%
1/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.3%
1/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
14.8%
4/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.1%
2/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
5.6%
3/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.6%
2/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.4%
1/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.6%
1/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Immune system disorders
Contrast media allergy
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.4%
1/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.6%
1/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Immune system disorders
Cytokine release syndrome
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.3%
4/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
5.1%
2/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
8.7%
2/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.1%
1/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.8%
1/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
5.1%
2/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Infections and infestations
Anorectal infection
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
16.7%
1/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.7%
1/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.3%
4/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.6%
2/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.4%
1/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.6%
1/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Infections and infestations
Candida infection
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.7%
1/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.1%
1/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.6%
2/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.4%
2/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
5.1%
2/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Infections and infestations
Cellulitis
|
12.5%
1/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.3%
1/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.4%
2/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.3%
4/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.2%
1/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.4%
1/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.6%
1/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.8%
1/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.4%
2/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.4%
1/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Infections and infestations
Cystitis
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.2%
3/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.6%
1/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Infections and infestations
Ear infection
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.3%
1/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.7%
1/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.2%
3/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
5.5%
3/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.2%
1/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Infections and infestations
Eye infection
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
16.7%
1/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.3%
1/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.4%
2/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.2%
3/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
5.6%
3/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.3%
4/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
3/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
9.8%
4/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.6%
1/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Infections and infestations
Fungal infection
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
13.0%
3/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.3%
1/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.7%
1/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.1%
1/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.6%
2/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.3%
1/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.7%
1/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
5.6%
3/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.6%
2/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Infections and infestations
Groin abscess
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.8%
1/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
5.1%
2/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Infections and infestations
Hordeolum
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.8%
2/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.2%
1/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.4%
1/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Infections and infestations
Infected bite
|
12.5%
1/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Infections and infestations
Influenza
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
13.0%
3/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
11.1%
3/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
5.6%
3/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.6%
2/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.4%
1/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.6%
1/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Infections and infestations
Localised infection
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.3%
1/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.7%
1/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.6%
2/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.9%
2/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.6%
1/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.7%
1/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.8%
1/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.2%
1/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
5.1%
2/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Infections and infestations
Mastitis
|
12.5%
1/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
8.7%
2/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.7%
1/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.3%
4/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
5.6%
3/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
9.1%
5/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
20.0%
3/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
12.2%
5/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.7%
1/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.1%
1/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.6%
2/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
12.2%
5/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.7%
1/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.1%
2/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.8%
2/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.9%
2/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Infections and infestations
Paronychia
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.8%
1/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.2%
1/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
13.3%
2/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.4%
1/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.6%
1/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Infections and infestations
Periorbital infection
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.8%
1/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
16.7%
1/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.7%
1/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.1%
1/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Infections and infestations
Pneumonia
|
12.5%
1/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
8.7%
2/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.1%
1/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.4%
2/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.4%
1/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.6%
1/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Infections and infestations
Rash pustular
|
12.5%
1/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.3%
1/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.1%
1/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.6%
2/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.4%
1/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.6%
1/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Infections and infestations
Rhinitis
|
12.5%
1/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.1%
2/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.6%
1/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Infections and infestations
Sepsis
|
12.5%
1/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
8.7%
2/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
18.5%
5/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.4%
7/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.7%
2/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.3%
4/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.2%
1/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.3%
3/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
15.4%
6/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Infections and infestations
Skin infection
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.8%
2/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.2%
1/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.9%
2/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Infections and infestations
Staphylococcal infection
|
25.0%
2/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.1%
1/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.8%
1/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Infections and infestations
Tinea pedis
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.7%
1/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.1%
1/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.8%
1/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.4%
1/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.6%
1/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
8.7%
2/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.7%
1/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
10.6%
10/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
9.4%
5/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
18.5%
10/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
9.1%
5/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
11.1%
5/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
13.3%
2/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
20.0%
3/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
9.8%
4/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
15.4%
6/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Infections and infestations
Urinary tract infection
|
12.5%
1/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
21.7%
5/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
14.8%
4/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
19.1%
18/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
5.7%
3/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
5.6%
3/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
14.5%
8/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
13.3%
6/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
13.3%
2/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
13.3%
2/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
12.2%
5/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
25.6%
10/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Infections and infestations
Wound infection staphylococcal
|
12.5%
1/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.3%
1/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.1%
1/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.6%
2/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.4%
1/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
16.7%
1/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.3%
1/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.1%
1/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
5.6%
3/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
5.5%
3/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.2%
1/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
12.8%
5/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.3%
1/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.1%
1/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.4%
4/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
20.0%
3/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.3%
3/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.7%
3/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.1%
2/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.8%
1/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
5.1%
2/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.3%
4/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.1%
1/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.8%
1/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.2%
1/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.1%
2/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.8%
1/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.4%
2/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.9%
2/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
5.1%
2/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
5.1%
2/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Injury, poisoning and procedural complications
Sunburn
|
12.5%
1/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
8.7%
2/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.1%
1/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.9%
2/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
16.7%
1/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Injury, poisoning and procedural complications
Wound haemorrhage
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.8%
1/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.6%
1/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
8.7%
2/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
11.1%
3/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.4%
7/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
20.4%
11/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
10.9%
6/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.4%
2/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
20.0%
3/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
19.5%
8/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
12.8%
5/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
16.7%
1/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
8.7%
2/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
14.8%
4/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
12.8%
12/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
18.5%
10/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
18.2%
10/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
3/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
20.0%
3/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
14.6%
6/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
15.4%
6/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.3%
1/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.4%
2/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
14.9%
14/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.8%
2/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
20.4%
11/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
12.7%
7/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.4%
2/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
33.3%
5/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
12.2%
5/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
10.3%
4/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.2%
1/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.3%
3/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.6%
1/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.4%
2/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
5.3%
5/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.8%
2/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.4%
4/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.8%
1/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.2%
1/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
9.8%
4/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
12.8%
5/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Investigations
Blood iron decreased
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Investigations
Blood potassium decreased
|
12.5%
1/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.1%
1/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.8%
1/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Investigations
Blood pressure increased
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.1%
1/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Investigations
Blood testosterone decreased
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
8.7%
2/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.8%
1/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Investigations
Blood thyroid stimulating hormone increased
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.7%
1/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.1%
1/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Investigations
Carbon dioxide increased
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
5.6%
3/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.3%
1/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.7%
1/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.4%
6/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
9.1%
5/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.2%
1/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.9%
2/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
13.0%
3/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
11.1%
3/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
12.8%
12/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
20.4%
11/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
10.9%
6/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
13.3%
6/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
20.0%
3/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
14.6%
6/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
15.4%
6/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Investigations
Liver function test abnormal
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Investigations
Lymphocyte count decreased
|
12.5%
1/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.3%
1/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.1%
2/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
9.3%
5/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.6%
2/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.2%
1/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.9%
2/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
5.1%
2/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Investigations
Mean cell volume decreased
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
16.7%
1/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.4%
2/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
5.6%
3/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.8%
1/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.9%
2/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
5.1%
2/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Investigations
Platelet count decreased
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.7%
1/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.1%
1/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.8%
1/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.3%
3/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.7%
3/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Investigations
Protein urine present
|
12.5%
1/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Investigations
Thyroxine free decreased
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.3%
1/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.1%
2/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Investigations
Transaminases increased
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.1%
2/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.4%
4/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
13.3%
2/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.4%
1/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.6%
1/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Investigations
Weight decreased
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
13.0%
3/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
5.3%
5/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.5%
4/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
14.8%
8/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
10.9%
6/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
3/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
13.3%
2/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
9.8%
4/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.7%
3/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Investigations
Weight increased
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
16.7%
1/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
21.7%
5/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.4%
2/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.2%
3/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.3%
4/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.4%
2/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.4%
1/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.6%
1/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.7%
2/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.6%
2/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
12.2%
5/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.7%
3/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
50.0%
4/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
50.0%
3/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
8.7%
2/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
25.9%
7/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
24.5%
23/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
20.8%
11/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
33.3%
18/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
29.1%
16/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
15.6%
7/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
13.3%
2/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
20.0%
3/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
29.3%
12/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
35.9%
14/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
13.0%
3/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.4%
2/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
12.8%
12/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.4%
4/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
9.1%
5/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.4%
2/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
12.2%
5/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
15.4%
6/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.6%
1/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
16.7%
1/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.1%
2/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.4%
1/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
13.0%
3/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
8.5%
8/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
5.7%
3/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
11.1%
6/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
9.1%
5/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
9.8%
4/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.7%
3/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
8.7%
2/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.7%
1/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.3%
4/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.5%
4/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.6%
2/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
13.3%
2/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.6%
1/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.1%
1/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.4%
1/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.7%
2/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.6%
2/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.2%
1/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.4%
6/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.4%
4/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
5.5%
3/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.2%
1/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
13.3%
2/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
12.2%
5/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
5.1%
2/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.4%
2/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
13.8%
13/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
5.7%
3/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
9.1%
5/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.2%
1/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
20.0%
3/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
12.2%
5/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.7%
3/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
12.5%
1/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.4%
7/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
5.5%
3/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.2%
1/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.9%
2/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
8.7%
2/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.4%
2/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
11.7%
11/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
9.3%
5/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
12.7%
7/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.2%
1/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
13.3%
2/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
12.2%
5/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
10.3%
4/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
8.7%
2/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.7%
1/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
8.5%
8/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.5%
4/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
9.3%
5/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.6%
2/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.2%
1/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
14.6%
6/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
5.1%
2/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Metabolism and nutrition disorders
Impaired fasting glucose
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.8%
1/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Metabolism and nutrition disorders
Increased appetite
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.4%
1/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
5.1%
2/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
12.5%
1/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.3%
1/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.7%
1/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.1%
1/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
25.0%
2/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
33.3%
2/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
26.1%
6/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
22.2%
6/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
19.1%
18/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
34.0%
18/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
51.9%
28/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
34.5%
19/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
26.7%
12/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
60.0%
9/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
53.3%
8/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
41.5%
17/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
43.6%
17/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.7%
2/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.8%
1/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
5.1%
2/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.3%
1/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
22.2%
6/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
13.8%
13/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
11.3%
6/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
13.0%
7/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
21.8%
12/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
17.8%
8/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
26.7%
4/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
9.8%
4/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
10.3%
4/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
16.7%
1/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.7%
1/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.2%
3/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
5.5%
3/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.6%
1/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
12.5%
1/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
8.7%
2/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.4%
7/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.8%
2/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
5.5%
3/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
20.0%
3/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.6%
1/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
16.7%
1/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.7%
1/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.8%
1/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
12.5%
1/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
16.7%
1/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
21.7%
5/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.4%
2/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
13.8%
13/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.8%
2/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
5.6%
3/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
20.0%
11/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.4%
2/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
17.1%
7/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
12.8%
5/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
12.5%
1/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
8.7%
2/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
11.1%
3/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.4%
6/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
13.0%
7/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
12.7%
7/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
8.9%
4/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
13.3%
2/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.9%
2/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.7%
3/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
12.5%
1/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
16.7%
1/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
8.7%
2/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.7%
1/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.2%
3/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
5.6%
3/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.6%
2/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.4%
2/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.9%
2/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
10.3%
4/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
12.5%
1/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
8.7%
2/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.4%
2/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
8.5%
8/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
11.3%
6/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.4%
4/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
10.9%
6/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
9.8%
4/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
5.1%
2/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.3%
1/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.4%
2/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.1%
1/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.8%
2/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.8%
1/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.4%
1/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
5.1%
2/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
25.0%
2/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
16.7%
1/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
8.7%
2/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
22.2%
6/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
18.1%
17/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
22.6%
12/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
29.6%
16/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
21.8%
12/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.4%
2/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
20.0%
3/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
29.3%
12/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
20.5%
8/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
12.5%
1/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.4%
2/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
5.3%
5/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
9.4%
5/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.4%
4/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
12.7%
7/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.4%
2/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
13.3%
2/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.9%
2/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
5.1%
2/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
16.7%
1/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
17.4%
4/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
18.5%
5/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
17.0%
16/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
20.8%
11/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
20.4%
11/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
23.6%
13/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
11.1%
5/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
26.7%
4/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
13.3%
2/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
12.2%
5/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
10.3%
4/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.2%
3/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
5.1%
2/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
8.7%
2/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.4%
1/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.8%
1/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.6%
1/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.1%
1/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.6%
1/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acrochordon
|
12.5%
1/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.3%
1/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.2%
3/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
9.4%
5/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
5.6%
3/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
9.1%
5/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
20.0%
3/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
20.0%
3/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.4%
1/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
10.3%
4/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
13.0%
3/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.7%
1/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.2%
3/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
5.6%
3/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
12.7%
7/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
13.3%
2/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
5.1%
2/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Fibrous histiocytoma
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.1%
1/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
5.5%
3/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.4%
1/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma of skin
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.7%
1/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.1%
2/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
5.6%
3/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.8%
1/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Juvenile melanoma benign
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Keratoacanthoma
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.1%
1/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
5.7%
3/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.8%
1/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
5.1%
2/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
12.5%
1/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.3%
1/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.1%
1/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
5.7%
3/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.4%
4/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
9.1%
5/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic keratosis
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
8.7%
2/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.4%
2/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.3%
4/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
9.4%
5/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
13.0%
7/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
10.9%
6/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
26.7%
4/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
9.8%
4/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
15.4%
6/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
37.5%
3/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
16.7%
1/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.3%
1/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.4%
2/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.1%
2/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
15.1%
8/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.4%
4/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.6%
2/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.4%
1/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.3%
1/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.7%
1/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.6%
1/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Nervous system disorders
Amnesia
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
5.5%
3/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.2%
1/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Nervous system disorders
Aphasia
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.4%
2/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.4%
1/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.6%
1/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Nervous system disorders
Ataxia
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.8%
1/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.6%
1/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.3%
1/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.7%
1/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.1%
2/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.8%
1/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Nervous system disorders
Burning sensation
|
12.5%
1/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.8%
1/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Nervous system disorders
Disturbance in attention
|
12.5%
1/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.7%
1/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.1%
1/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.7%
2/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.4%
1/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Nervous system disorders
Dizziness
|
12.5%
1/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
16.7%
1/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
17.4%
4/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
18.5%
5/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
25.5%
24/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
9.4%
5/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
22.2%
12/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
18.2%
10/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
15.6%
7/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
26.7%
4/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
34.1%
14/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
10.3%
4/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.1%
1/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.7%
1/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
5.3%
5/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
9.3%
5/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
9.1%
5/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.2%
1/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.9%
2/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.7%
3/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Nervous system disorders
Dyskinesia
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
8.7%
2/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Nervous system disorders
Facial paralysis
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.9%
2/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Nervous system disorders
Headache
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
50.0%
3/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
52.2%
12/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
29.6%
8/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
34.0%
32/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
32.1%
17/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
46.3%
25/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
32.7%
18/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
20.0%
9/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
33.3%
5/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
26.7%
4/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
31.7%
13/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
41.0%
16/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.8%
1/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Nervous system disorders
Hyperaesthesia
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.2%
3/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.6%
2/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
5.1%
2/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Nervous system disorders
Hypoaesthesia
|
12.5%
1/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
16.7%
1/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.3%
1/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.7%
1/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.3%
4/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
5.6%
3/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.3%
4/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.2%
1/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
13.3%
2/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.1%
1/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.3%
4/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.2%
1/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
13.3%
2/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.9%
2/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
16.7%
1/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
5.3%
5/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.7%
2/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.8%
1/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.4%
2/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.9%
2/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Nervous system disorders
Motor dysfunction
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.8%
1/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.2%
1/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.6%
1/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
16.7%
1/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
13.0%
3/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.7%
1/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.4%
6/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.5%
4/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.4%
4/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.3%
4/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.2%
1/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
13.3%
2/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.4%
1/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Nervous system disorders
Noninfective encephalitis
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.7%
2/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
13.3%
2/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Nervous system disorders
Nystagmus
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.7%
1/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.4%
6/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
11.3%
6/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.3%
4/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
3/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
13.3%
2/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.4%
1/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.6%
1/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Nervous system disorders
Partial seizures
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.1%
1/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.1%
2/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.3%
3/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.6%
1/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Nervous system disorders
Sedation
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Nervous system disorders
Seizure
|
12.5%
1/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.7%
1/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.1%
1/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.4%
4/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.8%
1/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.2%
1/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.4%
1/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Nervous system disorders
Sinus headache
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
16.7%
1/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.1%
1/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.1%
2/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
5.5%
3/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.4%
1/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Nervous system disorders
Syncope
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
16.7%
1/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.3%
1/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.2%
3/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
5.6%
3/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
5.5%
3/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.2%
1/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
9.8%
4/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.7%
3/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Psychiatric disorders
Confusional state
|
12.5%
1/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
16.7%
1/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
8.7%
2/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
5.3%
5/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
5.6%
3/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
10.9%
6/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.2%
1/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
9.8%
4/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
5.1%
2/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Psychiatric disorders
Depression
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.3%
1/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
14.8%
4/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.4%
6/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.8%
2/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
9.3%
5/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.3%
4/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.2%
1/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.9%
2/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.7%
3/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
16.7%
1/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
13.0%
3/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.7%
1/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.1%
1/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
9.3%
5/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.8%
1/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.4%
2/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.9%
2/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
5.1%
2/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Psychiatric disorders
Emotional disorder
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Psychiatric disorders
Insomnia
|
12.5%
1/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.3%
1/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
22.2%
6/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.4%
6/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.5%
4/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
13.0%
7/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
18.2%
10/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
13.3%
2/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
13.3%
2/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.3%
3/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
10.3%
4/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Psychiatric disorders
Irritability
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.7%
1/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
5.6%
3/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.4%
2/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.1%
1/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.8%
1/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Psychiatric disorders
Mood altered
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.1%
1/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Psychiatric disorders
Thinking abnormal
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Renal and urinary disorders
Dysuria
|
12.5%
1/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.3%
1/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.7%
1/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.3%
4/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.3%
4/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.9%
2/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
5.1%
2/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.3%
1/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.6%
2/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
13.3%
2/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.4%
1/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
10.3%
4/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.1%
1/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
13.3%
2/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.4%
1/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.6%
1/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
8.7%
2/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.1%
1/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.2%
1/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.3%
1/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.1%
2/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.5%
4/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.8%
1/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.3%
3/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
5.1%
2/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Renal and urinary disorders
Polyuria
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
5.5%
3/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Renal and urinary disorders
Renal injury
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.3%
1/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.8%
1/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.2%
1/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.4%
1/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
5.1%
2/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
8.7%
2/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.8%
1/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.6%
1/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Reproductive system and breast disorders
Menstruation irregular
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.7%
1/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.7%
1/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.1%
1/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
5.6%
3/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.6%
1/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.3%
1/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.1%
1/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.8%
1/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.2%
1/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.9%
2/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Reproductive system and breast disorders
Testicular pain
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.4%
2/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.8%
1/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.8%
1/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
37.5%
3/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
50.0%
3/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
21.7%
5/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
33.3%
9/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
23.4%
22/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
20.8%
11/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
18.5%
10/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
34.5%
19/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
11.1%
5/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
33.3%
5/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
26.7%
4/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
34.1%
14/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
30.8%
12/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
12.5%
1/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.7%
1/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.1%
1/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
5.5%
3/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.2%
1/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.3%
3/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
5.1%
2/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
12.5%
1/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
16.7%
1/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
21.7%
5/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
11.1%
3/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
12.8%
12/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.5%
4/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
13.0%
7/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
12.7%
7/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
11.1%
5/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
13.3%
2/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
12.2%
5/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
15.4%
6/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
33.3%
2/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.3%
1/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
5.3%
5/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.8%
1/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.4%
2/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.9%
2/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
5.1%
2/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
12.5%
1/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
16.7%
1/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.3%
1/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.4%
2/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.4%
6/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.7%
2/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
9.1%
5/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.2%
1/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.3%
3/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.6%
1/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
12.5%
1/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.7%
1/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.8%
1/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.6%
1/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
12.5%
1/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.8%
1/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.8%
1/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal haemorrhage
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
12.5%
1/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
16.7%
1/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
11.1%
3/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.4%
7/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
11.1%
6/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
10.9%
6/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.4%
2/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
9.8%
4/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
5.1%
2/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.1%
1/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.4%
1/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
12.5%
1/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
17.4%
4/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.7%
1/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
17.0%
16/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
13.0%
7/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
16.4%
9/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
3/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
13.3%
2/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.3%
3/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
12.8%
5/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Respiratory, thoracic and mediastinal disorders
Painful respiration
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
16.7%
1/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus hypersecretion
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
16.7%
1/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.4%
2/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.2%
3/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.4%
1/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.2%
3/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.8%
2/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
16.7%
9/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
5.5%
3/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.2%
1/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
13.3%
2/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.9%
2/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
10.3%
4/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.8%
1/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.3%
1/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.7%
1/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
5.5%
3/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.4%
1/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.3%
1/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.1%
2/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.5%
4/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.4%
4/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.8%
1/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.2%
1/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.4%
1/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.6%
1/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.3%
1/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.3%
4/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.8%
1/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.2%
1/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
13.3%
2/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.4%
1/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
5.1%
2/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.3%
1/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.4%
2/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.1%
2/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
5.6%
3/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.3%
4/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.4%
2/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.6%
1/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.4%
1/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.7%
1/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
5.6%
3/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.6%
2/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.4%
2/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.4%
1/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
12.5%
1/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.7%
1/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.1%
2/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.8%
1/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
8.7%
2/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.3%
4/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
5.6%
3/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.6%
2/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.2%
1/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
13.3%
2/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
16.7%
1/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
17.4%
4/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
11.1%
3/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
11.7%
11/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
11.3%
6/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
11.1%
6/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
21.8%
12/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.2%
1/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
13.3%
2/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
9.8%
4/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
17.9%
7/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.4%
2/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
8.5%
8/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
35.8%
19/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
14.8%
8/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
5.5%
3/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
11.1%
5/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
26.7%
4/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
26.7%
4/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
12.2%
5/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
5.1%
2/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Skin and subcutaneous tissue disorders
Blister
|
12.5%
1/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.7%
1/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.4%
1/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.7%
1/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.1%
1/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.7%
2/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.8%
1/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.4%
1/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.4%
2/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.7%
2/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.8%
1/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.2%
1/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
13.3%
2/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.4%
1/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
25.0%
2/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
13.0%
3/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
18.5%
5/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
12.8%
12/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.8%
2/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
11.1%
6/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
18.2%
10/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
20.0%
3/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
26.7%
4/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
14.6%
6/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
15.4%
6/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
8.7%
2/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.7%
1/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.1%
2/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.8%
1/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.4%
1/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
12.5%
1/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
16.7%
1/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
13.0%
3/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.4%
2/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
5.3%
5/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.8%
2/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
11.1%
6/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
20.0%
11/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
3/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
20.0%
3/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
14.6%
6/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
15.4%
6/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.3%
1/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.4%
2/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.7%
2/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.6%
2/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
12.5%
1/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
13.0%
3/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.7%
1/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.2%
3/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.7%
2/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.3%
4/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.4%
2/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
13.3%
2/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.4%
1/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
5.1%
2/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Skin and subcutaneous tissue disorders
Eczema asteatotic
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
25.0%
2/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
16.7%
1/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
8.7%
2/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
25.9%
7/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
5.3%
5/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
9.3%
5/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
18.2%
10/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.4%
2/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.4%
1/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.6%
1/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
3/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Skin and subcutaneous tissue disorders
Erythema nodosum
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.3%
1/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.7%
1/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.2%
3/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
5.5%
3/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.2%
1/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
20.0%
3/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.9%
2/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
5.1%
2/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Skin and subcutaneous tissue disorders
Hair texture abnormal
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.5%
4/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
3/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.6%
1/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
16.7%
1/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
17.4%
4/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.7%
1/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
10.6%
10/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
9.3%
5/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
10.9%
6/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.2%
1/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
13.3%
2/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
14.6%
6/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
10.3%
4/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
12.5%
1/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.3%
1/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.4%
2/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.3%
4/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
28.3%
15/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
9.3%
5/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
16.4%
9/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.2%
1/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
20.0%
3/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
13.3%
2/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
9.8%
4/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.6%
1/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Skin and subcutaneous tissue disorders
Keratosis pilaris
|
12.5%
1/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.8%
2/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
13.3%
2/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.6%
1/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Skin and subcutaneous tissue disorders
Macule
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.3%
1/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.1%
2/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.7%
2/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.8%
1/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.2%
1/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
12.5%
1/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
16.7%
1/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
17.4%
4/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
25.9%
7/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
17.0%
16/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
5.7%
3/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
20.4%
11/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
27.3%
15/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
3/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
20.0%
3/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
19.5%
8/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
23.1%
9/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Skin and subcutaneous tissue disorders
Nodular rash
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
16.7%
1/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.7%
1/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.1%
2/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.8%
1/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Skin and subcutaneous tissue disorders
Onychoclasis
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
16.7%
1/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.8%
1/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.3%
1/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.7%
1/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.2%
3/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
17.0%
9/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.4%
4/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.3%
4/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.4%
2/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
13.3%
2/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.9%
2/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.7%
3/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Skin and subcutaneous tissue disorders
Papule
|
12.5%
1/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
8.7%
2/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
5.3%
5/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.7%
2/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.6%
2/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.6%
1/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.3%
1/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.6%
2/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Skin and subcutaneous tissue disorders
Photodermatosis
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.7%
1/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.1%
2/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
5.5%
3/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.3%
1/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.1%
2/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
5.7%
3/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
5.6%
3/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.6%
2/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.2%
1/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.9%
2/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
5.1%
2/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Skin and subcutaneous tissue disorders
Pigmentation disorder
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.3%
1/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.8%
1/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
25.0%
2/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
16.7%
1/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
13.0%
3/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.7%
1/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.3%
4/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
15.1%
8/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
14.8%
8/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
14.5%
8/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
3/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
20.0%
3/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
13.3%
2/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
9.8%
4/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
17.9%
7/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
13.0%
3/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
14.8%
4/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.3%
4/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
13.2%
7/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.4%
4/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.6%
2/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
8.9%
4/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
13.3%
2/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
26.7%
4/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
14.6%
6/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
10.3%
4/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.3%
1/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.1%
1/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.4%
1/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Skin and subcutaneous tissue disorders
Rash
|
75.0%
6/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
33.3%
2/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
26.1%
6/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
33.3%
9/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
22.3%
21/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
35.8%
19/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
24.1%
13/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
32.7%
18/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
17.8%
8/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
26.7%
4/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
40.0%
6/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
34.1%
14/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
46.2%
18/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
12.5%
1/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
33.3%
2/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
17.4%
4/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
5.3%
5/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
5.7%
3/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.7%
2/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
10.9%
6/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.2%
1/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.4%
1/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
10.3%
4/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
13.0%
3/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
11.1%
3/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.1%
2/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.8%
2/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
9.3%
5/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.6%
2/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
26.7%
4/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.3%
3/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.7%
3/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.3%
1/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.4%
2/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
5.3%
5/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
5.7%
3/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
9.3%
5/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.3%
4/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.4%
2/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
20.0%
3/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
12.2%
5/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
17.9%
7/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.8%
2/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
5.6%
3/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.9%
2/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.6%
1/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
8.7%
2/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.3%
4/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
5.6%
3/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
5.5%
3/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.7%
3/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.6%
2/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Skin and subcutaneous tissue disorders
Skin haemorrhage
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
16.7%
1/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.3%
1/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.1%
1/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.8%
2/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.8%
1/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Skin and subcutaneous tissue disorders
Skin hypertrophy
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.8%
2/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.3%
1/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.7%
1/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
5.3%
5/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.7%
2/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.8%
1/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
13.3%
2/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.9%
2/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
10.3%
4/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Skin and subcutaneous tissue disorders
Solar lentigo
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.1%
1/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
5.6%
3/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
12.5%
1/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.7%
1/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.8%
1/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.4%
1/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.6%
1/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Skin and subcutaneous tissue disorders
Transient acantholytic dermatosis
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.4%
1/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
16.7%
1/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.1%
1/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
5.5%
3/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Skin and subcutaneous tissue disorders
Vitiligo
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.1%
1/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.8%
2/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.4%
1/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.7%
3/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Vascular disorders
Flushing
|
12.5%
1/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.3%
1/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.4%
7/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.5%
4/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
11.1%
6/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.8%
1/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.2%
1/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.4%
1/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
10.3%
4/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Vascular disorders
Hot flush
|
12.5%
1/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
8.7%
2/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.1%
2/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
9.3%
5/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.3%
4/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
13.3%
2/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.4%
1/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
12.8%
5/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Vascular disorders
Hypertension
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
8.7%
2/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
11.1%
3/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.4%
6/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.8%
2/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.4%
4/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
16.4%
9/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
8.9%
4/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
17.1%
7/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
17.9%
7/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Vascular disorders
Hypotension
|
12.5%
1/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
16.7%
1/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
13.0%
3/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.4%
2/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
9.6%
9/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.7%
2/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.3%
4/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
13.3%
2/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.3%
3/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
12.8%
5/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Vascular disorders
Labile blood pressure
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
16.7%
1/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.3%
1/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
3.7%
1/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.1%
1/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.3%
4/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.2%
1/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
13.3%
2/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
4.9%
2/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
7.7%
3/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Vascular disorders
Thrombophlebitis superficial
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
6.7%
1/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.4%
1/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
|
Vascular disorders
Vasculitis
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/23 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/27 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.1%
1/94 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/53 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
1.9%
1/54 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/55 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.2%
1/45 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
13.3%
2/15 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
2.4%
1/41 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
0.00%
0/39 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
- Publication restrictions are in place
Restriction type: OTHER