Trial Outcomes & Findings for Study of Efficacy and Safety of Asciminib in Combination With Imatinib in Patients With Chronic Myeloid Leukemia in Chronic Phase (CML-CP) Who Have Been Previously Treated With Imatinib and Have Not Achieved Deep Molecular Response. (NCT NCT03578367)
NCT ID: NCT03578367
Last Updated: 2026-04-21
Results Overview
Percentage of participants still treated with the randomized treatment at 48 weeks and are in MR\^4.5 (BCR::ABL1 ratio of ≤ 0.0032%) at 48 weeks (± assessment window), among all participants in the asciminib add-on arms vs imatinib arm.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
104 participants
Primary outcome timeframe
at Week 48
Results posted on
2026-04-21
Participant Flow
All the participants were enrolled at 30 sites.
A total of 104 participants were enrolled in total. 84 were enrolled to arms 1 to 4 and 20 to the asciminib single agent cohort (ASAC).
Participant milestones
| Measure |
Asciminib 40mg QD + Imatinib 400mg QD
Asciminib 40 mg taken once daily in combination with Imatinib 400 mg taken once daily
|
Asciminib 60mg QD + Imatinib 400mg QD
Asciminib 60 mg taken once daily in combination with Imatinib 400 mg taken once daily
|
Imatinib 400mg QD
Imatinib 400 mg taken once daily
|
Nilotinib 300mg BID
Nilotinib 300 mg taken twice daily
|
Asciminib 80mg QD
Asciminib 80 mg taken once daily
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
21
|
21
|
21
|
21
|
20
|
|
Overall Study
Treated
|
21
|
21
|
20
|
21
|
20
|
|
Overall Study
Discontinued From Treatment
|
3
|
5
|
16
|
10
|
1
|
|
Overall Study
Switched From Imatinib to Asciminib 60 mg Combo
|
0
|
14
|
0
|
0
|
0
|
|
Overall Study
COMPLETED
|
18
|
16
|
4
|
11
|
19
|
|
Overall Study
NOT COMPLETED
|
3
|
5
|
17
|
10
|
1
|
Reasons for withdrawal
| Measure |
Asciminib 40mg QD + Imatinib 400mg QD
Asciminib 40 mg taken once daily in combination with Imatinib 400 mg taken once daily
|
Asciminib 60mg QD + Imatinib 400mg QD
Asciminib 60 mg taken once daily in combination with Imatinib 400 mg taken once daily
|
Imatinib 400mg QD
Imatinib 400 mg taken once daily
|
Nilotinib 300mg BID
Nilotinib 300 mg taken twice daily
|
Asciminib 80mg QD
Asciminib 80 mg taken once daily
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
3
|
0
|
7
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
1
|
3
|
0
|
|
Overall Study
Physician Decision
|
0
|
0
|
14
|
0
|
0
|
|
Overall Study
Death
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Not treated
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Progressive disease
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Study of Efficacy and Safety of Asciminib in Combination With Imatinib in Patients With Chronic Myeloid Leukemia in Chronic Phase (CML-CP) Who Have Been Previously Treated With Imatinib and Have Not Achieved Deep Molecular Response.
Baseline characteristics by cohort
| Measure |
Asciminib 40mg QD + Imatinib 400mg QD
n=21 Participants
Asciminib 40 mg taken once daily in combination with Imatinib 400 mg taken once daily
|
Asciminib 60mg QD + Imatinib 400mg QD
n=21 Participants
Asciminib 60 mg taken once daily in combination with Imatinib 400 mg taken once daily
|
Imatinib 400mg QD
n=21 Participants
Imatinib 400 mg taken once daily
|
Nilotinib 300mg BID
n=21 Participants
Nilotinib 300 mg taken twice daily
|
Asciminib 80mg QD
n=20 Participants
Asciminib 80 mg taken once daily
|
Total
n=104 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Customized
18 - <65 years
|
18 Participants
n=13 Participants
|
19 Participants
n=13 Participants
|
16 Participants
n=26 Participants
|
19 Participants
n=15 Participants
|
14 Participants
n=25 Participants
|
86 Participants
n=6 Participants
|
|
Age, Customized
65 - <85 years
|
3 Participants
n=13 Participants
|
2 Participants
n=13 Participants
|
5 Participants
n=26 Participants
|
2 Participants
n=15 Participants
|
6 Participants
n=25 Participants
|
18 Participants
n=6 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=13 Participants
|
5 Participants
n=13 Participants
|
5 Participants
n=26 Participants
|
6 Participants
n=15 Participants
|
8 Participants
n=25 Participants
|
32 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=13 Participants
|
16 Participants
n=13 Participants
|
16 Participants
n=26 Participants
|
15 Participants
n=15 Participants
|
12 Participants
n=25 Participants
|
72 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
White
|
17 Participants
n=13 Participants
|
15 Participants
n=13 Participants
|
19 Participants
n=26 Participants
|
16 Participants
n=15 Participants
|
20 Participants
n=25 Participants
|
87 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Chinese
|
0 Participants
n=13 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=26 Participants
|
1 Participants
n=15 Participants
|
0 Participants
n=25 Participants
|
1 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Indian
|
0 Participants
n=13 Participants
|
1 Participants
n=13 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=25 Participants
|
1 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Korean
|
1 Participants
n=13 Participants
|
2 Participants
n=13 Participants
|
1 Participants
n=26 Participants
|
1 Participants
n=15 Participants
|
0 Participants
n=25 Participants
|
5 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Missing - Asian
|
3 Participants
n=13 Participants
|
1 Participants
n=13 Participants
|
0 Participants
n=26 Participants
|
2 Participants
n=15 Participants
|
0 Participants
n=25 Participants
|
6 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Missing - Overall
|
0 Participants
n=13 Participants
|
2 Participants
n=13 Participants
|
1 Participants
n=26 Participants
|
1 Participants
n=15 Participants
|
0 Participants
n=25 Participants
|
4 Participants
n=6 Participants
|
PRIMARY outcome
Timeframe: at Week 48Population: Full analysis set (FAS): The Full Analysis Set comprised all participants to whom study treatment has been assigned by randomization.
Percentage of participants still treated with the randomized treatment at 48 weeks and are in MR\^4.5 (BCR::ABL1 ratio of ≤ 0.0032%) at 48 weeks (± assessment window), among all participants in the asciminib add-on arms vs imatinib arm.
Outcome measures
| Measure |
Asciminib 40mg QD + Imatinib 400mg QD
n=21 Participants
Asciminib 40 mg taken once daily in combination with Imatinib 400 mg taken once daily
|
Asciminib 60mg QD + Imatinib 400mg QD
n=21 Participants
Asciminib 60 mg taken once daily in combination with Imatinib 400 mg taken once daily
|
Imatinib 400mg QD
n=21 Participants
Imatinib 400 mg taken once daily
|
Nilotinib 300mg BID
Nilotinib 300 mg taken twice daily
|
|---|---|---|---|---|
|
Molecular Response (MR)^4.5 Rate at 48 Weeks and Difference in Rate Between Asciminib + Imatinib and Imatinib Alone
|
19.0 Percentage of participants
Interval 6.8 to 38.4
|
28.6 Percentage of participants
Interval 13.2 to 48.7
|
0.0 Percentage of participants
Interval 0.0 to 13.3
|
—
|
SECONDARY outcome
Timeframe: at Week 48Population: FAS: The FAS comprised all participants to whom study treatment has been assigned by randomization.
Percentage of participants in MR\^4.5 (BCR::ABL1 ratio of ≤ 0.0032%) at 48 weeks in asciminib add-on arms vs nilotinib arm.
Outcome measures
| Measure |
Asciminib 40mg QD + Imatinib 400mg QD
n=21 Participants
Asciminib 40 mg taken once daily in combination with Imatinib 400 mg taken once daily
|
Asciminib 60mg QD + Imatinib 400mg QD
n=21 Participants
Asciminib 60 mg taken once daily in combination with Imatinib 400 mg taken once daily
|
Imatinib 400mg QD
n=21 Participants
Imatinib 400 mg taken once daily
|
Nilotinib 300mg BID
Nilotinib 300 mg taken twice daily
|
|---|---|---|---|---|
|
Rate of MR^4.5 at 48 Weeks (Asciminib add-on Arms vs Nilotinib)
|
19.0 Percentage of participants
Interval 6.8 to 38.4
|
28.6 Percentage of participants
Interval 13.2 to 48.7
|
4.8 Percentage of participants
Interval 0.2 to 20.7
|
—
|
SECONDARY outcome
Timeframe: by 48 weeksPopulation: FAS: The FAS comprised all participants to whom study treatment has been assigned by randomization.
Best observed MR\^4.5 rate (BCR::ABL1 ratio of ≤ 0.0032%) up to 48 weeks, i.e. the percentage of participants who achieved MR 4.5 anytime up to 48 weeks.
Outcome measures
| Measure |
Asciminib 40mg QD + Imatinib 400mg QD
n=21 Participants
Asciminib 40 mg taken once daily in combination with Imatinib 400 mg taken once daily
|
Asciminib 60mg QD + Imatinib 400mg QD
n=21 Participants
Asciminib 60 mg taken once daily in combination with Imatinib 400 mg taken once daily
|
Imatinib 400mg QD
n=21 Participants
Imatinib 400 mg taken once daily
|
Nilotinib 300mg BID
n=21 Participants
Nilotinib 300 mg taken twice daily
|
|---|---|---|---|---|
|
Rate of MR^4.5 by 48 Weeks (Randomized Arms)
|
19.0 Percentage of participants
Interval 6.8 to 38.4
|
28.6 Percentage of participants
Interval 13.2 to 48.7
|
0 Percentage of participants
Interval 0.0 to 13.3
|
14.3 Percentage of participants
Interval 4.0 to 32.9
|
SECONDARY outcome
Timeframe: at Week 96Population: FAS: The FAS comprised all participants to whom study treatment has been assigned by randomization.
Percentage of participants in MR\^4.5 (BCR::ABL1 ratio of ≤ 0.0032%) at 96 weeks in asciminib add-on arms vs nilotinib arm.
Outcome measures
| Measure |
Asciminib 40mg QD + Imatinib 400mg QD
n=21 Participants
Asciminib 40 mg taken once daily in combination with Imatinib 400 mg taken once daily
|
Asciminib 60mg QD + Imatinib 400mg QD
n=21 Participants
Asciminib 60 mg taken once daily in combination with Imatinib 400 mg taken once daily
|
Imatinib 400mg QD
n=21 Participants
Imatinib 400 mg taken once daily
|
Nilotinib 300mg BID
Nilotinib 300 mg taken twice daily
|
|---|---|---|---|---|
|
Rate of MR^4.5 at 96 Weeks (Randomized Arms) and Difference in Rate Between Asciminib + Imatinib and Nilotinib Alone
|
19.0 Percentage of participants
Interval 6.8 to 38.4
|
19.0 Percentage of participants
Interval 6.8 to 38.4
|
9.5 Percentage of participants
Interval 1.7 to 27.1
|
—
|
SECONDARY outcome
Timeframe: by 96 weeksPopulation: FAS: The FAS comprised all participants to whom study treatment has been assigned by randomization.
Best observed MR\^4.5 (BCR::ABL1 ratio of ≤ 0.0032%) rate up to 96 weeks, i.e. the percentage of participants who achieved MR\^4.5 anytime up to 96 weeks.
Outcome measures
| Measure |
Asciminib 40mg QD + Imatinib 400mg QD
n=21 Participants
Asciminib 40 mg taken once daily in combination with Imatinib 400 mg taken once daily
|
Asciminib 60mg QD + Imatinib 400mg QD
n=21 Participants
Asciminib 60 mg taken once daily in combination with Imatinib 400 mg taken once daily
|
Imatinib 400mg QD
n=21 Participants
Imatinib 400 mg taken once daily
|
Nilotinib 300mg BID
n=21 Participants
Nilotinib 300 mg taken twice daily
|
|---|---|---|---|---|
|
Rate of MR^4.5 by 96 Weeks (Randomized Arms)
|
28.6 Percentage of participants
Interval 13.2 to 48.7
|
28.6 Percentage of participants
Interval 13.2 to 48.7
|
9.5 Percentage of participants
Interval 1.7 to 27.1
|
19.0 Percentage of participants
Interval 6.8 to 38.4
|
SECONDARY outcome
Timeframe: at 96 weeksPopulation: FAS: The FAS comprised all participants to whom study treatment has been assigned by randomization.
Sustained MR\^4.5 (BCR::ABL1 ratio of ≤ 0.0032%) rate was defined as the percentage of participants who were in MR4.5 at 48 weeks and 96 weeks and who had no loss of MR4.5 in between those 2 time points.
Outcome measures
| Measure |
Asciminib 40mg QD + Imatinib 400mg QD
n=21 Participants
Asciminib 40 mg taken once daily in combination with Imatinib 400 mg taken once daily
|
Asciminib 60mg QD + Imatinib 400mg QD
n=21 Participants
Asciminib 60 mg taken once daily in combination with Imatinib 400 mg taken once daily
|
Imatinib 400mg QD
n=21 Participants
Imatinib 400 mg taken once daily
|
Nilotinib 300mg BID
n=21 Participants
Nilotinib 300 mg taken twice daily
|
|---|---|---|---|---|
|
Sustained MR^4.5 From at 96 Weeks (Randomized Arms)
|
14.3 Percentage of participants
Interval 4.0 to 32.9
|
9.5 Percentage of participants
Interval 1.7 to 27.1
|
0 Percentage of participants
Interval 0.0 to 13.3
|
4.8 Percentage of participants
Interval 0.2 to 20.7
|
SECONDARY outcome
Timeframe: 96 weeks after the last participant received the first study dosePopulation: MR\^4.5 responder set: This set consisted of the participants in the FAS who achieved MR\^4.5 under randomized treatment by the corresponding cut-off date.
Time to MR\^4.5 is the time from first dose to first MR\^4.5 (BCR::ABL1 ratio of ≤ 0.0032%) computed only for participants who achieved MR\^4.5 at least once before the cut-off date.
Outcome measures
| Measure |
Asciminib 40mg QD + Imatinib 400mg QD
n=7 Participants
Asciminib 40 mg taken once daily in combination with Imatinib 400 mg taken once daily
|
Asciminib 60mg QD + Imatinib 400mg QD
n=6 Participants
Asciminib 60 mg taken once daily in combination with Imatinib 400 mg taken once daily
|
Imatinib 400mg QD
n=2 Participants
Imatinib 400 mg taken once daily
|
Nilotinib 300mg BID
n=5 Participants
Nilotinib 300 mg taken twice daily
|
|---|---|---|---|---|
|
Time to MR^4.5 (Randomized Arms)
|
24.6 Weeks
Interval 8.0 to 120.0
|
12.4 Weeks
Interval 12.0 to 36.0
|
66.4 Weeks
Interval 61.0 to 72.0
|
36.3 Weeks
Interval 24.0 to 108.0
|
SECONDARY outcome
Timeframe: 96 weeks after the last participant received the first study dosePopulation: MR\^4.5 responder set: This set consisted of the subjects in the FAS who achieved MR\^4.5 under randomized treatment by the corresponding cut-off date.
Duration of MR\^4.5 was defined as the time from the first documented MR\^4.5 and the end date of MR\^4.5, i.e., the earliest date of loss of MR\^4.5 or CML-related death. Confirmed loss of MR\^4.5 is defined as an increase of the BCR::ABL1 ratio to \>0.0032% in two consecutive blood samples, by International Scale.
Outcome measures
| Measure |
Asciminib 40mg QD + Imatinib 400mg QD
n=7 Participants
Asciminib 40 mg taken once daily in combination with Imatinib 400 mg taken once daily
|
Asciminib 60mg QD + Imatinib 400mg QD
n=6 Participants
Asciminib 60 mg taken once daily in combination with Imatinib 400 mg taken once daily
|
Imatinib 400mg QD
n=2 Participants
Imatinib 400 mg taken once daily
|
Nilotinib 300mg BID
n=5 Participants
Nilotinib 300 mg taken twice daily
|
|---|---|---|---|---|
|
Duration of MR^4.5 (Randomized Arms)
|
24.1 Weeks
Interval 11.9 to
NA: Not estimable due to the small number of responders and too few events (loss of MR4.5)
|
NA Weeks
Interval 47.9 to
NA: Not estimable due to the small number of responders and too few events (loss of MR4.5)
|
24.4 Weeks
Interval 23.6 to
NA: Not estimable due to the small number of responders and too few events (loss of MR4.5)
|
NA Weeks
Interval 11.7 to
NA: Not estimable due to the small number of responders and too few events (loss of MR4.5)
|
SECONDARY outcome
Timeframe: Week 2 Day 14: pre-dose (0h), 1h, 2h, 3hr 4h and 8h post-dose; Week 4 Day 28: pre-dose (0h) 2h, 3h, 4h post-dosePopulation: Pharmacokinetic analysis set (PAS): The PAS included all participants randomized to the asciminib + imatinib arms who received at least one dose of asciminib or imatinib and provided at least one evaluable PK concentration.
The maximum (peak) observed plasma, blood, serum, or other body fluid drug concentration after single dose administration (mass x volume-1).
Outcome measures
| Measure |
Asciminib 40mg QD + Imatinib 400mg QD
n=20 Participants
Asciminib 40 mg taken once daily in combination with Imatinib 400 mg taken once daily
|
Asciminib 60mg QD + Imatinib 400mg QD
n=20 Participants
Asciminib 60 mg taken once daily in combination with Imatinib 400 mg taken once daily
|
Imatinib 400mg QD
n=19 Participants
Imatinib 400 mg taken once daily
|
Nilotinib 300mg BID
n=18 Participants
Nilotinib 300 mg taken twice daily
|
|---|---|---|---|---|
|
Pharmacokinetic Profile of Asciminib 40/60 mg and Imatinib When Administered in Combination - Cmax (Randomized Arms)
Week 2 Day 14
|
701.75 ng/mL
Geometric Coefficient of Variation 32.16
|
2562.96 ng/mL
Geometric Coefficient of Variation 29.49
|
1078.92 ng/mL
Geometric Coefficient of Variation 34.48
|
2237.83 ng/mL
Geometric Coefficient of Variation 30.42
|
|
Pharmacokinetic Profile of Asciminib 40/60 mg and Imatinib When Administered in Combination - Cmax (Randomized Arms)
Week 4 Day 28
|
720.21 ng/mL
Geometric Coefficient of Variation 25.53
|
2285.89 ng/mL
Geometric Coefficient of Variation 29.28
|
1000.70 ng/mL
Geometric Coefficient of Variation 33.50
|
2165.80 ng/mL
Geometric Coefficient of Variation 41.41
|
SECONDARY outcome
Timeframe: Week 2 Day 14: pre-dose (0h), 1h, 2h, 3hr 4h and 8h post-dose; Week 4 Day 28: pre-dose (0h) 2h, 3h, 4h post-dosePopulation: Pharmacokinetic analysis set (PAS): The PAS included all participants randomized to the asciminib + imatinib arms who received at least one dose of asciminib or imatinib and provided at least one evaluable PK concentration.
The time to reach maximum (peak) plasma, blood, serum, or other body fluid drug concentration after single dose administration (time).
Outcome measures
| Measure |
Asciminib 40mg QD + Imatinib 400mg QD
n=20 Participants
Asciminib 40 mg taken once daily in combination with Imatinib 400 mg taken once daily
|
Asciminib 60mg QD + Imatinib 400mg QD
n=20 Participants
Asciminib 60 mg taken once daily in combination with Imatinib 400 mg taken once daily
|
Imatinib 400mg QD
n=19 Participants
Imatinib 400 mg taken once daily
|
Nilotinib 300mg BID
n=18 Participants
Nilotinib 300 mg taken twice daily
|
|---|---|---|---|---|
|
Pharmacokinetic Profile of Asciminib 40/60 mg and Imatinib When Administered in Combination - Tmax (Randomized Arms)
Week 2 Day 14
|
2.76 hour (hr)
Geometric Coefficient of Variation 57.38
|
3.05 hour (hr)
Geometric Coefficient of Variation 36.31
|
2.30 hour (hr)
Geometric Coefficient of Variation 44.15
|
2.40 hour (hr)
Geometric Coefficient of Variation 59.04
|
|
Pharmacokinetic Profile of Asciminib 40/60 mg and Imatinib When Administered in Combination - Tmax (Randomized Arms)
Week 4 Day 28
|
2.67 hour (hr)
Geometric Coefficient of Variation 29.62
|
2.61 hour (hr)
Geometric Coefficient of Variation 29.97
|
2.61 hour (hr)
Geometric Coefficient of Variation 28.33
|
2.80 hour (hr)
Geometric Coefficient of Variation 25.99
|
SECONDARY outcome
Timeframe: Week 2 Day 14: pre-dose (0h), Week 4 Day 28: pre-dose (0h)Population: Pharmacokinetic analysis set (PAS): The PAS included all participants randomized to the asciminib + imatinib arms who received at least one dose of asciminib or imatinib and provided at least one evaluable PK concentration.
Minimum drug plasma(serum/blood) concentration
Outcome measures
| Measure |
Asciminib 40mg QD + Imatinib 400mg QD
n=20 Participants
Asciminib 40 mg taken once daily in combination with Imatinib 400 mg taken once daily
|
Asciminib 60mg QD + Imatinib 400mg QD
n=20 Participants
Asciminib 60 mg taken once daily in combination with Imatinib 400 mg taken once daily
|
Imatinib 400mg QD
n=19 Participants
Imatinib 400 mg taken once daily
|
Nilotinib 300mg BID
n=18 Participants
Nilotinib 300 mg taken twice daily
|
|---|---|---|---|---|
|
Pharmacokinetic Profile of Asciminib 40/60 mg and Imatinib When Administered in Combination - Cmin (Randomized Arms)
Week 2 Day 14
|
175 ng/mL
Geometric Coefficient of Variation 41.2
|
1050 ng/mL
Geometric Coefficient of Variation 39.1
|
221 ng/mL
Geometric Coefficient of Variation 62.7
|
904 ng/mL
Geometric Coefficient of Variation 62.4
|
|
Pharmacokinetic Profile of Asciminib 40/60 mg and Imatinib When Administered in Combination - Cmin (Randomized Arms)
Week 4 Day 28 (n = 20, 20, 18, 18)
|
152 ng/mL
Geometric Coefficient of Variation 58.5
|
962 ng/mL
Geometric Coefficient of Variation 39.3
|
249 ng/mL
Geometric Coefficient of Variation 52.6
|
894 ng/mL
Geometric Coefficient of Variation 39.8
|
SECONDARY outcome
Timeframe: Week 2 Day 14: pre-dose (0h), 1h, 2h, 3hr 4h and 8h post-dosePopulation: Pharmacokinetic analysis set (PAS): The PAS included all participants randomized to the asciminib + imatinib arms who received at least one dose of asciminib or imatinib and provided at least one evaluable PK concentration.
The AUC from time zero to the last measurable concentration sampling time (Tlast) (mass x time x volume-1).
Outcome measures
| Measure |
Asciminib 40mg QD + Imatinib 400mg QD
n=20 Participants
Asciminib 40 mg taken once daily in combination with Imatinib 400 mg taken once daily
|
Asciminib 60mg QD + Imatinib 400mg QD
n=20 Participants
Asciminib 60 mg taken once daily in combination with Imatinib 400 mg taken once daily
|
Imatinib 400mg QD
n=19 Participants
Imatinib 400 mg taken once daily
|
Nilotinib 300mg BID
n=18 Participants
Nilotinib 300 mg taken twice daily
|
|---|---|---|---|---|
|
Pharmacokinetic Profile of Asciminib 40/60 mg and Imatinib When Administered in Combination - AUClast (Randomized Arms)
|
8683.46 hr*ng/mL
Geometric Coefficient of Variation 47.19
|
37900.51 hr*ng/mL
Geometric Coefficient of Variation 47.43
|
11889.74 hr*ng/mL
Geometric Coefficient of Variation 38.07
|
34090.56 hr*ng/mL
Geometric Coefficient of Variation 44.54
|
SECONDARY outcome
Timeframe: Week 2 Day 14: pre-dose (0h), 1h, 2h, 3hr 4h and 8h post-dosePopulation: Pharmacokinetic analysis set (PAS): The PAS included all participants randomized to the asciminib + imatinib arms who received at least one dose of asciminib or imatinib and provided at least one evaluable PK concentration.
The AUC calculated to the end of a dosing interval (tau) at steady-state
Outcome measures
| Measure |
Asciminib 40mg QD + Imatinib 400mg QD
n=10 Participants
Asciminib 40 mg taken once daily in combination with Imatinib 400 mg taken once daily
|
Asciminib 60mg QD + Imatinib 400mg QD
n=5 Participants
Asciminib 60 mg taken once daily in combination with Imatinib 400 mg taken once daily
|
Imatinib 400mg QD
n=6 Participants
Imatinib 400 mg taken once daily
|
Nilotinib 300mg BID
n=2 Participants
Nilotinib 300 mg taken twice daily
|
|---|---|---|---|---|
|
Pharmacokinetic Profile of Asciminib 40/60 mg and Imatinib When Administered in Combination - AUCtau (Randomized Arms)
|
9137.59 hr*ng/mL
Geometric Coefficient of Variation 37.90
|
43794.83 hr*ng/mL
Geometric Coefficient of Variation 23.93
|
12315.06 hr*ng/mL
Geometric Coefficient of Variation 39.45
|
37440.73 hr*ng/mL
Geometric Coefficient of Variation 11.13
|
SECONDARY outcome
Timeframe: at Week 48Population: Full analysis set - ASAC: The full analysis set - ASAC (FAS-ASAC) includes all participants assigned to the ASAC.
Percentage of participants on asciminib 80 mg QD with MR\^4.5 (BCR::ABL1 ratio of ≤ 0.0032%) at 48 weeks.
Outcome measures
| Measure |
Asciminib 40mg QD + Imatinib 400mg QD
n=20 Participants
Asciminib 40 mg taken once daily in combination with Imatinib 400 mg taken once daily
|
Asciminib 60mg QD + Imatinib 400mg QD
Asciminib 60 mg taken once daily in combination with Imatinib 400 mg taken once daily
|
Imatinib 400mg QD
Imatinib 400 mg taken once daily
|
Nilotinib 300mg BID
Nilotinib 300 mg taken twice daily
|
|---|---|---|---|---|
|
Molecular Response (MR) 4.5 Rate at 48 Weeks (Asciminib Single Agent Cohort (ASAC))
|
35.0 Percentage of participants
Interval 17.7 to 55.8
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 48 weeks after the last enrolled participant (asciminib 80 mg cohort) received the first study dosePopulation: MR4.5 Responder Set - ASAC: consisted of the participants in the FAS-ASAC who achieved MR\^4.5 under treatment by the cut-off date.
Time from first dose of asciminib 80 mg QD to first MR\^4.5 (BCR::ABL1 ratio of ≤ 0.0032%) computed only for participants who achieved MR\^4.5.
Outcome measures
| Measure |
Asciminib 40mg QD + Imatinib 400mg QD
n=9 Participants
Asciminib 40 mg taken once daily in combination with Imatinib 400 mg taken once daily
|
Asciminib 60mg QD + Imatinib 400mg QD
Asciminib 60 mg taken once daily in combination with Imatinib 400 mg taken once daily
|
Imatinib 400mg QD
Imatinib 400 mg taken once daily
|
Nilotinib 300mg BID
Nilotinib 300 mg taken twice daily
|
|---|---|---|---|---|
|
Time to MR^4.5 (ASAC)
|
24.3 Weeks
Interval 8.0 to 61.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 48 weeks after the last enrolled participant (asciminib 80 mg cohort) received the first study dosePopulation: MR4.5 Responder Set - ASAC: consisted of the participants in the FAS-ASAC who achieved MR\^4.5 under treatment by the cut-off date.
Time from first MR\^4.5 (BCR::ABL1 ratio of ≤ 0.0032%) until confirmed loss of MR\^4.5 or CML-related death.
Outcome measures
| Measure |
Asciminib 40mg QD + Imatinib 400mg QD
n=9 Participants
Asciminib 40 mg taken once daily in combination with Imatinib 400 mg taken once daily
|
Asciminib 60mg QD + Imatinib 400mg QD
Asciminib 60 mg taken once daily in combination with Imatinib 400 mg taken once daily
|
Imatinib 400mg QD
Imatinib 400 mg taken once daily
|
Nilotinib 300mg BID
Nilotinib 300 mg taken twice daily
|
|---|---|---|---|---|
|
Duration of MR^4.5 (ASAC)
|
24.1 Weeks
Interval 0.0 to 76.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 2 Day 14: 0h (pre-dose), 1h, 2h, 3h, 4h, 8h post-dose; Week 4 Day 28: 0h (pre-dose), 2h, 3h, 4h post-dosePopulation: Pharmacokinetic Analysis Set - ASAC PAS-ASAC): includes all participants assigned to the ASAC who received at least one dose of asciminib 80 mg QD and provide at least one evaluable PK concentration.
The maximum (peak) observed plasma drug concentration after oral dose administration (mass x volume-1).
Outcome measures
| Measure |
Asciminib 40mg QD + Imatinib 400mg QD
n=19 Participants
Asciminib 40 mg taken once daily in combination with Imatinib 400 mg taken once daily
|
Asciminib 60mg QD + Imatinib 400mg QD
Asciminib 60 mg taken once daily in combination with Imatinib 400 mg taken once daily
|
Imatinib 400mg QD
Imatinib 400 mg taken once daily
|
Nilotinib 300mg BID
Nilotinib 300 mg taken twice daily
|
|---|---|---|---|---|
|
Pharmacokinetic Profile of Asciminib 80mg QD - Cmax (ASAC)
Week 2 Day 14
|
1319.32 ng/mL
Geometric Coefficient of Variation 39.70
|
—
|
—
|
—
|
|
Pharmacokinetic Profile of Asciminib 80mg QD - Cmax (ASAC)
Week 4 Day 28
|
1250.01 ng/mL
Geometric Coefficient of Variation 47.95
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 2 Day 14: 0h (pre-dose), 1h, 2h, 3h, 4h, 8h post-dose; Week 4 Day 28: 0h (pre-dose), 2h, 3h, 4h post-dosePopulation: Pharmacokinetic Analysis Set - ASAC PAS-ASAC): includes all participants assigned to the ASAC who received at least one dose of asciminib 80 mg QD and provide at least one evaluable PK concentration.
The time to reach maximum (Cmax) plasma drug concentration after oral dose administration (time).
Outcome measures
| Measure |
Asciminib 40mg QD + Imatinib 400mg QD
n=19 Participants
Asciminib 40 mg taken once daily in combination with Imatinib 400 mg taken once daily
|
Asciminib 60mg QD + Imatinib 400mg QD
Asciminib 60 mg taken once daily in combination with Imatinib 400 mg taken once daily
|
Imatinib 400mg QD
Imatinib 400 mg taken once daily
|
Nilotinib 300mg BID
Nilotinib 300 mg taken twice daily
|
|---|---|---|---|---|
|
Pharmacokinetic Profile of Asciminib 80mg QD - Tmax (ASAC)
Week 2 Day 14
|
1.93 hour (hr)
Geometric Coefficient of Variation 89.09
|
—
|
—
|
—
|
|
Pharmacokinetic Profile of Asciminib 80mg QD - Tmax (ASAC)
Week 4 Day 28
|
2.22 hour (hr)
Geometric Coefficient of Variation 24.38
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 2 Day 14: 0h (pre-dose), Week 4 Day 28: 0h (pre-dose)Population: Pharmacokinetic Analysis Set - ASAC PAS-ASAC): includes all participants assigned to the ASAC who received at least one dose of asciminib 80 mg QD and provide at least one evaluable PK concentration.
Minimum drug plasma (serum/blood) concentration
Outcome measures
| Measure |
Asciminib 40mg QD + Imatinib 400mg QD
n=19 Participants
Asciminib 40 mg taken once daily in combination with Imatinib 400 mg taken once daily
|
Asciminib 60mg QD + Imatinib 400mg QD
Asciminib 60 mg taken once daily in combination with Imatinib 400 mg taken once daily
|
Imatinib 400mg QD
Imatinib 400 mg taken once daily
|
Nilotinib 300mg BID
Nilotinib 300 mg taken twice daily
|
|---|---|---|---|---|
|
Pharmacokinetic Profile of Asciminib 80mg QD - Cmin (ASAC)
Week 2 Day 14
|
169 ng/mL
Geometric Coefficient of Variation 53.1
|
—
|
—
|
—
|
|
Pharmacokinetic Profile of Asciminib 80mg QD - Cmin (ASAC)
Week 4 Day 28 (n = 18)
|
171 ng/mL
Geometric Coefficient of Variation 52.1
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 2 Day 14: 0h (pre-dose), 1h, 2h, 3h, 4h, 8h post-dosePopulation: Pharmacokinetic Analysis Set - ASAC PAS-ASAC): includes all participants assigned to the ASAC who received at least one dose of asciminib 80 mg QD and provide at least one evaluable PK concentration.
The AUC from time zero to the last measurable concentration sampling time (Tlast) (mass x time x volume-1).
Outcome measures
| Measure |
Asciminib 40mg QD + Imatinib 400mg QD
n=19 Participants
Asciminib 40 mg taken once daily in combination with Imatinib 400 mg taken once daily
|
Asciminib 60mg QD + Imatinib 400mg QD
Asciminib 60 mg taken once daily in combination with Imatinib 400 mg taken once daily
|
Imatinib 400mg QD
Imatinib 400 mg taken once daily
|
Nilotinib 300mg BID
Nilotinib 300 mg taken twice daily
|
|---|---|---|---|---|
|
Pharmacokinetic Profile of Asciminib 80mg QD - AUClast (ASAC)
|
13363.35 hr*ng/mL
Geometric Coefficient of Variation 48.33
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 2 Day 14: 0h (pre-dose), 1h, 2h, 3h, 4h, 8h post-dosePopulation: Pharmacokinetic Analysis Set - ASAC PAS-ASAC): includes all participants assigned to the ASAC who received at least one dose of asciminib 80 mg QD and provide at least one evaluable PK concentration.
The AUC calculated to the end of a dosing interval (tau) at steady-state (amount x time x volume-1)
Outcome measures
| Measure |
Asciminib 40mg QD + Imatinib 400mg QD
n=8 Participants
Asciminib 40 mg taken once daily in combination with Imatinib 400 mg taken once daily
|
Asciminib 60mg QD + Imatinib 400mg QD
Asciminib 60 mg taken once daily in combination with Imatinib 400 mg taken once daily
|
Imatinib 400mg QD
Imatinib 400 mg taken once daily
|
Nilotinib 300mg BID
Nilotinib 300 mg taken twice daily
|
|---|---|---|---|---|
|
Pharmacokinetic Profile of Asciminib 80mg QD - AUCtau (ASAC)
|
13725.57 hr*ng/mL
Geometric Coefficient of Variation 47.31
|
—
|
—
|
—
|
Adverse Events
On-treatment Period Asciminib 40 mg + Imatinib
Serious events: 3 serious events
Other events: 20 other events
Deaths: 1 deaths
On-treatment Period Asciminib 60 mg + Imatinib
Serious events: 4 serious events
Other events: 18 other events
Deaths: 0 deaths
On-treatment Period Imatinib
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
On-treatment Period Nilotinib
Serious events: 5 serious events
Other events: 21 other events
Deaths: 0 deaths
On-treatment Period Asciminib 80 mg
Serious events: 2 serious events
Other events: 18 other events
Deaths: 0 deaths
On-treatment Period Switched From Imatinib to Asciminib 60 mg Combo
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Post-treatment Period Asciminib 40 mg + Imatinib
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Post-treatment Period Asciminib 60 mg + Imatinib
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Post-treatment Period Imatinib
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Post-treatment Period Nilotinib
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Post-treatment Period Asciminib 80 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Post-treatment Period Switched From Imatinib to Asciminib 60 mg Combo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
On-treatment Period Asciminib 40 mg + Imatinib
n=21 participants at risk
On-treatment period Asciminib 40 mg + imatinib from first dose of treatment to 30 days post-treatment.
|
On-treatment Period Asciminib 60 mg + Imatinib
n=21 participants at risk
On-treatment period Asciminib 60 mg + imatinib from first dose of treatment to 30 days post-treatment.
|
On-treatment Period Imatinib
n=20 participants at risk
On-treatment period Imatinib from first dose of treatment to 30 days post-treatment.
|
On-treatment Period Nilotinib
n=21 participants at risk
On-treatment period Nilotinib from first dose of treatment to 30 days post-treatment.
|
On-treatment Period Asciminib 80 mg
n=20 participants at risk
On-treatment period Asciminib 80 mg from first dose of treatment to 30 days post-treatment.
|
On-treatment Period Switched From Imatinib to Asciminib 60 mg Combo
n=14 participants at risk
On-treatment period Switched from Imatinib to Asciminib 60 mg combo from date of switch to 30 days post-treatment.
|
Post-treatment Period Asciminib 40 mg + Imatinib
n=18 participants at risk
Post-treatment period Asciminib 40 mg + imatinib from Day 31 to end of study.
|
Post-treatment Period Asciminib 60 mg + Imatinib
n=18 participants at risk
Post-treatment period Asciminib 60 mg + imatinib from Day 31 to end of study.
|
Post-treatment Period Imatinib
n=19 participants at risk
Post-treatment period Imatinib from Day 31 to end of study.
|
Post-treatment Period Nilotinib
n=19 participants at risk
Post-treatment period Nilotinib from Day 31 to end of study.
|
Post-treatment Period Asciminib 80 mg
n=20 participants at risk
Post-treatment period Asciminib 80 mg from Day 31 to end of study.
|
Post-treatment Period Switched From Imatinib to Asciminib 60 mg Combo
n=14 participants at risk
Post-treatment period Switched from Imatinib to Asciminib 60 mg combo from Day 31 after switch to end of study.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Cardiac arrest
|
4.8%
1/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Gastrointestinal disorders
Appendiceal mucocoele
|
0.00%
0/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
4.8%
1/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
4.8%
1/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Gastrointestinal disorders
Oedematous pancreatitis
|
0.00%
0/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
5.0%
1/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
4.8%
1/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
4.8%
1/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Infections and infestations
Abscess intestinal
|
0.00%
0/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
5.0%
1/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
4.8%
1/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Infections and infestations
COVID-19
|
0.00%
0/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
4.8%
1/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Infections and infestations
COVID-19 pneumonia
|
4.8%
1/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Infections and infestations
Diverticulitis intestinal perforated
|
0.00%
0/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
5.0%
1/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Infections and infestations
Urinary tract infection
|
4.8%
1/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
5.0%
1/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Investigations
Lipase increased
|
0.00%
0/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
4.8%
1/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
4.8%
1/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.00%
0/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
4.8%
1/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
4.8%
1/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostatic adenoma
|
0.00%
0/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
7.1%
1/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
4.8%
1/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
Other adverse events
| Measure |
On-treatment Period Asciminib 40 mg + Imatinib
n=21 participants at risk
On-treatment period Asciminib 40 mg + imatinib from first dose of treatment to 30 days post-treatment.
|
On-treatment Period Asciminib 60 mg + Imatinib
n=21 participants at risk
On-treatment period Asciminib 60 mg + imatinib from first dose of treatment to 30 days post-treatment.
|
On-treatment Period Imatinib
n=20 participants at risk
On-treatment period Imatinib from first dose of treatment to 30 days post-treatment.
|
On-treatment Period Nilotinib
n=21 participants at risk
On-treatment period Nilotinib from first dose of treatment to 30 days post-treatment.
|
On-treatment Period Asciminib 80 mg
n=20 participants at risk
On-treatment period Asciminib 80 mg from first dose of treatment to 30 days post-treatment.
|
On-treatment Period Switched From Imatinib to Asciminib 60 mg Combo
n=14 participants at risk
On-treatment period Switched from Imatinib to Asciminib 60 mg combo from date of switch to 30 days post-treatment.
|
Post-treatment Period Asciminib 40 mg + Imatinib
n=18 participants at risk
Post-treatment period Asciminib 40 mg + imatinib from Day 31 to end of study.
|
Post-treatment Period Asciminib 60 mg + Imatinib
n=18 participants at risk
Post-treatment period Asciminib 60 mg + imatinib from Day 31 to end of study.
|
Post-treatment Period Imatinib
n=19 participants at risk
Post-treatment period Imatinib from Day 31 to end of study.
|
Post-treatment Period Nilotinib
n=19 participants at risk
Post-treatment period Nilotinib from Day 31 to end of study.
|
Post-treatment Period Asciminib 80 mg
n=20 participants at risk
Post-treatment period Asciminib 80 mg from Day 31 to end of study.
|
Post-treatment Period Switched From Imatinib to Asciminib 60 mg Combo
n=14 participants at risk
Post-treatment period Switched from Imatinib to Asciminib 60 mg combo from Day 31 after switch to end of study.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
9.5%
2/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
4.8%
1/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
4.8%
1/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Congenital, familial and genetic disorders
Gilbert's syndrome
|
0.00%
0/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
14.3%
3/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Ear and labyrinth disorders
Tinnitus
|
9.5%
2/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
10.0%
2/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Eye disorders
Dry eye
|
4.8%
1/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
7.1%
1/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
4.8%
1/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
9.5%
2/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
15.0%
3/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
7.1%
1/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
9.5%
2/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
4.8%
1/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
9.5%
2/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
25.0%
5/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Gastrointestinal disorders
Constipation
|
4.8%
1/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
5.0%
1/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
14.3%
3/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
10.0%
2/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Gastrointestinal disorders
Diarrhoea
|
23.8%
5/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
14.3%
3/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
15.0%
3/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
4.8%
1/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
14.3%
2/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.00%
0/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
10.0%
2/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Gastrointestinal disorders
Nausea
|
33.3%
7/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
14.3%
3/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
10.0%
2/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
14.3%
3/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
10.0%
2/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
14.3%
2/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
9.5%
2/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Gastrointestinal disorders
Vomiting
|
9.5%
2/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
4.8%
1/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
10.0%
2/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
4.8%
1/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
10.0%
2/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
7.1%
1/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
General disorders
Drug withdrawal syndrome
|
0.00%
0/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
10.0%
2/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
General disorders
Facial pain
|
0.00%
0/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
7.1%
1/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
General disorders
Fatigue
|
14.3%
3/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
9.5%
2/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
9.5%
2/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
10.0%
2/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Infections and infestations
COVID-19
|
19.0%
4/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
42.9%
9/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
10.0%
2/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
23.8%
5/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
10.0%
2/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
14.3%
2/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Infections and infestations
Conjunctivitis
|
9.5%
2/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
5.0%
1/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
5.0%
1/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
14.3%
3/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Infections and infestations
Nasopharyngitis
|
4.8%
1/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
9.5%
2/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
5.0%
1/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
10.0%
2/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Infections and infestations
Periodontitis
|
0.00%
0/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
7.1%
1/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Infections and infestations
Respiratory tract infection
|
4.8%
1/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
10.0%
2/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
4.8%
1/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
14.3%
2/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Infections and infestations
Urinary tract infection
|
9.5%
2/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
4.8%
1/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
5.0%
1/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
4.8%
1/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
5.0%
1/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Infections and infestations
Viral infection
|
0.00%
0/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
4.8%
1/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
15.0%
3/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
7.1%
1/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Investigations
Alanine aminotransferase increased
|
9.5%
2/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
4.8%
1/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
23.8%
5/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
10.0%
2/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Investigations
Amylase increased
|
4.8%
1/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
4.8%
1/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
10.0%
2/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
4.8%
1/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
10.0%
2/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Investigations
Aspartate aminotransferase increased
|
9.5%
2/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
4.8%
1/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
14.3%
3/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
5.0%
1/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Investigations
Blood bilirubin increased
|
4.8%
1/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
14.3%
3/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
4.8%
1/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
14.3%
3/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
5.0%
1/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Investigations
Blood creatine phosphokinase increased
|
14.3%
3/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
19.0%
4/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
10.0%
2/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
4.8%
1/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
5.0%
1/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Investigations
Blood creatinine increased
|
9.5%
2/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
9.5%
2/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Investigations
Blood phosphorus decreased
|
9.5%
2/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
4.8%
1/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
5.0%
1/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Investigations
Gamma-glutamyltransferase increased
|
4.8%
1/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
9.5%
2/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
15.0%
3/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Investigations
Lipase increased
|
19.0%
4/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
19.0%
4/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
15.0%
3/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
9.5%
2/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
25.0%
5/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
14.3%
2/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
7.1%
1/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
9.5%
2/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
4.8%
1/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
10.0%
2/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
9.5%
2/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
5.0%
1/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
10.0%
2/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
9.5%
2/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
9.5%
2/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
15.0%
3/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
9.5%
2/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
14.3%
2/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
4.8%
1/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
10.0%
2/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.8%
1/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
5.0%
1/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
4.8%
1/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
30.0%
6/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
14.3%
2/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
7.1%
1/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.8%
1/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
4.8%
1/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
9.5%
2/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
5.0%
1/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
7.1%
1/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
4.8%
1/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
5.0%
1/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
7.1%
1/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
14.3%
3/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
5.0%
1/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
4.8%
1/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
5.0%
1/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Nervous system disorders
Headache
|
14.3%
3/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
4.8%
1/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
9.5%
2/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
10.0%
2/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
23.8%
5/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
4.8%
1/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
5.0%
1/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
9.5%
2/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
15.0%
3/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
7.1%
1/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
4.8%
1/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
7.1%
1/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
4.8%
1/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
4.8%
1/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
15.0%
3/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
5.0%
1/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
7.1%
1/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Nervous system disorders
Dizziness
|
4.8%
1/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
4.8%
1/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
7.1%
1/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Nervous system disorders
Migraine
|
0.00%
0/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
10.0%
2/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
4.8%
1/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
10.0%
2/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
4.8%
1/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
5.0%
1/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
7.1%
1/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Psychiatric disorders
Anxiety
|
4.8%
1/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
4.8%
1/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
10.0%
2/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
7.1%
1/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
7.1%
1/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
4.8%
1/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
7.1%
1/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
14.3%
3/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
19.0%
4/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
4.8%
1/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Skin and subcutaneous tissue disorders
Blood blister
|
0.00%
0/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
7.1%
1/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
9.5%
2/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
14.3%
3/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
19.0%
4/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
4.8%
1/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
9.5%
2/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
5.0%
1/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
7.1%
1/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Skin and subcutaneous tissue disorders
Rash
|
19.0%
4/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
4.8%
1/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
5.0%
1/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
38.1%
8/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
20.0%
4/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
7.1%
1/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Vascular disorders
Hot flush
|
0.00%
0/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
7.1%
1/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Vascular disorders
Hypertension
|
4.8%
1/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
4.8%
1/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
5.0%
1/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
14.3%
3/21 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
10.0%
2/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
14.3%
2/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/18 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/19 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/20 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/14 • From first dose of study treatment to 30 days after last dose of study treatment for a minimum of 48 weeks and a maximum of 196 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
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 pooled data (i.e., data from all sites) in clinical trial or disclosure of trial results in their entirety.
- Publication restrictions are in place
Restriction type: OTHER