Trial Outcomes & Findings for Extension Study of AG-348 in Adult Participants With Pyruvate Kinase Deficiency Previously Enrolled in AG-348-006 or AG348-C-007 (NCT NCT03853798)
NCT ID: NCT03853798
Last Updated: 2025-11-18
Results Overview
A clinical adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the study drug. TEAEs are AEs with an initial onset date during the on-treatment period or worsening from baseline and include both serious and non-serious TEAEs. Severity of AEs was evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE; Version 4.03): grade 1: mild; grade 2: moderate; grade 3: severe or medically significant but not immediately life-threatening; grade 4: life threatening or disabling; grade 5: death related to AE.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
90 participants
Primary outcome timeframe
Up to 197 weeks
Results posted on
2025-11-18
Participant Flow
Participants were enrolled at 42 investigative sites in Denmark, France, Italy, Spain, Germany, United Kingdom, Netherlands, Ireland, Switzerland, United States, Canada, Japan, Korea, Thailand, Brazil and Turkey from 21 March 2019 to 03 July 2024.
A total of 90 participants who had completed Study AG348-C-006 (NCT03548220) or AG348-C-007 (NCT03559699), were enrolled in this extension study to receive mitapivat treatment. Participants were assigned to Cohorts 1, 2 or 3 depending on the previous treatment received in the antecedent studies.
Participant milestones
| Measure |
Cohort 1: 5 mg
Participants who received placebo in Study AG348-C-006 and met the eligibility criteria of this extension study were enrolled to receive mitapivat tablets, 5 milligrams (mg), twice daily (BID), administered orally, for 4 weeks as a starting dose, followed by two potential sequential dose level increases to 20 mg and 50 mg BID at Weeks 4 and 8 respectively as determined by the investigator based on safety and efficacy. The optimized dose for each participant was determined as 5 mg, BID, at Week 12, which was followed for a period of 12 weeks (Weeks 13-24) as a fixed dose and then from Week 25 to Week 193, until study withdrawal, or the study was closed.
|
Cohort 1: 20 mg
Participants who received placebo in Study AG348-C-006 and met the eligibility criteria of this extension study were enrolled to receive mitapivat tablets, 5 mg, BID, administered orally, for 4 weeks as a starting dose, followed by two potential sequential dose level increases to 20 mg and 50 mg BID at Weeks 4 and 8 respectively as determined by the investigator based on safety and efficacy. The optimized dose for each participant was determined as 20 mg, BID, at Week 12, which was followed for a period of 12 weeks (Weeks 13-24) as a fixed dose and then from Week 25 to Week 193, until study withdrawal, or the study was closed.
|
Cohort 1: 50 mg
Participants who received placebo in Study AG348-C-006 and met the eligibility criteria of this extension study were enrolled to receive mitapivat tablets, 5 mg, BID, administered orally, for 4 weeks as a starting dose, followed by two potential sequential dose level increases to 20 mg and 50 mg BID at Weeks 4 and 8 respectively as determined by the investigator based on safety and efficacy. The optimized dose for each participant was determined as 50 mg, BID, at Week 12, which was followed for a period of 12 weeks (Weeks 13-24) as a fixed dose and then from Week 25 to Week 193, until study withdrawal, or the study was closed.
|
Cohort 2: 5 mg
Participants who received mitapivat at a dose of 5 mg, BID, in the fixed dose period of Study AG348-C-006 and met the eligibility criteria of this extension study continued to receive the same mitapivat dose up to Week 193 or until study withdrawal, or the study was closed.
|
Cohort 2: 20 mg
Participants who received mitapivat at a dose of 20 mg, BID, in the fixed dose period of Study AG348-C-006 and met the eligibility criteria of this extension study continued to receive the same mitapivat dose up to Week 193 or until study withdrawal, or the study was closed.
|
Cohort 2: 50 mg
Participants who received mitapivat at a dose of 50 mg, BID, in the fixed dose period of Study AG348-C-006 and met the eligibility criteria of this extension study continued to receive the same mitapivat dose up to Week 193 or until study withdrawal, or the study was closed.
|
Cohort 3: 5 mg
Participants who received mitapivat at a dose of 5 mg, BID, in the fixed dose period of Study AG348-C-007 and met the eligibility criteria of this extension study continued to receive the same mitapivat dose up to Week 193 or until study withdrawal, or the study was closed.
|
Cohort 3: 20 mg
Participants who received mitapivat at a dose of 20 mg, BID, in the fixed dose period of Study AG348-C-007 and met the eligibility criteria of this extension study continued to receive the same mitapivat dose up to Week 193 or until study withdrawal, or the study was closed.
|
Cohort 3: 50 mg
Participants who received mitapivat at a dose of 50 mg, BID, in the fixed dose period of Study AG348-C-007 and met the eligibility criteria of this extension study continued to receive the same mitapivat dose up to Week 193 or until study withdrawal, or the study was closed.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
1
|
1
|
36
|
2
|
3
|
30
|
0
|
1
|
16
|
|
Overall Study
COMPLETED
|
0
|
0
|
25
|
2
|
3
|
22
|
0
|
1
|
10
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
11
|
0
|
0
|
8
|
0
|
0
|
6
|
Reasons for withdrawal
| Measure |
Cohort 1: 5 mg
Participants who received placebo in Study AG348-C-006 and met the eligibility criteria of this extension study were enrolled to receive mitapivat tablets, 5 milligrams (mg), twice daily (BID), administered orally, for 4 weeks as a starting dose, followed by two potential sequential dose level increases to 20 mg and 50 mg BID at Weeks 4 and 8 respectively as determined by the investigator based on safety and efficacy. The optimized dose for each participant was determined as 5 mg, BID, at Week 12, which was followed for a period of 12 weeks (Weeks 13-24) as a fixed dose and then from Week 25 to Week 193, until study withdrawal, or the study was closed.
|
Cohort 1: 20 mg
Participants who received placebo in Study AG348-C-006 and met the eligibility criteria of this extension study were enrolled to receive mitapivat tablets, 5 mg, BID, administered orally, for 4 weeks as a starting dose, followed by two potential sequential dose level increases to 20 mg and 50 mg BID at Weeks 4 and 8 respectively as determined by the investigator based on safety and efficacy. The optimized dose for each participant was determined as 20 mg, BID, at Week 12, which was followed for a period of 12 weeks (Weeks 13-24) as a fixed dose and then from Week 25 to Week 193, until study withdrawal, or the study was closed.
|
Cohort 1: 50 mg
Participants who received placebo in Study AG348-C-006 and met the eligibility criteria of this extension study were enrolled to receive mitapivat tablets, 5 mg, BID, administered orally, for 4 weeks as a starting dose, followed by two potential sequential dose level increases to 20 mg and 50 mg BID at Weeks 4 and 8 respectively as determined by the investigator based on safety and efficacy. The optimized dose for each participant was determined as 50 mg, BID, at Week 12, which was followed for a period of 12 weeks (Weeks 13-24) as a fixed dose and then from Week 25 to Week 193, until study withdrawal, or the study was closed.
|
Cohort 2: 5 mg
Participants who received mitapivat at a dose of 5 mg, BID, in the fixed dose period of Study AG348-C-006 and met the eligibility criteria of this extension study continued to receive the same mitapivat dose up to Week 193 or until study withdrawal, or the study was closed.
|
Cohort 2: 20 mg
Participants who received mitapivat at a dose of 20 mg, BID, in the fixed dose period of Study AG348-C-006 and met the eligibility criteria of this extension study continued to receive the same mitapivat dose up to Week 193 or until study withdrawal, or the study was closed.
|
Cohort 2: 50 mg
Participants who received mitapivat at a dose of 50 mg, BID, in the fixed dose period of Study AG348-C-006 and met the eligibility criteria of this extension study continued to receive the same mitapivat dose up to Week 193 or until study withdrawal, or the study was closed.
|
Cohort 3: 5 mg
Participants who received mitapivat at a dose of 5 mg, BID, in the fixed dose period of Study AG348-C-007 and met the eligibility criteria of this extension study continued to receive the same mitapivat dose up to Week 193 or until study withdrawal, or the study was closed.
|
Cohort 3: 20 mg
Participants who received mitapivat at a dose of 20 mg, BID, in the fixed dose period of Study AG348-C-007 and met the eligibility criteria of this extension study continued to receive the same mitapivat dose up to Week 193 or until study withdrawal, or the study was closed.
|
Cohort 3: 50 mg
Participants who received mitapivat at a dose of 50 mg, BID, in the fixed dose period of Study AG348-C-007 and met the eligibility criteria of this extension study continued to receive the same mitapivat dose up to Week 193 or until study withdrawal, or the study was closed.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Death
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Adverse Event
|
0
|
0
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
4
|
0
|
0
|
5
|
0
|
0
|
4
|
|
Overall Study
Physician Decision
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Lack of Efficacy
|
0
|
0
|
2
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Approved Drug Available for Indication
|
0
|
0
|
1
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Other un-specified
|
0
|
0
|
2
|
0
|
0
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Number analyzed is the number of participants that were evaluable for analysis at the baseline.
Baseline characteristics by cohort
| Measure |
Cohort 1
n=38 Participants
Participants who received placebo in Study AG348-C-006 and met the eligibility criteria of this extension study were enrolled to receive mitapivat tablets, 5 mg, BID, administered orally, for 4 weeks as a starting dose, followed by two potential sequential dose level increases to 20 mg and 50 mg BID at Weeks 4 and 8 respectively as determined by the investigator based on safety and efficacy. The optimized dose for each participant was determined at Week 12, and participants then received that optimized dose for a period of 12 weeks (Weeks 13-24) as a fixed dose and from Week 25 to Week 193, until study withdrawal, or the study was closed.
|
Cohort 2
n=35 Participants
Participants who received mitapivat at a dose of 5 mg, 20 mg, or 50 mg, BID, in the fixed dose period of Study AG348-C-006 and met the eligibility criteria of this extension study continued to receive the same mitapivat dose up to Week 193 or until study withdrawal, or the study was closed.
|
Cohort 3
n=17 Participants
Participants who received mitapivat at a dose of 5 mg, 20 mg, or 50 mg, BID, in the fixed dose period of Study AG348-C-007 and met the eligibility criteria of this extension study continued to receive the same mitapivat dose up to Week 193 or until study withdrawal, or the study was closed.
|
Total
n=90 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
38.0 Years
STANDARD_DEVIATION 15.95 • n=38 Participants
|
36.9 Years
STANDARD_DEVIATION 15.77 • n=35 Participants
|
36.9 Years
STANDARD_DEVIATION 15.09 • n=17 Participants
|
37.4 Years
STANDARD_DEVIATION 15.56 • n=90 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=38 Participants
|
20 Participants
n=35 Participants
|
12 Participants
n=17 Participants
|
55 Participants
n=90 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=38 Participants
|
15 Participants
n=35 Participants
|
5 Participants
n=17 Participants
|
35 Participants
n=90 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=38 Participants
|
2 Participants
n=35 Participants
|
0 Participants
n=17 Participants
|
3 Participants
n=90 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
33 Participants
n=38 Participants
|
23 Participants
n=35 Participants
|
12 Participants
n=17 Participants
|
68 Participants
n=90 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=38 Participants
|
10 Participants
n=35 Participants
|
5 Participants
n=17 Participants
|
19 Participants
n=90 Participants
|
|
Race/Ethnicity, Customized
White
|
31 Participants
n=38 Participants
|
23 Participants
n=35 Participants
|
13 Participants
n=17 Participants
|
67 Participants
n=90 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 Participants
n=38 Participants
|
5 Participants
n=35 Participants
|
2 Participants
n=17 Participants
|
10 Participants
n=90 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=38 Participants
|
1 Participants
n=35 Participants
|
0 Participants
n=17 Participants
|
1 Participants
n=90 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=38 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=17 Participants
|
1 Participants
n=90 Participants
|
|
Race/Ethnicity, Customized
Not reported
|
3 Participants
n=38 Participants
|
6 Participants
n=35 Participants
|
2 Participants
n=17 Participants
|
11 Participants
n=90 Participants
|
|
Femoral Total: T-score
|
-0.834 T-score
STANDARD_DEVIATION 1.1182 • n=38 Participants • Number analyzed is the number of participants that were evaluable for analysis at the baseline.
|
-1.139 T-score
STANDARD_DEVIATION 1.0995 • n=34 Participants • Number analyzed is the number of participants that were evaluable for analysis at the baseline.
|
-0.813 T-score
STANDARD_DEVIATION 0.6748 • n=17 Participants • Number analyzed is the number of participants that were evaluable for analysis at the baseline.
|
-0.946 T-score
STANDARD_DEVIATION 1.0416 • n=89 Participants • Number analyzed is the number of participants that were evaluable for analysis at the baseline.
|
|
Femoral Total: Z-score
|
-0.548 Z-score
STANDARD_DEVIATION 1.1574 • n=38 Participants • Number analyzed is the number of participants that were evaluable for analysis at the baseline.
|
-0.916 Z-score
STANDARD_DEVIATION 1.0657 • n=34 Participants • Number analyzed is the number of participants that were evaluable for analysis at the baseline.
|
-0.529 Z-score
STANDARD_DEVIATION 0.7137 • n=17 Participants • Number analyzed is the number of participants that were evaluable for analysis at the baseline.
|
-0.685 Z-score
STANDARD_DEVIATION 1.0560 • n=89 Participants • Number analyzed is the number of participants that were evaluable for analysis at the baseline.
|
|
Adjusted Spine: T-Score
|
-1.143 T-score
STANDARD_DEVIATION 1.0926 • n=38 Participants • Number analyzed is the number of participants that were evaluable for analysis at the baseline.
|
-1.808 T-score
STANDARD_DEVIATION 1.1589 • n=34 Participants • Number analyzed is the number of participants that were evaluable for analysis at the baseline.
|
-1.161 T-score
STANDARD_DEVIATION 1.0469 • n=17 Participants • Number analyzed is the number of participants that were evaluable for analysis at the baseline.
|
-1.400 T-score
STANDARD_DEVIATION 1.1440 • n=89 Participants • Number analyzed is the number of participants that were evaluable for analysis at the baseline.
|
|
Adjusted Spine: Z-score
|
-0.804 Z-score
STANDARD_DEVIATION 1.2529 • n=38 Participants • Number analyzed is the number of participants that were evaluable for analysis at the baseline.
|
-1.536 Z-score
STANDARD_DEVIATION 1.2469 • n=34 Participants • Number analyzed is the number of participants that were evaluable for analysis at the baseline.
|
-0.848 Z-score
STANDARD_DEVIATION 1.0420 • n=17 Participants • Number analyzed is the number of participants that were evaluable for analysis at the baseline.
|
-1.092 Z-score
STANDARD_DEVIATION 1.2506 • n=89 Participants • Number analyzed is the number of participants that were evaluable for analysis at the baseline.
|
PRIMARY outcome
Timeframe: Up to 197 weeksPopulation: The safety analysis set included all participants who received at least 1 dose of study treatment. Due to limited number of participants with optimal dose of 5 mg or 20 mg in antecedent studies AG348-C-006 (NCT03548220) and AG348-C-007 (NCT03559699), it was pre-specified in the SAP to report data for this outcome measure (OM) by Cohort.
A clinical adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the study drug. TEAEs are AEs with an initial onset date during the on-treatment period or worsening from baseline and include both serious and non-serious TEAEs. Severity of AEs was evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE; Version 4.03): grade 1: mild; grade 2: moderate; grade 3: severe or medically significant but not immediately life-threatening; grade 4: life threatening or disabling; grade 5: death related to AE.
Outcome measures
| Measure |
Cohort 1
n=38 Participants
Participants who received placebo in Study AG348-C-006 and met the eligibility criteria of this extension study were enrolled to receive mitapivat tablets, 5 mg, BID, administered orally, for 4 weeks as a starting dose, followed by two potential sequential dose level increases to 20 mg and 50 mg BID at Weeks 4 and 8 respectively as determined by the investigator based on safety and efficacy. The optimized dose for each participant was determined at Week 12, and participants then received that optimized dose for a period of 12 weeks (Weeks 13-24) as a fixed dose and from Week 25 to Week 193, until study withdrawal, or the study was closed.
|
Cohort 2
n=35 Participants
Participants who received mitapivat at a dose of 5 mg, 20 mg, or 50 mg, BID, in the fixed dose period of Study AG348-C-006 and met the eligibility criteria of this extension study continued to receive the same mitapivat dose up to Week 193 or until study withdrawal, or the study was closed.
|
Cohort 3
n=17 Participants
Participants who received mitapivat at a dose of 5 mg, 20 mg, or 50 mg, BID, in the fixed dose period of Study AG348-C-007 and met the eligibility criteria of this extension study continued to receive the same mitapivat dose up to Week 193 or until study withdrawal, or the study was closed.
|
|---|---|---|---|
|
All Cohorts: Number of Participants With at Least One Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, Related TEAEs and TEAEs With Severity Greater Than or Equal to Grade 3
Participants with TEAEs
|
37 Participants
|
33 Participants
|
15 Participants
|
|
All Cohorts: Number of Participants With at Least One Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, Related TEAEs and TEAEs With Severity Greater Than or Equal to Grade 3
Participants with Serious TEAEs
|
11 Participants
|
8 Participants
|
4 Participants
|
|
All Cohorts: Number of Participants With at Least One Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, Related TEAEs and TEAEs With Severity Greater Than or Equal to Grade 3
Participants with TEAEs related to study drug
|
22 Participants
|
14 Participants
|
4 Participants
|
|
All Cohorts: Number of Participants With at Least One Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, Related TEAEs and TEAEs With Severity Greater Than or Equal to Grade 3
Participants with any TEAE of Grade ≥ 3
|
16 Participants
|
10 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: Up to 197 weeksPopulation: The safety analysis set included all participants who received at least 1 dose of study treatment. Due to limited number of participants with optimal dose of 5 mg or 20 mg in antecedent studies AG348-C-006 (NCT03548220) and AG348-C-007 (NCT03559699), it was pre-specified in the SAP to report data for this OM by Cohort.
A clinical AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the study drug. TEAEs are AEs with an initial onset date during the on-treatment period or worsening from baseline and include both serious and non-serious TEAEs. Number of participants with TEAEs leading to dose reduction, treatment interruption and treatment discontinuation are reported.
Outcome measures
| Measure |
Cohort 1
n=38 Participants
Participants who received placebo in Study AG348-C-006 and met the eligibility criteria of this extension study were enrolled to receive mitapivat tablets, 5 mg, BID, administered orally, for 4 weeks as a starting dose, followed by two potential sequential dose level increases to 20 mg and 50 mg BID at Weeks 4 and 8 respectively as determined by the investigator based on safety and efficacy. The optimized dose for each participant was determined at Week 12, and participants then received that optimized dose for a period of 12 weeks (Weeks 13-24) as a fixed dose and from Week 25 to Week 193, until study withdrawal, or the study was closed.
|
Cohort 2
n=35 Participants
Participants who received mitapivat at a dose of 5 mg, 20 mg, or 50 mg, BID, in the fixed dose period of Study AG348-C-006 and met the eligibility criteria of this extension study continued to receive the same mitapivat dose up to Week 193 or until study withdrawal, or the study was closed.
|
Cohort 3
n=17 Participants
Participants who received mitapivat at a dose of 5 mg, 20 mg, or 50 mg, BID, in the fixed dose period of Study AG348-C-007 and met the eligibility criteria of this extension study continued to receive the same mitapivat dose up to Week 193 or until study withdrawal, or the study was closed.
|
|---|---|---|---|
|
All Cohorts: Number of Participants With TEAEs Leading to Dose Reduction, Treatment Interruption and Treatment Discontinuation
Participants with TEAEs Leading to Interruption
|
3 Participants
|
4 Participants
|
0 Participants
|
|
All Cohorts: Number of Participants With TEAEs Leading to Dose Reduction, Treatment Interruption and Treatment Discontinuation
Participants with TEAEs Leading to Dose Reduction
|
2 Participants
|
2 Participants
|
1 Participants
|
|
All Cohorts: Number of Participants With TEAEs Leading to Dose Reduction, Treatment Interruption and Treatment Discontinuation
Participants with TEAEs Leading to Discontinuation
|
2 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 197 weeksPopulation: The safety analysis set included all participants who received at least 1 dose of study treatment. Due to limited number of participants with optimal dose of 5 mg or 20 mg in antecedent studies AG348-C-006 (NCT03548220) and AG348-C-007 (NCT03559699), it was pre-specified in the SAP to report data for this OM by Cohort.
Clinical laboratory assessments including hematology, clinical chemistry, triglycerides, urate, coagulation, urinalysis, and liver function tests were performed in the study. Clinically significant treatment-emergent laboratory abnormalities were graded according to the NCI CTCAE; Version 4.03: grade 1: mild; grade 2: moderate; grade 3: severe or medically significant but not immediately life-threatening; grade 4: life threatening or disabling; grade 5: death related to AE. Clinical significance was determined based on the judgment of the Investigator.
Outcome measures
| Measure |
Cohort 1
n=38 Participants
Participants who received placebo in Study AG348-C-006 and met the eligibility criteria of this extension study were enrolled to receive mitapivat tablets, 5 mg, BID, administered orally, for 4 weeks as a starting dose, followed by two potential sequential dose level increases to 20 mg and 50 mg BID at Weeks 4 and 8 respectively as determined by the investigator based on safety and efficacy. The optimized dose for each participant was determined at Week 12, and participants then received that optimized dose for a period of 12 weeks (Weeks 13-24) as a fixed dose and from Week 25 to Week 193, until study withdrawal, or the study was closed.
|
Cohort 2
n=35 Participants
Participants who received mitapivat at a dose of 5 mg, 20 mg, or 50 mg, BID, in the fixed dose period of Study AG348-C-006 and met the eligibility criteria of this extension study continued to receive the same mitapivat dose up to Week 193 or until study withdrawal, or the study was closed.
|
Cohort 3
n=17 Participants
Participants who received mitapivat at a dose of 5 mg, 20 mg, or 50 mg, BID, in the fixed dose period of Study AG348-C-007 and met the eligibility criteria of this extension study continued to receive the same mitapivat dose up to Week 193 or until study withdrawal, or the study was closed.
|
|---|---|---|---|
|
All Cohorts: Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters Reported as Grade Greater Than or Equal to (≥)3 TEAEs
Anaemia
|
3 Participants
|
1 Participants
|
0 Participants
|
|
All Cohorts: Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters Reported as Grade Greater Than or Equal to (≥)3 TEAEs
Haemolysis
|
1 Participants
|
2 Participants
|
0 Participants
|
|
All Cohorts: Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters Reported as Grade Greater Than or Equal to (≥)3 TEAEs
Alanine aminotransferase increased
|
0 Participants
|
0 Participants
|
1 Participants
|
|
All Cohorts: Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters Reported as Grade Greater Than or Equal to (≥)3 TEAEs
Aspartate aminotransferase increased
|
2 Participants
|
1 Participants
|
1 Participants
|
|
All Cohorts: Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters Reported as Grade Greater Than or Equal to (≥)3 TEAEs
Blood bilirubin increased
|
0 Participants
|
0 Participants
|
1 Participants
|
|
All Cohorts: Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters Reported as Grade Greater Than or Equal to (≥)3 TEAEs
Blood triglycerides increased
|
1 Participants
|
0 Participants
|
0 Participants
|
|
All Cohorts: Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters Reported as Grade Greater Than or Equal to (≥)3 TEAEs
Hypertriglyceridaemia
|
1 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 197 weeksPopulation: The safety analysis set included all participants who received at least 1 dose of study treatment. Due to limited number of participants with optimal dose of 5 mg or 20 mg in antecedent studies AG348-C-006 (NCT03548220) and AG348-C-007 (NCT03559699), it was pre-specified in the SAP to report data for this OM by Cohort.
Vital signs and physical examinations including height, weight, body mass index (BMI), systolic blood pressure, diastolic blood pressure, pulse rate, temperature were assessed. Number of participants who experienced clinically significant abnormalities in vital signs and physical examinations as TEAEs were reported. Clinical significance was determined based on the judgment of the Investigator.
Outcome measures
| Measure |
Cohort 1
n=38 Participants
Participants who received placebo in Study AG348-C-006 and met the eligibility criteria of this extension study were enrolled to receive mitapivat tablets, 5 mg, BID, administered orally, for 4 weeks as a starting dose, followed by two potential sequential dose level increases to 20 mg and 50 mg BID at Weeks 4 and 8 respectively as determined by the investigator based on safety and efficacy. The optimized dose for each participant was determined at Week 12, and participants then received that optimized dose for a period of 12 weeks (Weeks 13-24) as a fixed dose and from Week 25 to Week 193, until study withdrawal, or the study was closed.
|
Cohort 2
n=35 Participants
Participants who received mitapivat at a dose of 5 mg, 20 mg, or 50 mg, BID, in the fixed dose period of Study AG348-C-006 and met the eligibility criteria of this extension study continued to receive the same mitapivat dose up to Week 193 or until study withdrawal, or the study was closed.
|
Cohort 3
n=17 Participants
Participants who received mitapivat at a dose of 5 mg, 20 mg, or 50 mg, BID, in the fixed dose period of Study AG348-C-007 and met the eligibility criteria of this extension study continued to receive the same mitapivat dose up to Week 193 or until study withdrawal, or the study was closed.
|
|---|---|---|---|
|
All Cohorts: Number of Participants With Clinically Significant Abnormalities in Vital Signs Measurements and Physical Examinations Reported as TEAEs
Weight decreased
|
0 Participants
|
1 Participants
|
1 Participants
|
|
All Cohorts: Number of Participants With Clinically Significant Abnormalities in Vital Signs Measurements and Physical Examinations Reported as TEAEs
Hot flush
|
2 Participants
|
0 Participants
|
2 Participants
|
|
All Cohorts: Number of Participants With Clinically Significant Abnormalities in Vital Signs Measurements and Physical Examinations Reported as TEAEs
Hypotension
|
1 Participants
|
0 Participants
|
0 Participants
|
|
All Cohorts: Number of Participants With Clinically Significant Abnormalities in Vital Signs Measurements and Physical Examinations Reported as TEAEs
Hypertension
|
1 Participants
|
2 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 192 weeksPopulation: The safety analysis set included all participants who received at least 1 dose of study treatment. Due to limited number of participants with optimal dose of 5 mg or 20 mg in antecedent studies AG348-C-006 (NCT03548220) and AG348-C-007 (NCT03559699), it was pre-specified in the SAP to report data for this OM by Cohort.
BMD was measured by dual-energy X-ray absorptiometry (DXA) scans during the study. Number of participants with clinically significant abnormalities were reported. Clinical significance was determined based on the judgment of the Investigator.
Outcome measures
| Measure |
Cohort 1
n=38 Participants
Participants who received placebo in Study AG348-C-006 and met the eligibility criteria of this extension study were enrolled to receive mitapivat tablets, 5 mg, BID, administered orally, for 4 weeks as a starting dose, followed by two potential sequential dose level increases to 20 mg and 50 mg BID at Weeks 4 and 8 respectively as determined by the investigator based on safety and efficacy. The optimized dose for each participant was determined at Week 12, and participants then received that optimized dose for a period of 12 weeks (Weeks 13-24) as a fixed dose and from Week 25 to Week 193, until study withdrawal, or the study was closed.
|
Cohort 2
n=35 Participants
Participants who received mitapivat at a dose of 5 mg, 20 mg, or 50 mg, BID, in the fixed dose period of Study AG348-C-006 and met the eligibility criteria of this extension study continued to receive the same mitapivat dose up to Week 193 or until study withdrawal, or the study was closed.
|
Cohort 3
n=17 Participants
Participants who received mitapivat at a dose of 5 mg, 20 mg, or 50 mg, BID, in the fixed dose period of Study AG348-C-007 and met the eligibility criteria of this extension study continued to receive the same mitapivat dose up to Week 193 or until study withdrawal, or the study was closed.
|
|---|---|---|---|
|
All Cohorts: Number of Participants With Clinically Significant Abnormalities in Bone Mineral Density (BMD)
|
0 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 192Population: The safety analysis set included all participants who received at least 1 dose of study treatment. Here, overall number of participants analyzed indicates the number of participants who were evaluable for this OM. Due to limited number of participants with optimal dose of 5 mg or 20 mg in antecedent studies AG348-C-006 (NCT03548220) and AG348-C-007 (NCT03559699), it was pre-specified in the SAP to report data for this OM by Cohort.
T-score of adjusted spine were assessed by DXA scans. The T-score is the number of standard deviations that bone density is above or below the average. A score of ≥ -1 indicates normal bone density; score between \< -1 and \> -2.5 indicates a sign of osteopenia (bone density below normal), and score of ≤ -2.5 indicates a sign of osteoporosis.
Outcome measures
| Measure |
Cohort 1
n=24 Participants
Participants who received placebo in Study AG348-C-006 and met the eligibility criteria of this extension study were enrolled to receive mitapivat tablets, 5 mg, BID, administered orally, for 4 weeks as a starting dose, followed by two potential sequential dose level increases to 20 mg and 50 mg BID at Weeks 4 and 8 respectively as determined by the investigator based on safety and efficacy. The optimized dose for each participant was determined at Week 12, and participants then received that optimized dose for a period of 12 weeks (Weeks 13-24) as a fixed dose and from Week 25 to Week 193, until study withdrawal, or the study was closed.
|
Cohort 2
n=20 Participants
Participants who received mitapivat at a dose of 5 mg, 20 mg, or 50 mg, BID, in the fixed dose period of Study AG348-C-006 and met the eligibility criteria of this extension study continued to receive the same mitapivat dose up to Week 193 or until study withdrawal, or the study was closed.
|
Cohort 3
n=8 Participants
Participants who received mitapivat at a dose of 5 mg, 20 mg, or 50 mg, BID, in the fixed dose period of Study AG348-C-007 and met the eligibility criteria of this extension study continued to receive the same mitapivat dose up to Week 193 or until study withdrawal, or the study was closed.
|
|---|---|---|---|
|
All Cohorts: Change From Baseline in Adjusted Spine T-score
|
0.046 T-score
Standard Deviation 0.4874
|
0.234 T-score
Standard Deviation 0.4383
|
0.416 T-score
Standard Deviation 1.1090
|
PRIMARY outcome
Timeframe: Baseline, Week 192Population: The safety analysis set included all participants who received at least 1 dose of study treatment. Here, overall number of participants analyzed indicates the number of participants who were evaluable for this OM. Due to limited number of participants with optimal dose of 5 mg or 20 mg in antecedent studies AG348-C-006 (NCT03548220) and AG348-C-007 (NCT03559699), it was pre-specified in the SAP to report data for this OM by Cohort.
The Z-score is a statistical measure to describe whether a value was above or below the standard. A Z-score of 0 is equal to the standard. Lower numbers indicate values lower than the standard and higher numbers indicate values higher than the standard.
Outcome measures
| Measure |
Cohort 1
n=24 Participants
Participants who received placebo in Study AG348-C-006 and met the eligibility criteria of this extension study were enrolled to receive mitapivat tablets, 5 mg, BID, administered orally, for 4 weeks as a starting dose, followed by two potential sequential dose level increases to 20 mg and 50 mg BID at Weeks 4 and 8 respectively as determined by the investigator based on safety and efficacy. The optimized dose for each participant was determined at Week 12, and participants then received that optimized dose for a period of 12 weeks (Weeks 13-24) as a fixed dose and from Week 25 to Week 193, until study withdrawal, or the study was closed.
|
Cohort 2
n=20 Participants
Participants who received mitapivat at a dose of 5 mg, 20 mg, or 50 mg, BID, in the fixed dose period of Study AG348-C-006 and met the eligibility criteria of this extension study continued to receive the same mitapivat dose up to Week 193 or until study withdrawal, or the study was closed.
|
Cohort 3
n=8 Participants
Participants who received mitapivat at a dose of 5 mg, 20 mg, or 50 mg, BID, in the fixed dose period of Study AG348-C-007 and met the eligibility criteria of this extension study continued to receive the same mitapivat dose up to Week 193 or until study withdrawal, or the study was closed.
|
|---|---|---|---|
|
All Cohorts: Change From Baseline in Adjusted Spine Z-score
|
0.152 Z-score
Standard Deviation 0.4585
|
0.332 Z-score
Standard Deviation 0.4002
|
0.530 Z-score
Standard Deviation 1.2409
|
PRIMARY outcome
Timeframe: Baseline, Week 192Population: The safety analysis set included all participants who received at least 1 dose of study treatment. Here, overall number of participants analyzed indicates the number of participants who were evaluable for this OM. Due to limited number of participants with optimal dose of 5 mg or 20 mg in antecedent studies AG348-C-006 (NCT03548220) and AG348-C-007 (NCT03559699), it was pre-specified in the SAP to report data for this OM by Cohort.
T-score of femoral total were assessed by DXA scans. The T-score is the number of standard deviations that bone density is above or below the average. A score of ≥ -1 indicates normal bone density; score between \< -1 and \> -2.5 indicates a sign of osteopenia (bone density below normal), and score of ≤ -2.5 indicates a sign of osteoporosis.
Outcome measures
| Measure |
Cohort 1
n=24 Participants
Participants who received placebo in Study AG348-C-006 and met the eligibility criteria of this extension study were enrolled to receive mitapivat tablets, 5 mg, BID, administered orally, for 4 weeks as a starting dose, followed by two potential sequential dose level increases to 20 mg and 50 mg BID at Weeks 4 and 8 respectively as determined by the investigator based on safety and efficacy. The optimized dose for each participant was determined at Week 12, and participants then received that optimized dose for a period of 12 weeks (Weeks 13-24) as a fixed dose and from Week 25 to Week 193, until study withdrawal, or the study was closed.
|
Cohort 2
n=20 Participants
Participants who received mitapivat at a dose of 5 mg, 20 mg, or 50 mg, BID, in the fixed dose period of Study AG348-C-006 and met the eligibility criteria of this extension study continued to receive the same mitapivat dose up to Week 193 or until study withdrawal, or the study was closed.
|
Cohort 3
n=8 Participants
Participants who received mitapivat at a dose of 5 mg, 20 mg, or 50 mg, BID, in the fixed dose period of Study AG348-C-007 and met the eligibility criteria of this extension study continued to receive the same mitapivat dose up to Week 193 or until study withdrawal, or the study was closed.
|
|---|---|---|---|
|
All Cohorts: Change From Baseline in Femoral Total T-score
|
-0.020 T-score
Standard Deviation 0.2612
|
0.047 T-score
Standard Deviation 0.3893
|
0.114 T-score
Standard Deviation 0.5050
|
PRIMARY outcome
Timeframe: Baseline, Week 192Population: The safety analysis set included all participants who received at least 1 dose of study treatment. Here, overall number of participants analyzed indicates the number of participants who were evaluable for this OM. Due to limited number of participants with optimal dose of 5 mg or 20 mg in antecedent studies AG348-C-006 (NCT03548220) and AG348-C-007 (NCT03559699), it was pre-specified in the SAP to report data for this OM by Cohort.
The Z-score is a statistical measure to describe whether a value was above or below the standard. A Z-score of 0 is equal to the standard. Lower numbers indicate values lower than the standard and higher numbers indicate values higher than the standard.
Outcome measures
| Measure |
Cohort 1
n=24 Participants
Participants who received placebo in Study AG348-C-006 and met the eligibility criteria of this extension study were enrolled to receive mitapivat tablets, 5 mg, BID, administered orally, for 4 weeks as a starting dose, followed by two potential sequential dose level increases to 20 mg and 50 mg BID at Weeks 4 and 8 respectively as determined by the investigator based on safety and efficacy. The optimized dose for each participant was determined at Week 12, and participants then received that optimized dose for a period of 12 weeks (Weeks 13-24) as a fixed dose and from Week 25 to Week 193, until study withdrawal, or the study was closed.
|
Cohort 2
n=20 Participants
Participants who received mitapivat at a dose of 5 mg, 20 mg, or 50 mg, BID, in the fixed dose period of Study AG348-C-006 and met the eligibility criteria of this extension study continued to receive the same mitapivat dose up to Week 193 or until study withdrawal, or the study was closed.
|
Cohort 3
n=8 Participants
Participants who received mitapivat at a dose of 5 mg, 20 mg, or 50 mg, BID, in the fixed dose period of Study AG348-C-007 and met the eligibility criteria of this extension study continued to receive the same mitapivat dose up to Week 193 or until study withdrawal, or the study was closed.
|
|---|---|---|---|
|
All Cohorts: Change From Baseline in Femoral Total Z-score
|
0.054 Z- score
Standard Deviation 0.2468
|
0.126 Z- score
Standard Deviation 0.3631
|
0.214 Z- score
Standard Deviation 0.5099
|
PRIMARY outcome
Timeframe: Up to 197 weeksPopulation: The safety analysis set included all participants who received at least 1 dose of study treatment. Due to limited number of participants with optimal dose of 5 mg or 20 mg in antecedent studies AG348-C-006 (NCT03548220) and AG348-C-007 (NCT03559699), it was pre-specified in the SAP to report data for this OM by Cohort.
The following ECG parameters including RR, PR, heart rate-corrected QT interval using the Fridericia's formula (QRS), QT, and QTc were assessed during the study. Number of Participants with clinically significant abnormalities in ECG parameters as TEAEs were reported. Clinical significance was determined based on the judgment of the Investigator.
Outcome measures
| Measure |
Cohort 1
n=38 Participants
Participants who received placebo in Study AG348-C-006 and met the eligibility criteria of this extension study were enrolled to receive mitapivat tablets, 5 mg, BID, administered orally, for 4 weeks as a starting dose, followed by two potential sequential dose level increases to 20 mg and 50 mg BID at Weeks 4 and 8 respectively as determined by the investigator based on safety and efficacy. The optimized dose for each participant was determined at Week 12, and participants then received that optimized dose for a period of 12 weeks (Weeks 13-24) as a fixed dose and from Week 25 to Week 193, until study withdrawal, or the study was closed.
|
Cohort 2
n=35 Participants
Participants who received mitapivat at a dose of 5 mg, 20 mg, or 50 mg, BID, in the fixed dose period of Study AG348-C-006 and met the eligibility criteria of this extension study continued to receive the same mitapivat dose up to Week 193 or until study withdrawal, or the study was closed.
|
Cohort 3
n=17 Participants
Participants who received mitapivat at a dose of 5 mg, 20 mg, or 50 mg, BID, in the fixed dose period of Study AG348-C-007 and met the eligibility criteria of this extension study continued to receive the same mitapivat dose up to Week 193 or until study withdrawal, or the study was closed.
|
|---|---|---|---|
|
All Cohorts: Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG) Parameters Reported as TEAEs
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline up to Week 24Population: FAS included all participants who received at least 1 dose of study treatment. Due to limited number of participants with optimal dose of 5 mg or 20 mg in antecedent Study AG348-C-006 (NCT03548220), it was pre-specified in the SAP to report data for this OM by Cohort. As per planned analysis, data for this OM was reported for Cohort 1 only based on FAS.
The Hb response was defined as a greater than or equal to (≥)1.5 grams per deciliter (g/dL) (0.93 millimoles per liter \[mmol/L\]) increase in Hb concentration from baseline that is sustained at 2 or more scheduled assessments, excluding those within 2 months (61 days) of transfusion. The baseline value for cohort 1 participants was the average of all available measurements from the central laboratory within 45 (42+3) days before start of study treatment in study AG348-C-011, excluding values within 61 days after a transfusion, or the baseline value from study AG348-C-006 if no assessment is available.
Outcome measures
| Measure |
Cohort 1
n=38 Participants
Participants who received placebo in Study AG348-C-006 and met the eligibility criteria of this extension study were enrolled to receive mitapivat tablets, 5 mg, BID, administered orally, for 4 weeks as a starting dose, followed by two potential sequential dose level increases to 20 mg and 50 mg BID at Weeks 4 and 8 respectively as determined by the investigator based on safety and efficacy. The optimized dose for each participant was determined at Week 12, and participants then received that optimized dose for a period of 12 weeks (Weeks 13-24) as a fixed dose and from Week 25 to Week 193, until study withdrawal, or the study was closed.
|
Cohort 2
Participants who received mitapivat at a dose of 5 mg, 20 mg, or 50 mg, BID, in the fixed dose period of Study AG348-C-006 and met the eligibility criteria of this extension study continued to receive the same mitapivat dose up to Week 193 or until study withdrawal, or the study was closed.
|
Cohort 3
Participants who received mitapivat at a dose of 5 mg, 20 mg, or 50 mg, BID, in the fixed dose period of Study AG348-C-007 and met the eligibility criteria of this extension study continued to receive the same mitapivat dose up to Week 193 or until study withdrawal, or the study was closed.
|
|---|---|---|---|
|
Cohort 1: Percentage of Participants Who Achieved a Hemoglobin (Hb) Response
|
39.5 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 16, 20, and 24Population: FAS included all participants who received at least 1 dose of study treatment. Overall number of participants analyzed indicates number of participants were evaluable for this OM. Due to limited number of participants with optimal dose of 5 mg or 20 mg in antecedent study AG348-C-006 (NCT03548220), it was pre-specified in the SAP to report data for this OM by Cohort. As per planned analysis, data for this OM was reported for Cohort 1 only based on FAS.
The baseline value for participants was the average of all available measurements from the central laboratory within 45 (42+3) days before start of study treatment in study AG348-C-011, excluding values within 61 days after a transfusion, or the baseline value from study AG348-C-006 if no assessment is available. The mean of average change from baseline in Hb concentration across Weeks 16, 20 and 24 is reported.
Outcome measures
| Measure |
Cohort 1
n=36 Participants
Participants who received placebo in Study AG348-C-006 and met the eligibility criteria of this extension study were enrolled to receive mitapivat tablets, 5 mg, BID, administered orally, for 4 weeks as a starting dose, followed by two potential sequential dose level increases to 20 mg and 50 mg BID at Weeks 4 and 8 respectively as determined by the investigator based on safety and efficacy. The optimized dose for each participant was determined at Week 12, and participants then received that optimized dose for a period of 12 weeks (Weeks 13-24) as a fixed dose and from Week 25 to Week 193, until study withdrawal, or the study was closed.
|
Cohort 2
Participants who received mitapivat at a dose of 5 mg, 20 mg, or 50 mg, BID, in the fixed dose period of Study AG348-C-006 and met the eligibility criteria of this extension study continued to receive the same mitapivat dose up to Week 193 or until study withdrawal, or the study was closed.
|
Cohort 3
Participants who received mitapivat at a dose of 5 mg, 20 mg, or 50 mg, BID, in the fixed dose period of Study AG348-C-007 and met the eligibility criteria of this extension study continued to receive the same mitapivat dose up to Week 193 or until study withdrawal, or the study was closed.
|
|---|---|---|---|
|
Cohort 1: Average Change From Baseline in Hb Concentration at Weeks 16, 20, and 24
|
16.45 grams per liter
Standard Deviation 15.634
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 2, 4, and 8 hours post-dose at Week 12Population: PK analysis population: all participants who were enrolled \& received at least 1 dose of mitapivat with at least 1 nonzero plasma concentration of mitapivat at Week 12 visit. Overall number of participants analyzed: number of participants who received 50 mg BID mitapivat in Cohort 1 and were evaluable for this OM. As per planned analysis, data for this OM was reported by cohort and for Cohort 1 only based on FAS.
Outcome measures
| Measure |
Cohort 1
n=23 Participants
Participants who received placebo in Study AG348-C-006 and met the eligibility criteria of this extension study were enrolled to receive mitapivat tablets, 5 mg, BID, administered orally, for 4 weeks as a starting dose, followed by two potential sequential dose level increases to 20 mg and 50 mg BID at Weeks 4 and 8 respectively as determined by the investigator based on safety and efficacy. The optimized dose for each participant was determined at Week 12, and participants then received that optimized dose for a period of 12 weeks (Weeks 13-24) as a fixed dose and from Week 25 to Week 193, until study withdrawal, or the study was closed.
|
Cohort 2
Participants who received mitapivat at a dose of 5 mg, 20 mg, or 50 mg, BID, in the fixed dose period of Study AG348-C-006 and met the eligibility criteria of this extension study continued to receive the same mitapivat dose up to Week 193 or until study withdrawal, or the study was closed.
|
Cohort 3
Participants who received mitapivat at a dose of 5 mg, 20 mg, or 50 mg, BID, in the fixed dose period of Study AG348-C-007 and met the eligibility criteria of this extension study continued to receive the same mitapivat dose up to Week 193 or until study withdrawal, or the study was closed.
|
|---|---|---|---|
|
Cohort 1: Area Under the Plasma Concentration-Time Curve From Time Zero to 8-hours Post-dose (AUC0-8) of Mitapivat
|
3016 hour*nanograms per milliliter (hr*ng/mL)
Geometric Coefficient of Variation 27.5
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 2, 4, and 8 hours post-dose at Week 12Population: PK analysis population: all participants who were enrolled \& received at least 1 dose of mitapivat with at least 1 nonzero plasma concentration of mitapivat at Week 12 visit. Overall number of participants analyzed: number of participants who received 50 mg BID mitapivat in Cohort 1 and were evaluable for this OM. As per planned analysis, data for this OM was reported by cohort and for Cohort 1 only based on FAS.
Outcome measures
| Measure |
Cohort 1
n=28 Participants
Participants who received placebo in Study AG348-C-006 and met the eligibility criteria of this extension study were enrolled to receive mitapivat tablets, 5 mg, BID, administered orally, for 4 weeks as a starting dose, followed by two potential sequential dose level increases to 20 mg and 50 mg BID at Weeks 4 and 8 respectively as determined by the investigator based on safety and efficacy. The optimized dose for each participant was determined at Week 12, and participants then received that optimized dose for a period of 12 weeks (Weeks 13-24) as a fixed dose and from Week 25 to Week 193, until study withdrawal, or the study was closed.
|
Cohort 2
Participants who received mitapivat at a dose of 5 mg, 20 mg, or 50 mg, BID, in the fixed dose period of Study AG348-C-006 and met the eligibility criteria of this extension study continued to receive the same mitapivat dose up to Week 193 or until study withdrawal, or the study was closed.
|
Cohort 3
Participants who received mitapivat at a dose of 5 mg, 20 mg, or 50 mg, BID, in the fixed dose period of Study AG348-C-007 and met the eligibility criteria of this extension study continued to receive the same mitapivat dose up to Week 193 or until study withdrawal, or the study was closed.
|
|---|---|---|---|
|
Cohort 1: Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-last) of Mitapivat
|
2990 hr*ng/mL
Geometric Coefficient of Variation 26.3
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 2, 4, and 8 hours post-dose at Week 12Population: PK analysis population: all participants who were enrolled \& received at least 1 dose of mitapivat with at least 1 nonzero plasma concentration of mitapivat at Week 12 visit. Overall number of participants analyzed: number of participants who received 50 mg BID mitapivat in Cohort 1 and were evaluable for this OM. As per planned analysis, data for this OM was reported by cohort and for Cohort 1 only based on FAS.
Outcome measures
| Measure |
Cohort 1
n=30 Participants
Participants who received placebo in Study AG348-C-006 and met the eligibility criteria of this extension study were enrolled to receive mitapivat tablets, 5 mg, BID, administered orally, for 4 weeks as a starting dose, followed by two potential sequential dose level increases to 20 mg and 50 mg BID at Weeks 4 and 8 respectively as determined by the investigator based on safety and efficacy. The optimized dose for each participant was determined at Week 12, and participants then received that optimized dose for a period of 12 weeks (Weeks 13-24) as a fixed dose and from Week 25 to Week 193, until study withdrawal, or the study was closed.
|
Cohort 2
Participants who received mitapivat at a dose of 5 mg, 20 mg, or 50 mg, BID, in the fixed dose period of Study AG348-C-006 and met the eligibility criteria of this extension study continued to receive the same mitapivat dose up to Week 193 or until study withdrawal, or the study was closed.
|
Cohort 3
Participants who received mitapivat at a dose of 5 mg, 20 mg, or 50 mg, BID, in the fixed dose period of Study AG348-C-007 and met the eligibility criteria of this extension study continued to receive the same mitapivat dose up to Week 193 or until study withdrawal, or the study was closed.
|
|---|---|---|---|
|
Cohort 1: Maximum Observed Plasma Concentration (Cmax) of Mitapivat
|
1018 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 22.5
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 2, 4, and 8 hours post-dose at Week 12Population: PK analysis population: all participants who were enrolled \& received at least 1 dose of mitapivat with at least 1 nonzero plasma concentration of mitapivat at Week 12 visit. Overall number of participants analyzed: number of participants who received 50 mg BID mitapivat in Cohort 1 and were evaluable for this OM. As per planned analysis, data for this OM was reported by cohort and for Cohort 1 only based on FAS.
Outcome measures
| Measure |
Cohort 1
n=30 Participants
Participants who received placebo in Study AG348-C-006 and met the eligibility criteria of this extension study were enrolled to receive mitapivat tablets, 5 mg, BID, administered orally, for 4 weeks as a starting dose, followed by two potential sequential dose level increases to 20 mg and 50 mg BID at Weeks 4 and 8 respectively as determined by the investigator based on safety and efficacy. The optimized dose for each participant was determined at Week 12, and participants then received that optimized dose for a period of 12 weeks (Weeks 13-24) as a fixed dose and from Week 25 to Week 193, until study withdrawal, or the study was closed.
|
Cohort 2
Participants who received mitapivat at a dose of 5 mg, 20 mg, or 50 mg, BID, in the fixed dose period of Study AG348-C-006 and met the eligibility criteria of this extension study continued to receive the same mitapivat dose up to Week 193 or until study withdrawal, or the study was closed.
|
Cohort 3
Participants who received mitapivat at a dose of 5 mg, 20 mg, or 50 mg, BID, in the fixed dose period of Study AG348-C-007 and met the eligibility criteria of this extension study continued to receive the same mitapivat dose up to Week 193 or until study withdrawal, or the study was closed.
|
|---|---|---|---|
|
Cohort 1: Time to Reach Maximum Observed Plasma Concentration (Tmax) of Mitapivat
|
1.00 hours
Interval 0.45 to 4.3
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 2, 4, and 8 hours post-dose at Week 12Population: PK analysis population: all participants who were enrolled \& received at least 1 dose of mitapivat with at least 1 nonzero plasma concentration of mitapivat at Week 12 visit. Overall number of participants analyzed: number of participants who received 50 mg BID mitapivat in Cohort 1 and were evaluable for this OM. As per planned analysis, data for this OM was reported by cohort and for Cohort 1 only based on FAS.
Outcome measures
| Measure |
Cohort 1
n=28 Participants
Participants who received placebo in Study AG348-C-006 and met the eligibility criteria of this extension study were enrolled to receive mitapivat tablets, 5 mg, BID, administered orally, for 4 weeks as a starting dose, followed by two potential sequential dose level increases to 20 mg and 50 mg BID at Weeks 4 and 8 respectively as determined by the investigator based on safety and efficacy. The optimized dose for each participant was determined at Week 12, and participants then received that optimized dose for a period of 12 weeks (Weeks 13-24) as a fixed dose and from Week 25 to Week 193, until study withdrawal, or the study was closed.
|
Cohort 2
Participants who received mitapivat at a dose of 5 mg, 20 mg, or 50 mg, BID, in the fixed dose period of Study AG348-C-006 and met the eligibility criteria of this extension study continued to receive the same mitapivat dose up to Week 193 or until study withdrawal, or the study was closed.
|
Cohort 3
Participants who received mitapivat at a dose of 5 mg, 20 mg, or 50 mg, BID, in the fixed dose period of Study AG348-C-007 and met the eligibility criteria of this extension study continued to receive the same mitapivat dose up to Week 193 or until study withdrawal, or the study was closed.
|
|---|---|---|---|
|
Cohort 1: Time of Last Quantifiable Concentration (Tlast) of Mitapivat
|
7.61 hours
Interval 3.57 to 8.53
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 2, 4, and 8 hours post-dose at Week 12Population: PK analysis population: all participants who were enrolled \& received at least 1 dose of mitapivat with at least 1 nonzero plasma concentration of mitapivat at Week 12 visit. Overall number of participants analyzed: number of participants who received 50 mg BID mitapivat in Cohort 1 and were evaluable for this OM. As per planned analysis, data for this OM was reported by cohort and for Cohort 1 only based on FAS.
Outcome measures
| Measure |
Cohort 1
n=28 Participants
Participants who received placebo in Study AG348-C-006 and met the eligibility criteria of this extension study were enrolled to receive mitapivat tablets, 5 mg, BID, administered orally, for 4 weeks as a starting dose, followed by two potential sequential dose level increases to 20 mg and 50 mg BID at Weeks 4 and 8 respectively as determined by the investigator based on safety and efficacy. The optimized dose for each participant was determined at Week 12, and participants then received that optimized dose for a period of 12 weeks (Weeks 13-24) as a fixed dose and from Week 25 to Week 193, until study withdrawal, or the study was closed.
|
Cohort 2
Participants who received mitapivat at a dose of 5 mg, 20 mg, or 50 mg, BID, in the fixed dose period of Study AG348-C-006 and met the eligibility criteria of this extension study continued to receive the same mitapivat dose up to Week 193 or until study withdrawal, or the study was closed.
|
Cohort 3
Participants who received mitapivat at a dose of 5 mg, 20 mg, or 50 mg, BID, in the fixed dose period of Study AG348-C-007 and met the eligibility criteria of this extension study continued to receive the same mitapivat dose up to Week 193 or until study withdrawal, or the study was closed.
|
|---|---|---|---|
|
Cohort 1: Plasma Concentration (Ctrough) at the End of a Dosing Interval of Mitapivat
|
62.8 ng/mL
Geometric Coefficient of Variation 72.7
|
—
|
—
|
SECONDARY outcome
Timeframe: First dose to up to 24 weeksPopulation: After the dose optimization period, the 5 mg and 20 mg doses each had a single participant and the 50 mg dose had 36 participants. The exposure-relationship analysis planned cannot be performed with a single participant in multiple groups.
Outcome measures
| Measure |
Cohort 1
n=1 Participants
Participants who received placebo in Study AG348-C-006 and met the eligibility criteria of this extension study were enrolled to receive mitapivat tablets, 5 mg, BID, administered orally, for 4 weeks as a starting dose, followed by two potential sequential dose level increases to 20 mg and 50 mg BID at Weeks 4 and 8 respectively as determined by the investigator based on safety and efficacy. The optimized dose for each participant was determined at Week 12, and participants then received that optimized dose for a period of 12 weeks (Weeks 13-24) as a fixed dose and from Week 25 to Week 193, until study withdrawal, or the study was closed.
|
Cohort 2
n=1 Participants
Participants who received mitapivat at a dose of 5 mg, 20 mg, or 50 mg, BID, in the fixed dose period of Study AG348-C-006 and met the eligibility criteria of this extension study continued to receive the same mitapivat dose up to Week 193 or until study withdrawal, or the study was closed.
|
Cohort 3
n=36 Participants
Participants who received mitapivat at a dose of 5 mg, 20 mg, or 50 mg, BID, in the fixed dose period of Study AG348-C-007 and met the eligibility criteria of this extension study continued to receive the same mitapivat dose up to Week 193 or until study withdrawal, or the study was closed.
|
|---|---|---|---|
|
Cohort 1: Exposure-response (E-R) Relationship Between Safety Parameters and Mitapivat Concentration and Relevant Mitapivat Pharmacokinetic Parameters
|
NA Percent probability
After the dose optimization period, the 5 mg and 20 mg doses each had a single participant and the 50 mg dose had 36 participants. The exposure-relationship analysis planned cannot be performed with a single participant in multiple groups.
|
NA Percent probability
After the dose optimization period, the 5 mg and 20 mg doses each had a single participant and the 50 mg dose had 36 participants. The exposure-relationship analysis planned cannot be performed with a single participant in multiple groups.
|
NA Percent probability
After the dose optimization period, the 5 mg and 20 mg doses each had a single participant and the 50 mg dose had 36 participants. The exposure-relationship analysis planned cannot be performed with a single participant in multiple groups.
|
SECONDARY outcome
Timeframe: Baseline, Week 192Population: FAS included all participants who received at least 1 dose of study treatment. Here, overall number of participants analyzed indicates the number of participants who were evaluable for this OM. Due to limited number of participants with optimal dose of 5 mg or 20 mg in antecedent study AG348-C-006 (NCT03548220), it was pre-specified in the SAP to report data for this OM by Cohort. As per planned analysis, data for this OM was reported for Cohort 1 and 2 only based on FAS.
The baseline value for cohort 1 participant was the average of all available measurements from the central laboratory within 45 (42+3) days before start of study treatment in study AG348-C-011, excluding values within 61 days after a transfusion, or the baseline value from study AG348-C-006 if no assessment was available. The baseline value for cohort 2 was from Study AG348-C-006.
Outcome measures
| Measure |
Cohort 1
n=22 Participants
Participants who received placebo in Study AG348-C-006 and met the eligibility criteria of this extension study were enrolled to receive mitapivat tablets, 5 mg, BID, administered orally, for 4 weeks as a starting dose, followed by two potential sequential dose level increases to 20 mg and 50 mg BID at Weeks 4 and 8 respectively as determined by the investigator based on safety and efficacy. The optimized dose for each participant was determined at Week 12, and participants then received that optimized dose for a period of 12 weeks (Weeks 13-24) as a fixed dose and from Week 25 to Week 193, until study withdrawal, or the study was closed.
|
Cohort 2
n=23 Participants
Participants who received mitapivat at a dose of 5 mg, 20 mg, or 50 mg, BID, in the fixed dose period of Study AG348-C-006 and met the eligibility criteria of this extension study continued to receive the same mitapivat dose up to Week 193 or until study withdrawal, or the study was closed.
|
Cohort 3
Participants who received mitapivat at a dose of 5 mg, 20 mg, or 50 mg, BID, in the fixed dose period of Study AG348-C-007 and met the eligibility criteria of this extension study continued to receive the same mitapivat dose up to Week 193 or until study withdrawal, or the study was closed.
|
|---|---|---|---|
|
Cohorts 1 and 2: Change From Baseline in Hb Concentration
|
22.39 grams per liter
Standard Deviation 21.211
|
21.32 grams per liter
Standard Deviation 20.721
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 192Population: FAS included all participants who received at least 1 dose of study treatment. Here, overall number of participants analyzed indicates the number of participants who were evaluable for this OM. Due to limited number of participants with optimal dose of 5 mg or 20 mg in antecedent study AG348-C-006 (NCT03548220), it was pre-specified in the SAP to report data for this OM by Cohort. As per planned analysis, data for this OM was reported for Cohort 1 and 2 only based on FAS.
The baseline value for cohort 1 participant was the average of all available measurements from the central laboratory within 45 (42+3) days before start of study treatment in study AG348-C-011, excluding values within 61 days after a transfusion, or the baseline value from study AG348-C-006 if no assessment is available. The baseline value for cohort 2 was from Study AG348-C-006.
Outcome measures
| Measure |
Cohort 1
n=22 Participants
Participants who received placebo in Study AG348-C-006 and met the eligibility criteria of this extension study were enrolled to receive mitapivat tablets, 5 mg, BID, administered orally, for 4 weeks as a starting dose, followed by two potential sequential dose level increases to 20 mg and 50 mg BID at Weeks 4 and 8 respectively as determined by the investigator based on safety and efficacy. The optimized dose for each participant was determined at Week 12, and participants then received that optimized dose for a period of 12 weeks (Weeks 13-24) as a fixed dose and from Week 25 to Week 193, until study withdrawal, or the study was closed.
|
Cohort 2
n=21 Participants
Participants who received mitapivat at a dose of 5 mg, 20 mg, or 50 mg, BID, in the fixed dose period of Study AG348-C-006 and met the eligibility criteria of this extension study continued to receive the same mitapivat dose up to Week 193 or until study withdrawal, or the study was closed.
|
Cohort 3
Participants who received mitapivat at a dose of 5 mg, 20 mg, or 50 mg, BID, in the fixed dose period of Study AG348-C-007 and met the eligibility criteria of this extension study continued to receive the same mitapivat dose up to Week 193 or until study withdrawal, or the study was closed.
|
|---|---|---|---|
|
Cohorts 1 and 2: Change From Baseline in Indirect Bilirubin
|
-57.50 micromoles per liter (μmol/L)
Standard Deviation 54.542
|
-36.73 micromoles per liter (μmol/L)
Standard Deviation 35.511
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 192Population: FAS included all participants who received at least 1 dose of study treatment. Here, overall number of participants analyzed indicates the number of participants who were evaluable for this OM. Due to limited number of participants with optimal dose of 5 mg or 20 mg in antecedent study AG348-C-006 (NCT03548220), it was pre-specified in the SAP to report data for this OM by Cohort. As per planned analysis, data for this OM was reported for Cohort 1 and 2 only based on FAS.
The baseline value for cohort 1 participant was the average of all available measurements from the central laboratory within 45 (42+3) days before start of study treatment in study AG348-C-011, excluding values within 61 days after a transfusion, or the baseline value from study AG348-C-006 if no assessment was available. The baseline value for cohort 2 was from Study AG348-C-006.
Outcome measures
| Measure |
Cohort 1
n=24 Participants
Participants who received placebo in Study AG348-C-006 and met the eligibility criteria of this extension study were enrolled to receive mitapivat tablets, 5 mg, BID, administered orally, for 4 weeks as a starting dose, followed by two potential sequential dose level increases to 20 mg and 50 mg BID at Weeks 4 and 8 respectively as determined by the investigator based on safety and efficacy. The optimized dose for each participant was determined at Week 12, and participants then received that optimized dose for a period of 12 weeks (Weeks 13-24) as a fixed dose and from Week 25 to Week 193, until study withdrawal, or the study was closed.
|
Cohort 2
n=22 Participants
Participants who received mitapivat at a dose of 5 mg, 20 mg, or 50 mg, BID, in the fixed dose period of Study AG348-C-006 and met the eligibility criteria of this extension study continued to receive the same mitapivat dose up to Week 193 or until study withdrawal, or the study was closed.
|
Cohort 3
Participants who received mitapivat at a dose of 5 mg, 20 mg, or 50 mg, BID, in the fixed dose period of Study AG348-C-007 and met the eligibility criteria of this extension study continued to receive the same mitapivat dose up to Week 193 or until study withdrawal, or the study was closed.
|
|---|---|---|---|
|
Cohorts 1 and 2: Change From Baseline in Lactate Dehydrogenase (LDH)
|
-46.10 Units per Liter (U/L)
Standard Deviation 75.310
|
-130.80 Units per Liter (U/L)
Standard Deviation 275.424
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 192Population: FAS included all participants who received at least 1 dose of study treatment. Here, overall number of participants analyzed indicates the number of participants who were evaluable for this OM. Due to limited number of participants with optimal dose of 5 mg or 20 mg in antecedent study AG348-C-006 (NCT03548220), it was pre-specified in the SAP to report data for this OM by Cohort. As per planned analysis, data for this OM was reported for Cohort 1 and 2 only based on FAS.
The baseline value for Cohort 1 participant was the average of all available measurements from the central laboratory within 45 (42+3) days before start of study treatment in study AG348-C-011, excluding values within 61 days after a transfusion, or the baseline value from study AG348-C-006 if no assessment was available. The baseline value for Cohort 2 was from Study AG348-C-006.
Outcome measures
| Measure |
Cohort 1
n=24 Participants
Participants who received placebo in Study AG348-C-006 and met the eligibility criteria of this extension study were enrolled to receive mitapivat tablets, 5 mg, BID, administered orally, for 4 weeks as a starting dose, followed by two potential sequential dose level increases to 20 mg and 50 mg BID at Weeks 4 and 8 respectively as determined by the investigator based on safety and efficacy. The optimized dose for each participant was determined at Week 12, and participants then received that optimized dose for a period of 12 weeks (Weeks 13-24) as a fixed dose and from Week 25 to Week 193, until study withdrawal, or the study was closed.
|
Cohort 2
n=25 Participants
Participants who received mitapivat at a dose of 5 mg, 20 mg, or 50 mg, BID, in the fixed dose period of Study AG348-C-006 and met the eligibility criteria of this extension study continued to receive the same mitapivat dose up to Week 193 or until study withdrawal, or the study was closed.
|
Cohort 3
Participants who received mitapivat at a dose of 5 mg, 20 mg, or 50 mg, BID, in the fixed dose period of Study AG348-C-007 and met the eligibility criteria of this extension study continued to receive the same mitapivat dose up to Week 193 or until study withdrawal, or the study was closed.
|
|---|---|---|---|
|
Cohorts 1 and 2: Change From Baseline in Haptoglobin Levels
|
0.254 grams per liter
Standard Deviation 0.4340
|
0.250 grams per liter
Standard Deviation 0.4689
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 192Population: FAS included all participants who received at least 1 dose of study treatment. Here, overall number of participants analyzed indicates the number of participants who were evaluable for this OM. Due to limited number of participants with optimal dose of 5 mg or 20 mg in antecedent study AG348-C-006 (NCT03548220), it was pre-specified in the SAP to report data for this OM by Cohort. As per planned analysis, data for this OM was reported for Cohort 1 and 2 only based on FAS.
The baseline value for Cohort 1 participants was the average of all available measurements from the central laboratory within 45 (42+3) days before start of study treatment in study AG348-C-011, excluding values within 61 days after a transfusion, or the baseline value from study AG348-C-006 if no assessment was available. The baseline value for Cohort 2 was from Study AG348-C-006.
Outcome measures
| Measure |
Cohort 1
n=22 Participants
Participants who received placebo in Study AG348-C-006 and met the eligibility criteria of this extension study were enrolled to receive mitapivat tablets, 5 mg, BID, administered orally, for 4 weeks as a starting dose, followed by two potential sequential dose level increases to 20 mg and 50 mg BID at Weeks 4 and 8 respectively as determined by the investigator based on safety and efficacy. The optimized dose for each participant was determined at Week 12, and participants then received that optimized dose for a period of 12 weeks (Weeks 13-24) as a fixed dose and from Week 25 to Week 193, until study withdrawal, or the study was closed.
|
Cohort 2
n=20 Participants
Participants who received mitapivat at a dose of 5 mg, 20 mg, or 50 mg, BID, in the fixed dose period of Study AG348-C-006 and met the eligibility criteria of this extension study continued to receive the same mitapivat dose up to Week 193 or until study withdrawal, or the study was closed.
|
Cohort 3
Participants who received mitapivat at a dose of 5 mg, 20 mg, or 50 mg, BID, in the fixed dose period of Study AG348-C-007 and met the eligibility criteria of this extension study continued to receive the same mitapivat dose up to Week 193 or until study withdrawal, or the study was closed.
|
|---|---|---|---|
|
Cohorts 1 and 2: Change From Baseline in Reticulocytes/Erythrocytes Ratio
|
-0.1696 Reticulocytes/Erythrocytes Ratio
Standard Deviation 0.16243
|
-0.1565 Reticulocytes/Erythrocytes Ratio
Standard Deviation 0.14631
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 192Population: FAS included all participants who received at least 1 dose of study treatment. Due to limited number of participants with optimal dose of 5 mg or 20 mg in antecedent study AG348-C-007 (NCT03559699), it was pre-specified in the SAP to report data for this OM by Cohort. As per planned analysis, data for this OM was reported for Cohort 3 only based on FAS.
Number of transfusions at baseline was determined based on the transfusion data during the 52 weeks before informed consent for Cohort 3. Number of on-study transfusions was based on transfusions collected up to the end of the fixed dose period and standardized to 52 weeks. The change from baseline in number of transfusions was summarized for Cohort 3.
Outcome measures
| Measure |
Cohort 1
n=17 Participants
Participants who received placebo in Study AG348-C-006 and met the eligibility criteria of this extension study were enrolled to receive mitapivat tablets, 5 mg, BID, administered orally, for 4 weeks as a starting dose, followed by two potential sequential dose level increases to 20 mg and 50 mg BID at Weeks 4 and 8 respectively as determined by the investigator based on safety and efficacy. The optimized dose for each participant was determined at Week 12, and participants then received that optimized dose for a period of 12 weeks (Weeks 13-24) as a fixed dose and from Week 25 to Week 193, until study withdrawal, or the study was closed.
|
Cohort 2
Participants who received mitapivat at a dose of 5 mg, 20 mg, or 50 mg, BID, in the fixed dose period of Study AG348-C-006 and met the eligibility criteria of this extension study continued to receive the same mitapivat dose up to Week 193 or until study withdrawal, or the study was closed.
|
Cohort 3
Participants who received mitapivat at a dose of 5 mg, 20 mg, or 50 mg, BID, in the fixed dose period of Study AG348-C-007 and met the eligibility criteria of this extension study continued to receive the same mitapivat dose up to Week 193 or until study withdrawal, or the study was closed.
|
|---|---|---|---|
|
Cohort 3: Change From Baseline in Number of Transfusion Episodes
|
4.14 number of transfusion episodes
Standard Deviation 5.487
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 192Population: FAS included all participants who received at least 1 dose of study treatment. Due to limited number of participants with optimal dose of 5 mg or 20 mg in antecedent study AG348-C-007 (NCT03559699), it was pre-specified in the SAP to report data for this OM by Cohort. As per planned analysis, data for this OM was reported for Cohort 3 only based on FAS.
Annualized total number of RBC units transfused (units/52-week) during the study, including data up to end of study (EOS), was the total number of RBC units transfused during the entire study\*52 / \[(date of EOS - date of start of study treatment + 1)/7\]. Number of RBC units were determined based on the transfusion data during the 52 weeks before informed consent of the antecedent study for Cohort 3. Number of on-study RBC units was based on transfusion data collected up to the end of the fixed dose period and standardized to 52 weeks.
Outcome measures
| Measure |
Cohort 1
n=17 Participants
Participants who received placebo in Study AG348-C-006 and met the eligibility criteria of this extension study were enrolled to receive mitapivat tablets, 5 mg, BID, administered orally, for 4 weeks as a starting dose, followed by two potential sequential dose level increases to 20 mg and 50 mg BID at Weeks 4 and 8 respectively as determined by the investigator based on safety and efficacy. The optimized dose for each participant was determined at Week 12, and participants then received that optimized dose for a period of 12 weeks (Weeks 13-24) as a fixed dose and from Week 25 to Week 193, until study withdrawal, or the study was closed.
|
Cohort 2
Participants who received mitapivat at a dose of 5 mg, 20 mg, or 50 mg, BID, in the fixed dose period of Study AG348-C-006 and met the eligibility criteria of this extension study continued to receive the same mitapivat dose up to Week 193 or until study withdrawal, or the study was closed.
|
Cohort 3
Participants who received mitapivat at a dose of 5 mg, 20 mg, or 50 mg, BID, in the fixed dose period of Study AG348-C-007 and met the eligibility criteria of this extension study continued to receive the same mitapivat dose up to Week 193 or until study withdrawal, or the study was closed.
|
|---|---|---|---|
|
Cohort 3: Change From Baseline in Number of Red Blood Cell (RBC) Units Transfused
|
7.25 number of RBC units transfused
Standard Deviation 7.915
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: FAS included all participants who received at least 1 dose of study treatment. Here, overall number of participants analyzed indicates the number of participants who were evaluable for this OM. Due to limited number of participants with optimal dose of 5 mg or 20 mg in antecedent studies AG348-C-006 (NCT03548220) and AG348-C-007 (NCT03559699), it was pre-specified in the SAP to report data for this OM by Cohort.
The PKDD is a validated, daily 7-item PRO instrument with a recall period of 24 hours that measures the core signs and symptoms associated with pyruvate kinase deficiency in adults. The symptoms include tiredness, jaundice, bone pain, shortness of breath, and energy level. PKDD daily scores were calculated based on the participant's response to the PKDD questionnaire. Score ranges from 25 to 76, with higher scores indicating more severe symptoms and a higher disease burden. The change from baseline in weekly mean scores was summarized. A negative change from baseline indicates a lower disease burden. Baseline of weekly mean score was defined as average of daily scores collected within 7 days before start of study treatment (mitapivat). For Cohort 1, last measurement before the start of study treatment in AG348-C-011 was used as baseline; if baseline was missing, then baseline value from AG348-C-006 was used. For Cohorts 2 \& 3 baseline values from -006 and-007, respectively, were used.
Outcome measures
| Measure |
Cohort 1
n=27 Participants
Participants who received placebo in Study AG348-C-006 and met the eligibility criteria of this extension study were enrolled to receive mitapivat tablets, 5 mg, BID, administered orally, for 4 weeks as a starting dose, followed by two potential sequential dose level increases to 20 mg and 50 mg BID at Weeks 4 and 8 respectively as determined by the investigator based on safety and efficacy. The optimized dose for each participant was determined at Week 12, and participants then received that optimized dose for a period of 12 weeks (Weeks 13-24) as a fixed dose and from Week 25 to Week 193, until study withdrawal, or the study was closed.
|
Cohort 2
n=24 Participants
Participants who received mitapivat at a dose of 5 mg, 20 mg, or 50 mg, BID, in the fixed dose period of Study AG348-C-006 and met the eligibility criteria of this extension study continued to receive the same mitapivat dose up to Week 193 or until study withdrawal, or the study was closed.
|
Cohort 3
n=10 Participants
Participants who received mitapivat at a dose of 5 mg, 20 mg, or 50 mg, BID, in the fixed dose period of Study AG348-C-007 and met the eligibility criteria of this extension study continued to receive the same mitapivat dose up to Week 193 or until study withdrawal, or the study was closed.
|
|---|---|---|---|
|
All Cohorts: Change From Baseline in Health-Related Quality of Life (HRQoL) Patient-Reported Outcome (PRO) Scores: Pyruvate Kinase Deficiency Diary (PKDD)
|
-3.75 score on a scale
Standard Deviation 5.805
|
-6.09 score on a scale
Standard Deviation 7.617
|
-5.04 score on a scale
Standard Deviation 12.273
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: FAS included all participants who received at least 1 dose of study treatment. Here, overall number of participants analyzed indicates the number of participants who were evaluable for this OM. Due to limited number of participants with optimal dose of 5 mg or 20 mg in antecedent studies AG348-C-006 (NCT03548220) and AG348-C-007 (NCT03559699), it was pre-specified in the SAP to report data for this OM by Cohort.
PKDIA is a 12-item PRO measure of common impacts of PK deficiency on activities of daily living. Participants rated how PK deficiency has impacted aspects of daily living in past 7 days, including impacts on relationships \& leisure and social, mental, and physical activities. PKDIA score at each visit was based on 8 items that were retained after in-trial psychometric validation and calculated at each visit based on participant's response to PKDIA questionnaire. Score ranges from 30 to 76, with higher scores indicating higher disease burden. Negative change from baseline indicates lower disease burden. Baseline was defined as the last complete assessment (with no missing item in response) before start of study treatment. For Cohort 1, last measurement before start of study treatment in AG348-C-011 was used as baseline; if baseline was missing, then baseline value from AG348-C-006 was used. For Cohorts 2 and 3, the baseline values from 006 and 007, respectively, were used.
Outcome measures
| Measure |
Cohort 1
n=31 Participants
Participants who received placebo in Study AG348-C-006 and met the eligibility criteria of this extension study were enrolled to receive mitapivat tablets, 5 mg, BID, administered orally, for 4 weeks as a starting dose, followed by two potential sequential dose level increases to 20 mg and 50 mg BID at Weeks 4 and 8 respectively as determined by the investigator based on safety and efficacy. The optimized dose for each participant was determined at Week 12, and participants then received that optimized dose for a period of 12 weeks (Weeks 13-24) as a fixed dose and from Week 25 to Week 193, until study withdrawal, or the study was closed.
|
Cohort 2
n=28 Participants
Participants who received mitapivat at a dose of 5 mg, 20 mg, or 50 mg, BID, in the fixed dose period of Study AG348-C-006 and met the eligibility criteria of this extension study continued to receive the same mitapivat dose up to Week 193 or until study withdrawal, or the study was closed.
|
Cohort 3
n=14 Participants
Participants who received mitapivat at a dose of 5 mg, 20 mg, or 50 mg, BID, in the fixed dose period of Study AG348-C-007 and met the eligibility criteria of this extension study continued to receive the same mitapivat dose up to Week 193 or until study withdrawal, or the study was closed.
|
|---|---|---|---|
|
All Cohorts: Change From Baseline in HRQoL PRO Scores: Pyruvate Kinase Deficiency Impact Assessment (PKDIA)
|
-3.9 score on a scale
Standard Deviation 7.38
|
-6.6 score on a scale
Standard Deviation 8.75
|
-5.4 score on a scale
Standard Deviation 12.83
|
Adverse Events
Cohort 1: 5 mg
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 1: 20 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 1: 50 mg
Serious events: 10 serious events
Other events: 35 other events
Deaths: 0 deaths
Cohort 2: 5 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort 2: 20 mg
Serious events: 2 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort 2: 50 mg
Serious events: 6 serious events
Other events: 27 other events
Deaths: 1 deaths
Cohort 3: 5 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 3: 20 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 3: 50 mg
Serious events: 4 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1: 5 mg
n=1 participants at risk
Participants who received placebo in Study AG348-C-006 and met the eligibility criteria of this extension study were enrolled to receive mitapivat tablets, 5 mg, BID, administered orally, for 4 weeks as a starting dose, followed by two potential sequential dose level increases to 20 mg and 50 mg BID at Weeks 4 and 8 respectively as determined by the investigator based on safety and efficacy. The optimized dose for each participant was determined as 5 mg, BID, at Week 12, which was followed for a period of 12 weeks (Weeks 13-24) as a fixed dose and then from Week 25 to Week 193, until study withdrawal, or the study was closed.
|
Cohort 1: 20 mg
n=1 participants at risk
Participants who received placebo in Study AG348-C-006 and met the eligibility criteria of this extension study were enrolled to receive mitapivat tablets, 5 mg, BID, administered orally, for 4 weeks as a starting dose, followed by two potential sequential dose level increases to 20 mg and 50 mg BID at Weeks 4 and 8 respectively as determined by the investigator based on safety and efficacy. The optimized dose for each participant was determined as 20 mg, BID, at Week 12, which was followed for a period of 12 weeks (Weeks 13-24) as a fixed dose and then from Week 25 to Week 193, until study withdrawal, or the study was closed.
|
Cohort 1: 50 mg
n=36 participants at risk
Participants who received placebo in Study AG348-C-006 and met the eligibility criteria of this extension study were enrolled to receive mitapivat tablets, 5 mg, BID, administered orally, for 4 weeks as a starting dose, followed by two potential sequential dose level increases to 20 mg and 50 mg BID at Weeks 4 and 8 respectively as determined by the investigator based on safety and efficacy. The optimized dose for each participant was determined as 50 mg, BID, at Week 12, which was followed for a period of 12 weeks (Weeks 13-24) as a fixed dose and then from Week 25 to Week 193, until study withdrawal, or the study was closed.
|
Cohort 2: 5 mg
n=2 participants at risk
Participants who received mitapivat at a dose of 5 mg, BID, in the fixed dose period of Study AG348-C-006 and met the eligibility criteria of this extension study continued to receive the same mitapivat dose up to Week 193 or until study withdrawal, or the study was closed.
|
Cohort 2: 20 mg
n=3 participants at risk
Participants who received mitapivat at a dose of 20 mg, BID, in the fixed dose period of Study AG348-C-006 and met the eligibility criteria of this extension study continued to receive the same mitapivat dose up to Week 193 or until study withdrawal, or the study was closed.
|
Cohort 2: 50 mg
n=30 participants at risk
Participants who received mitapivat at a dose of 50 mg, BID, in the fixed dose period of Study AG348-C-006 and met the eligibility criteria of this extension study continued to receive the same mitapivat dose up to Week 193 or until study withdrawal, or the study was closed.
|
Cohort 3: 5 mg
Participants who received mitapivat at a dose of 5 mg, BID, in the fixed dose period of Study AG348-C-007 and met the eligibility criteria of this extension study continued to receive the same mitapivat dose up to Week 193 or until study withdrawal, or the study was closed.
|
Cohort 3: 20 mg
n=1 participants at risk
Participants who received mitapivat at a dose of 20 mg, BID, in the fixed dose period of Study AG348-C-007 and met the eligibility criteria of this extension study continued to receive the same mitapivat dose up to Week 193 or until study withdrawal, or the study was closed.
|
Cohort 3: 50 mg
n=16 participants at risk
Participants who received mitapivat at a dose of 50 mg, BID, in the fixed dose period of Study AG348-C-007 and met the eligibility criteria of this extension study continued to receive the same mitapivat dose up to Week 193 or until study withdrawal, or the study was closed.
|
|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Sepsis
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
8.3%
3/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
5.6%
2/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
5.6%
2/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
2.8%
1/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
3.3%
1/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Cytomegalovirus infection
|
100.0%
1/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
2.8%
1/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Erysipelas
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
2.8%
1/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
2.8%
1/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Varicella zoster virus infection
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
2.8%
1/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
2.8%
1/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
6.2%
1/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Syncope
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
2.8%
1/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
33.3%
1/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Seizure
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
2.8%
1/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Carotid artery aneurysm
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
6.2%
1/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Intracranial aneurysm
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
6.2%
1/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
3.3%
1/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
6.2%
1/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
2.8%
1/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
2.8%
1/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Accident
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
3.3%
1/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
3.3%
1/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hodgkin's disease
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
2.8%
1/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
3.3%
1/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic malignant melanoma
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
3.3%
1/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
6.2%
1/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Blood and lymphatic system disorders
Haemolysis
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
2.8%
1/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
3.3%
1/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
33.3%
1/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
3.3%
1/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
2.8%
1/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
General disorders
Pyrexia
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
2.8%
1/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
2.8%
1/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Vascular disorders
Vascular stenosis
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
2.8%
1/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
6.2%
1/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
Other adverse events
| Measure |
Cohort 1: 5 mg
n=1 participants at risk
Participants who received placebo in Study AG348-C-006 and met the eligibility criteria of this extension study were enrolled to receive mitapivat tablets, 5 mg, BID, administered orally, for 4 weeks as a starting dose, followed by two potential sequential dose level increases to 20 mg and 50 mg BID at Weeks 4 and 8 respectively as determined by the investigator based on safety and efficacy. The optimized dose for each participant was determined as 5 mg, BID, at Week 12, which was followed for a period of 12 weeks (Weeks 13-24) as a fixed dose and then from Week 25 to Week 193, until study withdrawal, or the study was closed.
|
Cohort 1: 20 mg
n=1 participants at risk
Participants who received placebo in Study AG348-C-006 and met the eligibility criteria of this extension study were enrolled to receive mitapivat tablets, 5 mg, BID, administered orally, for 4 weeks as a starting dose, followed by two potential sequential dose level increases to 20 mg and 50 mg BID at Weeks 4 and 8 respectively as determined by the investigator based on safety and efficacy. The optimized dose for each participant was determined as 20 mg, BID, at Week 12, which was followed for a period of 12 weeks (Weeks 13-24) as a fixed dose and then from Week 25 to Week 193, until study withdrawal, or the study was closed.
|
Cohort 1: 50 mg
n=36 participants at risk
Participants who received placebo in Study AG348-C-006 and met the eligibility criteria of this extension study were enrolled to receive mitapivat tablets, 5 mg, BID, administered orally, for 4 weeks as a starting dose, followed by two potential sequential dose level increases to 20 mg and 50 mg BID at Weeks 4 and 8 respectively as determined by the investigator based on safety and efficacy. The optimized dose for each participant was determined as 50 mg, BID, at Week 12, which was followed for a period of 12 weeks (Weeks 13-24) as a fixed dose and then from Week 25 to Week 193, until study withdrawal, or the study was closed.
|
Cohort 2: 5 mg
n=2 participants at risk
Participants who received mitapivat at a dose of 5 mg, BID, in the fixed dose period of Study AG348-C-006 and met the eligibility criteria of this extension study continued to receive the same mitapivat dose up to Week 193 or until study withdrawal, or the study was closed.
|
Cohort 2: 20 mg
n=3 participants at risk
Participants who received mitapivat at a dose of 20 mg, BID, in the fixed dose period of Study AG348-C-006 and met the eligibility criteria of this extension study continued to receive the same mitapivat dose up to Week 193 or until study withdrawal, or the study was closed.
|
Cohort 2: 50 mg
n=30 participants at risk
Participants who received mitapivat at a dose of 50 mg, BID, in the fixed dose period of Study AG348-C-006 and met the eligibility criteria of this extension study continued to receive the same mitapivat dose up to Week 193 or until study withdrawal, or the study was closed.
|
Cohort 3: 5 mg
Participants who received mitapivat at a dose of 5 mg, BID, in the fixed dose period of Study AG348-C-007 and met the eligibility criteria of this extension study continued to receive the same mitapivat dose up to Week 193 or until study withdrawal, or the study was closed.
|
Cohort 3: 20 mg
n=1 participants at risk
Participants who received mitapivat at a dose of 20 mg, BID, in the fixed dose period of Study AG348-C-007 and met the eligibility criteria of this extension study continued to receive the same mitapivat dose up to Week 193 or until study withdrawal, or the study was closed.
|
Cohort 3: 50 mg
n=16 participants at risk
Participants who received mitapivat at a dose of 50 mg, BID, in the fixed dose period of Study AG348-C-007 and met the eligibility criteria of this extension study continued to receive the same mitapivat dose up to Week 193 or until study withdrawal, or the study was closed.
|
|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
5.6%
2/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
33.3%
1/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
10.0%
3/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Suspected COVID-19
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
11.1%
4/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
12.5%
2/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
11.1%
4/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Hordeolum
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
8.3%
3/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
2.8%
1/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
33.3%
1/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
3.3%
1/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
8.3%
3/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
13.9%
5/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
33.3%
1/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
6.7%
2/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
12.5%
2/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
2.8%
1/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
3.3%
1/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
100.0%
1/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
5.6%
2/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Respiratory tract infection viral
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
5.6%
2/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
3.3%
1/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
2.8%
1/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
12.5%
2/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Anosmia
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
2.8%
1/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
50.0%
1/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
3.3%
1/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
12.5%
2/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Acarodermatitis
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
3.3%
1/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
100.0%
1/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
5.6%
2/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
5.6%
2/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
5.6%
2/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Conjunctivitis viral
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
6.2%
1/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Ear lobe infection
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
6.2%
1/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Enterovirus infection
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
6.2%
1/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
6.2%
1/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Migraine
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
8.3%
3/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
3.3%
1/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
6.2%
1/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Eye infection
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
6.2%
1/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Vascular disorders
Hot flush
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
5.6%
2/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
12.5%
2/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Helminthic infection
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
6.2%
1/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Implant site infection
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
6.2%
1/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Infective tenosynovitis
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
100.0%
1/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
6.2%
1/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Viral infection
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
6.2%
1/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Viral sinusitis
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
6.2%
1/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
General disorders
Fatigue
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
100.0%
1/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
27.8%
10/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
50.0%
1/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
33.3%
1/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
20.0%
6/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
25.0%
4/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
General disorders
Pyrexia
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
27.8%
10/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
100.0%
2/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
23.3%
7/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
18.8%
3/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
General disorders
Influenza like illness
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
11.1%
4/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
33.3%
1/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
3.3%
1/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
12.5%
2/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
General disorders
Oedema peripheral
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
8.3%
3/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
3.3%
1/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
12.5%
2/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
General disorders
Asthenia
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
5.6%
2/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
10.0%
3/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
General disorders
Injection site pain
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
5.6%
2/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
3.3%
1/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
General disorders
Chest pain
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
33.3%
1/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
3.3%
1/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
General disorders
Face oedema
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
6.2%
1/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
General disorders
Inflammation
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
6.2%
1/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
General disorders
Peripheral swelling
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
6.2%
1/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
25.0%
9/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
66.7%
2/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
16.7%
5/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
100.0%
1/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
12.5%
2/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
COVID-19
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
33.3%
12/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
50.0%
1/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
66.7%
2/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
43.3%
13/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
100.0%
1/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
31.2%
5/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
16.7%
6/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
50.0%
1/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
16.7%
5/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
100.0%
1/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
12.5%
2/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
25.0%
9/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
13.3%
4/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
6.2%
1/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
13.9%
5/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
3.3%
1/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
25.0%
4/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Influenza
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
5.6%
2/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
50.0%
1/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
10.0%
3/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
12.5%
2/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
5.6%
2/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
33.3%
1/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
6.7%
2/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
18.8%
3/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
13.9%
5/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
50.0%
1/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
6.7%
2/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
6.2%
1/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
11.1%
4/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
33.3%
1/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
10.0%
3/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
5.6%
2/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
3.3%
1/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
100.0%
1/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
12.5%
2/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
8.3%
3/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
33.3%
1/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
6.2%
1/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
16.7%
5/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
5.6%
2/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
100.0%
1/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
6.2%
1/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
2.8%
1/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
3.3%
1/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
6.2%
1/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
5.6%
2/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
3.3%
1/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
6.2%
1/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
2.8%
1/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
6.2%
1/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
2.8%
1/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
100.0%
1/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Gouty arthritis
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
6.2%
1/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
6.2%
1/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Headache
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
100.0%
1/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
55.6%
20/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
100.0%
2/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
20.0%
6/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
100.0%
1/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
18.8%
3/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
8.3%
3/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
33.3%
1/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
3.3%
1/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
6.2%
1/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Ageusia
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
50.0%
1/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
3.3%
1/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
12.5%
2/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
5.6%
2/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
3.3%
1/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
5.6%
2/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Carotid artery aneurysm
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
6.2%
1/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
6.2%
1/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Intracranial aneurysm
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
6.2%
1/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
16.7%
6/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
33.3%
1/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
13.3%
4/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
12.5%
2/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
16.7%
6/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
10.0%
3/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
100.0%
1/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
12.5%
2/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
5.6%
2/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
3.3%
1/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
100.0%
1/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
18.8%
3/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
2.8%
1/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
50.0%
1/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
6.7%
2/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
12.5%
2/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
33.3%
1/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
13.3%
4/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
6.2%
1/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
5.6%
2/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
6.7%
2/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
8.3%
3/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
5.6%
2/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
6.2%
1/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
5.6%
2/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
3.3%
1/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
11.1%
4/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
33.3%
1/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
13.3%
4/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
25.0%
4/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
13.9%
5/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
6.7%
2/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
12.5%
2/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
13.9%
5/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
66.7%
2/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
3.3%
1/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
2.8%
1/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
33.3%
1/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
12.5%
2/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
8.3%
3/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
3.3%
1/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
5.6%
2/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
3.3%
1/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
6.2%
1/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
22.2%
8/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
50.0%
1/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
13.3%
4/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
18.8%
3/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
16.7%
6/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
50.0%
1/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
6.7%
2/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
25.0%
4/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Investigations
Vitamin D decreased
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
2.8%
1/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
3.3%
1/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
6.2%
1/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
3.3%
1/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
6.2%
1/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Investigations
High density lipoprotein increased
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
3.3%
1/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
6.2%
1/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Investigations
Weight decreased
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
3.3%
1/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
100.0%
1/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Investigations
Haemoglobin increased
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
6.2%
1/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Investigations
Liver iron concentration increased
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
6.2%
1/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Psychiatric disorders
Middle insomnia
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
22.2%
8/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
6.7%
2/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
6.2%
1/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Psychiatric disorders
Initial insomnia
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
27.8%
10/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Psychiatric disorders
Depression
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
5.6%
2/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
3.3%
1/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
6.2%
1/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
5.6%
2/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
3.3%
1/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Psychiatric disorders
Panic attack
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
5.6%
2/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
2.8%
1/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
6.2%
1/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Psychiatric disorders
Stress
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
6.2%
1/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
5.6%
2/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
50.0%
1/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
10.0%
3/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
100.0%
1/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
18.8%
3/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Iron overload
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
5.6%
2/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
50.0%
1/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
3.3%
1/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
2.8%
1/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
3.3%
1/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
100.0%
1/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
5.6%
2/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
8.3%
3/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
33.3%
1/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
6.7%
2/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
6.2%
1/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Immunisation reaction
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
8.3%
3/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
33.3%
1/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
6.7%
2/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
8.3%
3/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
3.3%
1/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Bone contusion
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
66.7%
2/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
5.6%
2/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
6.2%
1/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
6.2%
1/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Lip injury
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
6.2%
1/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Lipohaemarthrosis
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
6.2%
1/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
6.2%
1/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
13.9%
5/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
6.7%
2/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
6.2%
1/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Blood and lymphatic system disorders
Haemolysis
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
5.6%
2/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
3.3%
1/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
6.2%
1/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
8.3%
3/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Blood and lymphatic system disorders
Blood loss anaemia
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
6.2%
1/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
6.2%
1/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
2.8%
1/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
6.7%
2/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
3.3%
1/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
6.2%
1/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
3.3%
1/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
6.2%
1/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Hepatobiliary disorders
Biliary colic
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
6.2%
1/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Hepatobiliary disorders
Hepatic pain
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
6.2%
1/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
5.6%
2/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
10.0%
3/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
6.7%
2/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Renal and urinary disorders
Polyuria
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
5.6%
2/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
6.2%
1/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Renal and urinary disorders
Renal cyst
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
6.2%
1/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
100.0%
1/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
2.8%
1/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
6.7%
2/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Reproductive system and breast disorders
Menstruation irregular
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
6.7%
2/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
12.5%
2/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Reproductive system and breast disorders
Intermenstrual bleeding
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
12.5%
2/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Reproductive system and breast disorders
Bartholin's cyst
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
100.0%
1/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Reproductive system and breast disorders
Breast cyst
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
6.2%
1/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Reproductive system and breast disorders
Perineal cyst
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
6.2%
1/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
6.2%
1/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
5.6%
2/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
100.0%
1/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
5.6%
2/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
6.2%
1/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Hair growth abnormal
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
6.2%
1/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Skin hypertrophy
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
6.2%
1/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Vascular disorders
Hypertension
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
2.8%
1/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
33.3%
1/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
3.3%
1/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Vascular disorders
Arteriosclerosis
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
2.8%
1/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
6.2%
1/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Vascular disorders
Haematoma
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
6.2%
1/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
8.3%
3/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
8.3%
3/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Ear and labyrinth disorders
Deafness unilateral
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
6.2%
1/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
6.2%
1/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
2.8%
1/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
33.3%
1/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
3.3%
1/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
5.6%
2/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Cardiac disorders
Hypertensive heart disease
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
6.2%
1/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Eye disorders
Cataract
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
3.3%
1/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
6.2%
1/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Eye disorders
Vision blurred
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
5.6%
2/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
6.2%
1/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Eye disorders
Meibomian gland dysfunction
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
6.2%
1/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
5.6%
2/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
6.2%
1/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Superficial spreading melanoma stage unspecified
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/36 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/3 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/30 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
—
0/0 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
6.2%
1/16 • Up to 197 weeks
The safety analysis set included all participants who received at least 1 dose of study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The information obtained from the clinical study will be used towards the development of mitapivat and may be disclosed to regulatory authority(ies), other Investigators, corporate partners, or consultants as required.
- Publication restrictions are in place
Restriction type: OTHER