Trial Outcomes & Findings for A Study of Efruxifermin in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH) (Symmetry) (NCT NCT05039450)
NCT ID: NCT05039450
Last Updated: 2026-07-21
Results Overview
Proportion of subjects who achieve ≥ 1 stage improvement in fibrosis (based on NASH CRN fibrosis score) and no worsening of steatohepatitis at Week 36. No worsening of steatohepatitis was defined as no increase in score for any of the 3 components of NAS. The evaluation of the NAS endpoint was calculated using the following 3 categorical features: steatosis \[0-3\], lobular inflammation \[0-3\], and hepatocellular ballooning \[0-2\]. NAS was derived as the unweighted sum of steatosis, lobular inflammation, and hepatocellular ballooning scores.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
213 participants
Primary outcome timeframe
Week 36
Results posted on
2026-07-21
Participant Flow
The Main Study was initiated (first subject screened) on 30 July 2021. The last subject visit occurred on 14 November 2024. Sixty-five sites in North America were activated; 61 sites screened subjects; 182 subjects were enrolled at 47 sites, of which 181 started study drug. Cohort D was a 12-week separate assessment of 32 separate subjects, of which 31 started study drug. Participant flow and key secondary endpoint details related to Cohort D only are presented.
Participants with any of the following were not eligible: weight loss \>10% within 90 days of the eligibility liver biopsy; type 1 diabetes; poorly controlled T2D; significant hypoglycemia; osteoporosis; uncontrolled hypertension; current/history of decompensated liver disease; history of pancreatitis; other causes of liver disease, alcoholic liver disease, or autoimmune disorders; or any medical conditions such that inclusion in the study may not have been in the participant's best interest.
Participant milestones
| Measure |
Placebo (Main Study)
Placebo: Placebo
|
EFX 28 mg (Main Study)
EFX: Investigational drug, Efruxifermin
|
EFX 50 mg (Main Study)
EFX: Investigational drug, Efruxifermin
|
Placebo (Cohort D)
Placebo Comparator: Placebo + GLP-1 (Cohort D)
|
EFX 50 mg (Cohort D)
Drug EFX Investigational drug, Efruxifermin + GLP-1 (Cohort D)
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
61
|
58
|
63
|
10
|
21
|
|
Overall Study
COMPLETED
|
49
|
40
|
47
|
10
|
19
|
|
Overall Study
NOT COMPLETED
|
12
|
18
|
16
|
0
|
2
|
Reasons for withdrawal
| Measure |
Placebo (Main Study)
Placebo: Placebo
|
EFX 28 mg (Main Study)
EFX: Investigational drug, Efruxifermin
|
EFX 50 mg (Main Study)
EFX: Investigational drug, Efruxifermin
|
Placebo (Cohort D)
Placebo Comparator: Placebo + GLP-1 (Cohort D)
|
EFX 50 mg (Cohort D)
Drug EFX Investigational drug, Efruxifermin + GLP-1 (Cohort D)
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
5
|
9
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
3
|
5
|
3
|
0
|
1
|
|
Overall Study
At the discretion of the investigator or sponsor for noncompliance
|
2
|
2
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
2
|
2
|
1
|
0
|
0
|
|
Overall Study
Clinical Outcome Event (excluding death)
|
0
|
1
|
2
|
0
|
0
|
|
Overall Study
Administrative decision by the investigator or sponsor or designee
|
1
|
1
|
0
|
0
|
0
|
|
Overall Study
Site closure or patient relocation
|
3
|
2
|
1
|
0
|
0
|
Baseline Characteristics
Participant score data was not collected from Cohort D.
Baseline characteristics by cohort
| Measure |
Placebo (Main Study)
n=61 Participants
Placebo: Placebo
|
EFX 28 mg (Main Study)
n=57 Participants
EFX: Investigational drug, Efruxifermin
|
EFX 50 mg (Main Study)
n=63 Participants
EFX: Investigational drug, Efruxifermin
|
Placebo (Cohort D)
n=10 Participants
Placebo Comparator: Placebo + GLP-1 (Cohort D)
|
EFX 50 mg (Cohort D)
n=21 Participants
EFX: Investigational drug, Efruxifermin + GLP-1 (Cohort D)
|
Total
n=212 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
43 Participants
n=61 Participants
|
35 Participants
n=57 Participants
|
40 Participants
n=63 Participants
|
10 Participants
n=10 Participants
|
15 Participants
n=21 Participants
|
143 Participants
n=212 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=61 Participants
|
0 Participants
n=57 Participants
|
0 Participants
n=63 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=212 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
38 Participants
n=61 Participants
|
36 Participants
n=57 Participants
|
44 Participants
n=63 Participants
|
10 Participants
n=10 Participants
|
16 Participants
n=21 Participants
|
144 Participants
n=212 Participants
|
|
Age, Categorical
>=65 years
|
23 Participants
n=61 Participants
|
21 Participants
n=57 Participants
|
19 Participants
n=63 Participants
|
0 Participants
n=10 Participants
|
5 Participants
n=21 Participants
|
68 Participants
n=212 Participants
|
|
Age, Continuous
|
61.0 years
STANDARD_DEVIATION 7.48 • n=61 Participants
|
61.7 years
STANDARD_DEVIATION 8.25 • n=57 Participants
|
59.4 years
STANDARD_DEVIATION 8.79 • n=63 Participants
|
55.1 years
STANDARD_DEVIATION 5.17 • n=10 Participants
|
58.5 years
STANDARD_DEVIATION 8.68 • n=21 Participants
|
60.7 years
STANDARD_DEVIATION 8.21 • n=212 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=61 Participants
|
39 Participants
n=57 Participants
|
44 Participants
n=63 Participants
|
9 Participants
n=10 Participants
|
9 Participants
n=21 Participants
|
139 Participants
n=212 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=61 Participants
|
18 Participants
n=57 Participants
|
19 Participants
n=63 Participants
|
1 Participants
n=10 Participants
|
12 Participants
n=21 Participants
|
73 Participants
n=212 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
17 Participants
n=61 Participants
|
22 Participants
n=57 Participants
|
21 Participants
n=63 Participants
|
0 Participants
n=10 Participants
|
6 Participants
n=21 Participants
|
66 Participants
n=212 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=61 Participants
|
0 Participants
n=57 Participants
|
2 Participants
n=63 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=21 Participants
|
3 Participants
n=212 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
54 Participants
n=61 Participants
|
55 Participants
n=57 Participants
|
56 Participants
n=63 Participants
|
7 Participants
n=10 Participants
|
18 Participants
n=21 Participants
|
190 Participants
n=212 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
3 Participants
n=61 Participants
|
0 Participants
n=57 Participants
|
2 Participants
n=63 Participants
|
1 Participants
n=10 Participants
|
1 Participants
n=21 Participants
|
7 Participants
n=212 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
1 Participants
n=61 Participants
|
1 Participants
n=57 Participants
|
2 Participants
n=63 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=21 Participants
|
5 Participants
n=212 Participants
|
|
Race/Ethnicity, Customized
Race · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=61 Participants
|
0 Participants
n=57 Participants
|
0 Participants
n=63 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=212 Participants
|
|
Race/Ethnicity, Customized
Race · American Indian or Alaskan Native
|
0 Participants
n=61 Participants
|
0 Participants
n=57 Participants
|
0 Participants
n=63 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=212 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
3 Participants
n=61 Participants
|
1 Participants
n=57 Participants
|
3 Participants
n=63 Participants
|
0 Participants
n=10 Participants
|
2 Participants
n=21 Participants
|
9 Participants
n=212 Participants
|
|
Region of Enrollment
United States
|
57 Participants
n=61 Participants
|
50 Participants
n=57 Participants
|
55 Participants
n=63 Participants
|
10 Participants
n=10 Participants
|
21 Participants
n=21 Participants
|
193 Participants
n=212 Participants
|
|
Region of Enrollment
Puerto Rico
|
2 Participants
n=61 Participants
|
3 Participants
n=57 Participants
|
3 Participants
n=63 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=21 Participants
|
8 Participants
n=212 Participants
|
|
Region of Enrollment
Mexico
|
2 Participants
n=61 Participants
|
4 Participants
n=57 Participants
|
5 Participants
n=63 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=21 Participants
|
11 Participants
n=212 Participants
|
|
Total NAFLD Activity Score (NAS) Category
≤3
|
25 Participants
n=61 Participants • Participant score data was not collected from Cohort D.
|
23 Participants
n=57 Participants • Participant score data was not collected from Cohort D.
|
18 Participants
n=63 Participants • Participant score data was not collected from Cohort D.
|
—
|
—
|
66 Participants
n=181 Participants • Participant score data was not collected from Cohort D.
|
|
Total NAFLD Activity Score (NAS) Category
>3
|
36 Participants
n=61 Participants • Participant score data was not collected from Cohort D.
|
34 Participants
n=57 Participants • Participant score data was not collected from Cohort D.
|
45 Participants
n=63 Participants • Participant score data was not collected from Cohort D.
|
—
|
—
|
115 Participants
n=181 Participants • Participant score data was not collected from Cohort D.
|
|
Weight
|
102.26 kg
STANDARD_DEVIATION 22.011 • n=61 Participants
|
98.91 kg
STANDARD_DEVIATION 21.882 • n=57 Participants
|
94.56 kg
STANDARD_DEVIATION 18.906 • n=63 Participants
|
95.65 kg
STANDARD_DEVIATION 18.856 • n=10 Participants
|
100.70 kg
STANDARD_DEVIATION 18.893 • n=21 Participants
|
98.52 kg
STANDARD_DEVIATION 21.068 • n=212 Participants
|
|
Type 2 Diabetes Status
Yes
|
50 Participants
n=61 Participants
|
46 Participants
n=57 Participants
|
49 Participants
n=63 Participants
|
9 Participants
n=10 Participants
|
21 Participants
n=21 Participants
|
175 Participants
n=212 Participants
|
|
Type 2 Diabetes Status
No
|
11 Participants
n=61 Participants
|
11 Participants
n=57 Participants
|
14 Participants
n=63 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=21 Participants
|
37 Participants
n=212 Participants
|
|
Diagnosis of Cryptogenic Cirrhosis Presumed Secondary to NASH
Yes
|
16 Participants
n=61 Participants • Participant data was not collected from Cohort D.
|
12 Participants
n=57 Participants • Participant data was not collected from Cohort D.
|
11 Participants
n=63 Participants • Participant data was not collected from Cohort D.
|
—
|
—
|
39 Participants
n=181 Participants • Participant data was not collected from Cohort D.
|
|
Diagnosis of Cryptogenic Cirrhosis Presumed Secondary to NASH
No
|
45 Participants
n=61 Participants • Participant data was not collected from Cohort D.
|
45 Participants
n=57 Participants • Participant data was not collected from Cohort D.
|
52 Participants
n=63 Participants • Participant data was not collected from Cohort D.
|
—
|
—
|
142 Participants
n=181 Participants • Participant data was not collected from Cohort D.
|
PRIMARY outcome
Timeframe: Week 36Population: 36-Week Liver Biopsy Analysis Set
Proportion of subjects who achieve ≥ 1 stage improvement in fibrosis (based on NASH CRN fibrosis score) and no worsening of steatohepatitis at Week 36. No worsening of steatohepatitis was defined as no increase in score for any of the 3 components of NAS. The evaluation of the NAS endpoint was calculated using the following 3 categorical features: steatosis \[0-3\], lobular inflammation \[0-3\], and hepatocellular ballooning \[0-2\]. NAS was derived as the unweighted sum of steatosis, lobular inflammation, and hepatocellular ballooning scores.
Outcome measures
| Measure |
EFX 28 mg (Main Study)
n=46 Participants
EFX: Investigational drug, Efruxifermin
|
EFX 50 mg (Main Study)
n=51 Participants
EFX: Investigational drug, Efruxifermin
|
Placebo (Main Study)
n=57 Participants
Placebo: Placebo
|
|---|---|---|---|
|
Main: Change From Baseline in Fibrosis With no Worsening Steatohepatitis Assessed by NASH CRN System
Responder
|
10 Participants
|
12 Participants
|
8 Participants
|
|
Main: Change From Baseline in Fibrosis With no Worsening Steatohepatitis Assessed by NASH CRN System
Non-responder
|
36 Participants
|
39 Participants
|
49 Participants
|
SECONDARY outcome
Timeframe: Week 36, Week 96Population: 36-Week and 96-Week Liver Biopsy Analysis Sets, only participants with definitive NASH at baseline included.
Proportion of subjects who achieve NASH resolution (defined as a NAS of 0-1 for inflammation and 0 for ballooning) as determined by the NASH CRN criteria at Week 36 and Week 96.
Outcome measures
| Measure |
EFX 28 mg (Main Study)
n=46 Participants
EFX: Investigational drug, Efruxifermin
|
EFX 50 mg (Main Study)
n=51 Participants
EFX: Investigational drug, Efruxifermin
|
Placebo (Main Study)
n=57 Participants
Placebo: Placebo
|
|---|---|---|---|
|
Main: Resolution of NASH Assessed by the NASH CRN System
Week 96 · Non-responder
|
13 Participants
|
18 Participants
|
28 Participants
|
|
Main: Resolution of NASH Assessed by the NASH CRN System
Week 36 · Responder
|
24 Participants
|
25 Participants
|
11 Participants
|
|
Main: Resolution of NASH Assessed by the NASH CRN System
Week 36 · Non-responder
|
12 Participants
|
18 Participants
|
31 Participants
|
|
Main: Resolution of NASH Assessed by the NASH CRN System
Week 96 · Responder
|
19 Participants
|
22 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Week 36, Week 96Population: 36-Week and 96-Week Liver Biopsy Analysis Set; subjects w/ definitive NASH at baseline included in analysis
Proportion of subjects who achieve NASH resolution (defined as a NAS of 0-1 for inflammation and 0 for ballooning) and ≥ 1 stage improvement in fibrosis (based on NASH CRN fibrosis score) at Week 36 and Week 96
Outcome measures
| Measure |
EFX 28 mg (Main Study)
n=46 Participants
EFX: Investigational drug, Efruxifermin
|
EFX 50 mg (Main Study)
n=51 Participants
EFX: Investigational drug, Efruxifermin
|
Placebo (Main Study)
n=57 Participants
Placebo: Placebo
|
|---|---|---|---|
|
Main: Fibrosis Improvement and Resolution of NASH Assessed by the NASH CRN System
Week 36 · Responder
|
8 Participants
|
6 Participants
|
4 Participants
|
|
Main: Fibrosis Improvement and Resolution of NASH Assessed by the NASH CRN System
Week 36 · Non-responder
|
28 Participants
|
37 Participants
|
38 Participants
|
|
Main: Fibrosis Improvement and Resolution of NASH Assessed by the NASH CRN System
Week 96 · Responder
|
10 Participants
|
9 Participants
|
2 Participants
|
|
Main: Fibrosis Improvement and Resolution of NASH Assessed by the NASH CRN System
Week 96 · Non-responder
|
22 Participants
|
31 Participants
|
32 Participants
|
SECONDARY outcome
Timeframe: Week 96Population: 96-Week Liver Biopsy Analysis Set
Proportion of subjects who achieve ≥ 1 stage improvement in fibrosis (based on NASH CRN fibrosis score) and no worsening of steatohepatitis at Week 96
Outcome measures
| Measure |
EFX 28 mg (Main Study)
n=41 Participants
EFX: Investigational drug, Efruxifermin
|
EFX 50 mg (Main Study)
n=46 Participants
EFX: Investigational drug, Efruxifermin
|
Placebo (Main Study)
n=47 Participants
Placebo: Placebo
|
|---|---|---|---|
|
Main: Change From Baseline in Fibrosis With no Worsening of Steatohepatitis Assessed by the NASH CRN System
Responder
|
12 Participants
|
18 Participants
|
7 Participants
|
|
Main: Change From Baseline in Fibrosis With no Worsening of Steatohepatitis Assessed by the NASH CRN System
Non-responder
|
29 Participants
|
28 Participants
|
40 Participants
|
SECONDARY outcome
Timeframe: Week 36, Week 96Population: 36-Week and 96-Week Liver Biopsy Analysis Set
Proportion of subjects who achieve ≥ 1 stage improvement in fibrosis (based on NASH CRN fibrosis score) at Week 36 and Week 96
Outcome measures
| Measure |
EFX 28 mg (Main Study)
n=46 Participants
EFX: Investigational drug, Efruxifermin
|
EFX 50 mg (Main Study)
n=51 Participants
EFX: Investigational drug, Efruxifermin
|
Placebo (Main Study)
n=57 Participants
Placebo: Placebo
|
|---|---|---|---|
|
Main: Change From Baseline in Fibrosis by NASH CRN System
Week 36 · Non-responder
|
35 Participants
|
38 Participants
|
46 Participants
|
|
Main: Change From Baseline in Fibrosis by NASH CRN System
Week 96 · Responder
|
15 Participants
|
20 Participants
|
9 Participants
|
|
Main: Change From Baseline in Fibrosis by NASH CRN System
Week 96 · Non-responder
|
26 Participants
|
26 Participants
|
38 Participants
|
|
Main: Change From Baseline in Fibrosis by NASH CRN System
Week 36 · Responder
|
11 Participants
|
13 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: Week 36, Week 48, Week 72, Week 96Population: Full Analysis Set; only subjects with non-missing baseline and the specified visit are included.
Change from baseline in Serum Pro-C3 (N-terminal type III collagen propeptide), a biomarker of type III collagen formation reflecting fibrogenesis, measured in ug/L.
Outcome measures
| Measure |
EFX 28 mg (Main Study)
n=57 Participants
EFX: Investigational drug, Efruxifermin
|
EFX 50 mg (Main Study)
n=63 Participants
EFX: Investigational drug, Efruxifermin
|
Placebo (Main Study)
n=61 Participants
Placebo: Placebo
|
|---|---|---|---|
|
Main: Change From Baseline in S-Pro-C3
Pro-C3 - Week 36
|
-58.37 ug/L
Standard Error 5.359
|
-48.78 ug/L
Standard Error 5.288
|
-16.36 ug/L
Standard Error 4.920
|
|
Main: Change From Baseline in S-Pro-C3
Pro-C3 - Week 48
|
-55.84 ug/L
Standard Error 8.846
|
-53.01 ug/L
Standard Error 8.404
|
-30.94 ug/L
Standard Error 7.866
|
|
Main: Change From Baseline in S-Pro-C3
Pro-C3 - Week 72
|
-58.45 ug/L
Standard Error 7.216
|
-53.91 ug/L
Standard Error 6.973
|
-34.85 ug/L
Standard Error 6.462
|
|
Main: Change From Baseline in S-Pro-C3
Pro-C3 - Week 96
|
-57.00 ug/L
Standard Error 7.304
|
-56.06 ug/L
Standard Error 7.040
|
-30.14 ug/L
Standard Error 6.594
|
SECONDARY outcome
Timeframe: Week 36, Week 48, Week 72, Week 96Population: Full Analysis Set; only subjects with non-missing baseline and the specified visit are included.
ELF score is a composite serum biomarker score derived from HA, PIIINP, and TIMP-1 concentrations. Scores range approximately from 6 to 16, with higher scores indicating greater liver fibrosis severity.
Outcome measures
| Measure |
EFX 28 mg (Main Study)
n=57 Participants
EFX: Investigational drug, Efruxifermin
|
EFX 50 mg (Main Study)
n=63 Participants
EFX: Investigational drug, Efruxifermin
|
Placebo (Main Study)
n=61 Participants
Placebo: Placebo
|
|---|---|---|---|
|
Main: Change From Baseline in Enhanced Liver Fibrosis (ELF) Score
ELF Score - Week 36
|
-0.208 units on a scale
Standard Error 0.0947
|
-0.331 units on a scale
Standard Error 0.0925
|
0.094 units on a scale
Standard Error 0.0875
|
|
Main: Change From Baseline in Enhanced Liver Fibrosis (ELF) Score
ELF Score - Week 48
|
-0.176 units on a scale
Standard Error 0.1010
|
-0.465 units on a scale
Standard Error 0.0970
|
0.216 units on a scale
Standard Error 0.0923
|
|
Main: Change From Baseline in Enhanced Liver Fibrosis (ELF) Score
ELF Score - Week 72
|
-0.206 units on a scale
Standard Error 0.1083
|
-0.433 units on a scale
Standard Error 0.1051
|
0.162 units on a scale
Standard Error 0.0989
|
|
Main: Change From Baseline in Enhanced Liver Fibrosis (ELF) Score
ELF Score - Week 96
|
-0.338 units on a scale
Standard Error 0.1233
|
-0.532 units on a scale
Standard Error 0.1177
|
0.220 units on a scale
Standard Error 0.1136
|
SECONDARY outcome
Timeframe: Week 36, Week 48, Week 72, Week 96Population: Full Analysis Set; only subjects with non-missing baseline and the specified visit are included
Change from baseline in liver stiffness assessed by liver elastography (kPa)
Outcome measures
| Measure |
EFX 28 mg (Main Study)
n=57 Participants
EFX: Investigational drug, Efruxifermin
|
EFX 50 mg (Main Study)
n=63 Participants
EFX: Investigational drug, Efruxifermin
|
Placebo (Main Study)
n=61 Participants
Placebo: Placebo
|
|---|---|---|---|
|
Main: Change From Baseline in Liver Stiffness Assessed by Liver Elastography (kPa)
Liver Stiffness Measurement - Week 72
|
-5.78 kPa
Standard Error 1.405
|
-6.24 kPa
Standard Error 1.368
|
-2.14 kPa
Standard Error 1.270
|
|
Main: Change From Baseline in Liver Stiffness Assessed by Liver Elastography (kPa)
Liver Stiffness Measurement - Week 96
|
-6.48 kPa
Standard Error 1.206
|
-7.34 kPa
Standard Error 1.171
|
-4.95 kPa
Standard Error 1.105
|
|
Main: Change From Baseline in Liver Stiffness Assessed by Liver Elastography (kPa)
Liver Stiffness Measurement - Week 36
|
-3.55 kPa
Standard Error 1.358
|
-3.80 kPa
Standard Error 1.321
|
-4.20 kPa
Standard Error 1.253
|
|
Main: Change From Baseline in Liver Stiffness Assessed by Liver Elastography (kPa)
Liver Stiffness Measurement - Week 48
|
-4.71 kPa
Standard Error 1.266
|
-4.95 kPa
Standard Error 1.218
|
-3.95 kPa
Standard Error 1.144
|
SECONDARY outcome
Timeframe: Week 36, Week 48, Week 72, Week 96Population: Full Analysis Set; only subjects with non-missing baseline and the specified visit are included at each time point
Change from baseline in Triglycerides (mg/dL), total cholesterol (mg/dL), high-density lipoprotein (HDL-C) (mg/dL), non-HDL-C (mg/dL), and low-density lipoprotein (LDL-C) (mg/dL)
Outcome measures
| Measure |
EFX 28 mg (Main Study)
n=57 Participants
EFX: Investigational drug, Efruxifermin
|
EFX 50 mg (Main Study)
n=63 Participants
EFX: Investigational drug, Efruxifermin
|
Placebo (Main Study)
n=61 Participants
Placebo: Placebo
|
|---|---|---|---|
|
Main: Change From Baseline in Lipoproteins
Non-HDL-C (mg/dL) - Week 48
|
-13.4 mg/dL
Standard Error 3.82
|
-22.1 mg/dL
Standard Error 3.64
|
-5.1 mg/dL
Standard Error 3.48
|
|
Main: Change From Baseline in Lipoproteins
Non-HDL-C (mg/dL) - Week 72
|
-15.2 mg/dL
Standard Error 3.95
|
-25.7 mg/dL
Standard Error 3.76
|
-5.1 mg/dL
Standard Error 3.56
|
|
Main: Change From Baseline in Lipoproteins
Non-HDL-C (mg/dL) - Week 96
|
-18.5 mg/dL
Standard Error 4.37
|
-21.1 mg/dL
Standard Error 4.11
|
-9.6 mg/dL
Standard Error 3.96
|
|
Main: Change From Baseline in Lipoproteins
LDL-C (mg/dL) - Week 36
|
-5.9 mg/dL
Standard Error 3.21
|
-11.7 mg/dL
Standard Error 3.12
|
-4.3 mg/dL
Standard Error 2.94
|
|
Main: Change From Baseline in Lipoproteins
LDL-C (mg/dL) - Week 48
|
-8.1 mg/dL
Standard Error 3.20
|
-12.5 mg/dL
Standard Error 3.08
|
-5.2 mg/dL
Standard Error 2.90
|
|
Main: Change From Baseline in Lipoproteins
LDL-C (mg/dL) - Week 72
|
-11.4 mg/dL
Standard Error 3.56
|
-15.5 mg/dL
Standard Error 3.41
|
-3.9 mg/dL
Standard Error 3.20
|
|
Main: Change From Baseline in Lipoproteins
LDL-C (mg/dL) - Week 96
|
-14.4 mg/dL
Standard Error 3.86
|
-13.4 mg/dL
Standard Error 3.67
|
-9.5 mg/dL
Standard Error 3.48
|
|
Main: Change From Baseline in Lipoproteins
Triglycerides (mg/dL) - Week 36
|
-36.9 mg/dL
Standard Error 6.18
|
-41.6 mg/dL
Standard Error 6.01
|
-10.9 mg/dL
Standard Error 5.68
|
|
Main: Change From Baseline in Lipoproteins
Triglycerides (mg/dL) - Week 48
|
-31.0 mg/dL
Standard Error 6.54
|
-44.6 mg/dL
Standard Error 6.21
|
1.2 mg/dL
Standard Error 5.91
|
|
Main: Change From Baseline in Lipoproteins
Triglycerides (mg/dL) - Week 72
|
-22.3 mg/dL
Standard Error 6.88
|
-47.6 mg/dL
Standard Error 6.54
|
-6.7 mg/dL
Standard Error 6.22
|
|
Main: Change From Baseline in Lipoproteins
Triglycerides (mg/dL) - Week 96
|
-26.9 mg/dL
Standard Error 8.93
|
-32.6 mg/dL
Standard Error 8.47
|
-3.3 mg/dL
Standard Error 8.11
|
|
Main: Change From Baseline in Lipoproteins
Total Cholesterol (mg/dL) - Week 36
|
-2.2 mg/dL
Standard Error 3.76
|
-9.0 mg/dL
Standard Error 3.63
|
-5.5 mg/dL
Standard Error 3.46
|
|
Main: Change From Baseline in Lipoproteins
Total Cholesterol (mg/dL) - Week 48
|
-3.7 mg/dL
Standard Error 3.88
|
-10.0 mg/dL
Standard Error 3.69
|
-5.1 mg/dL
Standard Error 3.52
|
|
Main: Change From Baseline in Lipoproteins
Total Cholesterol (mg/dL) - Week 72
|
-9.5 mg/dL
Standard Error 4.05
|
-14.8 mg/dL
Standard Error 3.85
|
-4.3 mg/dL
Standard Error 3.64
|
|
Main: Change From Baseline in Lipoproteins
Total Cholesterol (mg/dL) - Week 96
|
-11.9 mg/dL
Standard Error 4.23
|
-11.5 mg/dL
Standard Error 3.97
|
-10.4 mg/dL
Standard Error 3.83
|
|
Main: Change From Baseline in Lipoproteins
HDL-C (mg/dL) - Week 36
|
9.5 mg/dL
Standard Error 1.48
|
10.9 mg/dL
Standard Error 1.44
|
0.1 mg/dL
Standard Error 1.37
|
|
Main: Change From Baseline in Lipoproteins
HDL-C (mg/dL) - Week 48
|
8.8 mg/dL
Standard Error 1.49
|
11.4 mg/dL
Standard Error 1.42
|
-1.1 mg/dL
Standard Error 1.36
|
|
Main: Change From Baseline in Lipoproteins
HDL-C (mg/dL) - Week 72
|
5.0 mg/dL
Standard Error 1.60
|
10.4 mg/dL
Standard Error 1.52
|
0.0 mg/dL
Standard Error 1.44
|
|
Main: Change From Baseline in Lipoproteins
HDL-C (mg/dL) - Week 96
|
5.5 mg/dL
Standard Error 1.75
|
9.0 mg/dL
Standard Error 1.65
|
-1.8 mg/dL
Standard Error 1.58
|
|
Main: Change From Baseline in Lipoproteins
Non-HDL-C (mg/dL) - Week 36
|
-13.2 mg/dL
Standard Error 3.72
|
-20.1 mg/dL
Standard Error 3.59
|
-6.7 mg/dL
Standard Error 3.42
|
SECONDARY outcome
Timeframe: Week 36, Week 48, Week 72, Week 96Population: Full Analysis Set; only subjects with non-missing baseline and the specified visit are included
Glycated hemoglobin (HbA1c), expressed as a percentage, reflects average blood glucose levels over approximately 2 to 3 months and is used as a measure of glycemic control
Outcome measures
| Measure |
EFX 28 mg (Main Study)
n=57 Participants
EFX: Investigational drug, Efruxifermin
|
EFX 50 mg (Main Study)
n=63 Participants
EFX: Investigational drug, Efruxifermin
|
Placebo (Main Study)
n=61 Participants
Placebo: Placebo
|
|---|---|---|---|
|
Main: Change From Baseline in HbA1c (%)
Hemoglobin A1C (%) - Week 36
|
-0.38 percent
Standard Error 0.121
|
-0.17 percent
Standard Error 0.117
|
-0.15 percent
Standard Error 0.113
|
|
Main: Change From Baseline in HbA1c (%)
Hemoglobin A1C (%) - Week 48
|
-0.39 percent
Standard Error 0.140
|
-0.08 percent
Standard Error 0.135
|
-0.01 percent
Standard Error 0.129
|
|
Main: Change From Baseline in HbA1c (%)
Hemoglobin A1C (%) - Week 72
|
-0.20 percent
Standard Error 0.153
|
0.02 percent
Standard Error 0.147
|
0.16 percent
Standard Error 0.140
|
|
Main: Change From Baseline in HbA1c (%)
Hemoglobin A1C (%) - Week 96
|
0.07 percent
Standard Error 0.191
|
0.09 percent
Standard Error 0.180
|
0.30 percent
Standard Error 0.174
|
SECONDARY outcome
Timeframe: Week 36, Week 48, Week 72, Week 96Population: Full Analysis Set; only subjects with non-missing baseline and the specified visit are included
C-peptide reflects endogenous insulin secretion and pancreatic beta-cell function. Change from baseline represents the difference between the post-baseline value and the baseline measurement.
Outcome measures
| Measure |
EFX 28 mg (Main Study)
n=57 Participants
EFX: Investigational drug, Efruxifermin
|
EFX 50 mg (Main Study)
n=63 Participants
EFX: Investigational drug, Efruxifermin
|
Placebo (Main Study)
n=61 Participants
Placebo: Placebo
|
|---|---|---|---|
|
Main: Change From Baseline in C-peptide (ug/L)
C-peptide (ug/L) - Week 36
|
-1.368 ug/L
Standard Error 0.1882
|
-1.363 ug/L
Standard Error 0.1858
|
-0.630 ug/L
Standard Error 0.1730
|
|
Main: Change From Baseline in C-peptide (ug/L)
C-peptide (ug/L) - Week 48
|
-1.174 ug/L
Standard Error 0.2217
|
-1.282 ug/L
Standard Error 0.2111
|
-0.308 ug/L
Standard Error 0.2006
|
|
Main: Change From Baseline in C-peptide (ug/L)
C-peptide (ug/L) - Week 72
|
-0.935 ug/L
Standard Error 0.2834
|
-1.339 ug/L
Standard Error 0.2754
|
-0.329 ug/L
Standard Error 0.2557
|
|
Main: Change From Baseline in C-peptide (ug/L)
C-peptide (ug/L) - Week 96
|
-0.911 ug/L
Standard Error 0.2618
|
-1.049 ug/L
Standard Error 0.2528
|
-0.143 ug/L
Standard Error 0.2416
|
SECONDARY outcome
Timeframe: Week 36, Week 48, Week 72, Week 96Population: Full Analysis Set; only subjects with non-missing baseline and the specified visit are included
Adiponectin is involved in glucose and lipid metabolism and is used as a marker of metabolic status. Change from baseline represents the difference between the post-baseline value and the baseline measurement.
Outcome measures
| Measure |
EFX 28 mg (Main Study)
n=57 Participants
EFX: Investigational drug, Efruxifermin
|
EFX 50 mg (Main Study)
n=63 Participants
EFX: Investigational drug, Efruxifermin
|
Placebo (Main Study)
n=61 Participants
Placebo: Placebo
|
|---|---|---|---|
|
Main: Change From Baseline in Adiponectin (mg/L)
Adiponectin (mg/L) - Week 36
|
6.4083 mg/L
Standard Error 1.07085
|
4.7773 mg/L
Standard Error 1.02632
|
0.4376 mg/L
Standard Error 0.98819
|
|
Main: Change From Baseline in Adiponectin (mg/L)
Adiponectin (mg/L) - Week 48
|
2.8647 mg/L
Standard Error 0.70025
|
3.6737 mg/L
Standard Error 0.67306
|
-0.1639 mg/L
Standard Error 0.64120
|
|
Main: Change From Baseline in Adiponectin (mg/L)
Adiponectin (mg/L) - Week 72
|
2.2318 mg/L
Standard Error 0.67399
|
3.2341 mg/L
Standard Error 0.65346
|
-0.1238 mg/L
Standard Error 0.61431
|
|
Main: Change From Baseline in Adiponectin (mg/L)
Adiponectin (mg/L) - Week 96
|
1.7717 mg/L
Standard Error 0.78554
|
3.3032 mg/L
Standard Error 0.75450
|
0.1953 mg/L
Standard Error 0.71504
|
SECONDARY outcome
Timeframe: Week 36, Week 48, Week 72, Week 96Population: Full Analysis Set; only subjects with non-missing baseline and the specified visit are included
Insulin reflects endogenous insulin levels measured after a period of fasting. Change from baseline represents the difference between the post-baseline value and the baseline measurement.
Outcome measures
| Measure |
EFX 28 mg (Main Study)
n=57 Participants
EFX: Investigational drug, Efruxifermin
|
EFX 50 mg (Main Study)
n=63 Participants
EFX: Investigational drug, Efruxifermin
|
Placebo (Main Study)
n=61 Participants
Placebo: Placebo
|
|---|---|---|---|
|
Main: Change From Baseline in Insulin (mIU/L)
Insulin (mIU/L) - Week 72
|
-9.65 mIU/L
Standard Error 2.848
|
-10.60 mIU/L
Standard Error 2.767
|
-4.51 mIU/L
Standard Error 2.565
|
|
Main: Change From Baseline in Insulin (mIU/L)
Insulin (mIU/L) - Week 36
|
-12.59 mIU/L
Standard Error 2.302
|
-10.29 mIU/L
Standard Error 2.271
|
-4.27 mIU/L
Standard Error 2.095
|
|
Main: Change From Baseline in Insulin (mIU/L)
Insulin (mIU/L) - Week 48
|
-10.88 mIU/L
Standard Error 2.305
|
-13.06 mIU/L
Standard Error 2.197
|
-3.74 mIU/L
Standard Error 2.070
|
|
Main: Change From Baseline in Insulin (mIU/L)
Insulin (mIU/L) - Week 96
|
-8.53 mIU/L
Standard Error 3.194
|
-10.21 mIU/L
Standard Error 3.068
|
-1.34 mIU/L
Standard Error 2.928
|
SECONDARY outcome
Timeframe: Week 36, Week 48, Week 72, Week 96Population: Full Analysis Set; only subjects with non-missing baseline and the specified visit are included
HOMA-IR has no fixed upper limit. Values near 1 are typically observed in individuals with normal insulin sensitivity, while progressively higher values indicate increasing insulin resistance. The clinical significance of a given value may vary depending on the population and assay methodology. Change from baseline represents the difference between the post-baseline value and the baseline measurement.
Outcome measures
| Measure |
EFX 28 mg (Main Study)
n=57 Participants
EFX: Investigational drug, Efruxifermin
|
EFX 50 mg (Main Study)
n=63 Participants
EFX: Investigational drug, Efruxifermin
|
Placebo (Main Study)
n=61 Participants
Placebo: Placebo
|
|---|---|---|---|
|
Main: Change From Baseline in HOMA-IR
HOMA-IR - Week 36
|
-4.935 units on a scale
Standard Error 1.2207
|
-3.467 units on a scale
Standard Error 1.2040
|
-1.135 units on a scale
Standard Error 1.1206
|
|
Main: Change From Baseline in HOMA-IR
HOMA-IR - Week 48
|
-4.259 units on a scale
Standard Error 0.9928
|
-5.203 units on a scale
Standard Error 0.9497
|
-1.241 units on a scale
Standard Error 0.9029
|
|
Main: Change From Baseline in HOMA-IR
HOMA-IR - Week 72
|
-3.313 units on a scale
Standard Error 1.2417
|
-3.731 units on a scale
Standard Error 1.2108
|
-2.619 units on a scale
Standard Error 1.1268
|
|
Main: Change From Baseline in HOMA-IR
HOMA-IR - Week 96
|
-3.414 units on a scale
Standard Error 1.5579
|
-4.120 units on a scale
Standard Error 1.4892
|
1.557 units on a scale
Standard Error 1.4454
|
SECONDARY outcome
Timeframe: Week 36, Week 48, Week 96Population: Full Analysis Set; only subjects with non-missing baseline and the specified visit are included.
Change from baseline in body weight (kg)
Outcome measures
| Measure |
EFX 28 mg (Main Study)
n=57 Participants
EFX: Investigational drug, Efruxifermin
|
EFX 50 mg (Main Study)
n=63 Participants
EFX: Investigational drug, Efruxifermin
|
Placebo (Main Study)
n=61 Participants
Placebo: Placebo
|
|---|---|---|---|
|
Main: Change From Baseline in Body Weight
Body Weight Change from Baseline to Week 96
|
-2.27 kg
Standard Error 1.110
|
-2.04 kg
Standard Error 1.052
|
-1.95 kg
Standard Error 1.007
|
|
Main: Change From Baseline in Body Weight
Body Weight Change from Baseline to Week 36
|
-0.86 kg
Standard Error 0.726
|
-1.42 kg
Standard Error 0.697
|
-0.83 kg
Standard Error 0.681
|
|
Main: Change From Baseline in Body Weight
Body Weight Change from Baseline to Week 48
|
-1.43 kg
Standard Error 0.846
|
-1.39 kg
Standard Error 0.810
|
-1.00 kg
Standard Error 0.783
|
SECONDARY outcome
Timeframe: Through Week 96Population: Safety Analysis Set; ADA result is negative with negative ADA screening or negative ADA confirmatory assay; ADA result is positive with positive ADA confirmatory assay. Per protocol, subjects in the placebo group were not dosed with EFX; and therefore, were not included in this analysis.
Detect and measure ADA against EFX
Outcome measures
| Measure |
EFX 28 mg (Main Study)
n=40 Participants
EFX: Investigational drug, Efruxifermin
|
EFX 50 mg (Main Study)
n=47 Participants
EFX: Investigational drug, Efruxifermin
|
Placebo (Main Study)
Placebo: Placebo
|
|---|---|---|---|
|
Main: Number of Participants With ADA Against EFX
Positive
|
13 Participants
|
20 Participants
|
0 Participants
|
|
Main: Number of Participants With ADA Against EFX
Negative
|
27 Participants
|
27 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Through Week 96Population: Safety Analysis Set; Treatment-emergent adverse events (TEAEs) were defined as any adverse events (AEs) with an onset date on or after the study drugs start date and no later than 30 days after permanent discontinuation of study drugs; or any AEs leading to premature discontinuation of study drugs. AE reported terms were coded using the Medical Dictionary for Regulatory Activities (MedDRA) Version 24.0.
Safety and tolerability will be assessed through the reporting of AEs, clinical laboratory tests, ECGs, ultrasounds, vital sign assessments, and concomitant medication usage
Outcome measures
| Measure |
EFX 28 mg (Main Study)
n=57 Participants
EFX: Investigational drug, Efruxifermin
|
EFX 50 mg (Main Study)
n=63 Participants
EFX: Investigational drug, Efruxifermin
|
Placebo (Main Study)
n=61 Participants
Placebo: Placebo
|
|---|---|---|---|
|
Main: To Assess the Safety and Tolerability of EFX
Subjects with any TEAEs
|
56 Participants
|
63 Participants
|
59 Participants
|
|
Main: To Assess the Safety and Tolerability of EFX
Subjects with any study treatment-related TEAEs
|
36 Participants
|
47 Participants
|
30 Participants
|
|
Main: To Assess the Safety and Tolerability of EFX
Subjects with any study procedure-related TEAEs
|
17 Participants
|
22 Participants
|
19 Participants
|
|
Main: To Assess the Safety and Tolerability of EFX
Subjects with any treatment-emergent serious AEs (TESAEs)
|
15 Participants
|
15 Participants
|
11 Participants
|
|
Main: To Assess the Safety and Tolerability of EFX
Subjects with any TEAEs leading to premature discontinuation of study drug
|
6 Participants
|
11 Participants
|
2 Participants
|
|
Main: To Assess the Safety and Tolerability of EFX
Subjects with any TEAEs leading to premature discontinuation of study
|
6 Participants
|
11 Participants
|
1 Participants
|
|
Main: To Assess the Safety and Tolerability of EFX
Subjects with any study treatment-related TEAEs leading to discontinuation of study drug
|
3 Participants
|
9 Participants
|
1 Participants
|
|
Main: To Assess the Safety and Tolerability of EFX
Subjects with any SAEs leading to death
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Through Week 12Population: Safety Analysis Set for Cohort D only; TEAEs are defined as any AEs with an onset date on or after the study drugs start date and no later than 30 days after permanent discontinuation of study drugs; or any AEs leading to premature discontinuation of study drugs. AE reported terms were coded using the Medical Dictionary for Regulatory Activities (MedDRA) Version 24.0.
Safety and tolerability will be assessed through the reporting of AEs, clinical laboratory assessments, ECGs, ultrasounds, vital sign assessments, and concomitant medication usage
Outcome measures
| Measure |
EFX 28 mg (Main Study)
n=21 Participants
EFX: Investigational drug, Efruxifermin
|
EFX 50 mg (Main Study)
EFX: Investigational drug, Efruxifermin
|
Placebo (Main Study)
n=10 Participants
Placebo: Placebo
|
|---|---|---|---|
|
Cohort D: To Assess the Safety and Tolerability of EFX Compared to Placebo When Added to an Existing GLP-1R Agonist in Subjects With Type 2 Diabetes and Liver Fibrosis Due to NASH
Subjects with any TEAEs leading to premature discontinuation of study
|
1 Participants
|
—
|
0 Participants
|
|
Cohort D: To Assess the Safety and Tolerability of EFX Compared to Placebo When Added to an Existing GLP-1R Agonist in Subjects With Type 2 Diabetes and Liver Fibrosis Due to NASH
Subjects with any treatment-emergent AEs (TEAEs)
|
18 Participants
|
—
|
7 Participants
|
|
Cohort D: To Assess the Safety and Tolerability of EFX Compared to Placebo When Added to an Existing GLP-1R Agonist in Subjects With Type 2 Diabetes and Liver Fibrosis Due to NASH
Subjects with any study treatment-related TEAEs
|
15 Participants
|
—
|
4 Participants
|
|
Cohort D: To Assess the Safety and Tolerability of EFX Compared to Placebo When Added to an Existing GLP-1R Agonist in Subjects With Type 2 Diabetes and Liver Fibrosis Due to NASH
Subjects with any study procedure-related TEAEs
|
2 Participants
|
—
|
0 Participants
|
|
Cohort D: To Assess the Safety and Tolerability of EFX Compared to Placebo When Added to an Existing GLP-1R Agonist in Subjects With Type 2 Diabetes and Liver Fibrosis Due to NASH
Subjects with any treatment-emergent serious AEs (TESAEs)
|
2 Participants
|
—
|
0 Participants
|
|
Cohort D: To Assess the Safety and Tolerability of EFX Compared to Placebo When Added to an Existing GLP-1R Agonist in Subjects With Type 2 Diabetes and Liver Fibrosis Due to NASH
Subjects with any TEAEs leading to premature discontinuation of study drug
|
1 Participants
|
—
|
0 Participants
|
|
Cohort D: To Assess the Safety and Tolerability of EFX Compared to Placebo When Added to an Existing GLP-1R Agonist in Subjects With Type 2 Diabetes and Liver Fibrosis Due to NASH
Subjects with any SAEs leading to death
|
0 Participants
|
—
|
0 Participants
|
Adverse Events
Placebo (Main Study)
Serious events: 11 serious events
Other events: 59 other events
Deaths: 1 deaths
EFX 28 mg (Main Study)
Serious events: 15 serious events
Other events: 56 other events
Deaths: 0 deaths
EFX 50 mg (Main Study)
Serious events: 15 serious events
Other events: 63 other events
Deaths: 0 deaths
Placebo (Cohort D)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
EFX 50 mg (Cohort D)
Serious events: 2 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo (Main Study)
n=61 participants at risk
Placebo: Placebo
|
EFX 28 mg (Main Study)
n=57 participants at risk
EFX: Investigational drug, Efruxifermin
|
EFX 50 mg (Main Study)
n=63 participants at risk
EFX: Investigational drug, Efruxifermin
|
Placebo (Cohort D)
n=10 participants at risk
Placebo Comparator: Placebo + GLP-1 (Cohort D)
|
EFX 50 mg (Cohort D)
n=21 participants at risk
Drug EFX Investigational drug, Efruxifermin + GLP-1 (Cohort D)
|
|---|---|---|---|---|---|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
1.8%
1/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
3.2%
2/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
1.8%
1/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
1.6%
1/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Cardiac disorders
Angina unstable
|
1.6%
1/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
1.6%
1/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
1.6%
1/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Cardiac disorders
Atrial flutter
|
1.6%
1/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
1.8%
1/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
3.5%
2/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
3.2%
2/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Infections and infestations
Hematoma infection
|
1.6%
1/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Infections and infestations
Pneumonia
|
1.6%
1/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
1.6%
1/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Infections and infestations
Post procedural cellulitis
|
1.6%
1/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Infections and infestations
Post procedural sepsis
|
1.6%
1/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
1.6%
1/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Infections and infestations
Respiratory tract infection viral
|
0.00%
0/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
1.6%
1/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
1.6%
1/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Gastrointestinal disorders
Chronic gastritis
|
0.00%
0/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
1.6%
1/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Gastrointestinal disorders
Hemorrhoidal haemorrhage
|
1.6%
1/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
1.6%
1/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Gastrointestinal disorders
Obstructive pancreatitis
|
0.00%
0/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
1.8%
1/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
1.8%
1/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
0.00%
0/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
1.6%
1/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.00%
0/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
1.8%
1/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
1.8%
1/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.6%
1/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Musculoskeletal and connective tissue disorders
Tendon disorder
|
0.00%
0/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
1.8%
1/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
5.3%
3/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Hepatobiliary disorders
Cholecystitis
|
1.6%
1/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
1.8%
1/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Hepatobiliary disorders
Hemobilia
|
1.6%
1/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Injury, poisoning and procedural complications
Acetabulum fracture
|
0.00%
0/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
1.8%
1/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
0.00%
0/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
1.6%
1/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Injury, poisoning and procedural complications
Post procedural hemorrhage
|
1.6%
1/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
4.8%
1/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
1.8%
1/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
1.8%
1/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Renal and urinary disorders
Nephrolithiasis
|
1.6%
1/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Renal and urinary disorders
Renal artery stenosis
|
0.00%
0/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
1.8%
1/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Vascular disorders
Arteriosclerosis
|
0.00%
0/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
1.6%
1/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Vascular disorders
Hypertension
|
0.00%
0/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
1.8%
1/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Vascular disorders
Thrombosis
|
0.00%
0/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
1.6%
1/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
General disorders
Generalised edema
|
0.00%
0/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
1.8%
1/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
1.8%
1/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.00%
0/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
1.8%
1/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Sinonasal papilloma
|
1.6%
1/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Nervous system disorders
Myasthenia gravis
|
0.00%
0/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
1.6%
1/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Nervous system disorders
Transient ischemic attack
|
1.6%
1/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
1.8%
1/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary thrombosis
|
0.00%
0/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
1.6%
1/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
1.8%
1/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Psychiatric disorders
Depression
|
0.00%
0/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
1.6%
1/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Psychiatric disorders
Depression suicidal
|
0.00%
0/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
1.6%
1/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
1.6%
1/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine cancer
|
0.00%
0/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
4.8%
1/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
Other adverse events
| Measure |
Placebo (Main Study)
n=61 participants at risk
Placebo: Placebo
|
EFX 28 mg (Main Study)
n=57 participants at risk
EFX: Investigational drug, Efruxifermin
|
EFX 50 mg (Main Study)
n=63 participants at risk
EFX: Investigational drug, Efruxifermin
|
Placebo (Cohort D)
n=10 participants at risk
Placebo Comparator: Placebo + GLP-1 (Cohort D)
|
EFX 50 mg (Cohort D)
n=21 participants at risk
Drug EFX Investigational drug, Efruxifermin + GLP-1 (Cohort D)
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
29.5%
18/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
42.1%
24/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
54.0%
34/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
30.0%
3/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
28.6%
6/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Gastrointestinal disorders
Nausea
|
29.5%
18/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
29.8%
17/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
46.0%
29/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
10.0%
1/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
38.1%
8/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Gastrointestinal disorders
Vomiting
|
13.1%
8/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
28.1%
16/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
20.6%
13/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
20.0%
2/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
9.5%
2/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
11.5%
7/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
15.8%
9/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
7.9%
5/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
4.8%
1/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Gastrointestinal disorders
Abdominal pain
|
6.6%
4/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
14.0%
8/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
12.7%
8/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
10.0%
1/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Gastrointestinal disorders
Constipation
|
11.5%
7/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
8.8%
5/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
9.5%
6/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Gastrointestinal disorders
Abdominal distension
|
9.8%
6/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
7.0%
4/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
9.5%
6/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Gastrointestinal disorders
Frequent bowel movements
|
1.6%
1/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
12.3%
7/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
11.1%
7/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
4.8%
1/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
4.9%
3/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
7.0%
4/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
3.2%
2/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Gastrointestinal disorders
Dyspepsia
|
4.9%
3/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
7.0%
4/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
3.2%
2/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
4.8%
1/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Infections and infestations
COVID-19
|
29.5%
18/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
22.8%
13/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
22.2%
14/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
4.8%
1/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Infections and infestations
Upper respiratory tract infection
|
19.7%
12/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
17.5%
10/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
15.9%
10/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
20.0%
2/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
9.5%
2/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Infections and infestations
Sinusitis
|
13.1%
8/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
12.3%
7/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
17.5%
11/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
10.0%
1/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
4.8%
1/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Infections and infestations
Nasopharyngitis
|
13.1%
8/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
17.5%
10/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
7.9%
5/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Infections and infestations
Gastroenteritis
|
8.2%
5/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
7.0%
4/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
6.3%
4/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Infections and infestations
Influenza
|
4.9%
3/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
7.0%
4/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
7.9%
5/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Infections and infestations
Bronchitis
|
8.2%
5/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
7.0%
4/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
3.2%
2/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Infections and infestations
Acute sinusitis
|
1.6%
1/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
3.5%
2/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
7.9%
5/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Infections and infestations
Cellulitis
|
6.6%
4/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
5.3%
3/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
1.6%
1/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Infections and infestations
Ear infection
|
0.00%
0/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
7.0%
4/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
3.2%
2/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
General disorders
Injection site bruising
|
19.7%
12/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
19.3%
11/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
20.6%
13/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
General disorders
Injection site erythema
|
9.8%
6/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
22.8%
13/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
25.4%
16/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
9.5%
2/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
General disorders
Fatigue
|
19.7%
12/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
19.3%
11/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
15.9%
10/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
9.5%
2/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
General disorders
Edema peripheral
|
6.6%
4/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
10.5%
6/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
6.3%
4/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
General disorders
Pain
|
9.8%
6/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
8.8%
5/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
4.8%
3/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
10.0%
1/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
General disorders
Injection site pruritus
|
3.3%
2/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
7.0%
4/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
9.5%
6/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
4.8%
1/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
General disorders
Chills
|
3.3%
2/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
1.8%
1/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
6.3%
4/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
General disorders
Pyrexia
|
6.6%
4/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
3.2%
2/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Metabolism and nutrition disorders
Increased appetite
|
6.6%
4/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
15.8%
9/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
39.7%
25/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
28.6%
6/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
13.1%
8/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
12.3%
7/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
19.0%
12/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
9.5%
2/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
21.3%
13/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
10.5%
6/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
11.1%
7/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
8.2%
5/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
8.8%
5/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
4.8%
3/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
20.0%
2/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
14.3%
3/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
3.3%
2/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
1.8%
1/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
6.3%
4/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
21.3%
13/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
15.8%
9/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
19.0%
12/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
4.8%
1/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.4%
10/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
7.0%
4/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
15.9%
10/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
4.9%
3/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
7.0%
4/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
14.3%
9/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
4.8%
1/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.6%
4/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
5.3%
3/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
7.9%
5/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
4.8%
1/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
1.6%
1/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
3.5%
2/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
6.3%
4/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Investigations
Weight increased
|
0.00%
0/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
5.3%
3/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
4.8%
1/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
4.9%
3/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
5.3%
3/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
1.6%
1/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.6%
1/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
1.8%
1/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
7.9%
5/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.6%
4/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
1.8%
1/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
1.6%
1/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
14.8%
9/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
15.8%
9/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
7.9%
5/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
10.0%
1/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Injury, poisoning and procedural complications
Contusion
|
11.5%
7/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
8.8%
5/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
11.1%
7/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
6.6%
4/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
8.8%
5/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
3.2%
2/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Injury, poisoning and procedural complications
Fall
|
4.9%
3/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
5.3%
3/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
6.3%
4/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
6.6%
4/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
1.8%
1/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
3.2%
2/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Injury, poisoning and procedural complications
Post-traumatic pain
|
1.6%
1/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
5.3%
3/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
4.8%
3/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.2%
5/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
12.3%
7/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
11.1%
7/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
10.0%
1/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
8.2%
5/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
5.3%
3/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
1.6%
1/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
6.6%
4/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
3.5%
2/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
3.2%
2/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
9.5%
2/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
1.6%
1/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
5.3%
3/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
3.2%
2/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Nervous system disorders
Headache
|
13.1%
8/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
14.0%
8/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
20.6%
13/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
10.0%
1/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
14.3%
3/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Nervous system disorders
Dizziness
|
8.2%
5/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
7.0%
4/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
4.8%
3/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
4.8%
1/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
1.8%
1/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
7.9%
5/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.9%
3/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
8.8%
5/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
7.9%
5/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
3.3%
2/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
8.8%
5/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
6.3%
4/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
1.6%
1/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
5.3%
3/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
7.9%
5/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
4.8%
1/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.3%
2/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
5.3%
3/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
6.3%
4/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
4.8%
1/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Vascular disorders
Hypertension
|
8.2%
5/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
14.0%
8/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
15.9%
10/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Renal and urinary disorders
Renal cyst
|
3.3%
2/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
5.3%
3/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
3.2%
2/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Hepatobiliary disorders
Cholelithiasis
|
6.6%
4/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
3.5%
2/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
6.3%
4/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Hepatobiliary disorders
Gallbladder polyp
|
1.6%
1/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
6.3%
4/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
5.3%
3/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Psychiatric disorders
Insomnia
|
6.6%
4/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
3.5%
2/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
4.8%
3/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
4.8%
1/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Psychiatric disorders
Depression
|
6.6%
4/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
1.8%
1/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
4.8%
3/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Cardiac disorders
Palpitations
|
1.6%
1/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
7.0%
4/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
1.6%
1/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
4.8%
1/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Blood and lymphatic system disorders
Anemia
|
3.3%
2/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
8.8%
5/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
3.2%
2/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Blood and lymphatic system disorders
Iron deficiency anemia
|
3.3%
2/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
7.0%
4/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
3.2%
2/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Endocrine disorders
Hypothyroidism
|
1.6%
1/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
5.3%
3/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
9.5%
6/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
5.3%
3/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
5.3%
3/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
6.3%
4/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
5.3%
3/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
6.3%
4/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
4.8%
1/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
7.9%
5/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
4.8%
1/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Gastrointestinal disorders
Hemorrhoidal hemorrhage
|
0.00%
0/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
6.3%
4/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
General disorders
Swelling face
|
0.00%
0/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
5.3%
3/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Infections and infestations
Urinary tract infection
|
13.1%
8/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
10.5%
6/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
28.6%
18/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
5.3%
3/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
5.3%
3/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
10.0%
1/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
4.8%
1/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Gastrointestinal disorders
Dental carries
|
0.00%
0/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
10.0%
1/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Gastrointestinal disorders
Food Poisoning
|
0.00%
0/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
4.8%
1/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Gastrointestinal disorders
Post-tussive vomiting
|
0.00%
0/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
4.8%
1/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
0.00%
0/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
4.8%
1/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Metabolism and nutrition disorders
Hyperphagia
|
0.00%
0/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
9.5%
2/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
10.0%
1/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
4.8%
1/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.00%
0/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
10.0%
1/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial hyperreactivity
|
0.00%
0/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
4.8%
1/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
4.8%
1/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
4.8%
1/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
4.8%
1/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
4.8%
1/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Nervous system disorders
Syncope
|
0.00%
0/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
4.8%
1/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Nervous system disorders
Tremor
|
0.00%
0/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
4.8%
1/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
General disorders
Early satiety
|
0.00%
0/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
4.8%
1/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
General disorders
Injection site rash
|
0.00%
0/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
4.8%
1/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
General disorders
Injection site urticaria
|
0.00%
0/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
4.8%
1/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
4.8%
1/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
4.8%
1/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Injury, poisoning and procedural complications
Procedural Nausea
|
0.00%
0/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
4.8%
1/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
10.0%
1/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
4.8%
1/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
4.8%
1/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
4.8%
1/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
10.0%
1/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Soft tissue sarcoma
|
0.00%
0/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
4.8%
1/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine cancer
|
0.00%
0/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
4.8%
1/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
4.8%
1/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.00%
0/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
4.8%
1/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Vascular disorders
Hypotension
|
0.00%
0/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
4.8%
1/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/61 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/57 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/63 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
10.0%
1/10 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
0.00%
0/21 • Main Study: Up to 126 weeks (96 weeks of treatment + 30 days follow-up); Cohort D: Up to 16 weeks (12 weeks of treatment + 30 days follow-up)
AEs that occurred after the first dose of study drug, during study treatment, and through the safety follow-up period were collected. In addition, after the informed consent, but prior to initiation of study drug, AEs related to protocol procedures were collected. All other untoward medical occurrences observed after informed consent and prior to the first dose of study drug, including exacerbation or changes in medical history, were collected.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor has published the results of this study: Noureddin, M., Rinella, M. E., Chalasani, N. P., Neff, G. W., Lucas, K. J., Rodriguez, M. E., … Yale, K. (2025). Efruxifermin in compensated liver cirrhosis caused by mash. New England Journal of Medicine. doi:10.1056/nejmoa2502242
- Publication restrictions are in place
Restriction type: OTHER