Trial Outcomes & Findings for Study of the Effects of Oral AT1001 (Migalastat Hydrochloride) in Patients With Fabry Disease (NCT NCT00925301)
NCT ID: NCT00925301
Last Updated: 2018-10-30
Results Overview
Renal biopsies were taken at Baseline and Month 6 (Stage 1). The specimens were evaluated using virtual microscopy. The annotation, scoring, and adjudication of the kidney histology assessments were performed by the Clinical Pathology Endpoints Committee. The number of kidney IC GL-3 inclusions was assessed by 3 renal pathologists who were blinded to treatment assignments, participants' data, and biopsy sequence. One pathologist served as annotator and identified the 300 capillaries on up to 8 slides per specimen to be scored. Two pathologists served as scorers; these pathologists completed the blinded paired assessments. Each pathologist served as annotator/adjudicator for 1/3 of the cases. Paired assessments were undertaken at Baseline and Month 6. Assessments were made using digital images. A responder was defined as a participant with a ≥50% reduction from Baseline to Month 6 in the average number of kidney IC GL-3 inclusions.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
67 participants
Primary outcome timeframe
Baseline, Month 6
Results posted on
2018-10-30
Participant Flow
During Stage 1 (0-6 Months), all participants were randomized to either Migalastat or Placebo. After Stage 1, all participants progressed to Stage 2 where they received open-label migalastat for 6 months (\>6-12 Months). After Stage 2, participants were eligible to enter the optional, 12-month, open-label extension (OLE) (\>12-24 Months).
Participant milestones
| Measure |
Migalastat (0-6 Months)
Migalastat hydrochloride (migalastat) 150-milligram (mg) capsule (equivalent to 123 mg of migalastat) given orally every other day (QOD) during the 6-month, double-blind, randomized placebo-controlled treatment period (Stage 1). After Stage 1, participants progressed to Stage 2 where they received open-label migalastat for 6 months.
|
Placebo (0-6 Months)
Placebo capsule given orally QOD during the 6-month, double-blind, randomized placebo-controlled treatment period (Stage 1). After Stage 1, participants progressed to Stage 2 where they received open-label migalastat for 6 months.
|
Migalastat (>6-12 Months)
Migalastat 150-mg capsule given orally QOD during the 6-month open-label treatment period (Stage 2). Includes all participants who progressed from both the migalastat (0-6 Months) and the placebo (0-6 Months) Stage 1 treatment groups. After Stage 2, participants were eligible to enter the optional, 12-month OLE.
|
Migalastat (>12-24 Months)
Migalastat 150-mg capsule given orally QOD for up to 12 months during the optional OLE. Includes all participants who decided to continue treatment after completing the 6-month, open-label Stage 2 treatment period.
|
|---|---|---|---|---|
|
6-Month Double-blind (Stage 1)
STARTED
|
34
|
33
|
0
|
0
|
|
6-Month Double-blind (Stage 1)
Received at Least 1 Dose of Study Drug
|
34
|
33
|
0
|
0
|
|
6-Month Double-blind (Stage 1)
Intent-to-Treat (ITT)
|
34
|
33
|
0
|
0
|
|
6-Month Double-blind (Stage 1)
Modified Intent-to-Treat (mITT)
|
30
|
30
|
0
|
0
|
|
6-Month Double-blind (Stage 1)
COMPLETED
|
34
|
30
|
0
|
0
|
|
6-Month Double-blind (Stage 1)
NOT COMPLETED
|
0
|
3
|
0
|
0
|
|
6-Month Open-label (Stage 2)
STARTED
|
0
|
0
|
63
|
0
|
|
6-Month Open-label (Stage 2)
ITT-amenable
|
0
|
0
|
47
|
0
|
|
6-Month Open-label (Stage 2)
COMPLETED
|
0
|
0
|
60
|
0
|
|
6-Month Open-label (Stage 2)
NOT COMPLETED
|
0
|
0
|
3
|
0
|
|
12-Month Open-label Extension (Optional)
STARTED
|
0
|
0
|
0
|
57
|
|
12-Month Open-label Extension (Optional)
ITT-amenable
|
0
|
0
|
0
|
42
|
|
12-Month Open-label Extension (Optional)
COMPLETED
|
0
|
0
|
0
|
54
|
|
12-Month Open-label Extension (Optional)
NOT COMPLETED
|
0
|
0
|
0
|
3
|
Reasons for withdrawal
| Measure |
Migalastat (0-6 Months)
Migalastat hydrochloride (migalastat) 150-milligram (mg) capsule (equivalent to 123 mg of migalastat) given orally every other day (QOD) during the 6-month, double-blind, randomized placebo-controlled treatment period (Stage 1). After Stage 1, participants progressed to Stage 2 where they received open-label migalastat for 6 months.
|
Placebo (0-6 Months)
Placebo capsule given orally QOD during the 6-month, double-blind, randomized placebo-controlled treatment period (Stage 1). After Stage 1, participants progressed to Stage 2 where they received open-label migalastat for 6 months.
|
Migalastat (>6-12 Months)
Migalastat 150-mg capsule given orally QOD during the 6-month open-label treatment period (Stage 2). Includes all participants who progressed from both the migalastat (0-6 Months) and the placebo (0-6 Months) Stage 1 treatment groups. After Stage 2, participants were eligible to enter the optional, 12-month OLE.
|
Migalastat (>12-24 Months)
Migalastat 150-mg capsule given orally QOD for up to 12 months during the optional OLE. Includes all participants who decided to continue treatment after completing the 6-month, open-label Stage 2 treatment period.
|
|---|---|---|---|---|
|
6-Month Double-blind (Stage 1)
Withdrawal by Subject
|
0
|
2
|
0
|
0
|
|
6-Month Double-blind (Stage 1)
Pregnancy
|
0
|
1
|
0
|
0
|
|
6-Month Open-label (Stage 2)
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
|
6-Month Open-label (Stage 2)
Adverse Event
|
0
|
0
|
2
|
0
|
|
12-Month Open-label Extension (Optional)
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
|
12-Month Open-label Extension (Optional)
Pregnancy
|
0
|
0
|
0
|
1
|
|
12-Month Open-label Extension (Optional)
Lost to Follow-up
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Study of the Effects of Oral AT1001 (Migalastat Hydrochloride) in Patients With Fabry Disease
Baseline characteristics by cohort
| Measure |
Migalastat-Migalastat
n=34 Participants
Migalastat 150-mg capsule given orally QOD during the 6-month, double-blind, randomized placebo-controlled treatment period (Stage 1), during the 6-month open-label treatment period (Stage 2), and for up to 12 months during the OLE.
|
Placebo-Migalastat
n=33 Participants
Placebo capsule given orally QOD during the 6-month, double-blind, randomized placebo-controlled treatment period (Stage 1). Migalastat 150-mg capsule given orally QOD during the 6-month open-label treatment period (Stage 2) and for up to 12 months during the OLE.
|
Total
n=67 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
40.0 years
STANDARD_DEVIATION 13.29 • n=5 Participants
|
44.5 years
STANDARD_DEVIATION 10.18 • n=7 Participants
|
42.2 years
STANDARD_DEVIATION 11.99 • n=5 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Month 6Population: ITT: All randomized participants regardless of their participation in the study beyond randomization. As per the statistical analysis plan, analysis excluded participants who were missing baseline kidney biopsy results.
Renal biopsies were taken at Baseline and Month 6 (Stage 1). The specimens were evaluated using virtual microscopy. The annotation, scoring, and adjudication of the kidney histology assessments were performed by the Clinical Pathology Endpoints Committee. The number of kidney IC GL-3 inclusions was assessed by 3 renal pathologists who were blinded to treatment assignments, participants' data, and biopsy sequence. One pathologist served as annotator and identified the 300 capillaries on up to 8 slides per specimen to be scored. Two pathologists served as scorers; these pathologists completed the blinded paired assessments. Each pathologist served as annotator/adjudicator for 1/3 of the cases. Paired assessments were undertaken at Baseline and Month 6. Assessments were made using digital images. A responder was defined as a participant with a ≥50% reduction from Baseline to Month 6 in the average number of kidney IC GL-3 inclusions.
Outcome measures
| Measure |
Migalastat
n=32 Participants
Migalastat 150-mg capsule given orally QOD during the 6-month, double-blind, randomized placebo-controlled treatment period (Stage 1).
|
Placebo
n=32 Participants
Placebo capsule given orally QOD during the 6-month, double-blind, randomized placebo-controlled treatment period (Stage 1).
|
|---|---|---|
|
Percentage Of Participants With At Least A 50% Reduction From Baseline To Month 6 In The Average Number Of Kidney Interstitial Capillary (IC) Globotriaosylceramide (GL-3) Inclusions
Responder
|
13 Participants
|
9 Participants
|
|
Percentage Of Participants With At Least A 50% Reduction From Baseline To Month 6 In The Average Number Of Kidney Interstitial Capillary (IC) Globotriaosylceramide (GL-3) Inclusions
Non-Responder
|
19 Participants
|
23 Participants
|
SECONDARY outcome
Timeframe: Baseline, Month 6Population: ITT: All randomized participants regardless of their participation in the study beyond randomization.
Renal biopsies were taken at Baseline and Month 6. The specimens were evaluated using virtual microscopy. The annotation, scoring, and adjudication of the kidney histology assessments were performed by the Clinical Pathology Endpoints Committee. The number of kidney IC GL-3 inclusions was assessed by 3 renal pathologists who were blinded to treatment assignments, participants' data, and biopsy sequence. One pathologist served as annotator and identified the 300 capillaries on up to 8 slides per specimen to be scored. Two pathologists served as scorers; these pathologists completed the blinded paired assessments. Each pathologist served as annotator/adjudicator for 1/3 of the cases. Paired assessments were undertaken at Baseline and Month 6. Assessments were made using digital images.
Outcome measures
| Measure |
Migalastat
n=34 Participants
Migalastat 150-mg capsule given orally QOD during the 6-month, double-blind, randomized placebo-controlled treatment period (Stage 1).
|
Placebo
n=33 Participants
Placebo capsule given orally QOD during the 6-month, double-blind, randomized placebo-controlled treatment period (Stage 1).
|
|---|---|---|
|
Percent Change In Kidney IC GL-3 Inclusions From Baseline To Month 6
|
-7.948 percent change
Standard Deviation 105.2736
|
12.985 percent change
Standard Deviation 90.5131
|
SECONDARY outcome
Timeframe: Baseline, Months 6, 12, and 24Population: Stage 1: ITT, all randomized participants regardless of participation in the study beyond randomization. Stage 2: participants who completed Stage 1 and entered Stage 2. OLE: participants who completed Stage 2 and entered the optional OLE. Once assay and sample issues were identified, later samples were not further analyzed; all data was listed.
The effect of migalastat versus placebo on urine GL-3 levels was measured by liquid chromatography-mass spectrometry/mass spectrometry. The 24-hour urine samples were collected at Baseline, Month 6 (Stage 1), Month 12 (Stage 2), and Month 24 (OLE). Results are presented as changes in nanograms (ng)/mg creatinine from Baseline to the end of the 3 stages.
Outcome measures
| Measure |
Migalastat
n=33 Participants
Migalastat 150-mg capsule given orally QOD during the 6-month, double-blind, randomized placebo-controlled treatment period (Stage 1).
|
Placebo
n=30 Participants
Placebo capsule given orally QOD during the 6-month, double-blind, randomized placebo-controlled treatment period (Stage 1).
|
|---|---|---|
|
Change From Baseline Through Month 24 In Urine GL-3 Levels
Stage 1
|
-234.80 ng/mg creatinine
Standard Deviation 853.451
|
-186.24 ng/mg creatinine
Standard Deviation 957.119
|
|
Change From Baseline Through Month 24 In Urine GL-3 Levels
Stage 2
|
-179.63 ng/mg creatinine
Standard Deviation 699.157
|
-537.95 ng/mg creatinine
Standard Deviation 1169.883
|
|
Change From Baseline Through Month 24 In Urine GL-3 Levels
OLE
|
-62.37 ng/mg creatinine
Standard Deviation 615.944
|
-177.42 ng/mg creatinine
Standard Deviation 288.224
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Month 6, Month 12Population: mITT with amenable mutations: Randomized participants who switched from placebo to migalastat during Stage 2, received at least 1 dose of study drug, and underwent a renal biopsy at both Baseline and Month 6. Amenable mutations are mutant forms of α-galactosidase A (α Gal-A) amenable to migalastat. Amenable mutations based on the GLP HEK assay.
Renal biopsies were taken at Month 6 and Month 12. The specimens were evaluated using virtual microscopy. The annotation, scoring, and adjudication of the kidney histology assessments were performed by the Clinical Pathology Endpoints Committee. The number of kidney IC GL-3 inclusions was assessed by 3 renal pathologists who were blinded to treatment assignments, participants' data, and biopsy sequence. One pathologist served as annotator and identified the 300 capillaries on up to 8 slides per specimen to be scored. Two pathologists served as scorers; these pathologists completed the blinded paired assessments. Each pathologist served as annotator/adjudicator for 1/3 of the cases. Paired assessments were undertaken at Month 6 and Month 12. Assessments were made using digital images.
Outcome measures
| Measure |
Migalastat
n=20 Participants
Migalastat 150-mg capsule given orally QOD during the 6-month, double-blind, randomized placebo-controlled treatment period (Stage 1).
|
Placebo
Placebo capsule given orally QOD during the 6-month, double-blind, randomized placebo-controlled treatment period (Stage 1).
|
|---|---|---|
|
Change From Month 6 To Month 12 In Average Number Of Kidney IC GL-3 Inclusions
|
-0.320 kidney IC GL-3 inclusions
Interval -0.5719 to -0.0677
|
—
|
POST_HOC outcome
Timeframe: Baseline, Month 6Population: ITT-amenable: Randomized participants with amenable mutations who received study drug during Stage 1. Amenable mutations are mutant forms of α Gal-A amenable to migalastat. Amenable mutations based on the GLP HEK assay. Participants were analyzed according to their original randomized treatment group.
Renal biopsies were taken at Baseline and Month 6. The specimens were evaluated using virtual microscopy. The annotation, scoring, and adjudication of the kidney histology assessments were performed by the Clinical Pathology Endpoints Committee. The number of kidney IC GL-3 inclusions was assessed by 3 renal pathologists who were blinded to treatment assignments, participants' data, and biopsy sequence. One pathologist served as annotator and identified the 300 capillaries on up to 8 slides per specimen to be scored. Two pathologists served as scorers; these pathologists completed the blinded paired assessments. Each pathologist served as annotator/adjudicator for 1/3 of the cases. Paired assessments were undertaken at Baseline and Month 6. Assessments were made using digital images. Treatment effect was estimated using the LS mean difference between treatments within the context of the ANCOVA model.
Outcome measures
| Measure |
Migalastat
n=25 Participants
Migalastat 150-mg capsule given orally QOD during the 6-month, double-blind, randomized placebo-controlled treatment period (Stage 1).
|
Placebo
Placebo capsule given orally QOD during the 6-month, double-blind, randomized placebo-controlled treatment period (Stage 1).
|
|---|---|---|
|
Change From Baseline To Month 6 In Average Number Of Kidney IC GL-3 Inclusions
|
-0.250 kidney IC GL-3 inclusions
Standard Deviation 0.5126
|
—
|
Adverse Events
Migalastat (0-6 Months)
Serious events: 2 serious events
Other events: 31 other events
Deaths: 0 deaths
Placebo (0-6 Months)
Serious events: 4 serious events
Other events: 30 other events
Deaths: 0 deaths
All Migalastat (>6-12 Months)
Serious events: 5 serious events
Other events: 50 other events
Deaths: 0 deaths
All Migalastat (>12-24 Months)
Serious events: 11 serious events
Other events: 46 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Migalastat (0-6 Months)
n=34 participants at risk
Migalastat 150-mg capsule given orally QOD during the 6-month, double-blind, randomized placebo-controlled treatment period (Stage 1). After Stage 1, participants progressed to Stage 2 where they received open-label migalastat for 6 months.
|
Placebo (0-6 Months)
n=33 participants at risk
Placebo capsule given orally QOD during the 6-month, double-blind, randomized placebo-controlled treatment period (Stage 1). After Stage 1, participants progressed to Stage 2 where they received open-label migalastat for 6 months.
|
All Migalastat (>6-12 Months)
n=63 participants at risk
Migalastat 150-mg capsule given orally QOD during the 6-month open-label treatment period (Stage 2). Includes all participants who progressed from both the migalastat (0-6 Months) and the placebo (0-6 Months) Stage 1 treatment groups. After Stage 2, participants were eligible to enter the optional, 12-month OLE.
|
All Migalastat (>12-24 Months)
n=57 participants at risk
Migalastat 150-mg capsule given orally QOD for up to 12 months during the optional OLE. Includes all participants who decided to continue treatment after completing the 6-month, open-label Stage 2 treatment period.
|
|---|---|---|---|---|
|
Vascular disorders
Deep Vein Thrombosis
|
0.00%
0/34 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
0.00%
0/33 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
1.6%
1/63 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
0.00%
0/57 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
|
Injury, poisoning and procedural complications
Multiple Fractures
|
0.00%
0/34 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
0.00%
0/33 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
0.00%
0/63 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
1.8%
1/57 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
|
Injury, poisoning and procedural complications
Post Procedural Haematoma
|
2.9%
1/34 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
0.00%
0/33 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
0.00%
0/63 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
0.00%
0/57 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
|
Injury, poisoning and procedural complications
Post Procedural Haemorrhage
|
0.00%
0/34 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
3.0%
1/33 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
0.00%
0/63 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
0.00%
0/57 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anaplastic Large Cell Lymphoma T - and Null - Cell Types
|
0.00%
0/34 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
3.0%
1/33 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
0.00%
0/63 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
0.00%
0/57 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/34 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
0.00%
0/33 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
0.00%
0/63 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
1.8%
1/57 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
|
Cardiac disorders
Ventricular Tachycardia
|
0.00%
0/34 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
0.00%
0/33 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
1.6%
1/63 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
0.00%
0/57 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/34 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
0.00%
0/33 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
0.00%
0/63 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
1.8%
1/57 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.00%
0/34 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
0.00%
0/33 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
3.2%
2/63 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
0.00%
0/57 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
|
Nervous system disorders
Amyotrophic Lateral Sclerosis
|
0.00%
0/34 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
0.00%
0/33 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
1.6%
1/63 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
0.00%
0/57 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
|
Nervous system disorders
Cerebral Haemorrhage
|
0.00%
0/34 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
0.00%
0/33 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
1.6%
1/63 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
0.00%
0/57 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
|
Nervous system disorders
Syncope
|
0.00%
0/34 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
0.00%
0/33 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
0.00%
0/63 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
1.8%
1/57 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/34 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
0.00%
0/33 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
0.00%
0/63 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
1.8%
1/57 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
|
Nervous system disorders
Transient Ischaemic Attack
|
0.00%
0/34 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
0.00%
0/33 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
0.00%
0/63 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
1.8%
1/57 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
|
General disorders
Fatigue
|
0.00%
0/34 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
0.00%
0/33 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
0.00%
0/63 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
1.8%
1/57 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
|
General disorders
Malaise
|
0.00%
0/34 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
0.00%
0/33 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
0.00%
0/63 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
1.8%
1/57 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/34 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
0.00%
0/33 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
0.00%
0/63 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
1.8%
1/57 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
|
Psychiatric disorders
Bulimia Nervosa
|
0.00%
0/34 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
0.00%
0/33 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
1.6%
1/63 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
0.00%
0/57 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
|
Gastrointestinal disorders
Abdominal Pain Lower
|
0.00%
0/34 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
0.00%
0/33 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
0.00%
0/63 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
1.8%
1/57 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/34 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
0.00%
0/33 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
0.00%
0/63 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
1.8%
1/57 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
|
Renal and urinary disorders
Hydronephrosis
|
2.9%
1/34 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
0.00%
0/33 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
0.00%
0/63 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
0.00%
0/57 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
|
Musculoskeletal and connective tissue disorders
Bone Cyst
|
0.00%
0/34 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
0.00%
0/33 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
1.6%
1/63 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
0.00%
0/57 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
|
Infections and infestations
Bacterial Infection
|
0.00%
0/34 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
3.0%
1/33 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
0.00%
0/63 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
0.00%
0/57 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
|
Infections and infestations
Helicobacter Gastritis
|
0.00%
0/34 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
0.00%
0/33 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
0.00%
0/63 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
1.8%
1/57 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
|
Infections and infestations
Meningitis Viral
|
0.00%
0/34 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
3.0%
1/33 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
0.00%
0/63 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
0.00%
0/57 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
Other adverse events
| Measure |
Migalastat (0-6 Months)
n=34 participants at risk
Migalastat 150-mg capsule given orally QOD during the 6-month, double-blind, randomized placebo-controlled treatment period (Stage 1). After Stage 1, participants progressed to Stage 2 where they received open-label migalastat for 6 months.
|
Placebo (0-6 Months)
n=33 participants at risk
Placebo capsule given orally QOD during the 6-month, double-blind, randomized placebo-controlled treatment period (Stage 1). After Stage 1, participants progressed to Stage 2 where they received open-label migalastat for 6 months.
|
All Migalastat (>6-12 Months)
n=63 participants at risk
Migalastat 150-mg capsule given orally QOD during the 6-month open-label treatment period (Stage 2). Includes all participants who progressed from both the migalastat (0-6 Months) and the placebo (0-6 Months) Stage 1 treatment groups. After Stage 2, participants were eligible to enter the optional, 12-month OLE.
|
All Migalastat (>12-24 Months)
n=57 participants at risk
Migalastat 150-mg capsule given orally QOD for up to 12 months during the optional OLE. Includes all participants who decided to continue treatment after completing the 6-month, open-label Stage 2 treatment period.
|
|---|---|---|---|---|
|
General disorders
Fatigue
|
11.8%
4/34 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
12.1%
4/33 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
3.2%
2/63 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
5.3%
3/57 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
|
General disorders
Pyrexia
|
11.8%
4/34 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
3.0%
1/33 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
1.6%
1/63 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
0.00%
0/57 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
|
Psychiatric disorders
Depression
|
2.9%
1/34 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
0.00%
0/33 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
4.8%
3/63 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
7.0%
4/57 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
|
Psychiatric disorders
Insomnia
|
8.8%
3/34 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
6.1%
2/33 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
0.00%
0/63 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
0.00%
0/57 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
|
Injury, poisoning and procedural complications
Overdose
|
5.9%
2/34 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
3.0%
1/33 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
0.00%
0/63 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
0.00%
0/57 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
|
Injury, poisoning and procedural complications
Procedural Pain
|
5.9%
2/34 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
3.0%
1/33 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
11.1%
7/63 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
0.00%
0/57 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
8.8%
3/34 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
3.0%
1/33 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
1.6%
1/63 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
0.00%
0/57 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.8%
3/34 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
0.00%
0/33 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
1.6%
1/63 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
3.5%
2/57 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
8.8%
3/34 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
6.1%
2/33 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
0.00%
0/63 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
3.5%
2/57 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
|
Nervous system disorders
Dizziness
|
5.9%
2/34 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
3.0%
1/33 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
3.2%
2/63 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
1.8%
1/57 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
|
Nervous system disorders
Paraesthesia
|
11.8%
4/34 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
12.1%
4/33 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
6.3%
4/63 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
3.5%
2/57 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
|
Nervous system disorders
Headache
|
35.3%
12/34 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
21.2%
7/33 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
14.3%
9/63 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
10.5%
6/57 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
|
Ear and labyrinth disorders
Vertigo
|
5.9%
2/34 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
9.1%
3/33 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
4.8%
3/63 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
0.00%
0/57 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
5.9%
2/34 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
0.00%
0/33 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
3.2%
2/63 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
3.5%
2/57 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
|
Gastrointestinal disorders
Constipation
|
5.9%
2/34 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
6.1%
2/33 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
1.6%
1/63 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
3.5%
2/57 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
|
Gastrointestinal disorders
Dry Mouth
|
5.9%
2/34 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
6.1%
2/33 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
0.00%
0/63 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
0.00%
0/57 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
|
Gastrointestinal disorders
Diarrhoea
|
8.8%
3/34 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
3.0%
1/33 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
7.9%
5/63 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
3.5%
2/57 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
|
Gastrointestinal disorders
Nausea
|
11.8%
4/34 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
6.1%
2/33 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
3.2%
2/63 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
5.3%
3/57 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
|
Gastrointestinal disorders
Vomiting
|
2.9%
1/34 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
6.1%
2/33 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
1.6%
1/63 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
5.3%
3/57 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/34 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
0.00%
0/33 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
1.6%
1/63 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
15.8%
9/57 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
|
Renal and urinary disorders
Haematuria
|
8.8%
3/34 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
0.00%
0/33 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
1.6%
1/63 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
0.00%
0/57 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/34 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
6.1%
2/33 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
6.3%
4/63 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
8.8%
5/57 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
2.9%
1/34 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
9.1%
3/33 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
3.2%
2/63 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
1.8%
1/57 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
8.8%
3/34 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
0.00%
0/33 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
3.2%
2/63 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
5.3%
3/57 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.9%
2/34 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
3.0%
1/33 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
1.6%
1/63 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
3.5%
2/57 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
0.00%
0/34 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
12.1%
4/33 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
3.2%
2/63 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
3.5%
2/57 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
|
Infections and infestations
Bronchitis
|
2.9%
1/34 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
0.00%
0/33 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
1.6%
1/63 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
10.5%
6/57 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
|
Infections and infestations
Influenza
|
0.00%
0/34 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
9.1%
3/33 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
0.00%
0/63 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
3.5%
2/57 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
|
Infections and infestations
Nasopharyngitis
|
17.6%
6/34 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
6.1%
2/33 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
7.9%
5/63 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
5.3%
3/57 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
5.9%
2/34 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
9.1%
3/33 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
7.9%
5/63 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
5.3%
3/57 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
|
Infections and infestations
Urinary Tract Infection
|
5.9%
2/34 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
0.00%
0/33 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
4.8%
3/63 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
8.8%
5/57 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
|
Cardiac disorders
Atrial Fibrillation
|
5.9%
2/34 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
0.00%
0/33 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
1.6%
1/63 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
5.3%
3/57 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
|
Gastrointestinal disorders
Abdominal Distension
|
5.9%
2/34 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
3.0%
1/33 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
3.2%
2/63 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
0.00%
0/57 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
|
General disorders
Asthenia
|
5.9%
2/34 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
3.0%
1/33 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
0.00%
0/63 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
1.8%
1/57 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
|
Infections and infestations
Cystitis
|
5.9%
2/34 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
0.00%
0/33 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
0.00%
0/63 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
0.00%
0/57 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
|
Injury, poisoning and procedural complications
Post Procedural Complication
|
5.9%
2/34 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
0.00%
0/33 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
1.6%
1/63 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
0.00%
0/57 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
|
Investigations
Weight Increased
|
5.9%
2/34 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
3.0%
1/33 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
0.00%
0/63 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
0.00%
0/57 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
|
Musculoskeletal and connective tissue disorders
Torticollis
|
5.9%
2/34 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
0.00%
0/33 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
0.00%
0/63 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
0.00%
0/57 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
|
Nervous system disorders
Hypoaesthesia
|
5.9%
2/34 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
0.00%
0/33 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
3.2%
2/63 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
0.00%
0/57 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
|
Metabolism and nutrition disorders
Vitamin D Deficiency
|
2.9%
1/34 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
3.0%
1/33 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
1.6%
1/63 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
5.3%
3/57 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
|
Renal and urinary disorders
Microalbuminuria
|
0.00%
0/34 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
0.00%
0/33 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
0.00%
0/63 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
5.3%
3/57 • Adverse events (AEs) were monitored up to 25 months (±7 days) after the first dose of study drug. AEs were reported from the first dose of study medication at Baseline (Visit 1) in Stage 1 to 1 month (±7 days) after the date of the last study visit, whether during Stage 1, Stage 2, or the optional OLE, or after premature discontinuation from the study.
Stage 1 AEs were any AEs that started between the first dose of Stage 1 and the first dose of Stage 2 (or last Stage 1 administration for participants that discontinued during Stage 1). Stage 2 AEs were any AEs that started between the first dose of Stage 2 and the first dose of the OLE (or the last Stage 2 administration for participants that discontinued during Stage 2). OLE AEs were any AEs that started after the first dose of the OLE.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The investigator can publish only the results from this trial, provided they supply the sponsor (or authorized entity) a copy of any proposed publication for review prior to submission for publication. If requested and prior to publication, the investigator will remove information deemed confidential or proprietary by the sponsor and will withhold publication for an additional period of time to allow the sponsor to take appropriate measures to establish and preserve its proprietary rights.
- Publication restrictions are in place
Restriction type: OTHER