Trial Outcomes & Findings for Drug-Drug Interaction Study Between AT1001 (Migalastat Hydrochloride) and Agalsidase in Participants With Fabry Disease (NCT NCT01196871)
NCT ID: NCT01196871
Last Updated: 2018-12-19
Results Overview
This measure characterized the effects of migalastat on the plasma PK of agalsidase by measurement of the active α-Gal A enzyme level in plasma using a qualified assay that measured the rate of enzyme activity using an artificial, fluorescent substrate. The agalsidase plasma PK parameter values for AUC extrapolated from time 0 to infinity (AUCinfinity) and AUC to the last time point at which concentration is quantified (AUC0-t) are reported in hr\*\[nanomoles/hr/milliliter\] (hr\*\[nmol/hr/mL\]). In Period 1 of Stages 1 and 2, blood samples were collected: immediately before the agalsidase infusion and over a 24-hr period after infusion; on Days 2, 7, and 14. In Period 2 of Stages 1 and 2, blood samples were collected: prior to dosing with migalastat (2 hr prior to the agalsidase infusion) and 1 hr after migalastat dosing; immediately before initiation of the agalsidase infusion and over a 24-hr period after initiation of the agalsidase infusion; on Days 2, 7, and 14.
COMPLETED
PHASE2
20 participants
0 hr, 2 hr, 2 days, 7 days, 14 days post dose
2018-12-19
Participant Flow
The total number of unique participants in this study was 20: 3 from Stage 1 were re-enrolled and newly identified in Stage 2. Of those, 1 initially received 0.5 milligrams (mg)/kilogram (kg) agalsidase beta; after resolution of an agalsidase beta shortage, their dose was increased to 1.0 mg/kg; all remaining visits were completed at this dose.
Participant milestones
| Measure |
Agalsidase Beta (0.5 mg/kg)-Migalastat (150 mg)
Stage 1: This arm consisted of 3 sequential treatment periods (Period 1 - Period 3). A single 150-mg oral dose (1 capsule) of migalastat hydrochloride (HCl) (migalastat) 2 hours (hr) before initiation of an intravenous (IV) infusion of 0.5 mg/kg mg/kg agalsidase beta.
|
Agalsidase Beta (1.0 mg/kg)-Migalastat (150 mg)
Stage 1: This arm consisted of 3 sequential treatment periods (Period 1 - Period 3). A single 150-mg oral dose (1 capsule) of migalastat HCl 2 hr before initiation of an IV infusion of 1.0 mg/kg agalsidase beta.
|
Agalsidase Alfa (0.2 mg/kg)-Migalastat (150 mg)
Stage 1: This arm consisted of 3 sequential treatment periods (Period 1 - Period 3). A single 150-mg oral dose (1 capsule) of migalastat HCl 2 hr before initiation of an IV infusion of 0.2 mg/kg agalsidase alfa.
|
Agalsidase Beta (0.5 mg/kg)-Migalastat (450 mg)
Stage 2: This arm consisted of 2 sequential treatment periods (Period 1, Period 2). A single 450 mg oral dose (3 × 150-mg capsules) of migalastat HCl 2 hr before initiation of an IV infusion of 0.5 mg/kg agalsidase beta.
|
Agalsidase Beta (1.0 mg/kg)-Migalastat (450 mg)
Stage 2: This arm consisted of 2 sequential treatment periods (Period 1, Period 2). A single 450 mg oral dose (3 × 150-mg capsules) of migalastat HCl 2 hr before initiation of an IV infusion of 1.0 mg/kg agalsidase beta.
|
Agalsidase Alfa (0.2 mg/kg)-Migalastat (450 mg)
Stage 2: This arm consisted of 2 sequential treatment periods (Period 1, Period 2). A single 450 mg oral dose (3 x 150-mg capsules) of migalastat HCl 2 hr before initiation of an IV infusion of 0.2 mg/kg agalsidase alfa.
|
|---|---|---|---|---|---|---|
|
Stage 1: Period 1
STARTED
|
5
|
3
|
4
|
0
|
0
|
0
|
|
Stage 1: Period 1
PK Population
|
5
|
3
|
4
|
0
|
0
|
0
|
|
Stage 1: Period 1
Received at Least 1 Dose of Study Drug
|
5
|
3
|
4
|
0
|
0
|
0
|
|
Stage 1: Period 1
COMPLETED
|
5
|
3
|
4
|
0
|
0
|
0
|
|
Stage 1: Period 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Stage 1: Period 2
STARTED
|
5
|
3
|
4
|
0
|
0
|
0
|
|
Stage 1: Period 2
PK Population
|
5
|
3
|
4
|
0
|
0
|
0
|
|
Stage 1: Period 2
COMPLETED
|
5
|
3
|
4
|
0
|
0
|
0
|
|
Stage 1: Period 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Stage 1: Period 3
STARTED
|
5
|
3
|
4
|
0
|
0
|
0
|
|
Stage 1: Period 3
COMPLETED
|
5
|
3
|
4
|
0
|
0
|
0
|
|
Stage 1: Period 3
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Stage 2: Period 1
STARTED
|
0
|
0
|
0
|
2
|
5
|
4
|
|
Stage 2: Period 1
Received at Least 1 Dose of Study Drug
|
0
|
0
|
0
|
2
|
5
|
4
|
|
Stage 2: Period 1
PK Population
|
0
|
0
|
0
|
1
|
5
|
4
|
|
Stage 2: Period 1
COMPLETED
|
0
|
0
|
0
|
2
|
5
|
4
|
|
Stage 2: Period 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Stage 2: Period 2
STARTED
|
0
|
0
|
0
|
1
|
6
|
4
|
|
Stage 2: Period 2
PK Population
|
0
|
0
|
0
|
1
|
6
|
4
|
|
Stage 2: Period 2
COMPLETED
|
0
|
0
|
0
|
1
|
6
|
4
|
|
Stage 2: Period 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The total number of unique participants in this study was 20: 3 from Stage 1 were re-enrolled and newly identified in Stage 2. The total number of participants in Stage 2 was 11. One participant received both 0.5 and 1.0 mg/kg agalsidase beta (450 mg migalastat) in Stage 2 and appears under both treatment groups.
Baseline characteristics by cohort
| Measure |
Agalsidase Beta (0.5 mg/kg)-Migalastat (150 mg)
n=5 Participants
Stage 1: This arm consisted of 3 sequential treatment periods (Period 1 - Period 3). A single 150-mg oral dose (1 capsule) of migalastat HCl 2 hr before initiation of an IV infusion of 0.5 mg/kg agalsidase beta.
|
Agalsidase Beta (1.0 mg/kg)-Migalastat (150 mg)
n=3 Participants
Stage 1: This arm consisted of 3 sequential treatment periods (Period 1 - Period 3). A single 150-mg oral dose (1 capsule) of migalastat HCl 2 hr before initiation of an IV infusion of 1.0 mg/kg agalsidase beta.
|
Agalsidase Alfa (0.2 mg/kg)-Migalastat (150 mg)
n=4 Participants
Stage 1: This arm consisted of 3 sequential treatment periods (Period 1 - Period 3). A single 150-mg oral dose (1 capsule) of migalastat HCl 2 hr before initiation of an IV infusion of 0.2 mg/kg agalsidase alfa.
|
Agalsidase Beta (0.5 mg/kg)-Migalastat (450 mg)
n=2 Participants
Stage 2: This arm consisted of 2 sequential treatment periods (Period 1, Period 2). A single 450-mg oral dose (3 × 150-mg capsules) of migalastat HCl 2 hr before initiation of an IV infusion of 0.5 mg/kg agalsidase beta.
|
Agalsidase Beta (1.0 mg/kg)-Migalastat (450 mg)
n=6 Participants
Stage 2: This arm consisted of 2 sequential treatment periods (Period 1, Period 2). A single 450-mg oral dose (3 × 150-mg capsules) of migalastat HCl 2 hr before initiation of an IV infusion of 1.0 mg/kg agalsidase beta.
|
Agalsidase Alfa (0.2 mg/kg)-Migalastat (450 mg)
n=4 Participants
Stage 2: This arm consisted of 2 sequential treatment periods (Period 1, Period 2). A single 450-mg oral dose (3 x 150-mg capsules) of migalastat HCl 2 hr before initiation of an IV infusion of 0.2 mg/kg agalsidase alfa.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
Stage 1
|
50.6 years
STANDARD_DEVIATION 6.88 • n=5 Participants • The total number of unique participants in this study was 20: 3 from Stage 1 were re-enrolled and newly identified in Stage 2. The total number of participants in Stage 2 was 11. One participant received both 0.5 and 1.0 mg/kg agalsidase beta (450 mg migalastat) in Stage 2 and appears under both treatment groups.
|
45.7 years
STANDARD_DEVIATION 8.02 • n=3 Participants • The total number of unique participants in this study was 20: 3 from Stage 1 were re-enrolled and newly identified in Stage 2. The total number of participants in Stage 2 was 11. One participant received both 0.5 and 1.0 mg/kg agalsidase beta (450 mg migalastat) in Stage 2 and appears under both treatment groups.
|
43.5 years
STANDARD_DEVIATION 5.07 • n=4 Participants • The total number of unique participants in this study was 20: 3 from Stage 1 were re-enrolled and newly identified in Stage 2. The total number of participants in Stage 2 was 11. One participant received both 0.5 and 1.0 mg/kg agalsidase beta (450 mg migalastat) in Stage 2 and appears under both treatment groups.
|
—
|
—
|
—
|
47.0 years
STANDARD_DEVIATION 6.84 • n=12 Participants • The total number of unique participants in this study was 20: 3 from Stage 1 were re-enrolled and newly identified in Stage 2. The total number of participants in Stage 2 was 11. One participant received both 0.5 and 1.0 mg/kg agalsidase beta (450 mg migalastat) in Stage 2 and appears under both treatment groups.
|
|
Age, Continuous
Stage 2
|
—
|
—
|
—
|
53.5 years
STANDARD_DEVIATION 2.12 • n=2 Participants • The total number of unique participants in this study was 20: 3 from Stage 1 were re-enrolled and newly identified in Stage 2. The total number of participants in Stage 2 was 11. One participant received both 0.5 and 1.0 mg/kg agalsidase beta (450 mg migalastat) in Stage 2 and appears under both treatment groups.
|
38.7 years
STANDARD_DEVIATION 12.16 • n=6 Participants • The total number of unique participants in this study was 20: 3 from Stage 1 were re-enrolled and newly identified in Stage 2. The total number of participants in Stage 2 was 11. One participant received both 0.5 and 1.0 mg/kg agalsidase beta (450 mg migalastat) in Stage 2 and appears under both treatment groups.
|
38.5 years
STANDARD_DEVIATION 9.15 • n=4 Participants • The total number of unique participants in this study was 20: 3 from Stage 1 were re-enrolled and newly identified in Stage 2. The total number of participants in Stage 2 was 11. One participant received both 0.5 and 1.0 mg/kg agalsidase beta (450 mg migalastat) in Stage 2 and appears under both treatment groups.
|
40.1 years
STANDARD_DEVIATION 11.11 • n=12 Participants • The total number of unique participants in this study was 20: 3 from Stage 1 were re-enrolled and newly identified in Stage 2. The total number of participants in Stage 2 was 11. One participant received both 0.5 and 1.0 mg/kg agalsidase beta (450 mg migalastat) in Stage 2 and appears under both treatment groups.
|
|
Sex: Female, Male
Stage 1 · Female
|
0 Participants
n=5 Participants • The total number of unique participants in this study was 20: 3 from Stage 1 were re-enrolled and newly identified in Stage 2. The total number of participants in Stage 2 was 11. One participant received both 0.5 and 1.0 mg/kg agalsidase beta (450 mg migalastat) in Stage 2 and appears under both treatment groups.
|
0 Participants
n=3 Participants • The total number of unique participants in this study was 20: 3 from Stage 1 were re-enrolled and newly identified in Stage 2. The total number of participants in Stage 2 was 11. One participant received both 0.5 and 1.0 mg/kg agalsidase beta (450 mg migalastat) in Stage 2 and appears under both treatment groups.
|
0 Participants
n=4 Participants • The total number of unique participants in this study was 20: 3 from Stage 1 were re-enrolled and newly identified in Stage 2. The total number of participants in Stage 2 was 11. One participant received both 0.5 and 1.0 mg/kg agalsidase beta (450 mg migalastat) in Stage 2 and appears under both treatment groups.
|
—
|
—
|
—
|
0 Participants
n=12 Participants • The total number of unique participants in this study was 20: 3 from Stage 1 were re-enrolled and newly identified in Stage 2. The total number of participants in Stage 2 was 11. One participant received both 0.5 and 1.0 mg/kg agalsidase beta (450 mg migalastat) in Stage 2 and appears under both treatment groups.
|
|
Sex: Female, Male
Stage 1 · Male
|
5 Participants
n=5 Participants • The total number of unique participants in this study was 20: 3 from Stage 1 were re-enrolled and newly identified in Stage 2. The total number of participants in Stage 2 was 11. One participant received both 0.5 and 1.0 mg/kg agalsidase beta (450 mg migalastat) in Stage 2 and appears under both treatment groups.
|
3 Participants
n=3 Participants • The total number of unique participants in this study was 20: 3 from Stage 1 were re-enrolled and newly identified in Stage 2. The total number of participants in Stage 2 was 11. One participant received both 0.5 and 1.0 mg/kg agalsidase beta (450 mg migalastat) in Stage 2 and appears under both treatment groups.
|
4 Participants
n=4 Participants • The total number of unique participants in this study was 20: 3 from Stage 1 were re-enrolled and newly identified in Stage 2. The total number of participants in Stage 2 was 11. One participant received both 0.5 and 1.0 mg/kg agalsidase beta (450 mg migalastat) in Stage 2 and appears under both treatment groups.
|
—
|
—
|
—
|
12 Participants
n=12 Participants • The total number of unique participants in this study was 20: 3 from Stage 1 were re-enrolled and newly identified in Stage 2. The total number of participants in Stage 2 was 11. One participant received both 0.5 and 1.0 mg/kg agalsidase beta (450 mg migalastat) in Stage 2 and appears under both treatment groups.
|
|
Sex: Female, Male
Stage 2 · Female
|
—
|
—
|
—
|
0 Participants
n=2 Participants • The total number of unique participants in this study was 20: 3 from Stage 1 were re-enrolled and newly identified in Stage 2. The total number of participants in Stage 2 was 11. One participant received both 0.5 and 1.0 mg/kg agalsidase beta (450 mg migalastat) in Stage 2 and appears under both treatment groups.
|
0 Participants
n=6 Participants • The total number of unique participants in this study was 20: 3 from Stage 1 were re-enrolled and newly identified in Stage 2. The total number of participants in Stage 2 was 11. One participant received both 0.5 and 1.0 mg/kg agalsidase beta (450 mg migalastat) in Stage 2 and appears under both treatment groups.
|
0 Participants
n=4 Participants • The total number of unique participants in this study was 20: 3 from Stage 1 were re-enrolled and newly identified in Stage 2. The total number of participants in Stage 2 was 11. One participant received both 0.5 and 1.0 mg/kg agalsidase beta (450 mg migalastat) in Stage 2 and appears under both treatment groups.
|
0 Participants
n=12 Participants • The total number of unique participants in this study was 20: 3 from Stage 1 were re-enrolled and newly identified in Stage 2. The total number of participants in Stage 2 was 11. One participant received both 0.5 and 1.0 mg/kg agalsidase beta (450 mg migalastat) in Stage 2 and appears under both treatment groups.
|
|
Sex: Female, Male
Stage 2 · Male
|
—
|
—
|
—
|
2 Participants
n=2 Participants • The total number of unique participants in this study was 20: 3 from Stage 1 were re-enrolled and newly identified in Stage 2. The total number of participants in Stage 2 was 11. One participant received both 0.5 and 1.0 mg/kg agalsidase beta (450 mg migalastat) in Stage 2 and appears under both treatment groups.
|
6 Participants
n=6 Participants • The total number of unique participants in this study was 20: 3 from Stage 1 were re-enrolled and newly identified in Stage 2. The total number of participants in Stage 2 was 11. One participant received both 0.5 and 1.0 mg/kg agalsidase beta (450 mg migalastat) in Stage 2 and appears under both treatment groups.
|
4 Participants
n=4 Participants • The total number of unique participants in this study was 20: 3 from Stage 1 were re-enrolled and newly identified in Stage 2. The total number of participants in Stage 2 was 11. One participant received both 0.5 and 1.0 mg/kg agalsidase beta (450 mg migalastat) in Stage 2 and appears under both treatment groups.
|
12 Participants
n=12 Participants • The total number of unique participants in this study was 20: 3 from Stage 1 were re-enrolled and newly identified in Stage 2. The total number of participants in Stage 2 was 11. One participant received both 0.5 and 1.0 mg/kg agalsidase beta (450 mg migalastat) in Stage 2 and appears under both treatment groups.
|
PRIMARY outcome
Timeframe: 0 hr, 2 hr, 2 days, 7 days, 14 days post dosePopulation: PK Population: all participants with evaluable PK parameter data who had successfully completed at least Period 1 and Period 2 in any stage. All PK analyses were performed using the PK population.
This measure characterized the effects of migalastat on the plasma PK of agalsidase by measurement of the active α-Gal A enzyme level in plasma using a qualified assay that measured the rate of enzyme activity using an artificial, fluorescent substrate. The agalsidase plasma PK parameter values for AUC extrapolated from time 0 to infinity (AUCinfinity) and AUC to the last time point at which concentration is quantified (AUC0-t) are reported in hr\*\[nanomoles/hr/milliliter\] (hr\*\[nmol/hr/mL\]). In Period 1 of Stages 1 and 2, blood samples were collected: immediately before the agalsidase infusion and over a 24-hr period after infusion; on Days 2, 7, and 14. In Period 2 of Stages 1 and 2, blood samples were collected: prior to dosing with migalastat (2 hr prior to the agalsidase infusion) and 1 hr after migalastat dosing; immediately before initiation of the agalsidase infusion and over a 24-hr period after initiation of the agalsidase infusion; on Days 2, 7, and 14.
Outcome measures
| Measure |
Agalsidase Alfa (0.2 mg/kg)-Migalastat (150 mg)
n=4 Participants
Stage 1: This arm consisted of 3 sequential treatment periods (Period 1 - Period 3). A single 150-mg oral dose (1 capsule) of migalastat HCl 2 hr before initiation of an IV infusion of 0.2 mg/kg agalsidase alfa.
|
Agalsidase Beta (0.5 mg/kg)-Migalastat (450 mg)
n=1 Participants
Stage 2: This arm consisted of 2 sequential treatment periods (Period 1, Period 2). A single 450-mg oral dose (3 × 150-mg capsules) of migalastat HCl 2 hr before initiation of an IV infusion of 0.5 mg/kg agalsidase beta.
|
Agalsidase Beta (1.0 mg/kg)-Migalastat (450 mg)
n=6 Participants
Stage 2: This arm consisted of 2 sequential treatment periods (Period 1, Period 2). A single 450-mg oral dose (3 × 150-mg capsules) of migalastat HCl 2 hr before initiation of an IV infusion of 1.0 mg/kg agalsidase beta.
|
Agalsidase Alfa (0.2 mg/kg)-Migalastat (450 mg)
n=4 Participants
Stage 2: This arm consisted of 2 sequential treatment periods (Period 1, Period 2). A single 450-mg oral dose (3 x 150-mg capsules) of migalastat HCl 2 hr before initiation of an IV infusion of 0.2 mg/kg agalsidase alfa.
|
Agalsidase Beta (0.5 mg/kg)-Migalastat (150 mg)
n=5 Participants
Stage 1: This arm consisted of 3 sequential treatment periods (Period 1 - Period 3). A single 150-mg oral dose (1 capsule) of migalastat HCl 2 hr before initiation of an IV infusion of 0.5 mg/kg agalsidase beta.
|
Agalsidase Beta (1.0 mg/kg)-Migalastat (150 mg)
n=3 Participants
Stage 1: This arm consisted of 3 sequential treatment periods (Period 1 - Period 3). A single 150-mg oral dose (1 capsule) of migalastat HCl 2 hr before initiation of an IV infusion of 1.0 mg/kg agalsidase beta.
|
|---|---|---|---|---|---|---|
|
Change In Area Under The Plasma Concentration Versus Time Curve (AUC) For Active α-Galactosidase A (α-Gal A) Levels After Administration Of Migalastat
Period 1: AUC0-t
|
384.20 hr*[nmol/hr/mL]
Standard Deviation 86.904
|
2409.02 hr*[nmol/hr/mL]
Standard Deviation NA
Single Participant: Statistical analysis not performed.
|
5670.76 hr*[nmol/hr/mL]
Standard Deviation 3926.295
|
787.23 hr*[nmol/hr/mL]
Standard Deviation 509.967
|
1132.72 hr*[nmol/hr/mL]
Standard Deviation 223.215
|
4730.47 hr*[nmol/hr/mL]
Standard Deviation 1045.068
|
|
Change In Area Under The Plasma Concentration Versus Time Curve (AUC) For Active α-Galactosidase A (α-Gal A) Levels After Administration Of Migalastat
Period 2: AUC0-t
|
1602.58 hr*[nmol/hr/mL]
Standard Deviation 425.798
|
6127.75 hr*[nmol/hr/mL]
Standard Deviation NA
Single Participant: Statistical analysis not performed.
|
9908.56 hr*[nmol/hr/mL]
Standard Deviation 3097.746
|
2199.98 hr*[nmol/hr/mL]
Standard Deviation 875.140
|
3255.09 hr*[nmol/hr/mL]
Standard Deviation 904.716
|
9541.21 hr*[nmol/hr/mL]
Standard Deviation 2813.139
|
|
Change In Area Under The Plasma Concentration Versus Time Curve (AUC) For Active α-Galactosidase A (α-Gal A) Levels After Administration Of Migalastat
Period 1: AUCinfinity
|
388.10 hr*[nmol/hr/mL]
Standard Deviation 83.770
|
2523.87 hr*[nmol/hr/mL]
Standard Deviation NA
Single Participant: Statistical analysis not performed.
|
5851.62 hr*[nmol/hr/mL]
Standard Deviation 4345.407
|
800.38 hr*[nmol/hr/mL]
Standard Deviation 509.308
|
1145.73 hr*[nmol/hr/mL]
Standard Deviation 217.894
|
4871.66 hr*[nmol/hr/mL]
Standard Deviation 1242.965
|
|
Change In Area Under The Plasma Concentration Versus Time Curve (AUC) For Active α-Galactosidase A (α-Gal A) Levels After Administration Of Migalastat
Period 2: AUCinfinity
|
1626.67 hr*[nmol/hr/mL]
Standard Deviation 407.595
|
6197.71 hr*[nmol/hr/mL]
Standard Deviation NA
Single Participant: Statistical analysis not performed.
|
10280.79 hr*[nmol/hr/mL]
Standard Deviation 3399.342
|
2253.95 hr*[nmol/hr/mL]
Standard Deviation 859.586
|
3287.09 hr*[nmol/hr/mL]
Standard Deviation 907.073
|
9765.04 hr*[nmol/hr/mL]
Standard Deviation 3118.875
|
PRIMARY outcome
Timeframe: 0 hr, 2 hr, 2 days, 7 days, 14 days post dosePopulation: PK Population: all participants with evaluable PK parameter data who had successfully completed at least Period 1 and Period 2 in any stage. All PK analyses were performed using the PK population.
This measure characterized the effects of migalastat on the plasma PK of agalsidase by measurement of the active α-Gal A enzyme level in plasma using a qualified assay that measured the rate of enzyme activity using an artificial, fluorescent substrate. The agalsidase plasma PK parameter value for Cmax is reported in nmol/hr/mL. In Period 1 of Stages 1 and 2, blood samples were collected: immediately before the agalsidase infusion and over a 24-hr period after infusion; on Days 2, 7, and 14. In Period 2 of Stages 1 and 2, blood samples were collected: prior to dosing with migalastat (2 hr prior to the agalsidase infusion) and 1 hr after migalastat dosing; immediately before initiation of the agalsidase infusion and over a 24-hr period after initiation of the agalsidase infusion; on Days 2, 7, and 14.
Outcome measures
| Measure |
Agalsidase Alfa (0.2 mg/kg)-Migalastat (150 mg)
n=4 Participants
Stage 1: This arm consisted of 3 sequential treatment periods (Period 1 - Period 3). A single 150-mg oral dose (1 capsule) of migalastat HCl 2 hr before initiation of an IV infusion of 0.2 mg/kg agalsidase alfa.
|
Agalsidase Beta (0.5 mg/kg)-Migalastat (450 mg)
n=1 Participants
Stage 2: This arm consisted of 2 sequential treatment periods (Period 1, Period 2). A single 450-mg oral dose (3 × 150-mg capsules) of migalastat HCl 2 hr before initiation of an IV infusion of 0.5 mg/kg agalsidase beta.
|
Agalsidase Beta (1.0 mg/kg)-Migalastat (450 mg)
n=6 Participants
Stage 2: This arm consisted of 2 sequential treatment periods (Period 1, Period 2). A single 450-mg oral dose (3 × 150-mg capsules) of migalastat HCl 2 hr before initiation of an IV infusion of 1.0 mg/kg agalsidase beta.
|
Agalsidase Alfa (0.2 mg/kg)-Migalastat (450 mg)
n=4 Participants
Stage 2: This arm consisted of 2 sequential treatment periods (Period 1, Period 2). A single 450-mg oral dose (3 x 150-mg capsules) of migalastat HCl 2 hr before initiation of an IV infusion of 0.2 mg/kg agalsidase alfa.
|
Agalsidase Beta (0.5 mg/kg)-Migalastat (150 mg)
n=5 Participants
Stage 1: This arm consisted of 3 sequential treatment periods (Period 1 - Period 3). A single 150-mg oral dose (1 capsule) of migalastat HCl 2 hr before initiation of an IV infusion of 0.5 mg/kg agalsidase beta.
|
Agalsidase Beta (1.0 mg/kg)-Migalastat (150 mg)
n=3 Participants
Stage 1: This arm consisted of 3 sequential treatment periods (Period 1 - Period 3). A single 150-mg oral dose (1 capsule) of migalastat HCl 2 hr before initiation of an IV infusion of 1.0 mg/kg agalsidase beta.
|
|---|---|---|---|---|---|---|
|
Change In Maximum Observed Plasma Concentration (Cmax) For Active α-Gal A Levels After Administration Of Migalastat
Period 1:Cmax
|
309.02 nmol/hr/mL
Standard Deviation 91.568
|
684.36 nmol/hr/mL
Standard Deviation NA
Single Participant: Statistical analysis not performed.
|
1775.12 nmol/hr/mL
Standard Deviation 684.734
|
370.91 nmol/hr/mL
Standard Deviation 113.362
|
514.18 nmol/hr/mL
Standard Deviation 87.458
|
1682.13 nmol/hr/mL
Standard Deviation 407.862
|
|
Change In Maximum Observed Plasma Concentration (Cmax) For Active α-Gal A Levels After Administration Of Migalastat
Period 2: Cmax
|
515.34 nmol/hr/mL
Standard Deviation 77.207
|
1351.18 nmol/hr/mL
Standard Deviation NA
Single Participant: Statistical analysis not performed.
|
2413.31 nmol/hr/mL
Standard Deviation 798.090
|
619.00 nmol/hr/mL
Standard Deviation 141.411
|
899.93 nmol/hr/mL
Standard Deviation 235.701
|
2400.86 nmol/hr/mL
Standard Deviation 928.257
|
PRIMARY outcome
Timeframe: 0 hr, 2 hr, 2 days, 7 days, 14 days post dosePopulation: PK Population: all participants with evaluable PK parameter data who had successfully completed at least Period 1 and Period 2 in any stage. All PK analyses were performed using the PK population.
This measure characterized the effects of migalastat on the plasma PK of agalsidase by measurement of the active α-Gal A enzyme level in plasma using a qualified assay that measured the rate of enzyme activity using an artificial, fluorescent substrate. The agalsidase plasma PK parameter values for tmax and t1/2 are reported in hr. In Period 1 of Stages 1 and 2, blood samples were collected: immediately before the agalsidase infusion and over a 24-hr period after infusion; on Days 2, 7, and 14. In Period 2 of Stages 1 and 2, blood samples were collected: prior to dosing with migalastat (2 hr prior to the agalsidase infusion) and 1 hr after migalastat dosing; immediately before initiation of the agalsidase infusion and over a 24-hr period after initiation of the agalsidase infusion; on Days 2, 7, and 14.
Outcome measures
| Measure |
Agalsidase Alfa (0.2 mg/kg)-Migalastat (150 mg)
n=4 Participants
Stage 1: This arm consisted of 3 sequential treatment periods (Period 1 - Period 3). A single 150-mg oral dose (1 capsule) of migalastat HCl 2 hr before initiation of an IV infusion of 0.2 mg/kg agalsidase alfa.
|
Agalsidase Beta (0.5 mg/kg)-Migalastat (450 mg)
n=1 Participants
Stage 2: This arm consisted of 2 sequential treatment periods (Period 1, Period 2). A single 450-mg oral dose (3 × 150-mg capsules) of migalastat HCl 2 hr before initiation of an IV infusion of 0.5 mg/kg agalsidase beta.
|
Agalsidase Beta (1.0 mg/kg)-Migalastat (450 mg)
n=6 Participants
Stage 2: This arm consisted of 2 sequential treatment periods (Period 1, Period 2). A single 450-mg oral dose (3 × 150-mg capsules) of migalastat HCl 2 hr before initiation of an IV infusion of 1.0 mg/kg agalsidase beta.
|
Agalsidase Alfa (0.2 mg/kg)-Migalastat (450 mg)
n=4 Participants
Stage 2: This arm consisted of 2 sequential treatment periods (Period 1, Period 2). A single 450-mg oral dose (3 x 150-mg capsules) of migalastat HCl 2 hr before initiation of an IV infusion of 0.2 mg/kg agalsidase alfa.
|
Agalsidase Beta (0.5 mg/kg)-Migalastat (150 mg)
n=5 Participants
Stage 1: This arm consisted of 3 sequential treatment periods (Period 1 - Period 3). A single 150-mg oral dose (1 capsule) of migalastat HCl 2 hr before initiation of an IV infusion of 0.5 mg/kg agalsidase beta.
|
Agalsidase Beta (1.0 mg/kg)-Migalastat (150 mg)
n=3 Participants
Stage 1: This arm consisted of 3 sequential treatment periods (Period 1 - Period 3). A single 150-mg oral dose (1 capsule) of migalastat HCl 2 hr before initiation of an IV infusion of 1.0 mg/kg agalsidase beta.
|
|---|---|---|---|---|---|---|
|
Change In Time To Maximum Observed Plasma Concentration (Tmax) And Terminal Elimination Half-life (T1/2) For Active α-Gal A Levels After Administration Of Migalastat
Period 1: tmax
|
0.75 hr
Standard Deviation 0.170
|
3.00 hr
Standard Deviation NA
Single Participant: Statistical analysis not performed.
|
2.58 hr
Standard Deviation 0.801
|
0.75 hr
Standard Deviation 0.170
|
2.07 hr
Standard Deviation 0.149
|
2.16 hr
Standard Deviation 0.778
|
|
Change In Time To Maximum Observed Plasma Concentration (Tmax) And Terminal Elimination Half-life (T1/2) For Active α-Gal A Levels After Administration Of Migalastat
Period 2: tmax
|
0.75 hr
Standard Deviation 0.170
|
3.00 hr
Standard Deviation NA
Single Participant: Statistical analysis not performed.
|
2.58 hr
Standard Deviation 0.801
|
0.75 hr
Standard Deviation 0.170
|
2.30 hr
Standard Deviation 0.447
|
2.41 hr
Standard Deviation 0.526
|
|
Change In Time To Maximum Observed Plasma Concentration (Tmax) And Terminal Elimination Half-life (T1/2) For Active α-Gal A Levels After Administration Of Migalastat
Period 1: t1/2
|
4.48 hr
Standard Deviation 3.132
|
6.50 hr
Standard Deviation NA
Single Participant: Statistical analysis not performed.
|
3.11 hr
Standard Deviation 1.875
|
5.15 hr
Standard Deviation 3.645
|
3.91 hr
Standard Deviation 2.054
|
5.33 hr
Standard Deviation 4.082
|
|
Change In Time To Maximum Observed Plasma Concentration (Tmax) And Terminal Elimination Half-life (T1/2) For Active α-Gal A Levels After Administration Of Migalastat
Period 2: t1/2
|
4.27 hr
Standard Deviation 1.536
|
3.49 hr
Standard Deviation NA
Single Participant: Statistical analysis not performed.
|
4.96 hr
Standard Deviation 1.532
|
5.31 hr
Standard Deviation 2.462
|
3.51 hr
Standard Deviation 1.304
|
4.30 hr
Standard Deviation 1.712
|
PRIMARY outcome
Timeframe: 0 hr, 2 hr, 2 days, 7 days, 14 days post dosePopulation: PK Population: all participants with evaluable PK parameter data who had successfully completed at least Period 1 and Period 2 in any stage. All PK analyses were performed using the PK population.
This measure characterized the effects of migalastat on the plasma PK of agalsidase by measurement of the α-Gal A protein level in plasma by Western blot using anti-human Gal A antibody. The agalsidase plasma PK parameter value for AUC0-t is reported in hr\*\[nanogram (ng)/hr/mL\]. In Period 1 of Stages 1 and 2, blood samples were collected: immediately before the agalsidase infusion and over a 24-hr period after infusion; on Days 2, 7, and 14. In Period 2 of Stages 1 and 2, blood samples were collected: prior to dosing with migalastat (2 hr prior to the agalsidase infusion) and 1 hr after migalastat dosing; immediately before initiation of the agalsidase infusion and over a 24-hr period after initiation of the agalsidase infusion; on Days 2, 7, and 14.
Outcome measures
| Measure |
Agalsidase Alfa (0.2 mg/kg)-Migalastat (150 mg)
n=4 Participants
Stage 1: This arm consisted of 3 sequential treatment periods (Period 1 - Period 3). A single 150-mg oral dose (1 capsule) of migalastat HCl 2 hr before initiation of an IV infusion of 0.2 mg/kg agalsidase alfa.
|
Agalsidase Beta (0.5 mg/kg)-Migalastat (450 mg)
n=1 Participants
Stage 2: This arm consisted of 2 sequential treatment periods (Period 1, Period 2). A single 450-mg oral dose (3 × 150-mg capsules) of migalastat HCl 2 hr before initiation of an IV infusion of 0.5 mg/kg agalsidase beta.
|
Agalsidase Beta (1.0 mg/kg)-Migalastat (450 mg)
n=6 Participants
Stage 2: This arm consisted of 2 sequential treatment periods (Period 1, Period 2). A single 450-mg oral dose (3 × 150-mg capsules) of migalastat HCl 2 hr before initiation of an IV infusion of 1.0 mg/kg agalsidase beta.
|
Agalsidase Alfa (0.2 mg/kg)-Migalastat (450 mg)
n=4 Participants
Stage 2: This arm consisted of 2 sequential treatment periods (Period 1, Period 2). A single 450-mg oral dose (3 x 150-mg capsules) of migalastat HCl 2 hr before initiation of an IV infusion of 0.2 mg/kg agalsidase alfa.
|
Agalsidase Beta (0.5 mg/kg)-Migalastat (150 mg)
n=5 Participants
Stage 1: This arm consisted of 3 sequential treatment periods (Period 1 - Period 3). A single 150-mg oral dose (1 capsule) of migalastat HCl 2 hr before initiation of an IV infusion of 0.5 mg/kg agalsidase beta.
|
Agalsidase Beta (1.0 mg/kg)-Migalastat (150 mg)
n=3 Participants
Stage 1: This arm consisted of 3 sequential treatment periods (Period 1 - Period 3). A single 150-mg oral dose (1 capsule) of migalastat HCl 2 hr before initiation of an IV infusion of 1.0 mg/kg agalsidase beta.
|
|---|---|---|---|---|---|---|
|
Change In AUC For Total α-Gal A Protein Levels After Administration Of Migalastat
Period 1: AUC0-t
|
42256.74 hr*[ng/hr/mL]
Standard Deviation 13868.00
|
16229.13 hr*[ng/hr/mL]
Standard Deviation NA
Single Participant: Statistical analysis not performed.
|
17200.63 hr*[ng/hr/mL]
Standard Deviation 16906.97
|
28770.37 hr*[ng/hr/mL]
Standard Deviation 10941.44
|
57187.48 hr*[ng/hr/mL]
Standard Deviation 47381.96
|
29905.87 hr*[ng/hr/mL]
Standard Deviation 20470.28
|
|
Change In AUC For Total α-Gal A Protein Levels After Administration Of Migalastat
Period 2: AUC0-t
|
42528.55 hr*[ng/hr/mL]
Standard Deviation 14652.93
|
16272.03 hr*[ng/hr/mL]
Standard Deviation NA
Single Participant: Statistical analysis not performed.
|
22031.50 hr*[ng/hr/mL]
Standard Deviation 16754.04
|
29816.41 hr*[ng/hr/mL]
Standard Deviation 8956.789
|
56895.40 hr*[ng/hr/mL]
Standard Deviation 45753.77
|
34298.23 hr*[ng/hr/mL]
Standard Deviation 17022.13
|
PRIMARY outcome
Timeframe: 0 hr, 2 hr, 2 days, 7 days, 14 days post dosePopulation: PK Population: all participants with evaluable PK parameter data who had successfully completed at least Period 1 and Period 2 in any stage. All PK analyses were performed using the PK population.
This measure characterized the effects of migalastat on the plasma PK of agalsidase by measurement of the α-Gal A protein level by Western blot using anti-human Gal A antibody. The agalsidase plasma PK parameter values for AUCextrapolated % are reported. AUCextrapolated % is reported instead of AUCinfinity because small but quantifiable concentrations of α-Gal A protein past 24 hr post-dose extrapolated to infinity comprised \>50% of total AUC in most participants and were unevaluable. In Period 1 of Stages 1 and 2, blood samples were collected: immediately before the agalsidase infusion and over a 24-hr period after infusion; on Days 2, 7, and 14. In Period 2 of Stages 1 and 2, blood samples were collected: prior to dosing with migalastat (2 hr prior to the agalsidase infusion) and 1 hour after migalastat dosing; immediately before initiation of the agalsidase infusion and over a 24-hr period after initiation of the agalsidase infusion; on Days 2, 7, and 14.
Outcome measures
| Measure |
Agalsidase Alfa (0.2 mg/kg)-Migalastat (150 mg)
n=4 Participants
Stage 1: This arm consisted of 3 sequential treatment periods (Period 1 - Period 3). A single 150-mg oral dose (1 capsule) of migalastat HCl 2 hr before initiation of an IV infusion of 0.2 mg/kg agalsidase alfa.
|
Agalsidase Beta (0.5 mg/kg)-Migalastat (450 mg)
n=1 Participants
Stage 2: This arm consisted of 2 sequential treatment periods (Period 1, Period 2). A single 450-mg oral dose (3 × 150-mg capsules) of migalastat HCl 2 hr before initiation of an IV infusion of 0.5 mg/kg agalsidase beta.
|
Agalsidase Beta (1.0 mg/kg)-Migalastat (450 mg)
n=6 Participants
Stage 2: This arm consisted of 2 sequential treatment periods (Period 1, Period 2). A single 450-mg oral dose (3 × 150-mg capsules) of migalastat HCl 2 hr before initiation of an IV infusion of 1.0 mg/kg agalsidase beta.
|
Agalsidase Alfa (0.2 mg/kg)-Migalastat (450 mg)
n=4 Participants
Stage 2: This arm consisted of 2 sequential treatment periods (Period 1, Period 2). A single 450-mg oral dose (3 x 150-mg capsules) of migalastat HCl 2 hr before initiation of an IV infusion of 0.2 mg/kg agalsidase alfa.
|
Agalsidase Beta (0.5 mg/kg)-Migalastat (150 mg)
n=5 Participants
Stage 1: This arm consisted of 3 sequential treatment periods (Period 1 - Period 3). A single 150-mg oral dose (1 capsule) of migalastat HCl 2 hr before initiation of an IV infusion of 0.5 mg/kg agalsidase beta.
|
Agalsidase Beta (1.0 mg/kg)-Migalastat (150 mg)
n=3 Participants
Stage 1: This arm consisted of 3 sequential treatment periods (Period 1 - Period 3). A single 150-mg oral dose (1 capsule) of migalastat HCl 2 hr before initiation of an IV infusion of 1.0 mg/kg agalsidase beta.
|
|---|---|---|---|---|---|---|
|
Change In Percentage Of AUCinfinity Extrapolated From The Last Time Point At Which Concentration Is Quantified To Infinity (AUCextrapolated %) For Total α-Gal A Protein Levels After Administration Of Migalastat
Period 1
|
73.26 percentage of AUC
Standard Deviation 13.324
|
8.49 percentage of AUC
Standard Deviation NA
Single Participant: Statistical analysis not performed.
|
12.30 percentage of AUC
Standard Deviation 15.307
|
58.37 percentage of AUC
Standard Deviation 11.065
|
60.50 percentage of AUC
Standard Deviation 22.241
|
27.55 percentage of AUC
Standard Deviation 14.642
|
|
Change In Percentage Of AUCinfinity Extrapolated From The Last Time Point At Which Concentration Is Quantified To Infinity (AUCextrapolated %) For Total α-Gal A Protein Levels After Administration Of Migalastat
Period 2
|
54.06 percentage of AUC
Standard Deviation 21.538
|
3.25 percentage of AUC
Standard Deviation NA
Single Participant: Statistical analysis not performed.
|
11.90 percentage of AUC
Standard Deviation 13.029
|
47.47 percentage of AUC
Standard Deviation 18.832
|
33.97 percentage of AUC
Standard Deviation 31.662
|
17.91 percentage of AUC
Standard Deviation 11.091
|
PRIMARY outcome
Timeframe: 0 hr, 2 hr, 2 days, 7 days, 14 days post dosePopulation: PK Population: all participants with evaluable PK parameter data who had successfully completed at least Period 1 and Period 2 in any stage. All PK analyses were performed using the PK population.
This measure characterized the effects of migalastat on the plasma PK of agalsidase by measurement of the α-Gal A protein level in plasma by Western blot using anti-human Gal A antibody. The agalsidase plasma PK parameter values for Cmax is reported in nmol/hr/mL. In Period 1 of Stages 1 and 2, blood samples were collected: immediately before the agalsidase infusion and over a 24-hr period after infusion; on Days 2, 7, and 14. In Period 2 of Stages 1 and 2, blood samples were collected: prior to dosing with migalastat (2 hr prior to the agalsidase infusion) and 1 hr after migalastat dosing; immediately before initiation of the agalsidase infusion and over a 24-hr period after initiation of the agalsidase infusion; on Days 2, 7, and 14.
Outcome measures
| Measure |
Agalsidase Alfa (0.2 mg/kg)-Migalastat (150 mg)
n=4 Participants
Stage 1: This arm consisted of 3 sequential treatment periods (Period 1 - Period 3). A single 150-mg oral dose (1 capsule) of migalastat HCl 2 hr before initiation of an IV infusion of 0.2 mg/kg agalsidase alfa.
|
Agalsidase Beta (0.5 mg/kg)-Migalastat (450 mg)
n=1 Participants
Stage 2: This arm consisted of 2 sequential treatment periods (Period 1, Period 2). A single 450-mg oral dose (3 × 150-mg capsules) of migalastat HCl 2 hr before initiation of an IV infusion of 0.5 mg/kg agalsidase beta.
|
Agalsidase Beta (1.0 mg/kg)-Migalastat (450 mg)
n=6 Participants
Stage 2: This arm consisted of 2 sequential treatment periods (Period 1, Period 2). A single 450-mg oral dose (3 × 150-mg capsules) of migalastat HCl 2 hr before initiation of an IV infusion of 1.0 mg/kg agalsidase beta.
|
Agalsidase Alfa (0.2 mg/kg)-Migalastat (450 mg)
n=4 Participants
Stage 2: This arm consisted of 2 sequential treatment periods (Period 1, Period 2). A single 450-mg oral dose (3 x 150-mg capsules) of migalastat HCl 2 hr before initiation of an IV infusion of 0.2 mg/kg agalsidase alfa.
|
Agalsidase Beta (0.5 mg/kg)-Migalastat (150 mg)
n=5 Participants
Stage 1: This arm consisted of 3 sequential treatment periods (Period 1 - Period 3). A single 150-mg oral dose (1 capsule) of migalastat HCl 2 hr before initiation of an IV infusion of 0.5 mg/kg agalsidase beta.
|
Agalsidase Beta (1.0 mg/kg)-Migalastat (150 mg)
n=3 Participants
Stage 1: This arm consisted of 3 sequential treatment periods (Period 1 - Period 3). A single 150-mg oral dose (1 capsule) of migalastat HCl 2 hr before initiation of an IV infusion of 1.0 mg/kg agalsidase beta.
|
|---|---|---|---|---|---|---|
|
Change In Cmax For Total α-Gal A Protein Levels After Administration Of Migalastat
Period 1: Cmax
|
3813.49 nmol/hr/mL
Standard Deviation 1036.627
|
3141.84 nmol/hr/mL
Standard Deviation NA
Single Participant: Statistical analysis not performed.
|
3983.05 nmol/hr/mL
Standard Deviation 1422.734
|
3587.46 nmol/hr/mL
Standard Deviation 1181.299
|
7159.13 nmol/hr/mL
Standard Deviation 4599.113
|
5156.74 nmol/hr/mL
Standard Deviation 2411.601
|
|
Change In Cmax For Total α-Gal A Protein Levels After Administration Of Migalastat
Period 2: Cmax
|
4196.18 nmol/hr/mL
Standard Deviation 1264.763
|
2715.38 nmol/hr/mL
Standard Deviation NA
Single Participant: Statistical analysis not performed.
|
4170.15 nmol/hr/mL
Standard Deviation 935.512
|
3773.21 nmol/hr/mL
Standard Deviation 950.710
|
7060.29 nmol/hr/mL
Standard Deviation 5016.147
|
5572.63 nmol/hr/mL
Standard Deviation 1915.073
|
PRIMARY outcome
Timeframe: 0 hr, 2 hr, 2 days, 7 days, 14 days post dosePopulation: PK Population: all participants with evaluable PK parameter data who had successfully completed at least Period 1 and Period 2 in any stage. All PK analyses were performed using the PK population.
This measure characterized the effects of migalastat on the plasma PK of agalsidase by measurement of the total α-Gal A protein level in plasma by Western blot using anti-human Gal A antibody. The agalsidase plasma PK parameter values for tmax and t1/2 are reported in hr. In Period 1 of Stages 1 and 2, blood samples were collected: immediately before the agalsidase infusion and over a 24-hr period after infusion; on Days 2, 7, and 14. In Period 2 of Stages 1 and 2, blood samples were collected: prior to dosing with migalastat (2 hr prior to the agalsidase infusion) and 1 hr after migalastat dosing; immediately before initiation of the agalsidase infusion and over a 24-hr period after initiation of the agalsidase infusion; on Days 2, 7, and 14.
Outcome measures
| Measure |
Agalsidase Alfa (0.2 mg/kg)-Migalastat (150 mg)
n=4 Participants
Stage 1: This arm consisted of 3 sequential treatment periods (Period 1 - Period 3). A single 150-mg oral dose (1 capsule) of migalastat HCl 2 hr before initiation of an IV infusion of 0.2 mg/kg agalsidase alfa.
|
Agalsidase Beta (0.5 mg/kg)-Migalastat (450 mg)
n=1 Participants
Stage 2: This arm consisted of 2 sequential treatment periods (Period 1, Period 2). A single 450-mg oral dose (3 × 150-mg capsules) of migalastat HCl 2 hr before initiation of an IV infusion of 0.5 mg/kg agalsidase beta.
|
Agalsidase Beta (1.0 mg/kg)-Migalastat (450 mg)
n=6 Participants
Stage 2: This arm consisted of 2 sequential treatment periods (Period 1, Period 2). A single 450-mg oral dose (3 × 150-mg capsules) of migalastat HCl 2 hr before initiation of an IV infusion of 1.0 mg/kg agalsidase beta.
|
Agalsidase Alfa (0.2 mg/kg)-Migalastat (450 mg)
n=4 Participants
Stage 2: This arm consisted of 2 sequential treatment periods (Period 1, Period 2). A single 450-mg oral dose (3 x 150-mg capsules) of migalastat HCl 2 hr before initiation of an IV infusion of 0.2 mg/kg agalsidase alfa.
|
Agalsidase Beta (0.5 mg/kg)-Migalastat (150 mg)
n=5 Participants
Stage 1: This arm consisted of 3 sequential treatment periods (Period 1 - Period 3). A single 150-mg oral dose (1 capsule) of migalastat HCl 2 hr before initiation of an IV infusion of 0.5 mg/kg agalsidase beta.
|
Agalsidase Beta (1.0 mg/kg)-Migalastat (150 mg)
n=3 Participants
Stage 1: This arm consisted of 3 sequential treatment periods (Period 1 - Period 3). A single 150-mg oral dose (1 capsule) of migalastat HCl 2 hr before initiation of an IV infusion of 1.0 mg/kg agalsidase beta.
|
|---|---|---|---|---|---|---|
|
Change In Tmax And T1/2 For Total α-Gal A Protein Levels After Administration Of Migalastat
Period 1: tmax
|
0.75 hr
Standard Deviation 0.170
|
3.00 hr
Standard Deviation NA
Single Participant: Statistical analysis not performed.
|
2.50 hr
Standard Deviation 0.775
|
0.75 hr
Standard Deviation 0.170
|
2.07 hr
Standard Deviation 0.149
|
2.16 hr
Standard Deviation 0.778
|
|
Change In Tmax And T1/2 For Total α-Gal A Protein Levels After Administration Of Migalastat
Period 2: tmax
|
0.75 hr
Standard Deviation 0.166
|
3.00 hr
Standard Deviation NA
Single Participant: Statistical analysis not performed.
|
2.50 hr
Standard Deviation 0.548
|
0.75 hr
Standard Deviation 0.170
|
2.10 hr
Standard Deviation 0.548
|
2.24 hr
Standard Deviation 0.750
|
|
Change In Tmax And T1/2 For Total α-Gal A Protein Levels After Administration Of Migalastat
Period 1: t1/2
|
86.19 hr
Standard Deviation 92.048
|
2.96 hr
Standard Deviation NA
Single Participant: Statistical analysis not performed.
|
6.71 hr
Standard Deviation 7.702
|
30.32 hr
Standard Deviation 5.010
|
57.78 hr
Standard Deviation 40.019
|
17.77 hr
Standard Deviation 8.837
|
|
Change In Tmax And T1/2 For Total α-Gal A Protein Levels After Administration Of Migalastat
Period 2: t1/2
|
32.95 hr
Standard Deviation 20.282
|
2.00 hr
Standard Deviation NA
Single Participant: Statistical analysis not performed.
|
5.55 hr
Standard Deviation 5.553
|
28.05 hr
Standard Deviation 18.582
|
23.10 hr
Standard Deviation 22.338
|
9.15 hr
Standard Deviation 5.621
|
PRIMARY outcome
Timeframe: 0 hr, 1 day post dosePopulation: PK Population: all participants with evaluable PK parameter data who had successfully completed at least Period 1 and Period 2 in any stage. All PK analyses were performed using the PK population.
This measure characterized the effects of agalsidase on the plasma PK of migalastat using a validated liquid chromatography-tandem mass spectrometry (LC-MS) assay. The migalastat plasma PK parameter values for AUCinfinity and AUC0-t are reported in hr\*\[ng/hr/mL\]. In Period 2 of Stages 1 and 2, blood samples were collected: just before dosing with migalastat (2 hr prior to the agalsidase infusion) and at 1 hr after migalastat dosing; immediately before the agalsidase infusion and over a 24-hr period after infusion. In Period 3 (Stage 1 only), blood samples were collected before dosing and over the 24-hr period after administration of migalastat.
Outcome measures
| Measure |
Agalsidase Alfa (0.2 mg/kg)-Migalastat (150 mg)
n=4 Participants
Stage 1: This arm consisted of 3 sequential treatment periods (Period 1 - Period 3). A single 150-mg oral dose (1 capsule) of migalastat HCl 2 hr before initiation of an IV infusion of 0.2 mg/kg agalsidase alfa.
|
Agalsidase Beta (0.5 mg/kg)-Migalastat (450 mg)
n=1 Participants
Stage 2: This arm consisted of 2 sequential treatment periods (Period 1, Period 2). A single 450-mg oral dose (3 × 150-mg capsules) of migalastat HCl 2 hr before initiation of an IV infusion of 0.5 mg/kg agalsidase beta.
|
Agalsidase Beta (1.0 mg/kg)-Migalastat (450 mg)
n=6 Participants
Stage 2: This arm consisted of 2 sequential treatment periods (Period 1, Period 2). A single 450-mg oral dose (3 × 150-mg capsules) of migalastat HCl 2 hr before initiation of an IV infusion of 1.0 mg/kg agalsidase beta.
|
Agalsidase Alfa (0.2 mg/kg)-Migalastat (450 mg)
n=4 Participants
Stage 2: This arm consisted of 2 sequential treatment periods (Period 1, Period 2). A single 450-mg oral dose (3 x 150-mg capsules) of migalastat HCl 2 hr before initiation of an IV infusion of 0.2 mg/kg agalsidase alfa.
|
Agalsidase Beta (0.5 mg/kg)-Migalastat (150 mg)
n=5 Participants
Stage 1: This arm consisted of 3 sequential treatment periods (Period 1 - Period 3). A single 150-mg oral dose (1 capsule) of migalastat HCl 2 hr before initiation of an IV infusion of 0.5 mg/kg agalsidase beta.
|
Agalsidase Beta (1.0 mg/kg)-Migalastat (150 mg)
n=3 Participants
Stage 1: This arm consisted of 3 sequential treatment periods (Period 1 - Period 3). A single 150-mg oral dose (1 capsule) of migalastat HCl 2 hr before initiation of an IV infusion of 1.0 mg/kg agalsidase beta.
|
|---|---|---|---|---|---|---|
|
Change In AUC For Migalastat After Administration Of Agalsidase
Period 2: AUC0-t
|
16051.81 hr*[ng/hr/mL]
Standard Deviation 3441.663
|
49483.00 hr*[ng/hr/mL]
Standard Deviation NA
Single Participant: Statistical analysis not performed.
|
30450.61 hr*[ng/hr/mL]
Standard Deviation 10750.31
|
33920.71 hr*[ng/hr/mL]
Standard Deviation 8559.677
|
15717.87 hr*[ng/hr/mL]
Standard Deviation 7140.484
|
9413.79 hr*[ng/hr/mL]
Standard Deviation 2153.161
|
|
Change In AUC For Migalastat After Administration Of Agalsidase
Period 3: AUC0-t
|
16011.88 hr*[ng/hr/mL]
Standard Deviation 5361.097
|
NA hr*[ng/hr/mL]
Standard Deviation NA
No Period 3 for Stage 2.
|
NA hr*[ng/hr/mL]
Standard Deviation NA
No Period 3 for Stage 2.
|
NA hr*[ng/hr/mL]
Standard Deviation NA
No Period 3 for Stage 2.
|
13009.11 hr*[ng/hr/mL]
Standard Deviation 3747.086
|
9285.71 hr*[ng/hr/mL]
Standard Deviation 2270.875
|
|
Change In AUC For Migalastat After Administration Of Agalsidase
Period 2: AUCinfinity
|
16523.94 hr*[ng/hr/mL]
Standard Deviation 3804.018
|
53034.59 hr*[ng/hr/mL]
Standard Deviation NA
Single Participant: Statistical analysis not performed.
|
31856.37 hr*[ng/hr/mL]
Standard Deviation 11283.94
|
34700.89 hr*[ng/hr/mL]
Standard Deviation 8429.954
|
15889.34 hr*[ng/hr/mL]
Standard Deviation 7841.968
|
9653.09 hr*[ng/hr/mL]
Standard Deviation 2185.031
|
|
Change In AUC For Migalastat After Administration Of Agalsidase
Period 3: AUCinfinity
|
16586.14 hr*[ng/hr/mL]
Standard Deviation 5818.395
|
NA hr*[ng/hr/mL]
Standard Deviation NA
No Period 3 for Stage 2.
|
NA hr*[ng/hr/mL]
Standard Deviation NA
No Period 3 for Stage 2.
|
NA hr*[ng/hr/mL]
Standard Deviation NA
No Period 3 for Stage 2.
|
13708.03 hr*[ng/hr/mL]
Standard Deviation 4278.951
|
9597.10 hr*[ng/hr/mL]
Standard Deviation 2253.444
|
PRIMARY outcome
Timeframe: 0 hr, 1 day post dosePopulation: PK Population: all participants with evaluable PK parameter data who had successfully completed at least Period 1 and Period 2 in any stage. All PK analyses were performed using the PK population.
This measure characterized the effects of agalsidase on the plasma PK of migalastat using a validated liquid LC-MS assay. The migalastat plasma PK parameter values for Cmax are reported in nmol/hr/mL. In Period 2 of Stages 1 and 2, blood samples were collected: just before dosing with migalastat (2 hr prior to the agalsidase infusion) and at 1 hr after migalastat dosing; immediately before the agalsidase infusion and over a 24-hr period after infusion. In Period 3 (Stage 1 only), blood samples were collected before dosing and over the 24-hr period after administration of migalastat.
Outcome measures
| Measure |
Agalsidase Alfa (0.2 mg/kg)-Migalastat (150 mg)
n=4 Participants
Stage 1: This arm consisted of 3 sequential treatment periods (Period 1 - Period 3). A single 150-mg oral dose (1 capsule) of migalastat HCl 2 hr before initiation of an IV infusion of 0.2 mg/kg agalsidase alfa.
|
Agalsidase Beta (0.5 mg/kg)-Migalastat (450 mg)
n=1 Participants
Stage 2: This arm consisted of 2 sequential treatment periods (Period 1, Period 2). A single 450-mg oral dose (3 × 150-mg capsules) of migalastat HCl 2 hr before initiation of an IV infusion of 0.5 mg/kg agalsidase beta.
|
Agalsidase Beta (1.0 mg/kg)-Migalastat (450 mg)
n=6 Participants
Stage 2: This arm consisted of 2 sequential treatment periods (Period 1, Period 2). A single 450-mg oral dose (3 × 150-mg capsules) of migalastat HCl 2 hr before initiation of an IV infusion of 1.0 mg/kg agalsidase beta.
|
Agalsidase Alfa (0.2 mg/kg)-Migalastat (450 mg)
n=4 Participants
Stage 2: This arm consisted of 2 sequential treatment periods (Period 1, Period 2). A single 450-mg oral dose (3 x 150-mg capsules) of migalastat HCl 2 hr before initiation of an IV infusion of 0.2 mg/kg agalsidase alfa.
|
Agalsidase Beta (0.5 mg/kg)-Migalastat (150 mg)
n=5 Participants
Stage 1: This arm consisted of 3 sequential treatment periods (Period 1 - Period 3). A single 150-mg oral dose (1 capsule) of migalastat HCl 2 hr before initiation of an IV infusion of 0.5 mg/kg agalsidase beta.
|
Agalsidase Beta (1.0 mg/kg)-Migalastat (150 mg)
n=3 Participants
Stage 1: This arm consisted of 3 sequential treatment periods (Period 1 - Period 3). A single 150-mg oral dose (1 capsule) of migalastat HCl 2 hr before initiation of an IV infusion of 1.0 mg/kg agalsidase beta.
|
|---|---|---|---|---|---|---|
|
Change In Cmax For Migalastat After Administration Of Agalsidase
Period 2: Cmax
|
2047.50 nmol/hr/mL
Standard Deviation 192.592
|
4750.00 nmol/hr/mL
Standard Deviation NA
Single Participant: Statistical analysis not performed.
|
3763.33 nmol/hr/mL
Standard Deviation 984.574
|
4455.00 nmol/hr/mL
Standard Deviation 1840.697
|
1690.00 nmol/hr/mL
Standard Deviation 606.548
|
1295.67 nmol/hr/mL
Standard Deviation 501.654
|
|
Change In Cmax For Migalastat After Administration Of Agalsidase
Period 3: Cmax
|
2035.00 nmol/hr/mL
Standard Deviation 512.803
|
NA nmol/hr/mL
Standard Deviation NA
No Period 3 in Stage 2.
|
NA nmol/hr/mL
Standard Deviation NA
No Period 3 in Stage 2.
|
NA nmol/hr/mL
Standard Deviation NA
No Period 3 in Stage 2.
|
1634.00 nmol/hr/mL
Standard Deviation 396.081
|
1374.00 nmol/hr/mL
Standard Deviation 574.132
|
PRIMARY outcome
Timeframe: 0 hr, 1 day post dosePopulation: PK Population: all participants with evaluable PK parameter data who had successfully completed at least Period 1 and Period 2 in any stage. All PK analyses were performed using the PK population.
This measure characterized the effects of agalsidase on the plasma PK of migalastat using a validated LC-MS assay. The migalastat plasma PK parameter values for tmax and t1/2 are reported in hr. In Period 2 of Stages 1 and 2, blood samples were collected: just before dosing with migalastat (2 hr prior to the agalsidase infusion) and at 1 hr after migalastat dosing; immediately before the agalsidase infusion and over a 24-hr period after infusion. In Period 3 (Stage 1 only), blood samples were collected before dosing and over the 24-hr period after administration of migalastat.
Outcome measures
| Measure |
Agalsidase Alfa (0.2 mg/kg)-Migalastat (150 mg)
n=4 Participants
Stage 1: This arm consisted of 3 sequential treatment periods (Period 1 - Period 3). A single 150-mg oral dose (1 capsule) of migalastat HCl 2 hr before initiation of an IV infusion of 0.2 mg/kg agalsidase alfa.
|
Agalsidase Beta (0.5 mg/kg)-Migalastat (450 mg)
n=1 Participants
Stage 2: This arm consisted of 2 sequential treatment periods (Period 1, Period 2). A single 450-mg oral dose (3 × 150-mg capsules) of migalastat HCl 2 hr before initiation of an IV infusion of 0.5 mg/kg agalsidase beta.
|
Agalsidase Beta (1.0 mg/kg)-Migalastat (450 mg)
n=6 Participants
Stage 2: This arm consisted of 2 sequential treatment periods (Period 1, Period 2). A single 450-mg oral dose (3 × 150-mg capsules) of migalastat HCl 2 hr before initiation of an IV infusion of 1.0 mg/kg agalsidase beta.
|
Agalsidase Alfa (0.2 mg/kg)-Migalastat (450 mg)
n=4 Participants
Stage 2: This arm consisted of 2 sequential treatment periods (Period 1, Period 2). A single 450-mg oral dose (3 x 150-mg capsules) of migalastat HCl 2 hr before initiation of an IV infusion of 0.2 mg/kg agalsidase alfa.
|
Agalsidase Beta (0.5 mg/kg)-Migalastat (150 mg)
n=5 Participants
Stage 1: This arm consisted of 3 sequential treatment periods (Period 1 - Period 3). A single 150-mg oral dose (1 capsule) of migalastat HCl 2 hr before initiation of an IV infusion of 0.5 mg/kg agalsidase beta.
|
Agalsidase Beta (1.0 mg/kg)-Migalastat (150 mg)
n=3 Participants
Stage 1: This arm consisted of 3 sequential treatment periods (Period 1 - Period 3). A single 150-mg oral dose (1 capsule) of migalastat HCl 2 hr before initiation of an IV infusion of 1.0 mg/kg agalsidase beta.
|
|---|---|---|---|---|---|---|
|
Change In Tmax And T1/2 For Migalastat After Administration Of Agalsidase
Period 2: tmax
|
3.02 hr
Standard Deviation 0.818
|
4.00 hr
Standard Deviation NA
Single Participant: Statistical analysis not performed.
|
3.33 hr
Standard Deviation 1.102
|
4.50 hr
Standard Deviation 1.000
|
3.70 hr
Standard Deviation 0.651
|
3.33 hr
Standard Deviation 0.577
|
|
Change In Tmax And T1/2 For Migalastat After Administration Of Agalsidase
Period 3: tmax
|
3.03 hr
Standard Deviation 0.050
|
NA hr
Standard Deviation NA
No Period 3 for Stage 2.
|
NA hr
Standard Deviation NA
No Period 3 for Stage 2.
|
NA hr
Standard Deviation NA
No Period 3 for Stage 2.
|
3.03 hr
Standard Deviation 0.710
|
3.00 hr
Standard Deviation 0.000
|
|
Change In Tmax And T1/2 For Migalastat After Administration Of Agalsidase
Period 2: t1/2
|
4.86 hr
Standard Deviation 0.831
|
6.36 hr
Standard Deviation NA
Single Participant: Statistical analysis not performed.
|
4.87 hr
Standard Deviation 1.202
|
4.44 hr
Standard Deviation 1.328
|
5.39 hr
Standard Deviation 1.098
|
4.95 hr
Standard Deviation 0.335
|
|
Change In Tmax And T1/2 For Migalastat After Administration Of Agalsidase
Period 3: t1/2
|
4.81 hr
Standard Deviation 0.601
|
NA hr
Standard Deviation NA
No Period 3 for Stage 2.
|
NA hr
Standard Deviation NA
No Period 3 for Stage 2.
|
NA hr
Standard Deviation NA
No Period 3 for Stage 2.
|
5.31 hr
Standard Deviation 1.241
|
5.05 hr
Standard Deviation 0.558
|
SECONDARY outcome
Timeframe: Baseline, Day 7Population: PK Population: all participants with evaluable PK parameter data who had successfully completed at least Period 1 and Period 2 in any stage. All PK analyses were performed using the PK population.
This measure characterized the effects of agalsidase and migalastat on α-Gal A activity in the skin using a qualified assay that measured the rate of enzyme activity using an artificial, fluorescent substrate. Baseline was defined as Day 1/Period 1 pre-infusion level. α-Gal A activity is reported in picomoles/mg/hr (pmol/mg/hr). Biopsy samples were obtained: on Day -1/Period 1; 24 hr after initiation of the infusion during Period 1 and Period 2; on Day 7 of Period 1 and Period 2.
Outcome measures
| Measure |
Agalsidase Alfa (0.2 mg/kg)-Migalastat (150 mg)
n=4 Participants
Stage 1: This arm consisted of 3 sequential treatment periods (Period 1 - Period 3). A single 150-mg oral dose (1 capsule) of migalastat HCl 2 hr before initiation of an IV infusion of 0.2 mg/kg agalsidase alfa.
|
Agalsidase Beta (0.5 mg/kg)-Migalastat (450 mg)
n=1 Participants
Stage 2: This arm consisted of 2 sequential treatment periods (Period 1, Period 2). A single 450-mg oral dose (3 × 150-mg capsules) of migalastat HCl 2 hr before initiation of an IV infusion of 0.5 mg/kg agalsidase beta.
|
Agalsidase Beta (1.0 mg/kg)-Migalastat (450 mg)
n=6 Participants
Stage 2: This arm consisted of 2 sequential treatment periods (Period 1, Period 2). A single 450-mg oral dose (3 × 150-mg capsules) of migalastat HCl 2 hr before initiation of an IV infusion of 1.0 mg/kg agalsidase beta.
|
Agalsidase Alfa (0.2 mg/kg)-Migalastat (450 mg)
n=4 Participants
Stage 2: This arm consisted of 2 sequential treatment periods (Period 1, Period 2). A single 450-mg oral dose (3 x 150-mg capsules) of migalastat HCl 2 hr before initiation of an IV infusion of 0.2 mg/kg agalsidase alfa.
|
Agalsidase Beta (0.5 mg/kg)-Migalastat (150 mg)
n=5 Participants
Stage 1: This arm consisted of 3 sequential treatment periods (Period 1 - Period 3). A single 150-mg oral dose (1 capsule) of migalastat HCl 2 hr before initiation of an IV infusion of 0.5 mg/kg agalsidase beta.
|
Agalsidase Beta (1.0 mg/kg)-Migalastat (150 mg)
n=3 Participants
Stage 1: This arm consisted of 3 sequential treatment periods (Period 1 - Period 3). A single 150-mg oral dose (1 capsule) of migalastat HCl 2 hr before initiation of an IV infusion of 1.0 mg/kg agalsidase beta.
|
|---|---|---|---|---|---|---|
|
Change From Baseline To Day 7 In Active α-Gal A In Skin Following Treatment With Agalsidase Alone And Co-administration With Migalastat
Period 1: Day 2
|
121 pmol/mg/hr
Interval -52.0 to 371.0
|
89 pmol/mg/hr
Single Participant: Statistical analysis not performed.
|
1936 pmol/mg/hr
Interval 884.0 to 3162.0
|
18 pmol/mg/hr
Single Participant: Statistical analysis not performed.
|
334 pmol/mg/hr
Interval -141.0 to 998.0
|
857 pmol/mg/hr
Interval 795.0 to 919.0
|
|
Change From Baseline To Day 7 In Active α-Gal A In Skin Following Treatment With Agalsidase Alone And Co-administration With Migalastat
Period 2: Day 2
|
437 pmol/mg/hr
Interval 35.0 to 1146.0
|
647 pmol/mg/hr
Single Participant: Statistical analysis not performed.
|
4019 pmol/mg/hr
Interval 1777.0 to 6168.0
|
160 pmol/mg/hr
Single Participant: Statistical analysis not performed.
|
1508 pmol/mg/hr
Interval 221.0 to 4103.0
|
2977 pmol/mg/hr
Single Participant: Statistical analysis not performed.
|
|
Change From Baseline To Day 7 In Active α-Gal A In Skin Following Treatment With Agalsidase Alone And Co-administration With Migalastat
Period 1: Day 7
|
139 pmol/mg/hr
Interval 50.0 to 229.0
|
72 pmol/mg/hr
Single Participant: Statistical analysis not performed.
|
613 pmol/mg/hr
Interval 252.0 to 2001.0
|
—
|
137 pmol/mg/hr
Interval 45.0 to 234.0
|
553 pmol/mg/hr
Interval 315.0 to 791.0
|
|
Change From Baseline To Day 7 In Active α-Gal A In Skin Following Treatment With Agalsidase Alone And Co-administration With Migalastat
Period 2: Day 7
|
228 pmol/mg/hr
Interval 11.0 to 606.0
|
235 pmol/mg/hr
Single Participant: Statistical analysis not performed.
|
789 pmol/mg/hr
Interval -174.0 to 1935.0
|
-100 pmol/mg/hr
Single Participant: Statistical analysis not performed.
|
574 pmol/mg/hr
Interval -200.0 to 2588.0
|
855 pmol/mg/hr
Interval 460.0 to 1250.0
|
Adverse Events
Stage 1 Pd 1: 0.5 mg/kg Agal-B (Arm 1)
Stage 1 Pd 2: 150 mg Mig Before 0.5 mg/kg Agal-B (Arm 1)
Stage 1 Pd 3: 150 mg Mig (Arm 1)
Stage 1 Pd 1: 1.0 mg/kg Agal-B (Arm 2)
Stage 1 Pd 2: 150 mg Mig Before 1.0 mg/kg Agal-B (Arm 2)
Stage 1 Pd 3: 150 mg Mig (Arm 2)
Stage 1 Pd 1: 0.2 mg/kg Agal-A (Arm 3)
Stage 1 Pd 2: 150 mg Mig Before 0.2 mg/kg Agal-A (Arm 3)
Stage 1 Pd 3: 150 mg Mig (Arm 3)
Stage 2 Pd 1: 0.5 mg/kg Agal-B (Arm 4)
Stage 2 Pd 2: 450 mg Mig Before 0.5 mg/kg Agal-B (Arm 4)
Stage 2 Pd 1: 1.0 mg/kg Agal-B (Arm 5)
Stage 2 Pd 2: 450 Mig Before 1.0 mg/kg Agal-B (Arm 5)
Stage 2 Pd 1: 0.2 mg/kg Agal-A (Arm 6)
Stage 2 Pd 2: 450 Mig Before 0.2 mg/kg Agal-A (Arm 6)
Serious adverse events
| Measure |
Stage 1 Pd 1: 0.5 mg/kg Agal-B (Arm 1)
n=5 participants at risk
Period 1 of Stage 1 consisted of IV administration of 0.5 mg/kg agalsidase beta.
|
Stage 1 Pd 2: 150 mg Mig Before 0.5 mg/kg Agal-B (Arm 1)
n=5 participants at risk
Period 2 of Stage 1 consisted of administration of a single 150-mg oral dose of migalastat HCl 2 hr before initiation of an IV infusion of 0.5 mg/kg agalsidase beta.
|
Stage 1 Pd 3: 150 mg Mig (Arm 1)
n=5 participants at risk
Period 3 of Stage 1 consisted of a single 150-mg oral dose of migalastat HCl.
|
Stage 1 Pd 1: 1.0 mg/kg Agal-B (Arm 2)
n=3 participants at risk
Period 1 of Stage 1 consisted of IV administration of 1.0 mg/kg agalsidase beta.
|
Stage 1 Pd 2: 150 mg Mig Before 1.0 mg/kg Agal-B (Arm 2)
n=3 participants at risk
Period 2 of Stage 1 consisted of administration of a single 150-mg oral dose of migalastat HCl 2 hr before initiation of an IV infusion of 1.0 mg/kg agalsidase beta.
|
Stage 1 Pd 3: 150 mg Mig (Arm 2)
n=3 participants at risk
Period 3 of Stage 1 consisted of a single 150-mg oral dose of migalastat HCl.
|
Stage 1 Pd 1: 0.2 mg/kg Agal-A (Arm 3)
n=4 participants at risk
Period 1 of Stage 1 consisted of IV administration of 0.2 mg/kg agalsidase alfa.
|
Stage 1 Pd 2: 150 mg Mig Before 0.2 mg/kg Agal-A (Arm 3)
n=4 participants at risk
Period 2 of Stage 1 consisted of administration a single 150-mg oral dose of migalastat HCl 2 hr before initiation of an IV infusion of 0.2 mg/kg agalsidase alfa.
|
Stage 1 Pd 3: 150 mg Mig (Arm 3)
n=4 participants at risk
Period 3 of Stage 1 consisted of a single 150-mg oral dose of migalastat HCl.
|
Stage 2 Pd 1: 0.5 mg/kg Agal-B (Arm 4)
n=2 participants at risk
Period 1 of Stage 2 consisted of IV administration of 0.5 mg/kg agalsidase beta.
|
Stage 2 Pd 2: 450 mg Mig Before 0.5 mg/kg Agal-B (Arm 4)
n=1 participants at risk
Period 2 of Stage 2 consisted of a single 450-mg oral dose (3 x 150-mg capsules) of migalastat HCl 2 hr before IV administration of 0.5 mg/kg agalsidase beta.
|
Stage 2 Pd 1: 1.0 mg/kg Agal-B (Arm 5)
n=6 participants at risk
Period 1 of Stage 2 consisted of IV administration of 0.5 mg/kg agalsidase beta.
|
Stage 2 Pd 2: 450 Mig Before 1.0 mg/kg Agal-B (Arm 5)
n=6 participants at risk
Period 2 of Stage 2 consisted of a single 450-mg oral dose (3 x 150-mg capsules) of migalastat HCl 2 hr before IV administration of 1.0 mg/kg agalsidase beta.
|
Stage 2 Pd 1: 0.2 mg/kg Agal-A (Arm 6)
n=4 participants at risk
Period 1 of Stage 2 consisted of IV administration of 0.2 mg/kg agalsidase alfa.
|
Stage 2 Pd 2: 450 Mig Before 0.2 mg/kg Agal-A (Arm 6)
n=4 participants at risk
Period 2 of Stage 2 consisted of a single 450-mg oral dose (3 x 150-mg capsules) of migalastat HCl 2 hr before IV administration of 0.2 mg/kg agalsidase alfa.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Nervous system disorders
Acroparaesthesia
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
50.0%
1/2 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/1 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/6 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/6 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
Other adverse events
| Measure |
Stage 1 Pd 1: 0.5 mg/kg Agal-B (Arm 1)
n=5 participants at risk
Period 1 of Stage 1 consisted of IV administration of 0.5 mg/kg agalsidase beta.
|
Stage 1 Pd 2: 150 mg Mig Before 0.5 mg/kg Agal-B (Arm 1)
n=5 participants at risk
Period 2 of Stage 1 consisted of administration of a single 150-mg oral dose of migalastat HCl 2 hr before initiation of an IV infusion of 0.5 mg/kg agalsidase beta.
|
Stage 1 Pd 3: 150 mg Mig (Arm 1)
n=5 participants at risk
Period 3 of Stage 1 consisted of a single 150-mg oral dose of migalastat HCl.
|
Stage 1 Pd 1: 1.0 mg/kg Agal-B (Arm 2)
n=3 participants at risk
Period 1 of Stage 1 consisted of IV administration of 1.0 mg/kg agalsidase beta.
|
Stage 1 Pd 2: 150 mg Mig Before 1.0 mg/kg Agal-B (Arm 2)
n=3 participants at risk
Period 2 of Stage 1 consisted of administration of a single 150-mg oral dose of migalastat HCl 2 hr before initiation of an IV infusion of 1.0 mg/kg agalsidase beta.
|
Stage 1 Pd 3: 150 mg Mig (Arm 2)
n=3 participants at risk
Period 3 of Stage 1 consisted of a single 150-mg oral dose of migalastat HCl.
|
Stage 1 Pd 1: 0.2 mg/kg Agal-A (Arm 3)
n=4 participants at risk
Period 1 of Stage 1 consisted of IV administration of 0.2 mg/kg agalsidase alfa.
|
Stage 1 Pd 2: 150 mg Mig Before 0.2 mg/kg Agal-A (Arm 3)
n=4 participants at risk
Period 2 of Stage 1 consisted of administration a single 150-mg oral dose of migalastat HCl 2 hr before initiation of an IV infusion of 0.2 mg/kg agalsidase alfa.
|
Stage 1 Pd 3: 150 mg Mig (Arm 3)
n=4 participants at risk
Period 3 of Stage 1 consisted of a single 150-mg oral dose of migalastat HCl.
|
Stage 2 Pd 1: 0.5 mg/kg Agal-B (Arm 4)
n=2 participants at risk
Period 1 of Stage 2 consisted of IV administration of 0.5 mg/kg agalsidase beta.
|
Stage 2 Pd 2: 450 mg Mig Before 0.5 mg/kg Agal-B (Arm 4)
n=1 participants at risk
Period 2 of Stage 2 consisted of a single 450-mg oral dose (3 x 150-mg capsules) of migalastat HCl 2 hr before IV administration of 0.5 mg/kg agalsidase beta.
|
Stage 2 Pd 1: 1.0 mg/kg Agal-B (Arm 5)
n=6 participants at risk
Period 1 of Stage 2 consisted of IV administration of 0.5 mg/kg agalsidase beta.
|
Stage 2 Pd 2: 450 Mig Before 1.0 mg/kg Agal-B (Arm 5)
n=6 participants at risk
Period 2 of Stage 2 consisted of a single 450-mg oral dose (3 x 150-mg capsules) of migalastat HCl 2 hr before IV administration of 1.0 mg/kg agalsidase beta.
|
Stage 2 Pd 1: 0.2 mg/kg Agal-A (Arm 6)
n=4 participants at risk
Period 1 of Stage 2 consisted of IV administration of 0.2 mg/kg agalsidase alfa.
|
Stage 2 Pd 2: 450 Mig Before 0.2 mg/kg Agal-A (Arm 6)
n=4 participants at risk
Period 2 of Stage 2 consisted of a single 450-mg oral dose (3 x 150-mg capsules) of migalastat HCl 2 hr before IV administration of 0.2 mg/kg agalsidase alfa.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Atrial flutter
|
20.0%
1/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/2 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/1 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/6 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/6 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
33.3%
1/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/2 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/1 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/6 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/6 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
|
Cardiac disorders
Supraventricular extrasystoles
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
33.3%
1/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/2 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/1 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/6 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/6 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
25.0%
1/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/2 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/1 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/6 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/6 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
|
Ear and labyrinth disorders
Ear canal erythema
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
20.0%
1/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/2 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/1 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/6 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/6 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
|
Ear and labyrinth disorders
Tympanic membrane disorder
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
20.0%
1/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/2 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/1 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/6 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/6 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
|
Ear and labyrinth disorders
Ear Pain
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
25.0%
1/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/2 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/1 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/6 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/6 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
20.0%
1/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/2 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/1 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/6 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/6 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
33.3%
1/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/2 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/1 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/6 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/6 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
25.0%
1/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
25.0%
1/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
|
Gastrointestinal disorders
Faeces pale
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
33.3%
1/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/2 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/1 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/6 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/6 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
25.0%
1/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/2 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/1 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/6 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/6 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
|
General disorders
Oedema peripheral
|
20.0%
1/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
25.0%
1/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/2 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/1 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/6 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/6 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
|
General disorders
Pain
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
20.0%
1/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/2 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/1 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/6 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/6 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
|
General disorders
Fatigue
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
33.3%
1/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/2 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/1 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/6 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/6 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
|
General disorders
Malaise
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
33.3%
1/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/2 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/1 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/6 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/6 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
|
General disorders
Pyrexia
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
33.3%
1/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/2 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/1 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/6 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/6 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
|
General disorders
Vessel puncture site haematoma
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
33.3%
1/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/2 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/1 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/6 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/6 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
20.0%
1/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/2 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/1 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/6 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/6 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
20.0%
1/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/2 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/1 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/6 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/6 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
|
Investigations
Heart sounds abnormal
|
20.0%
1/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/2 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/1 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/6 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/6 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
|
Investigations
Lymph node palpable
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
33.3%
1/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/2 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/1 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/6 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/6 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
20.0%
1/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/2 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/1 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/6 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/6 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
|
Nervous system disorders
Headache
|
20.0%
1/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
25.0%
1/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/2 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/1 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
16.7%
1/6 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/6 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
25.0%
1/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
25.0%
1/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
33.3%
1/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/2 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/1 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/6 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/6 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
25.0%
1/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
25.0%
1/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/2 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/1 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/6 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/6 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
|
Infections and infestations
Ear infection
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
20.0%
1/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
25.0%
1/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/2 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/1 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/6 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/6 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
|
Infections and infestations
Bronchitis
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
33.3%
1/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/2 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/1 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/6 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/6 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
|
Skin and subcutaneous tissue disorders
Scar
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
33.3%
1/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/2 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/1 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/6 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/6 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
20.0%
1/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
25.0%
1/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/2 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/1 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/6 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/6 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
25.0%
1/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/2 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/1 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/6 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/6 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
25.0%
1/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
25.0%
1/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
50.0%
1/2 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/1 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
16.7%
1/6 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/6 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
|
Infections and infestations
Tinea capitis
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
50.0%
1/2 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/1 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/6 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/6 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
50.0%
1/2 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/1 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/6 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/6 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
50.0%
1/2 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/1 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/6 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/6 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
50.0%
1/2 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/1 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/6 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/6 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
|
Eye disorders
Amaurosis fugax
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/2 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/1 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/6 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
16.7%
1/6 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/2 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/1 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/6 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/6 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
25.0%
1/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/2 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/1 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
16.7%
1/6 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/6 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
25.0%
1/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
|
Injury, poisoning and procedural complications
Incision site blister
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/2 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/1 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/6 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
16.7%
1/6 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
33.3%
1/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/2 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/1 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
16.7%
1/6 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/6 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/2 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/1 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/6 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/6 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
25.0%
1/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
|
General disorders
Chest discomfort
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/2 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/1 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/6 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/6 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
25.0%
1/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
|
General disorders
Chills
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/2 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/1 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/6 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/6 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
25.0%
1/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/2 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/1 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/6 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/6 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
25.0%
1/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/2 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/1 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/6 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/6 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
25.0%
1/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/2 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/1 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/6 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/6 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
25.0%
1/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/2 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/1 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/6 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/6 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
25.0%
1/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
|
Nervous system disorders
Lethargy
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/2 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/1 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/6 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/6 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
25.0%
1/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
|
Psychiatric disorders
Aggression
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/2 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/1 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/6 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/6 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
25.0%
1/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
25.0%
1/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/2 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/1 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/6 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/6 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
25.0%
1/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/2 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/1 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/6 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/6 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
25.0%
1/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
|
Respiratory, thoracic and mediastinal disorders
Hyperventilation
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/2 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/1 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/6 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/6 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
25.0%
1/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
|
Congenital, familial and genetic disorders
Fabry's disease
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
50.0%
1/2 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/1 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/6 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/6 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
|
Investigations
Cardiac murmur
|
40.0%
2/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/5 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/3 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/2 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/1 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/6 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/6 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
0.00%
0/4 • Adverse events (AEs) were monitored up to 5.5 months after the first dose of study drug. For Period (Pd) 1 and 2 of Stages 1 and 2, AEs were reported starting 1 day prior (Day -1) to the first dose of study drug (Agalsidase Beta [Agal-B] or Agalsidase Alfa [Agal-A]) to 1 month after the last dose of study drug. For Pd 3 of Stage 1, AEs were reported starting on the day of the first dose of study drug (Day 1) to 1 month after the last dose of study drug (Migalastat [Mig]).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The investigator can only publish the results from this trial provided they supply the sponsor (or authorized entity) a copy of any proposed publication for review. If requested, 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