Trial Outcomes & Findings for Late-Onset Treatment Study Extension Protocol (NCT NCT00455195)

Last Updated: 2014-03-07

Results Overview

The numbers of participants who experienced Adverse Events (AEs), Serious Adverse Events (SAEs), treatment-related AEs, and Infusion Associated Reactions (IARs). Summary is based on treatment-emergent AEs (TEAEs), defined as AEs that occurred following the initiation of study treatment with alglucosidase alfa. Participants with long-term exposure to alglucosidase alfa (those from the Alglucosidase Alfa/Alglucosidase Alfa treatment group) are included. Time frames are stated from the start of the double-blind study AGLU02704 (NCT00158600).

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

81 participants

Primary outcome timeframe

Week 0 to 2.5 years

Results posted on

2014-03-07

Participant Flow

81 of the 90 participants enrolled in the double-blind placebo controlled AGLU02704 (NCT00158600) study continued on to the open-label extension study AGLU03206.

Participant milestones

Participant milestones
Measure	Alglucosidase Alfa/Alglucosidase Alfa Participants who received alglucosidase alfa during the double-blind study AGLU02704 (NCT00158600) and, if they completed the double blind study, continued alglucosidase alfa in the extension study. Both study experiences on alglucosidase alfa are represented within AGLU03206.	Placebo/Alglucosidase Alfa Participants who received placebo during the double-blind study AGLU02704 (NCT00158600), completed the double-blind study, and started alglucosidase alfa in the extension study. Only participants' experience on alglucosidase alfa in the extension study is represented.
Double-blind Study AGLU02704 STARTED	60	30
Double-blind Study AGLU02704 COMPLETED	55	26
Double-blind Study AGLU02704 NOT COMPLETED	5	4
Extension Study AGLU03206 STARTED	55	26
Extension Study AGLU03206 COMPLETED	55	26
Extension Study AGLU03206 NOT COMPLETED	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Alglucosidase Alfa/Alglucosidase Alfa Participants who received alglucosidase alfa during the double-blind study AGLU02704 (NCT00158600) and, if they completed the double blind study, continued alglucosidase alfa in the extension study. Both study experiences on alglucosidase alfa are represented within AGLU03206.	Placebo/Alglucosidase Alfa Participants who received placebo during the double-blind study AGLU02704 (NCT00158600), completed the double-blind study, and started alglucosidase alfa in the extension study. Only participants' experience on alglucosidase alfa in the extension study is represented.
Double-blind Study AGLU02704 Adverse Event	2	1
Double-blind Study AGLU02704 Death	1	0
Double-blind Study AGLU02704 Withdrawal by Subject	2	2
Double-blind Study AGLU02704 Unable to commit time to study	0	1

Baseline Characteristics

Late-Onset Treatment Study Extension Protocol

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Alglucosidase Alfa/Alglucosidase Alfa n=60 Participants Participants who received alglucosidase alfa during the double-blind study AGLU02704 (NCT00158600) and, if they completed the double blind study, continued alglucosidase alfa in the extension study. Both study experiences on alglucosidase alfa are represented within AGLU03206.	Placebo/Alglucosidase Alfa n=26 Participants Participants who received placebo during the double-blind study AGLU02704 (NCT00158600), completed the double-blind study, and started alglucosidase alfa in the extension study. Only participants' experience on alglucosidase alfa in the extension study is represented.	Total n=86 Participants Total of all reporting groups
Age, Continuous	45.3 years STANDARD_DEVIATION 12.37 • n=5 Participants	46.8 years STANDARD_DEVIATION 8.62 • n=7 Participants	45.73 years STANDARD_DEVIATION 11.34 • n=5 Participants
Sex: Female, Male Female	26 Participants n=5 Participants	15 Participants n=7 Participants	41 Participants n=5 Participants
Sex: Female, Male Male	34 Participants n=5 Participants	11 Participants n=7 Participants	45 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	1 participants n=5 Participants	1 participants n=7 Participants	2 participants n=5 Participants
Race/Ethnicity, Customized Asian	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants
Race/Ethnicity, Customized Black or African American	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants
Race/Ethnicity, Customized White	57 participants n=5 Participants	24 participants n=7 Participants	81 participants n=5 Participants
Race/Ethnicity, Customized Unknown or Not Reported	1 participants n=5 Participants	1 participants n=7 Participants	2 participants n=5 Participants

PRIMARY outcome

Timeframe: Week 0 to 2.5 years

Population: The safety population includes all participants randomized to alglucosidase alfa treatment in AGLU02704 (NCT00158600) who received at least one infusion of alglucosidase alfa.

Outcome measures

Outcome measures
Measure	Alglucosidase Alfa/Alglucosidase Alfa n=60 Participants Participants who received alglucosidase alfa during the double-blind study AGLU02704 (NCT00158600) and, if they completed the double blind study, continued alglucosidase alfa in the extension study. Both study experiences on alglucosidase alfa are represented within AGLU03206.
Summary of Participants Reporting Treatment-Emergent Adverse Events For Participants Treated With Alglucosidase Alfa During Study AGLU02704 (NCT00158600) Participants with Severe AEs	16 participants
Summary of Participants Reporting Treatment-Emergent Adverse Events For Participants Treated With Alglucosidase Alfa During Study AGLU02704 (NCT00158600) Participants with any AEs	60 participants
Summary of Participants Reporting Treatment-Emergent Adverse Events For Participants Treated With Alglucosidase Alfa During Study AGLU02704 (NCT00158600) Participants with Treatment-Related AEs	37 participants
Summary of Participants Reporting Treatment-Emergent Adverse Events For Participants Treated With Alglucosidase Alfa During Study AGLU02704 (NCT00158600) Participants with Infusion-Associated Reactions	21 participants
Summary of Participants Reporting Treatment-Emergent Adverse Events For Participants Treated With Alglucosidase Alfa During Study AGLU02704 (NCT00158600) Participants with Serious AEs	15 participants
Summary of Participants Reporting Treatment-Emergent Adverse Events For Participants Treated With Alglucosidase Alfa During Study AGLU02704 (NCT00158600) Participants- Discontinued Due to AEs (incl death)	3 participants
Summary of Participants Reporting Treatment-Emergent Adverse Events For Participants Treated With Alglucosidase Alfa During Study AGLU02704 (NCT00158600) Participants Who Died	1 participants

PRIMARY outcome

Timeframe: Week 0

Population: Intent-to-treat population.

Six-Minute Walk Test (6MWT) measures the distance walked (in meters) in 6 minutes. A longer distance indicates greater endurance. Time frames are stated from the start of the double-blind study AGLU02704 (NCT00158600).

Outcome measures

Outcome measures
Measure	Alglucosidase Alfa/Alglucosidase Alfa n=60 Participants Participants who received alglucosidase alfa during the double-blind study AGLU02704 (NCT00158600) and, if they completed the double blind study, continued alglucosidase alfa in the extension study. Both study experiences on alglucosidase alfa are represented within AGLU03206.
Baseline Values (Week 0) of Functional Endurance as Measured by Six-Minute Walk Test (6MWT) For Participants Treated With Alglucosidase Alfa During Study AGLU02704 (NCT00158600)	332.2 meters Standard Deviation 126.69

PRIMARY outcome

Timeframe: Week 0, Week 104

Population: Intent-to-treat population of participants who had both baseline (Week 0) and Week 104 data.

Outcome measures

Outcome measures
Measure	Alglucosidase Alfa/Alglucosidase Alfa n=53 Participants Participants who received alglucosidase alfa during the double-blind study AGLU02704 (NCT00158600) and, if they completed the double blind study, continued alglucosidase alfa in the extension study. Both study experiences on alglucosidase alfa are represented within AGLU03206.
Change From Baseline (Week 0) in the Six-Minute Walk Test (6MWT) at Week 104 For Participants Treated With Alglucosidase Alfa During Study AGLU02704 (NCT00158600)	21.3 meters Standard Deviation 78.02

PRIMARY outcome

Timeframe: Week 0

Population: Intent-to-treat population

Forced vital capacity (FVC) is a standard pulmonary function test used to quantify respiratory muscle weakness. FVC is the volume of air that can forcibly be blown out after full inspiration in the upright position, measured in liters. Predicted forced vital capacity is based on a formula using sex, age and height of a person, and is an estimate of healthy lung capacity. Percent of predicted FVC = (observed value)/(predicted value) \* 100%. Time frames are stated from the start of the double-blind study AGLU02704 (NCT00158600).

Outcome measures

Outcome measures
Measure	Alglucosidase Alfa/Alglucosidase Alfa n=60 Participants Participants who received alglucosidase alfa during the double-blind study AGLU02704 (NCT00158600) and, if they completed the double blind study, continued alglucosidase alfa in the extension study. Both study experiences on alglucosidase alfa are represented within AGLU03206.
Baseline Values (Week 0) for Percent Predicted Forced Vital Capacity (FVC) For Participants Treated With Alglucosidase Alfa During Study AGLU02704 (NCT00158600)	55.4 percent of predicted FVC Standard Deviation 14.44

PRIMARY outcome

Timeframe: Week 0, Week 104

Population: Intent-to-treat population of participants who had both baseline (Week 0) and Week 104 data.

Outcome measures

Outcome measures
Measure	Alglucosidase Alfa/Alglucosidase Alfa n=53 Participants Participants who received alglucosidase alfa during the double-blind study AGLU02704 (NCT00158600) and, if they completed the double blind study, continued alglucosidase alfa in the extension study. Both study experiences on alglucosidase alfa are represented within AGLU03206.
Change From Baseline (Week 0) in the Percent Predicted Forced Vital Capacity (FVC) at Week 104 For Participants Treated With Alglucosidase Alfa During Study AGLU02704 (NCT00158600)	0.8 percent of predicted FVC Standard Deviation 6.68

SECONDARY outcome

Timeframe: Week 0

Population: Intent-to-treat population

Quantitative muscle testing (QMT) is a standardized system to measure muscle force production during maximal voluntary isometric contraction. QMT data were collected directly from sensors into laptop computers. Predicted normal values for QMT are based on a formula using sex, age and body mass index of a person, and are an estimate of healthy muscle force. Percent of predicted QMT = (observed value)/(predicted value) \* 100%. The QMT Leg Score is the average of the bilateral means for percent predicted knee flexors and extensors. A value of 100% indicates 'normal' muscle strength.

Outcome measures

Outcome measures
Measure	Alglucosidase Alfa/Alglucosidase Alfa n=60 Participants Participants who received alglucosidase alfa during the double-blind study AGLU02704 (NCT00158600) and, if they completed the double blind study, continued alglucosidase alfa in the extension study. Both study experiences on alglucosidase alfa are represented within AGLU03206.
Baseline Values (Week 0) for Percent Predicted Proximal Muscle Strength of the Lower Limbs as Measured by Quantitative Muscle Testing (QMT) For Participants Treated With Alglucosidase Alfa During Study AGLU02704 (NCT00158600)	37.7 percent of predicted QMT Standard Deviation 18.88

SECONDARY outcome

Timeframe: Week 0, Week 104

Population: Intent-to-treat population of participants who had both baseline (Week 0) and Week 104 data.

Outcome measures

Outcome measures
Measure	Alglucosidase Alfa/Alglucosidase Alfa n=53 Participants Participants who received alglucosidase alfa during the double-blind study AGLU02704 (NCT00158600) and, if they completed the double blind study, continued alglucosidase alfa in the extension study. Both study experiences on alglucosidase alfa are represented within AGLU03206.
Change From Baseline (Week 0) for Percent Predicted Proximal Muscle Strength of the Lower Limbs as Measured by Quantitative Muscle Testing (QMT) at Week 104 For Participants Treated With Alglucosidase Alfa During Study AGLU02704 (NCT00158600)	2.1 percent of predicted QMT Standard Deviation 11.06

SECONDARY outcome

Timeframe: Week 0

Population: Intent-to-treat population of participants with valid baseline (Week 0) PCS surveys.

The Medical Outcomes Study Short Form (MOS SF)-36 questionnaire consists of 36 items grouped into 8 domains designed to assess generic health-related quality of life in healthy and ill adult populations. Physical Component Score reports the four domains of physical functioning, role-physical, bodily pain, and general health and are standardized as Z-scores (scale of 0-100). Higher scores are associated with better quality of life. Time frames are stated from the start of the double-blind study AGLU02704 (NCT00158600).

Outcome measures

Outcome measures
Measure	Alglucosidase Alfa/Alglucosidase Alfa n=58 Participants Participants who received alglucosidase alfa during the double-blind study AGLU02704 (NCT00158600) and, if they completed the double blind study, continued alglucosidase alfa in the extension study. Both study experiences on alglucosidase alfa are represented within AGLU03206.
Baseline Values (Week 0) for Quality of Life Related to Physical Component Score (PCS) as Measured by the Medical Outcomes Study (MOS) Short Form-36 Health Survey For Participants Treated With Alglucosidase Alfa During Study AGLU02704 (NCT00158600)	34.33 units on a scale Standard Deviation 8.934

SECONDARY outcome

Timeframe: Week 0 , Week 104

Population: Intent-to-treat population of participants who had valid baseline (Week 0) and Week 104 data.

The Medical Outcomes Study Short Form (MOS SF)-36 questionnaire consists of 36 items grouped into 8 domains designed to assess generic health-related quality of life in healthy and ill adult populations. Physical Component Score reports the four domains of physical functioning, role-physical, bodily pain, and general health and is standardized as Z-scores (scale of 0-100). Higher scores are associated with better quality of life. Change is calculated as the value minus the baseline value. Time frames are stated from the start of the double-blind study AGLU02704 (NCT00158600).

Outcome measures

Outcome measures
Measure	Alglucosidase Alfa/Alglucosidase Alfa n=49 Participants Participants who received alglucosidase alfa during the double-blind study AGLU02704 (NCT00158600) and, if they completed the double blind study, continued alglucosidase alfa in the extension study. Both study experiences on alglucosidase alfa are represented within AGLU03206.
Change From Baseline in Quality of Life Related to Physical Component Score (PCS) as Measured by the Medical Outcomes Study (MOS) Short Form-36 Health Survey For Participants Treated With Alglucosidase Alfa During Study AGLU02704 (NCT00158600)	0.64 units on a scale Standard Deviation 7.618 • Interval -1.6 to 2.8

Adverse Events

Alglucosidase Alfa/Alglucosidase Alfa

Serious events: 15 serious events

Other events: 60 other events

Deaths: 0 deaths

Placebo/Alglucosidase Alfa

Serious events: 2 serious events

Other events: 25 other events

Deaths: 0 deaths

Overall

Serious events: 17 serious events

Other events: 85 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

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Phone: 800-745-4447

Results disclosure agreements

Principal investigator is a sponsor employee In multi-site studies, PI can publish after Genzyme publishes or 18 months after study completion. PI gives Genzyme a draft 60 days before publication. Genzyme can ask that confidential information be removed, and can defer publication another 60 days upon notifying PI that it will file a patent application on inventions contained in the draft.
Publication restrictions are in place

Restriction type: OTHER

Serious adverse events
Measure	Alglucosidase Alfa/Alglucosidase Alfa n=60 participants at risk Participants who received alglucosidase alfa during the double-blind study AGLU02704 (NCT00158600) and, if they completed the double blind study, continued alglucosidase alfa in the extension study. Both study experiences on alglucosidase alfa are represented within AGLU03206.	Placebo/Alglucosidase Alfa n=26 participants at risk Participants who received placebo during the double-blind study AGLU02704 (NCT00158600) and, if they completed the double-blind study, started alglucosidase alfa in the extension study. Only participants' experience on alglucosidase alfa in the extension study is represented.	Overall n=86 participants at risk The combined alglucosidase alfa treatment experience from the two treatment groups.
Cardiac disorders Coronary artery disease	1.7% 1/60 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.	0.00% 0/26 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.	1.2% 1/86 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
Cardiac disorders Supraventricular tachycardia	1.7% 1/60 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.	0.00% 0/26 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.	1.2% 1/86 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
Gastrointestinal disorders Abdominal pain	1.7% 1/60 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.	0.00% 0/26 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.	1.2% 1/86 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
Gastrointestinal disorders Gastric ulcer	1.7% 1/60 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.	0.00% 0/26 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.	1.2% 1/86 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
General disorders Chest discomfort	1.7% 1/60 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.	0.00% 0/26 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.	1.2% 1/86 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
General disorders Non-cardiac chest pain	1.7% 1/60 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.	0.00% 0/26 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.	1.2% 1/86 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
Immune system disorders Hypersensitivity	3.3% 2/60 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.	0.00% 0/26 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.	2.3% 2/86 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
Infections and infestations Gastroenteritis	1.7% 1/60 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.	0.00% 0/26 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.	1.2% 1/86 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
Infections and infestations Pneumonia	1.7% 1/60 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.	0.00% 0/26 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.	1.2% 1/86 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
Injury, poisoning and procedural complications Fall	3.3% 2/60 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.	0.00% 0/26 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.	2.3% 2/86 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
Injury, poisoning and procedural complications Humerus fracture	1.7% 1/60 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.	0.00% 0/26 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.	1.2% 1/86 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
Injury, poisoning and procedural complications Spinal compression fracture	1.7% 1/60 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.	0.00% 0/26 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.	1.2% 1/86 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
Metabolism and nutrition disorders Dehydration	1.7% 1/60 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.	0.00% 0/26 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.	1.2% 1/86 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	1.7% 1/60 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.	0.00% 0/26 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.	1.2% 1/86 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cervix carcinoma stage II	0.00% 0/60 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.	3.8% 1/26 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.	1.2% 1/86 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
Nervous system disorders Brain stem ischaemia	1.7% 1/60 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.	0.00% 0/26 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.	1.2% 1/86 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
Renal and urinary disorders Hydronephrosis	0.00% 0/60 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.	3.8% 1/26 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.	1.2% 1/86 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
Renal and urinary disorders Nephrolithiasis	1.7% 1/60 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.	0.00% 0/26 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.	1.2% 1/86 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
Renal and urinary disorders Renal cyst	1.7% 1/60 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.	0.00% 0/26 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.	1.2% 1/86 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
Respiratory, thoracic and mediastinal disorders Lung disorder	1.7% 1/60 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.	0.00% 0/26 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.	1.2% 1/86 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
Respiratory, thoracic and mediastinal disorders Throat tightness	1.7% 1/60 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.	0.00% 0/26 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.	1.2% 1/86 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
Skin and subcutaneous tissue disorders Angioneurotic oedema	1.7% 1/60 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.	0.00% 0/26 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.	1.2% 1/86 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
Vascular disorders Aneurysm	1.7% 1/60 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.	0.00% 0/26 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.	1.2% 1/86 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.

Other adverse events
Measure	Alglucosidase Alfa/Alglucosidase Alfa n=60 participants at risk Participants who received alglucosidase alfa during the double-blind study AGLU02704 (NCT00158600) and, if they completed the double blind study, continued alglucosidase alfa in the extension study. Both study experiences on alglucosidase alfa are represented within AGLU03206.	Placebo/Alglucosidase Alfa n=26 participants at risk Participants who received placebo during the double-blind study AGLU02704 (NCT00158600) and, if they completed the double-blind study, started alglucosidase alfa in the extension study. Only participants' experience on alglucosidase alfa in the extension study is represented.	Overall n=86 participants at risk The combined alglucosidase alfa treatment experience from the two treatment groups.
Blood and lymphatic system disorders Anaemia	6.7% 4/60 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.	0.00% 0/26 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.	4.7% 4/86 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
Blood and lymphatic system disorders Lymphadenopathy	8.3% 5/60 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.	0.00% 0/26 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.	5.8% 5/86 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
Blood and lymphatic system disorders Macrocytosis	0.00% 0/60 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.	3.8% 1/26 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.	1.2% 1/86 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
Blood and lymphatic system disorders Normochromic normocytic anaemia	1.7% 1/60 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.	0.00% 0/26 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.	1.2% 1/86 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
Blood and lymphatic system disorders Spontaneous haematoma	0.00% 0/60 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.	3.8% 1/26 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.	1.2% 1/86 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
Cardiac disorders Angina pectoris	1.7% 1/60 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.	0.00% 0/26 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.	1.2% 1/86 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
Cardiac disorders Atrial hypertrophy	1.7% 1/60 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.	0.00% 0/26 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.	1.2% 1/86 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
Cardiac disorders Bundle branch block left	1.7% 1/60 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.	0.00% 0/26 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.	1.2% 1/86 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
Cardiac disorders Bundle branch block right	1.7% 1/60 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.	0.00% 0/26 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.	1.2% 1/86 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
Cardiac disorders Coronary artery disease	1.7% 1/60 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.	0.00% 0/26 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.	1.2% 1/86 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
Cardiac disorders Palpitations	5.0% 3/60 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.	0.00% 0/26 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.	3.5% 3/86 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
Cardiac disorders Sinus tachycardia	1.7% 1/60 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.	0.00% 0/26 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.	1.2% 1/86 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
Cardiac disorders Tachycardia	3.3% 2/60 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.	0.00% 0/26 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.	2.3% 2/86 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
Cardiac disorders Tricuspid valve incompetence	1.7% 1/60 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.	0.00% 0/26 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.	1.2% 1/86 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
Cardiac disorders Ventricular dysfunction	0.00% 0/60 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.	3.8% 1/26 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.	1.2% 1/86 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
Cardiac disorders Ventricular hypertrophy	0.00% 0/60 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.	3.8% 1/26 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.	1.2% 1/86 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
Ear and labyrinth disorders Auricular swelling	1.7% 1/60 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.	0.00% 0/26 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.	1.2% 1/86 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
Ear and labyrinth disorders Cerumen impaction	0.00% 0/60 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.	3.8% 1/26 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.	1.2% 1/86 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
Ear and labyrinth disorders Ear congestion	1.7% 1/60 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.	0.00% 0/26 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.	1.2% 1/86 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
Ear and labyrinth disorders Ear discomfort	8.3% 5/60 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.	0.00% 0/26 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.	5.8% 5/86 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
Ear and labyrinth disorders Ear pain	5.0% 3/60 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.	0.00% 0/26 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.	3.5% 3/86 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
Ear and labyrinth disorders Hypoacusis	38.3% 23/60 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.	11.5% 3/26 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.	30.2% 26/86 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
Ear and labyrinth disorders Presbyacusis	1.7% 1/60 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.	0.00% 0/26 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.	1.2% 1/86 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
Ear and labyrinth disorders Tinnitus	3.3% 2/60 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.	0.00% 0/26 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.	2.3% 2/86 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
Ear and labyrinth disorders Vertigo	8.3% 5/60 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.	0.00% 0/26 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.	5.8% 5/86 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
Ear and labyrinth disorders Vertigo positional	1.7% 1/60 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.	0.00% 0/26 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.	1.2% 1/86 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
Eye disorders Altered visual depth perception	1.7% 1/60 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.	0.00% 0/26 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.	1.2% 1/86 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
Eye disorders Asthenopia	1.7% 1/60 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.	0.00% 0/26 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.	1.2% 1/86 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
Eye disorders Cataract	6.7% 4/60 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.	3.8% 1/26 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.	5.8% 5/86 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
Eye disorders Conjunctivitis	1.7% 1/60 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.	0.00% 0/26 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.	1.2% 1/86 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
Eye disorders Diplopia	1.7% 1/60 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.	0.00% 0/26 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.	1.2% 1/86 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
Eye disorders Dry eye	1.7% 1/60 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.	0.00% 0/26 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.	1.2% 1/86 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
Eye disorders Eye irritation	1.7% 1/60 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.	0.00% 0/26 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.	1.2% 1/86 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
Eye disorders Eye pain	1.7% 1/60 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.	0.00% 0/26 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.	1.2% 1/86 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
Eye disorders Eye pruritus	1.7% 1/60 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.	0.00% 0/26 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.	1.2% 1/86 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
Eye disorders Eyelid ptosis	1.7% 1/60 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.	0.00% 0/26 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.	1.2% 1/86 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
Eye disorders Keratoconjunctivitis sicca	0.00% 0/60 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.	3.8% 1/26 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.	1.2% 1/86 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
Eye disorders Photophobia	1.7% 1/60 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.	0.00% 0/26 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.	1.2% 1/86 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
Eye disorders Pinguecula	1.7% 1/60 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.	0.00% 0/26 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.	1.2% 1/86 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
Eye disorders Retinal detachment	1.7% 1/60 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.	0.00% 0/26 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.	1.2% 1/86 • Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.