Trial Outcomes & Findings for A Study of the Safety and Efficacy of Fabrazyme in Patients With Fabry Disease (NCT NCT00081497)

Last Updated: 2015-04-02

Results Overview

The primary efficacy analysis was the summary of change in slope of inverse serum creatinine for Placebo/Fabrazyme patients in the Intent to Treat (ITT) Population. It compared the placebo period slope with the Fabrazyme period slope.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

67 participants

Primary outcome timeframe

Placebo period AGAL-008-00 (up to 35 months) through Fabrazyme period AGAL02503 (18 months)

Results posted on

2015-04-02

Participant Flow

Only those patients who successfully completed the AGAL-008-00 (NCT00074984) trial were eligible for participation in the AGAL02503 (NCT00081497) extension study.

Participant milestones

Participant milestones
Measure	Placebo/Fabrazyme Patients who had been randomized to placebo during AGAL-008-00 (NCT00074984) and were then transitioned to open-label Fabrazyme (1.0 mg/kg every 2 weeks) prior to or at entry to AGAL02503 (NCT00081497).	Fabrazyme/Fabrazyme Patients who had been randomized to Fabrazyme in AGAL-008-00 (NCT00074984) and were then transitioned to open-label Fabrazyme (1.0 mg/kg every 2 weeks) prior to or at entry into AGAL02503 (NCT00081497).
Overall Study STARTED	28	39
Overall Study COMPLETED	25	37
Overall Study NOT COMPLETED	3	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo/Fabrazyme Patients who had been randomized to placebo during AGAL-008-00 (NCT00074984) and were then transitioned to open-label Fabrazyme (1.0 mg/kg every 2 weeks) prior to or at entry to AGAL02503 (NCT00081497).	Fabrazyme/Fabrazyme Patients who had been randomized to Fabrazyme in AGAL-008-00 (NCT00074984) and were then transitioned to open-label Fabrazyme (1.0 mg/kg every 2 weeks) prior to or at entry into AGAL02503 (NCT00081497).
Overall Study Adverse Event	2	0
Overall Study Death	0	1
Overall Study Withdrawal by Subject	1	0
Overall Study Non-compliance	0	1

Baseline Characteristics

A Study of the Safety and Efficacy of Fabrazyme in Patients With Fabry Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo/Fabrazyme n=28 Participants Patients who had been randomized to placebo during AGAL-008-00 (NCT00074984) and were then transitioned to open-label Fabrazyme (1.0 mg/kg every 2 weeks) prior to or at entry to AGAL02503 (NCT00081497).	Fabrazyme/Fabrazyme n=39 Participants Patients who had been randomized to Fabrazyme in AGAL-008-00 (NCT00074984) and were then transitioned to open-label Fabrazyme (1.0 mg/kg every 2 weeks) prior to or at entry into AGAL02503 (NCT00081497).	Total n=67 Participants Total of all reporting groups
Age, Customized <40 years	8 participants n=93 Participants	7 participants n=4 Participants	15 participants n=27 Participants
Age, Customized ≥40 years	20 participants n=93 Participants	32 participants n=4 Participants	52 participants n=27 Participants
Age, Continuous	43.5 years STANDARD_DEVIATION 9.31 • n=93 Participants	46.6 years STANDARD_DEVIATION 9.72 • n=4 Participants	45.3 years STANDARD_DEVIATION 9.60 • n=27 Participants
Sex: Female, Male Female	4 Participants n=93 Participants	5 Participants n=4 Participants	9 Participants n=27 Participants
Sex: Female, Male Male	24 Participants n=93 Participants	34 Participants n=4 Participants	58 Participants n=27 Participants
Race/Ethnicity Caucasian	24 participants n=93 Participants	35 participants n=4 Participants	59 participants n=27 Participants
Race/Ethnicity Black	0 participants n=93 Participants	0 participants n=4 Participants	0 participants n=27 Participants
Race/Ethnicity Hispanic	2 participants n=93 Participants	3 participants n=4 Participants	5 participants n=27 Participants
Race/Ethnicity Asian	1 participants n=93 Participants	1 participants n=4 Participants	2 participants n=27 Participants
Race/Ethnicity Other	1 participants n=93 Participants	0 participants n=4 Participants	1 participants n=27 Participants

PRIMARY outcome

Timeframe: Placebo period AGAL-008-00 (up to 35 months) through Fabrazyme period AGAL02503 (18 months)

Population: ITT Population - Analysis compares results during the placebo period with those during the Fabrazyme period and includes only the 28 patients who were randomized to placebo in the AGAL-008-00 (NCT00074984) study; as such no formal sample size calculations were performed.

Outcome measures

Outcome measures
Measure	Placebo Period - AGAL-008-00 (NCT00074984) n=28 Participants Patients who had been randomized to placebo during AGAL-008-00 (NCT00074984).	Fabrazyme Period - AGAL02503 (NCT00081497) n=28 Participants Placebo patients who had been transitioned to open-label Fabrazyme prior to or at entry into AGAL02503 (NCT00081497). 1.0 mg/kg of Fabrazyme given to the patients every 2 weeks for 18 months.	Placebo - AGAL-008-00 (NCT00074984) eGFR ≤60 Patients who had been randomized to placebo during AGAL-008-00 (NCT00074984) and were then transitioned to open-label Fabrazyme prior to or at entry to AGAL02503 (NCT00081497) using only placebo period data from the AGAL-008-00 (NCT00074984) study.	Fabrazyme - AGAL02503 (NCT00081497) eGFR ≤60 Patients who had been randomized to Fabrazyme in AGAL-008-00 (NCT00074984) and were then transitioned to open-label Fabrazyme prior to or at entry into AGAL02503 (NCT00081497) using all Fabrazyme treatment period data from the AGAL00800 (NCT00074984) and AGAL02503 (NCT00081497) studies.
Difference in Inverse Serum Creatinine Within Patients' Slopes Between the Placebo AGAL-008-00 (NCT00074984) and Fabrazyme AGAL02503 (NCT00081497) Periods	-0.044 dL/mg/year Standard Error 0.012	-0.073 dL/mg/year Standard Error 0.011	—	—

SECONDARY outcome

Timeframe: Pre-Fabrazyme, 6, 12, and 18 months

Population: ITT population-67 patients had assessments at 6 and 12 months while 65 patients had assessments at 18 months in the open-label extension study.

Pre-Fabrazyme=baseline visit of AGAL-008-00 (NCT00074984) for Fabrazyme patients; assessment prior to open-label for placebo patients who transitioned to Fabrazyme in AGAL-008-00 (NCT00074984); assessment prior to first Fabrazyme infusion in AGAL02503 (NCT00081497) for placebo patients who did not transition to Fabrazyme in AGAL-008-00 (NCT00074984).

Outcome measures

Outcome measures
Measure	Placebo Period - AGAL-008-00 (NCT00074984) n=67 Participants Patients who had been randomized to placebo during AGAL-008-00 (NCT00074984).	Fabrazyme Period - AGAL02503 (NCT00081497) Placebo patients who had been transitioned to open-label Fabrazyme prior to or at entry into AGAL02503 (NCT00081497). 1.0 mg/kg of Fabrazyme given to the patients every 2 weeks for 18 months.	Placebo - AGAL-008-00 (NCT00074984) eGFR ≤60 Patients who had been randomized to placebo during AGAL-008-00 (NCT00074984) and were then transitioned to open-label Fabrazyme prior to or at entry to AGAL02503 (NCT00081497) using only placebo period data from the AGAL-008-00 (NCT00074984) study.	Fabrazyme - AGAL02503 (NCT00081497) eGFR ≤60 Patients who had been randomized to Fabrazyme in AGAL-008-00 (NCT00074984) and were then transitioned to open-label Fabrazyme prior to or at entry into AGAL02503 (NCT00081497) using all Fabrazyme treatment period data from the AGAL00800 (NCT00074984) and AGAL02503 (NCT00081497) studies.
Serum Creatinine at Pre-Fabrazyme and 6, 12, and 18 Months Serum Creatinine at Pre-Fabrazyme	1.7 mg/dL Standard Deviation 0.60	—	—	—
Serum Creatinine at Pre-Fabrazyme and 6, 12, and 18 Months Serum Creatinine at 6 months post-treatment	1.8 mg/dL Standard Deviation 0.77	—	—	—
Serum Creatinine at Pre-Fabrazyme and 6, 12, and 18 Months Serum Creatinine at 12 months post-treatment	1.9 mg/dL Standard Deviation 0.98	—	—	—
Serum Creatinine at Pre-Fabrazyme and 6, 12, and 18 Months Serum Creatinine at 18 months post-treatment	2.1 mg/dL Standard Deviation 1.21	—	—	—

SECONDARY outcome

Timeframe: Pre-Fabrazyme, 6, 12, and 18 months

Population: ITT population-67 patients had assessments at 6 and 12 months while 65 patients had assessments at 18 months in the open-label extension study.

Pre-Fabrazyme=baseline visit of AGAL-00-800 (NCT00074984) for Fabrazyme patients; assessment prior to open-label for placebo patients who transitioned to Fabrazyme in AGAL-008-00 (NCT00074984); assessment prior to first Fabrazyme infusion in AGAL02503 (NCT00081497) for placebo patients who did not transition to Fabrazyme in AGAL-008-00 (NCT00074984).

Outcome measures

Outcome measures
Measure	Placebo Period - AGAL-008-00 (NCT00074984) n=67 Participants Patients who had been randomized to placebo during AGAL-008-00 (NCT00074984).	Fabrazyme Period - AGAL02503 (NCT00081497) Placebo patients who had been transitioned to open-label Fabrazyme prior to or at entry into AGAL02503 (NCT00081497). 1.0 mg/kg of Fabrazyme given to the patients every 2 weeks for 18 months.	Placebo - AGAL-008-00 (NCT00074984) eGFR ≤60 Patients who had been randomized to placebo during AGAL-008-00 (NCT00074984) and were then transitioned to open-label Fabrazyme prior to or at entry to AGAL02503 (NCT00081497) using only placebo period data from the AGAL-008-00 (NCT00074984) study.	Fabrazyme - AGAL02503 (NCT00081497) eGFR ≤60 Patients who had been randomized to Fabrazyme in AGAL-008-00 (NCT00074984) and were then transitioned to open-label Fabrazyme prior to or at entry into AGAL02503 (NCT00081497) using all Fabrazyme treatment period data from the AGAL00800 (NCT00074984) and AGAL02503 (NCT00081497) studies.
Estimated Glomerular Filtration Rate (eGFR) at Pre-Fabrazyme and 6, 12, and 18 Months eGFR at Pre-Fabrazyme	53.1 ml/min/1.73m^2 Standard Deviation 19.62	—	—	—
Estimated Glomerular Filtration Rate (eGFR) at Pre-Fabrazyme and 6, 12, and 18 Months eGFR at 6 months post-treatment	52.6 ml/min/1.73m^2 Standard Deviation 23.24	—	—	—
Estimated Glomerular Filtration Rate (eGFR) at Pre-Fabrazyme and 6, 12, and 18 Months eGFR at 12 months post-treatment	50.4 ml/min/1.73m^2 Standard Deviation 22.73	—	—	—
Estimated Glomerular Filtration Rate (eGFR) at Pre-Fabrazyme and 6, 12, and 18 Months eGFR at 18 months post-treatment	47.8 ml/min/1.73m^2 Standard Deviation 23.62	—	—	—

SECONDARY outcome

Timeframe: Pre-Fabrazyme and 6, 12, and 18 months

Population: ITT population-64 patients had assessments at 6 and 18 months while 65 patients had assessments at 12 months in the open-label extension study.

Pre-Fabrazyme=baseline visit of AGAL00800 for Fabrazyme patients; assessment prior to open-label for placebo patients who transitioned to Fabrazyme in AGAL00800; assessment prior to first Fabrazyme infusion in AGAL02503 for placebo patients who did not transition to Fabrazyme in AGAL00800.

Outcome measures

Outcome measures
Measure	Placebo Period - AGAL-008-00 (NCT00074984) n=65 Participants Patients who had been randomized to placebo during AGAL-008-00 (NCT00074984).	Fabrazyme Period - AGAL02503 (NCT00081497) Placebo patients who had been transitioned to open-label Fabrazyme prior to or at entry into AGAL02503 (NCT00081497). 1.0 mg/kg of Fabrazyme given to the patients every 2 weeks for 18 months.	Placebo - AGAL-008-00 (NCT00074984) eGFR ≤60 Patients who had been randomized to placebo during AGAL-008-00 (NCT00074984) and were then transitioned to open-label Fabrazyme prior to or at entry to AGAL02503 (NCT00081497) using only placebo period data from the AGAL-008-00 (NCT00074984) study.	Fabrazyme - AGAL02503 (NCT00081497) eGFR ≤60 Patients who had been randomized to Fabrazyme in AGAL-008-00 (NCT00074984) and were then transitioned to open-label Fabrazyme prior to or at entry into AGAL02503 (NCT00081497) using all Fabrazyme treatment period data from the AGAL00800 (NCT00074984) and AGAL02503 (NCT00081497) studies.
Plasma Globotriaosylceramide (GL-3) (Normal Plasma GL-3 Level is ≤ 7.03 µg/mL) at Pre-Fabrazyme and 6, 12, and 18 Months Plasma GL-3 at Pre-Fabrazyme	9.0 µg/mL Standard Deviation 3.35	—	—	—
Plasma Globotriaosylceramide (GL-3) (Normal Plasma GL-3 Level is ≤ 7.03 µg/mL) at Pre-Fabrazyme and 6, 12, and 18 Months Plasma GL-3 at 6 months post-treatment	4.8 µg/mL Standard Deviation 1.76	—	—	—
Plasma Globotriaosylceramide (GL-3) (Normal Plasma GL-3 Level is ≤ 7.03 µg/mL) at Pre-Fabrazyme and 6, 12, and 18 Months Plasma GL-3 at 12 months post-treatment	4.7 µg/mL Standard Deviation 1.59	—	—	—
Plasma Globotriaosylceramide (GL-3) (Normal Plasma GL-3 Level is ≤ 7.03 µg/mL) at Pre-Fabrazyme and 6, 12, and 18 Months Plasma GL-3 at 18 months post-treatment	4.6 µg/mL Standard Deviation 1.82	—	—	—

SECONDARY outcome

Timeframe: Pre-Fabrazyme and 6, 12, and 18 months

Population: ITT population-62 patients had assessments at 6 months, 61 patients had assessments at 12 months, and 54 patients had assessments at 18 months in the open-label extension study.

Outcome measures

Outcome measures
Measure	Placebo Period - AGAL-008-00 (NCT00074984) n=62 Participants Patients who had been randomized to placebo during AGAL-008-00 (NCT00074984).	Fabrazyme Period - AGAL02503 (NCT00081497) Placebo patients who had been transitioned to open-label Fabrazyme prior to or at entry into AGAL02503 (NCT00081497). 1.0 mg/kg of Fabrazyme given to the patients every 2 weeks for 18 months.	Placebo - AGAL-008-00 (NCT00074984) eGFR ≤60 Patients who had been randomized to placebo during AGAL-008-00 (NCT00074984) and were then transitioned to open-label Fabrazyme prior to or at entry to AGAL02503 (NCT00081497) using only placebo period data from the AGAL-008-00 (NCT00074984) study.	Fabrazyme - AGAL02503 (NCT00081497) eGFR ≤60 Patients who had been randomized to Fabrazyme in AGAL-008-00 (NCT00074984) and were then transitioned to open-label Fabrazyme prior to or at entry into AGAL02503 (NCT00081497) using all Fabrazyme treatment period data from the AGAL00800 (NCT00074984) and AGAL02503 (NCT00081497) studies.
Proteinuria at Pre-Fabrazyme and 6, 12, and 18 Months Proteinuria at Pre-Fabrazyme	1.3 urine protein(mg/dL) / creatinine(mg/dL) Standard Deviation 1.46	—	—	—
Proteinuria at Pre-Fabrazyme and 6, 12, and 18 Months Proteinuria at 6 months post-treatment	1.1 urine protein(mg/dL) / creatinine(mg/dL) Standard Deviation 1.19	—	—	—
Proteinuria at Pre-Fabrazyme and 6, 12, and 18 Months Proteinuria at 12 months post-treatment	1.3 urine protein(mg/dL) / creatinine(mg/dL) Standard Deviation 1.77	—	—	—
Proteinuria at Pre-Fabrazyme and 6, 12, and 18 Months Proteinuria at 18 months post-treatment	1.3 urine protein(mg/dL) / creatinine(mg/dL) Standard Deviation 1.55	—	—	—

POST_HOC outcome

Timeframe: Throughout study; 18 months

Population: ITT population. For subgroup Estimated Glomerular Filtration Rate (eGFR) \>60, there were 9 placebo patients and 15 Fabrazyme patients. For subgroup eGFR ≤60, there were 19 placebo patients and 24 Fabrazyme patients. For randomized Fabrazyme patients, both the double-blind and open-label data was used.

Summary of differences in slopes of eGFR comparing randomized placebo vs Fabrazyme patients by baseline eGFR subgroups. Differences in slopes are the placebo slope minus the Fabrazyme slope. Therefore, a negative difference indicates a greater decline in the placebo patients relative to the Fabrazyme patients.

Outcome measures

Outcome measures
Measure	Placebo Period - AGAL-008-00 (NCT00074984) n=9 Participants Patients who had been randomized to placebo during AGAL-008-00 (NCT00074984).	Fabrazyme Period - AGAL02503 (NCT00081497) n=15 Participants Placebo patients who had been transitioned to open-label Fabrazyme prior to or at entry into AGAL02503 (NCT00081497). 1.0 mg/kg of Fabrazyme given to the patients every 2 weeks for 18 months.	Placebo - AGAL-008-00 (NCT00074984) eGFR ≤60 n=19 Participants Patients who had been randomized to placebo during AGAL-008-00 (NCT00074984) and were then transitioned to open-label Fabrazyme prior to or at entry to AGAL02503 (NCT00081497) using only placebo period data from the AGAL-008-00 (NCT00074984) study.	Fabrazyme - AGAL02503 (NCT00081497) eGFR ≤60 n=24 Participants Patients who had been randomized to Fabrazyme in AGAL-008-00 (NCT00074984) and were then transitioned to open-label Fabrazyme prior to or at entry into AGAL02503 (NCT00081497) using all Fabrazyme treatment period data from the AGAL00800 (NCT00074984) and AGAL02503 (NCT00081497) studies.
Differences in Slopes of Estimated Glomerular Filtration Rate (eGFR) Comparing Randomized Placebo vs Fabrazyme Patients (Based on the Original Randomization in AGAL-008-00 (NCT00074984)) by Baseline eGFR Subgroups of >60 and ≤60 mL/Min/1.73 m^2.	-7.685 mL/min/1.73m^2/year Standard Error 1.836	-0.898 mL/min/1.73m^2/year Standard Error 1.129	-2.575 mL/min/1.73m^2/year Standard Error 1.188	-4.906 mL/min/1.73m^2/year Standard Error 0.900

Adverse Events

Fabrazyme/Fabrazyme

Serious events: 19 serious events

Other events: 39 other events

Deaths: 0 deaths

Placebo/Fabrazyme

Serious events: 12 serious events

Other events: 27 other events

Deaths: 0 deaths

Total

Serious events: 31 serious events

Other events: 66 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

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Restriction type: OTHER

Serious adverse events
Measure	Fabrazyme/Fabrazyme n=39 participants at risk Patients who had been randomized to Fabrazyme in AGAL-008-00 (NCT00074984) and were then transitioned to open-label Fabrazyme (1.0 mg/kg every 2 weeks) prior to or at entry into AGAL02503 (NCT00081497).	Placebo/Fabrazyme n=28 participants at risk Patients who had been randomized to placebo during AGAL-008-00 (NCT00074984) and were then transitioned to open-label Fabrazyme (1.0 mg/kg every 2 weeks) prior to or at entry to AGAL02503 (NCT00081497).	Total n=67 participants at risk
Cardiac disorders Acute myocardial infarction	2.6% 1/39 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.	0.00% 0/28 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.	1.5% 1/67 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.
Cardiac disorders Angina pectoris	0.00% 0/39 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.	3.6% 1/28 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.	1.5% 1/67 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.
Cardiac disorders Atrial fibrillation	2.6% 1/39 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.	3.6% 1/28 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.	3.0% 2/67 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.
Cardiac disorders Atrioventricular block second degree	2.6% 1/39 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.	0.00% 0/28 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.	1.5% 1/67 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.
Cardiac disorders Cardiac failure congestive	2.6% 1/39 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.	0.00% 0/28 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.	1.5% 1/67 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.
Cardiac disorders Myocardial infarction	2.6% 1/39 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.	0.00% 0/28 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.	1.5% 1/67 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.
Cardiac disorders Myocardial ischaemia	2.6% 1/39 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.	0.00% 0/28 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.	1.5% 1/67 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.
Cardiac disorders Ventricular hypertrophy	2.6% 1/39 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.	0.00% 0/28 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.	1.5% 1/67 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.
Cardiac disorders Ventricular tachycardia	2.6% 1/39 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.	0.00% 0/28 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.	1.5% 1/67 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.
Ear and labyrinth disorders Meniere's disease	2.6% 1/39 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.	0.00% 0/28 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.	1.5% 1/67 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.
Gastrointestinal disorders Constipation	2.6% 1/39 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.	0.00% 0/28 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.	1.5% 1/67 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.
Gastrointestinal disorders Intestinal infarction	0.00% 0/39 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.	3.6% 1/28 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.	1.5% 1/67 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.
Gastrointestinal disorders Intestinal obstruction	0.00% 0/39 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.	3.6% 1/28 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.	1.5% 1/67 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.
Gastrointestinal disorders Large intestine perforation	0.00% 0/39 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.	3.6% 1/28 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.	1.5% 1/67 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.
Gastrointestinal disorders Nausea	2.6% 1/39 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.	0.00% 0/28 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.	1.5% 1/67 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.
Gastrointestinal disorders Peritonitis	0.00% 0/39 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.	3.6% 1/28 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.	1.5% 1/67 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.
Gastrointestinal disorders Vomiting	5.1% 2/39 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.	0.00% 0/28 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.	3.0% 2/67 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.
General disorders Chest pain	7.7% 3/39 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.	3.6% 1/28 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.	6.0% 4/67 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.
General disorders Pyrexia	5.1% 2/39 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.	0.00% 0/28 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.	3.0% 2/67 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.
Hepatobiliary disorders Cholelithiasis	7.7% 3/39 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.	0.00% 0/28 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.	4.5% 3/67 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.
Immune system disorders Kidney transplant rejection	0.00% 0/39 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.	3.6% 1/28 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.	1.5% 1/67 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.
Infections and infestations Cellulitis	2.6% 1/39 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.	0.00% 0/28 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.	1.5% 1/67 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.
Infections and infestations Lobar pneumonia	0.00% 0/39 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.	3.6% 1/28 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.	1.5% 1/67 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.
Infections and infestations Localised infection	2.6% 1/39 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.	0.00% 0/28 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.	1.5% 1/67 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.
Infections and infestations Peritonitis bacterial	2.6% 1/39 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.	0.00% 0/28 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.	1.5% 1/67 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.
Infections and infestations Pneumonia	2.6% 1/39 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.	0.00% 0/28 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.	1.5% 1/67 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.
Infections and infestations Sepsis	2.6% 1/39 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.	0.00% 0/28 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.	1.5% 1/67 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.
Infections and infestations Streptococcal infection	2.6% 1/39 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.	0.00% 0/28 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.	1.5% 1/67 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.
Infections and infestations Viral infection	0.00% 0/39 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.	3.6% 1/28 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.	1.5% 1/67 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.
Injury, poisoning and procedural complications Cardiac pacemaker malfunction	0.00% 0/39 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.	3.6% 1/28 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.	1.5% 1/67 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.
Injury, poisoning and procedural complications Femoral neck fracture	2.6% 1/39 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.	0.00% 0/28 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.	1.5% 1/67 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.
Injury, poisoning and procedural complications Hand fracture	0.00% 0/39 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.	3.6% 1/28 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.	1.5% 1/67 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.
Injury, poisoning and procedural complications Hip fracture	2.6% 1/39 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.	0.00% 0/28 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.	1.5% 1/67 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.
Injury, poisoning and procedural complications Implantable defibrillator malfunction	2.6% 1/39 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.	0.00% 0/28 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.	1.5% 1/67 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.
Injury, poisoning and procedural complications Joint dislocation	0.00% 0/39 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.	3.6% 1/28 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.	1.5% 1/67 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.
Injury, poisoning and procedural complications Medical device complication	2.6% 1/39 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.	0.00% 0/28 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.	1.5% 1/67 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.
Injury, poisoning and procedural complications Procedural hypertension	2.6% 1/39 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.	0.00% 0/28 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.	1.5% 1/67 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.
Investigations Liver function test abnormal	2.6% 1/39 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.	0.00% 0/28 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.	1.5% 1/67 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.
Investigations Skin test positive	0.00% 0/39 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.	3.6% 1/28 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.	1.5% 1/67 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.
Metabolism and nutrition disorders Dehydration	2.6% 1/39 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.	0.00% 0/28 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.	1.5% 1/67 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.

Other adverse events
Measure	Fabrazyme/Fabrazyme n=39 participants at risk Patients who had been randomized to Fabrazyme in AGAL-008-00 (NCT00074984) and were then transitioned to open-label Fabrazyme (1.0 mg/kg every 2 weeks) prior to or at entry into AGAL02503 (NCT00081497).	Placebo/Fabrazyme n=28 participants at risk Patients who had been randomized to placebo during AGAL-008-00 (NCT00074984) and were then transitioned to open-label Fabrazyme (1.0 mg/kg every 2 weeks) prior to or at entry to AGAL02503 (NCT00081497).	Total n=67 participants at risk
Blood and lymphatic system disorders Lymphadenopathy	5.1% 2/39 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.	0.00% 0/28 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.	3.0% 2/67 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.
Blood and lymphatic system disorders Nephrogenic anaemia	2.6% 1/39 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.	0.00% 0/28 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.	1.5% 1/67 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.
Blood and lymphatic system disorders Thrombocythaemia	0.00% 0/39 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.	3.6% 1/28 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.	1.5% 1/67 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.
Cardiac disorders Arrhythmia	2.6% 1/39 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.	0.00% 0/28 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.	1.5% 1/67 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.
Cardiac disorders Arrhythmia supraventricular	0.00% 0/39 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.	3.6% 1/28 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.	1.5% 1/67 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.
Cardiac disorders Atrial fibrillation	2.6% 1/39 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.	7.1% 2/28 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.	4.5% 3/67 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.
Cardiac disorders Atrial flutter	0.00% 0/39 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.	3.6% 1/28 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.	1.5% 1/67 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.
Cardiac disorders Atrioventricular block first degree	2.6% 1/39 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.	0.00% 0/28 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.	1.5% 1/67 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.
Cardiac disorders Bradycardia	5.1% 2/39 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.	0.00% 0/28 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.	3.0% 2/67 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.
Cardiac disorders Bundle branch block left	2.6% 1/39 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.	0.00% 0/28 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.	1.5% 1/67 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.
Cardiac disorders Bundle branch block right	10.3% 4/39 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.	0.00% 0/28 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.	6.0% 4/67 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.
Cardiac disorders Cardiac failure congestive	2.6% 1/39 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.	3.6% 1/28 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.	3.0% 2/67 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.
Cardiac disorders Cardiomegaly	2.6% 1/39 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.	0.00% 0/28 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.	1.5% 1/67 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.
Cardiac disorders Dilatation atrial	2.6% 1/39 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.	3.6% 1/28 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.	3.0% 2/67 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.
Musculoskeletal and connective tissue disorders Myalgia	20.5% 8/39 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.	3.6% 1/28 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.	13.4% 9/67 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.
Musculoskeletal and connective tissue disorders Neck pain	7.7% 3/39 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.	3.6% 1/28 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.	6.0% 4/67 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.
Blood and lymphatic system disorders Anaemia	12.8% 5/39 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.	17.9% 5/28 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.	14.9% 10/67 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.
Blood and lymphatic system disorders Leukopenia	0.00% 0/39 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.	3.6% 1/28 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.	1.5% 1/67 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.
Cardiac disorders Dilatation ventricular	2.6% 1/39 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.	0.00% 0/28 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.	1.5% 1/67 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.
Cardiac disorders Heart valve insufficiency	2.6% 1/39 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.	0.00% 0/28 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.	1.5% 1/67 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.
Cardiac disorders Mitral valve incompetence	2.6% 1/39 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.	0.00% 0/28 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.	1.5% 1/67 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.
Cardiac disorders Mitral valve prolapse	2.6% 1/39 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.	0.00% 0/28 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.	1.5% 1/67 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.
Cardiac disorders Myocardial infarction	2.6% 1/39 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.	0.00% 0/28 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.	1.5% 1/67 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.
Cardiac disorders Palpitations	10.3% 4/39 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.	0.00% 0/28 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.	6.0% 4/67 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.
Cardiac disorders Sinus bradycardia	5.1% 2/39 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.	0.00% 0/28 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.	3.0% 2/67 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.
Cardiac disorders Supraventricular extrasystoles	7.7% 3/39 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.	0.00% 0/28 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.	4.5% 3/67 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.
Cardiac disorders Tachyarrhythmia	2.6% 1/39 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.	0.00% 0/28 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.	1.5% 1/67 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.
Cardiac disorders Tachycardia	12.8% 5/39 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.	0.00% 0/28 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.	7.5% 5/67 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.
Cardiac disorders Ventricular dysfunction	2.6% 1/39 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.	0.00% 0/28 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.	1.5% 1/67 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.
Cardiac disorders Ventricular extrasystoles	2.6% 1/39 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.	3.6% 1/28 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.	3.0% 2/67 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.
Cardiac disorders Ventricular hypertrophy	7.7% 3/39 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.	3.6% 1/28 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.	6.0% 4/67 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.
Cardiac disorders Ventricular tachycardia	0.00% 0/39 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.	3.6% 1/28 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.	1.5% 1/67 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.
Cardiac disorders Ventricular wall thickening	5.1% 2/39 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.	0.00% 0/28 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.	3.0% 2/67 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.
Cardiac disorders Wolff-Parkinson-White syndrome	2.6% 1/39 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.	0.00% 0/28 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.	1.5% 1/67 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.
Congenital, familial and genetic disorders Exomphalos	0.00% 0/39 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.	3.6% 1/28 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.	1.5% 1/67 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.
Ear and labyrinth disorders Cerumen impaction	2.6% 1/39 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.	7.1% 2/28 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.	4.5% 3/67 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.
Ear and labyrinth disorders Deafness	2.6% 1/39 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.	0.00% 0/28 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.	1.5% 1/67 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.
Ear and labyrinth disorders Deafness neurosensory	0.00% 0/39 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.	3.6% 1/28 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.	1.5% 1/67 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.
Ear and labyrinth disorders Ear canal erythema	2.6% 1/39 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.	0.00% 0/28 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.	1.5% 1/67 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.
Ear and labyrinth disorders Ear congestion	2.6% 1/39 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.	0.00% 0/28 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.	1.5% 1/67 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.