Trial Outcomes & Findings for Observational Study That Will Collect Information on Patients With Urea Cycle Disorders (UCDs) (NCT NCT01948427)

NCT ID: NCT01948427

Last Updated: 2024-07-01

Results Overview

Retrospective is defined as the 12 months preceding enrollment.

Recruitment status

TERMINATED

Target enrollment

203 participants

Primary outcome timeframe

12 months prior to enrollment (retrospective), Baseline, Day 7 to 30, Month 6, Month 12, Month 18, Month 24, Month 30, Month 36, Month 42, Month 48, Month 54, Month 60, Month 66, Month 72

Results posted on

2024-07-01

Participant Flow

Participant milestones

Participant milestones
Measure	Sodium Phenylbutyrate Participants with a confirmed or suspected diagnosis of urea cycle disorder (UCD) receiving sodium phenylbutyrate at Baseline.	Ravicti Participants with a confirmed or suspected diagnosis of UCD receiving Ravicti at Baseline.	Sodium Benzoate Participants with a confirmed or suspected diagnosis of UCD receiving sodium benzoate at Baseline.	Carglumic Acid Participants with a confirmed or suspected diagnosis of UCD receiving carglumic acid at Baseline.	Other Participants with a confirmed or suspected diagnosis of UCD receiving other (not specified) ammonia-scavenging medication at Baseline.
Overall Study STARTED	49	89	4	1	60
Overall Study COMPLETED	42	72	4	1	46
Overall Study NOT COMPLETED	7	17	0	0	14

Reasons for withdrawal

Reasons for withdrawal
Measure	Sodium Phenylbutyrate Participants with a confirmed or suspected diagnosis of urea cycle disorder (UCD) receiving sodium phenylbutyrate at Baseline.	Ravicti Participants with a confirmed or suspected diagnosis of UCD receiving Ravicti at Baseline.	Other Participants with a confirmed or suspected diagnosis of UCD receiving other (not specified) ammonia-scavenging medication at Baseline.
Overall Study Serious Adverse Event	3	0	1
Overall Study Investigator Request	0	8	6
Overall Study Lost to Follow-up	1	0	4
Overall Study Withdrawal by Subject	2	0	1
Overall Study Other, Not Specified	1	9	2

Baseline Characteristics

Observational Study That Will Collect Information on Patients With Urea Cycle Disorders (UCDs)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sodium Phenylbutyrate n=49 Participants Participants with a confirmed or suspected diagnosis of UCD receiving sodium phenylbutyrate at Baseline.	Ravicti n=89 Participants Participants with a confirmed or suspected diagnosis of UCD receiving Ravicti at Baseline.	Sodium Benzoate n=4 Participants Participants with a confirmed or suspected diagnosis of UCD receiving sodium benzoate at Baseline.	Carglumic Acid n=1 Participants Participants with a confirmed or suspected diagnosis of UCD receiving carglumic acid at Baseline.	Other n=60 Participants Participants with a confirmed or suspected diagnosis of UCD receiving other (not specified) ammonia-scavenging medication at Baseline.	Total n=203 Participants Total of all reporting groups
Age, Continuous	10.9 years STANDARD_DEVIATION 13.5 • n=99 Participants	16.7 years STANDARD_DEVIATION 15.1 • n=107 Participants	9.3 years STANDARD_DEVIATION 8.7 • n=206 Participants	2.0 years STANDARD_DEVIATION NA • n=7 Participants	14.7 years STANDARD_DEVIATION 16.9 • n=31 Participants	14.5 years STANDARD_DEVIATION 15.3 • n=30 Participants
Sex: Female, Male Female	33 Participants n=99 Participants	54 Participants n=107 Participants	1 Participants n=206 Participants	0 Participants n=7 Participants	33 Participants n=31 Participants	121 Participants n=30 Participants
Sex: Female, Male Male	16 Participants n=99 Participants	35 Participants n=107 Participants	3 Participants n=206 Participants	1 Participants n=7 Participants	27 Participants n=31 Participants	82 Participants n=30 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	13 Participants n=99 Participants	16 Participants n=107 Participants	3 Participants n=206 Participants	0 Participants n=7 Participants	7 Participants n=31 Participants	39 Participants n=30 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	36 Participants n=99 Participants	73 Participants n=107 Participants	1 Participants n=206 Participants	1 Participants n=7 Participants	53 Participants n=31 Participants	164 Participants n=30 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants
Race White	30 Participants n=99 Participants	63 Participants n=107 Participants	4 Participants n=206 Participants	1 Participants n=7 Participants	48 Participants n=31 Participants	146 Participants n=30 Participants
Race Black or African-American	9 Participants n=99 Participants	9 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	4 Participants n=31 Participants	22 Participants n=30 Participants
Race Asian	1 Participants n=99 Participants	2 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	3 Participants n=31 Participants	6 Participants n=30 Participants
Race Native Hawaiian or Other Pacific Islander	1 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	1 Participants n=30 Participants
Race Other, Not Specified	8 Participants n=99 Participants	15 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	5 Participants n=31 Participants	28 Participants n=30 Participants

PRIMARY outcome

Timeframe: 12 months prior to enrollment (retrospective), Baseline, Day 7 to 30, Month 6, Month 12, Month 18, Month 24, Month 30, Month 36, Month 42, Month 48, Month 54, Month 60, Month 66, Month 72

Population: Participants with a Baseline visit and an assessment at given time point. Participants are grouped by last-known ammonia-scavenging medication at given time point (participants may have been on more than 1 therapy during the study).

Retrospective is defined as the 12 months preceding enrollment.

Outcome measures

Outcome measures
Measure	Sodium Phenylbutyrate n=40 Participants Participants with a confirmed or suspected diagnosis of UCD receiving sodium phenylbutyrate.	Ravicti n=67 Participants Participants with a confirmed or suspected diagnosis of UCD receiving Ravicti.	Sodium Benzoate n=6 Participants Participants with a confirmed or suspected diagnosis of UCD receiving sodium benzoate.	Carglumic Acid n=2 Participants Participants with a confirmed or suspected diagnosis of UCD receiving carglumic acid.	Other n=5 Participants Participants with a confirmed or suspected diagnosis of UCD receiving other (not specified) ammonia-scavenging medication.
Mean Blood Ammonia Levels Over Time, by Last Known Ammonia-Scavenging Medication Retrospective	86.5 µmol/L Standard Deviation 87.13	43.8 µmol/L Standard Deviation 27.59	23.0 µmol/L Standard Deviation NA 1 participant analyzed	13.0 µmol/L Standard Deviation NA 1 participant analyzed	963.7 µmol/L Standard Deviation 721.39
Mean Blood Ammonia Levels Over Time, by Last Known Ammonia-Scavenging Medication Baseline	64.5 µmol/L Standard Deviation 52.32	49.1 µmol/L Standard Deviation 43.58	48.0 µmol/L Standard Deviation 29.73	21.0 µmol/L Standard Deviation NA 1 participant analyzed	—
Mean Blood Ammonia Levels Over Time, by Last Known Ammonia-Scavenging Medication Day 7 to 30	64.0 µmol/L Standard Deviation 20.53	79.6 µmol/L Standard Deviation 72.23	55.0 µmol/L Standard Deviation NA 1 participant analyzed	—	143.5 µmol/L Standard Deviation 98.29
Mean Blood Ammonia Levels Over Time, by Last Known Ammonia-Scavenging Medication Month 6	48.7 µmol/L Standard Deviation 53.77	45.0 µmol/L Standard Deviation 30.26	190.3 µmol/L Standard Deviation 257.80	48.0 µmol/L Standard Deviation 25.46	129.4 µmol/L Standard Deviation 110.54
Mean Blood Ammonia Levels Over Time, by Last Known Ammonia-Scavenging Medication Month 12	42.4 µmol/L Standard Deviation 20.87	39.4 µmol/L Standard Deviation 24.43	51.0 µmol/L Standard Deviation 16.97	20.0 µmol/L Standard Deviation NA 1 participant analyzed	79.0 µmol/L Standard Deviation 57.98
Mean Blood Ammonia Levels Over Time, by Last Known Ammonia-Scavenging Medication Month 18	54.5 µmol/L Standard Deviation 53.89	45.9 µmol/L Standard Deviation 28.26	29.0 µmol/L Standard Deviation 11.79	13.0 µmol/L Standard Deviation NA 1 participant analyzed	106.0 µmol/L Standard Deviation 110.31
Mean Blood Ammonia Levels Over Time, by Last Known Ammonia-Scavenging Medication Month 24	53.9 µmol/L Standard Deviation 38.49	52.8 µmol/L Standard Deviation 78.14	43.3 µmol/L Standard Deviation 31.26	25.0 µmol/L Standard Deviation NA 1 participant analyzed	—
Mean Blood Ammonia Levels Over Time, by Last Known Ammonia-Scavenging Medication Month 30	42.0 µmol/L Standard Deviation 18.18	47.5 µmol/L Standard Deviation 33.27	79.8 µmol/L Standard Deviation 85.85	—	114.5 µmol/L Standard Deviation 127.99
Mean Blood Ammonia Levels Over Time, by Last Known Ammonia-Scavenging Medication Month 36	36.2 µmol/L Standard Deviation 18.90	45.9 µmol/L Standard Deviation 34.95	72.0 µmol/L Standard Deviation NA 1 participant analyzed	—	51.5 µmol/L Standard Deviation 34.65
Mean Blood Ammonia Levels Over Time, by Last Known Ammonia-Scavenging Medication Month 42	40.2 µmol/L Standard Deviation 14.39	43.3 µmol/L Standard Deviation 27.30	41.5 µmol/L Standard Deviation 0.71	—	—
Mean Blood Ammonia Levels Over Time, by Last Known Ammonia-Scavenging Medication Month 48	61.4 µmol/L Standard Deviation 57.78	54.2 µmol/L Standard Deviation 42.95	36.0 µmol/L Standard Deviation NA 1 participant analyzed	—	22.0 µmol/L Standard Deviation NA 1 participant analyzed
Mean Blood Ammonia Levels Over Time, by Last Known Ammonia-Scavenging Medication Month 54	55.6 µmol/L Standard Deviation 8.59	45.0 µmol/L Standard Deviation 29.44	66.0 µmol/L Standard Deviation 0.00	—	292.0 µmol/L Standard Deviation NA 1 participant analyzed
Mean Blood Ammonia Levels Over Time, by Last Known Ammonia-Scavenging Medication Month 60	57.3 µmol/L Standard Deviation 22.37	45.2 µmol/L Standard Deviation 32.78	8.9 µmol/L Standard Deviation NA 1 participant analyzed	—	—
Mean Blood Ammonia Levels Over Time, by Last Known Ammonia-Scavenging Medication Month 66	62.0 µmol/L Standard Deviation NA 1 participant analyzed	31.0 µmol/L Standard Deviation 11.05	—	—	—
Mean Blood Ammonia Levels Over Time, by Last Known Ammonia-Scavenging Medication Month 72	55.0 µmol/L Standard Deviation NA 1 participant analyzed	45.5 µmol/L Standard Deviation 43.13	—	—	—

PRIMARY outcome

Timeframe: 12 months prior to enrollment (retrospective), Baseline, Day 7 to 30, Month 6, Month 12, Month 18, Month 24, Month 30, Month 36, Month 42, Month 48, Month 54, Month 60, Month 66, Month 72

Retrospective is defined as the 12 months preceding enrollment.

Outcome measures

Outcome measures
Measure	Sodium Phenylbutyrate n=40 Participants Participants with a confirmed or suspected diagnosis of UCD receiving sodium phenylbutyrate.	Ravicti n=67 Participants Participants with a confirmed or suspected diagnosis of UCD receiving Ravicti.	Sodium Benzoate n=6 Participants Participants with a confirmed or suspected diagnosis of UCD receiving sodium benzoate.	Carglumic Acid n=2 Participants Participants with a confirmed or suspected diagnosis of UCD receiving carglumic acid.	Other n=5 Participants Participants with a confirmed or suspected diagnosis of UCD receiving other (not specified) ammonia-scavenging medication.
Median Blood Ammonia Levels Over Time, by Last-Known Ammonia-Scavenging Medication Month 72	55.0 µmol/L Interval 55.0 to 55.0	45.5 µmol/L Interval 15.0 to 76.0	—	—	—
Median Blood Ammonia Levels Over Time, by Last-Known Ammonia-Scavenging Medication Retrospective	46.0 µmol/L Interval 18.0 to 304.0	38.0 µmol/L Interval 11.0 to 95.0	23.0 µmol/L Interval 23.0 to 23.0	13.0 µmol/L Interval 13.0 to 13.0	1360.0 µmol/L Interval 131.0 to 1400.0
Median Blood Ammonia Levels Over Time, by Last-Known Ammonia-Scavenging Medication Baseline	50.0 µmol/L Interval 12.0 to 247.0	37.0 µmol/L Interval 11.0 to 247.0	46.5 µmol/L Interval 20.0 to 99.0	21.0 µmol/L Interval 21.0 to 21.0	—
Median Blood Ammonia Levels Over Time, by Last-Known Ammonia-Scavenging Medication Day 7 to 30	60.0 µmol/L Interval 32.0 to 93.0	61.5 µmol/L Interval 25.0 to 249.0	55.0 µmol/L Interval 55.0 to 55.0	—	143.5 µmol/L Interval 74.0 to 213.0
Median Blood Ammonia Levels Over Time, by Last-Known Ammonia-Scavenging Medication Month 6	33.0 µmol/L Interval 9.0 to 281.0	34.0 µmol/L Interval 9.0 to 158.0	44.0 µmol/L Interval 39.0 to 488.0	48.0 µmol/L Interval 30.0 to 66.0	96.0 µmol/L Interval 22.0 to 312.0
Median Blood Ammonia Levels Over Time, by Last-Known Ammonia-Scavenging Medication Month 12	42.0 µmol/L Interval 10.0 to 83.0	34.5 µmol/L Interval 9.0 to 122.0	51.0 µmol/L Interval 39.0 to 63.0	20.0 µmol/L Interval 20.0 to 20.0	79.0 µmol/L Interval 38.0 to 120.0
Median Blood Ammonia Levels Over Time, by Last-Known Ammonia-Scavenging Medication Month 18	36.0 µmol/L Interval 20.0 to 226.0	45.0 µmol/L Interval 10.0 to 123.0	26.0 µmol/L Interval 19.0 to 42.0	13.0 µmol/L Interval 13.0 to 13.0	51.0 µmol/L Interval 34.0 to 233.0
Median Blood Ammonia Levels Over Time, by Last-Known Ammonia-Scavenging Medication Month 24	47.0 µmol/L Interval 10.0 to 158.0	34.5 µmol/L Interval 9.0 to 575.0	48.0 µmol/L Interval 10.0 to 72.0	25.0 µmol/L Interval 25.0 to 25.0	—
Median Blood Ammonia Levels Over Time, by Last-Known Ammonia-Scavenging Medication Month 30	43.0 µmol/L Interval 19.0 to 81.0	35.0 µmol/L Interval 9.0 to 147.0	52.0 µmol/L Interval 10.0 to 205.0	—	114.5 µmol/L Interval 24.0 to 205.0
Median Blood Ammonia Levels Over Time, by Last-Known Ammonia-Scavenging Medication Month 36	38.0 µmol/L Interval 14.0 to 72.0	34.0 µmol/L Interval 9.0 to 151.0	72.0 µmol/L Interval 72.0 to 72.0	—	51.5 µmol/L Interval 27.0 to 76.0
Median Blood Ammonia Levels Over Time, by Last-Known Ammonia-Scavenging Medication Month 42	40.5 µmol/L Interval 16.0 to 61.0	38.0 µmol/L Interval 10.0 to 124.0	41.5 µmol/L Interval 41.0 to 42.0	—	—
Median Blood Ammonia Levels Over Time, by Last-Known Ammonia-Scavenging Medication Month 48	39.0 µmol/L Interval 21.0 to 187.0	40.0 µmol/L Interval 10.0 to 162.0	36.0 µmol/L Interval 36.0 to 36.0	—	22.0 µmol/L Interval 22.0 to 22.0
Median Blood Ammonia Levels Over Time, by Last-Known Ammonia-Scavenging Medication Month 54	57.0 µmol/L Interval 45.0 to 66.0	35.8 µmol/L Interval 12.0 to 134.0	66.0 µmol/L Interval 66.0 to 66.0	—	292.0 µmol/L Interval 292.0 to 292.0
Median Blood Ammonia Levels Over Time, by Last-Known Ammonia-Scavenging Medication Month 60	62.0 µmol/L Interval 33.0 to 77.0	29.0 µmol/L Interval 11.0 to 113.0	8.9 µmol/L Interval 8.9 to 8.9	—	—
Median Blood Ammonia Levels Over Time, by Last-Known Ammonia-Scavenging Medication Month 66	62.0 µmol/L Interval 62.0 to 62.0	27.5 µmol/L Interval 22.0 to 47.0	—	—	—

PRIMARY outcome

Timeframe: 12 months prior to enrollment (retrospective)

Population: Participants with a baseline visit.

Percentage of participants experiencing HAC (reported for the 12 months preceding enrollment).

Outcome measures

Outcome measures
Measure	Sodium Phenylbutyrate n=49 Participants Participants with a confirmed or suspected diagnosis of UCD receiving sodium phenylbutyrate.	Ravicti n=89 Participants Participants with a confirmed or suspected diagnosis of UCD receiving Ravicti.	Sodium Benzoate n=4 Participants Participants with a confirmed or suspected diagnosis of UCD receiving sodium benzoate.	Carglumic Acid n=1 Participants Participants with a confirmed or suspected diagnosis of UCD receiving carglumic acid.	Other n=60 Participants Participants with a confirmed or suspected diagnosis of UCD receiving other (not specified) ammonia-scavenging medication.
Percentage of Participants With Hyperammonemic Crisis (HAC) by Baseline Ammonia-Scavenging Medication, Retrospective Values	44.9 percentage of participants	15.7 percentage of participants	25.0 percentage of participants	100.0 percentage of participants	8.3 percentage of participants

PRIMARY outcome

Timeframe: From enrollment through the end of study (mean overall duration on study was 1187.7 days).

Population: Participants with a baseline visit and at least 1 measurement of this assessment while on therapy. Participants are grouped by last-known ammonia-scavenging medication; participants may have been on more than 1 therapy during the study and the number of participants analyzed may be greater than the overall number of participants.

Percentage of participants experiencing HAC (post-Baseline).

Outcome measures

Outcome measures
Measure	Sodium Phenylbutyrate n=61 Participants Participants with a confirmed or suspected diagnosis of UCD receiving sodium phenylbutyrate.	Ravicti n=118 Participants Participants with a confirmed or suspected diagnosis of UCD receiving Ravicti.	Sodium Benzoate n=10 Participants Participants with a confirmed or suspected diagnosis of UCD receiving sodium benzoate.	Carglumic Acid n=2 Participants Participants with a confirmed or suspected diagnosis of UCD receiving carglumic acid.	Other n=22 Participants Participants with a confirmed or suspected diagnosis of UCD receiving other (not specified) ammonia-scavenging medication.
Percentage of Participants With Hyperammonemic Crisis (HAC), Post-Baseline by Last Known Ammonia-Scavenging Medication	42.6 percentage of participants	37.3 percentage of participants	40.0 percentage of participants	0 percentage of participants	72.7 percentage of participants

PRIMARY outcome

Timeframe: From enrollment through the end of study (mean overall duration on study was 1187.7 days).

Population: All participants who attended a Baseline visit. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.

An SAE is an adverse event that: is fatal or life-threatening; results in persistent or significant disability or incapacity. Disability is defined as a substantial disruption of a person's ability to conduct normal life functions; requires inpatient hospitalization or prolongation of an existing hospitalization; is a congenital anomaly/birth defect; any other important medical event that may jeopardize the patient and may require medical or surgical intervention to prevent one of the outcomes listed above.

Outcome measures

Outcome measures
Measure	Sodium Phenylbutyrate n=49 Participants Participants with a confirmed or suspected diagnosis of UCD receiving sodium phenylbutyrate.	Ravicti n=89 Participants Participants with a confirmed or suspected diagnosis of UCD receiving Ravicti.	Sodium Benzoate n=4 Participants Participants with a confirmed or suspected diagnosis of UCD receiving sodium benzoate.	Carglumic Acid n=1 Participants Participants with a confirmed or suspected diagnosis of UCD receiving carglumic acid.	Other n=60 Participants Participants with a confirmed or suspected diagnosis of UCD receiving other (not specified) ammonia-scavenging medication.
Number of Participants With Serious Adverse Events (SAEs)	30 Participants	40 Participants	2 Participants	0 Participants	16 Participants

Adverse Events

Sodium Phenylbutyrate

Serious events: 30 serious events

Other events: 0 other events

Deaths: 3 deaths

Ravicti

Serious events: 40 serious events

Other events: 0 other events

Deaths: 2 deaths

Sodium Benzoate

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Carglumic Acid

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Other

Serious events: 16 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Sodium Phenylbutyrate n=49 participants at risk Participants with a confirmed or suspected diagnosis of UCD receiving sodium phenylbutyrate at Baseline.	Ravicti n=89 participants at risk Participants with a confirmed or suspected diagnosis of UCD receiving Ravicti at Baseline.	Sodium Benzoate n=4 participants at risk Participants with a confirmed or suspected diagnosis of UCD receiving sodium benzoate at Baseline.	Carglumic Acid n=1 participants at risk Participants with a confirmed or suspected diagnosis of UCD receiving carglumic acid at Baseline.	Other n=60 participants at risk Participants with a confirmed or suspected diagnosis of UCD receiving other (not specified) ammonia-scavenging medication at Baseline.
Blood and lymphatic system disorders Autoimmune Haemolytic Anaemia	0.00% 0/49 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	1.1% 1/89 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/4 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/1 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/60 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.
Blood and lymphatic system disorders Immune Thrombocytopenic Purpura	0.00% 0/49 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	1.1% 1/89 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/4 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/1 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/60 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.
Cardiac disorders Acute Myocardial Infarction	0.00% 0/49 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	1.1% 1/89 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/4 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/1 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/60 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.
Cardiac disorders Cardiac Arrest	2.0% 1/49 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/89 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/4 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/1 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/60 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.
Congenital, familial and genetic disorders Arginase Deficiency	0.00% 0/49 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	1.1% 1/89 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/4 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/1 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/60 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.
Eye disorders Eye Swelling	0.00% 0/49 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	1.1% 1/89 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/4 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/1 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/60 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.
Gastrointestinal disorders Abdominal Pain	0.00% 0/49 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	3.4% 3/89 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	25.0% 1/4 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/1 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/60 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.
Gastrointestinal disorders Constipation	2.0% 1/49 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	1.1% 1/89 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/4 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/1 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/60 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.
Gastrointestinal disorders Diarrhoea	6.1% 3/49 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	1.1% 1/89 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	25.0% 1/4 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/1 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/60 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.
Gastrointestinal disorders Diarrhoea Haemorrhagic	0.00% 0/49 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	1.1% 1/89 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/4 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/1 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/60 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.
Gastrointestinal disorders Intestinal Perforation	2.0% 1/49 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/89 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/4 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/1 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/60 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.
Gastrointestinal disorders Nausea	2.0% 1/49 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/89 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	25.0% 1/4 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/1 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/60 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.
Gastrointestinal disorders Pancreatitis	2.0% 1/49 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/89 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/4 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/1 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/60 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.
Gastrointestinal disorders Small Intestinal Obstruction	2.0% 1/49 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/89 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/4 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/1 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/60 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.
Gastrointestinal disorders Stomatitis	0.00% 0/49 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/89 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/4 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/1 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	1.7% 1/60 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.
Gastrointestinal disorders Vomiting	14.3% 7/49 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	5.6% 5/89 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	25.0% 1/4 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/1 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	3.3% 2/60 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.
General disorders Death	0.00% 0/49 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/89 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/4 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/1 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	1.7% 1/60 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.
General disorders Medical Device Site Pain	0.00% 0/49 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/89 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	25.0% 1/4 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/1 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/60 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.
General disorders Pneumatosis	2.0% 1/49 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/89 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/4 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/1 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/60 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.
General disorders Pyrexia	6.1% 3/49 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	2.2% 2/89 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/4 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/1 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/60 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.
Hepatobiliary disorders Bile Duct Stenosis	0.00% 0/49 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/89 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/4 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/1 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	1.7% 1/60 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.
Hepatobiliary disorders Hepatic Artery Thrombosis	4.1% 2/49 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/89 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/4 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/1 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/60 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.
Hepatobiliary disorders Hepatic Function Abnormal	0.00% 0/49 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	1.1% 1/89 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/4 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/1 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/60 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.
Immune system disorders Anaphylactic Reaction	0.00% 0/49 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/89 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/4 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/1 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	1.7% 1/60 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.
Infections and infestations Appendicitis Perforated	2.0% 1/49 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/89 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/4 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/1 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/60 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.
Infections and infestations Bronchiolitis	2.0% 1/49 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/89 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/4 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/1 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	1.7% 1/60 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.
Infections and infestations Cellulitis	0.00% 0/49 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	1.1% 1/89 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/4 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/1 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	1.7% 1/60 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.
Infections and infestations Clostridium Difficile Infection	4.1% 2/49 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/89 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/4 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/1 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	1.7% 1/60 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.
Infections and infestations Corona Virus Infection	2.0% 1/49 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/89 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/4 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/1 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/60 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.
Infections and infestations Croup Infectious	0.00% 0/49 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/89 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/4 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/1 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	1.7% 1/60 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.
Infections and infestations Ear Infection	0.00% 0/49 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/89 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	25.0% 1/4 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/1 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/60 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.
Infections and infestations Enterobacter Sepsis	0.00% 0/49 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	1.1% 1/89 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/4 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/1 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/60 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.
Infections and infestations Escherichia Infection	0.00% 0/49 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/89 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/4 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/1 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	1.7% 1/60 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.
Infections and infestations Gastroenteritis	2.0% 1/49 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	1.1% 1/89 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/4 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/1 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/60 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.
Infections and infestations Gastroenteritis Viral	4.1% 2/49 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	4.5% 4/89 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/4 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/1 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	5.0% 3/60 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.
Infections and infestations Gastrointestinal Viral Infection	0.00% 0/49 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/89 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/4 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/1 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	1.7% 1/60 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.
Infections and infestations Human Herpesvirus 6 Infection	2.0% 1/49 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/89 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/4 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/1 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/60 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.
Infections and infestations Influenza	4.1% 2/49 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	2.2% 2/89 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/4 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/1 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	3.3% 2/60 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.
Infections and infestations Medical Device Site Cellulitis	0.00% 0/49 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/89 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	25.0% 1/4 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/1 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/60 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.
Infections and infestations Metapneumovirus Infection	2.0% 1/49 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/89 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/4 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/1 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/60 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.
Infections and infestations Otitis Media Acute	2.0% 1/49 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/89 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/4 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/1 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	1.7% 1/60 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.
Infections and infestations Pneumonia Respiratory Syncytial Viral	2.0% 1/49 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/89 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/4 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/1 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/60 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.
Infections and infestations Pyelonephritis	0.00% 0/49 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/89 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/4 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/1 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	1.7% 1/60 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.
Infections and infestations Respiratory Syncytial Virus Bronchiolitis	0.00% 0/49 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	1.1% 1/89 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/4 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/1 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/60 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.
Infections and infestations Salmonellosis	2.0% 1/49 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/89 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/4 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/1 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/60 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.
Infections and infestations Subcutaneous Abscess	0.00% 0/49 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/89 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/4 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/1 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	1.7% 1/60 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.
Infections and infestations Upper Respiratory Tract Infection	2.0% 1/49 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/89 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/4 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/1 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	3.3% 2/60 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.
Infections and infestations Urinary Tract Infection	2.0% 1/49 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/89 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	25.0% 1/4 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/1 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/60 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.
Infections and infestations Viral Infection	0.00% 0/49 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	2.2% 2/89 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/4 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/1 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	1.7% 1/60 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.
Infections and infestations Viral Upper Respiratory Tract Infection	4.1% 2/49 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	1.1% 1/89 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/4 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/1 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/60 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.
Injury, poisoning and procedural complications Accidental Overdose	0.00% 0/49 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	1.1% 1/89 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/4 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/1 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/60 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.
Injury, poisoning and procedural complications Femur Fracture	2.0% 1/49 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	1.1% 1/89 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/4 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/1 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/60 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.
Injury, poisoning and procedural complications Procedural Vomiting	0.00% 0/49 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/89 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/4 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/1 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	1.7% 1/60 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.
Injury, poisoning and procedural complications Road Traffic Accident	2.0% 1/49 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	2.2% 2/89 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/4 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/1 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/60 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.
Investigations Ammonia Increased	4.1% 2/49 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/89 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/4 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/1 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/60 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.
Investigations Norovirus Test Positive	0.00% 0/49 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	1.1% 1/89 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/4 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/1 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/60 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.
Investigations Streptococcus Test Positive	0.00% 0/49 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	1.1% 1/89 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/4 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/1 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/60 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.
Investigations Transaminases Increased	0.00% 0/49 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	1.1% 1/89 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/4 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/1 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	1.7% 1/60 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.
Metabolism and nutrition disorders Dehydration	0.00% 0/49 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	1.1% 1/89 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/4 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/1 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	1.7% 1/60 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.
Metabolism and nutrition disorders Failure To Thrive	2.0% 1/49 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/89 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/4 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/1 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/60 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.
Metabolism and nutrition disorders Feeding Intolerance	2.0% 1/49 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/89 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/4 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/1 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/60 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.
Metabolism and nutrition disorders Fluid Overload	2.0% 1/49 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/89 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/4 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/1 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/60 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.
Metabolism and nutrition disorders Hyperammonaemia	38.8% 19/49 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	29.2% 26/89 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/4 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/1 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	3.3% 2/60 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.
Metabolism and nutrition disorders Hyperammonaemic Crisis	16.3% 8/49 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	3.4% 3/89 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/4 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/1 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	1.7% 1/60 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.
Metabolism and nutrition disorders Hypernatraemia	2.0% 1/49 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/89 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/4 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/1 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/60 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.
Metabolism and nutrition disorders Hypoglycaemia	2.0% 1/49 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	1.1% 1/89 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/4 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/1 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/60 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.
Metabolism and nutrition disorders Hypokalaemia	2.0% 1/49 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/89 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/4 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/1 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/60 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.
Metabolism and nutrition disorders Hypophagia	0.00% 0/49 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/89 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/4 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/1 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	1.7% 1/60 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.
Metabolism and nutrition disorders Metabolic Acidosis	0.00% 0/49 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/89 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/4 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/1 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	1.7% 1/60 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.
Metabolism and nutrition disorders Metabolic Disorder	0.00% 0/49 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/89 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/4 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/1 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	1.7% 1/60 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.
Musculoskeletal and connective tissue disorders Costochondritis	2.0% 1/49 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/89 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/4 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/1 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/60 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.
Musculoskeletal and connective tissue disorders Joint Swelling	0.00% 0/49 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/89 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/4 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/1 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	1.7% 1/60 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.
Musculoskeletal and connective tissue disorders Muscular Weakness	0.00% 0/49 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	1.1% 1/89 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/4 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/1 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/60 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.
Musculoskeletal and connective tissue disorders Pain In Extremity	0.00% 0/49 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	1.1% 1/89 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/4 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/1 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/60 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.
Musculoskeletal and connective tissue disorders Scoliosis	0.00% 0/49 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	1.1% 1/89 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/4 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/1 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/60 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.
Nervous system disorders Altered State Of Consciousness	2.0% 1/49 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/89 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/4 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/1 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/60 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.
Nervous system disorders Cerebral Venous Thrombosis	2.0% 1/49 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/89 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/4 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/1 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/60 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.
Nervous system disorders Chorea	0.00% 0/49 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/89 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/4 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/1 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	1.7% 1/60 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.
Nervous system disorders Dizziness	0.00% 0/49 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	1.1% 1/89 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/4 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/1 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/60 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.
Nervous system disorders Encephalopathy	0.00% 0/49 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	1.1% 1/89 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/4 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/1 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/60 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.
Nervous system disorders Epileptic Encephalopathy	2.0% 1/49 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/89 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/4 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/1 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/60 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.
Nervous system disorders Febrile Convulsion	2.0% 1/49 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/89 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/4 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/1 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/60 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.
Nervous system disorders Guillain-Barre Syndrome	2.0% 1/49 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/89 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/4 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/1 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/60 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.
Nervous system disorders Headache	0.00% 0/49 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	1.1% 1/89 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/4 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/1 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/60 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.
Nervous system disorders Hyperammonaemic Encephalopathy	2.0% 1/49 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	1.1% 1/89 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/4 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/1 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/60 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.
Nervous system disorders Incoherent	0.00% 0/49 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	1.1% 1/89 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/4 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/1 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/60 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.
Nervous system disorders Ischaemic Stroke	0.00% 0/49 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/89 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/4 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/1 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	1.7% 1/60 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.
Nervous system disorders Metabolic Encephalopathy	0.00% 0/49 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	1.1% 1/89 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/4 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/1 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/60 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.
Nervous system disorders Motor Developmental Delay	2.0% 1/49 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/89 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/4 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/1 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/60 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.
Nervous system disorders Seizure	0.00% 0/49 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	2.2% 2/89 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	25.0% 1/4 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/1 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/60 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.
Pregnancy, puerperium and perinatal conditions Delivery	0.00% 0/49 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	1.1% 1/89 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/4 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/1 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/60 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.
Product Issues Device Dislocation	2.0% 1/49 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/89 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/4 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/1 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/60 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.
Pregnancy, puerperium and perinatal conditions Device Occlusion	2.0% 1/49 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/89 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/4 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/1 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/60 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.
Psychiatric disorders Aggression	0.00% 0/49 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/89 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/4 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/1 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	1.7% 1/60 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.
Psychiatric disorders Confusional State	2.0% 1/49 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/89 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/4 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/1 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/60 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.
Psychiatric disorders Conversion Disorder	0.00% 0/49 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	1.1% 1/89 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/4 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/1 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/60 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.
Psychiatric disorders Delirium	0.00% 0/49 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	1.1% 1/89 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/4 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/1 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/60 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.
Psychiatric disorders Mental Status Changes	4.1% 2/49 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	3.4% 3/89 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/4 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/1 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/60 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.
Renal and urinary disorders Acute Kidney Injury	0.00% 0/49 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	1.1% 1/89 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/4 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/1 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/60 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.
Renal and urinary disorders Renal Failure	0.00% 0/49 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	1.1% 1/89 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/4 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/1 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/60 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.
Reproductive system and breast disorders Adnexal Torsion	0.00% 0/49 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	1.1% 1/89 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/4 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/1 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/60 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.
Respiratory, thoracic and mediastinal disorders Acute Respiratory Failure	2.0% 1/49 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/89 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/4 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/1 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/60 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.
Respiratory, thoracic and mediastinal disorders Dyspnoea	2.0% 1/49 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/89 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/4 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/1 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/60 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.
Respiratory, thoracic and mediastinal disorders Pleural Effusion	2.0% 1/49 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/89 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/4 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/1 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/60 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.
Respiratory, thoracic and mediastinal disorders Respiratory Disorder	2.0% 1/49 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/89 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/4 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/1 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/60 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.
Respiratory, thoracic and mediastinal disorders Respiratory Distress	2.0% 1/49 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/89 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/4 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/1 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/60 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.
Respiratory, thoracic and mediastinal disorders Respiratory Failure	2.0% 1/49 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/89 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/4 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/1 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/60 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.
Respiratory, thoracic and mediastinal disorders Sleep Apnoea Syndrome	0.00% 0/49 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/89 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/4 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/1 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	1.7% 1/60 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.
Respiratory, thoracic and mediastinal disorders Vocal Cord Disorder	0.00% 0/49 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	1.1% 1/89 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/4 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/1 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/60 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.
Social circumstances Treatment Noncompliance	2.0% 1/49 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/89 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/4 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/1 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/60 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.
Surgical and medical procedures Spinal Fusion Surgery	0.00% 0/49 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	1.1% 1/89 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/4 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/1 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/60 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.
Vascular disorders Deep Vein Thrombosis	0.00% 0/49 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	1.1% 1/89 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/4 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/1 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/60 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.
Vascular disorders Thrombophlebitis	0.00% 0/49 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/89 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/4 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	0.00% 0/1 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.	1.7% 1/60 • From enrollment through the end of study (mean overall duration on study was 1187.7 days). Per protocol, non-serious adverse events were not collected in this observational registry study. Due to data collection complexities in this observational study (e.g., switching of medications, incomplete data on medications, and missing SAE dates) AEs could not be reliably summarized according to a participant's treatment at the time of SAE, and was therefore summarized by treatment at baseline.

Other adverse events

Adverse event data not reported

Additional Information

Horizon Therapeutics, LLC

Phone: 866-479-6742

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Horizon requests that any investigator/institution that plans on presenting/publishing results provide written notification of their request 60 days prior to their presentation/publication. Horizon requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if Horizon needs to secure patent or proprietary protection.
Publication restrictions are in place

Restriction type: OTHER