Trial Outcomes & Findings for MS Study Evaluating Safety and Efficacy of Two Doses of Fingolimod Versus Copaxone (NCT NCT01633112)

Last Updated: 2019-05-28

Results Overview

Annualized relapse rate (ARR) was defined as the average number of confirmed relapses per year (i.e., the total number of confirmed relapses divided by the total days in the study multiplied by 365.25). The number of relapses included all the confirmed relapses experienced during the study from first dose to end of study.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

1064 participants

Primary outcome timeframe

up to 12 months

Results posted on

2019-05-28

Participant Flow

A total of 1461 subjects were screened for participation in this study; of those, 1064 subjects were randomly assigned to study treatment

Participant milestones

Participant milestones
Measure	FTY720 0.5 mg Fingolimod (FTY720) 0.5 mg orally once a day for up to 12 months	FTY720 0.25 mg Fingolimod (FTY720) 0.25 mg orally once a day for up to 12 months	GA 20 mg Glatiramer acetate (GA) 20 mg s.c. once a day for up to 12 months
Overall Study STARTED	352	370	342
Overall Study COMPLETED	299	310	250
Overall Study NOT COMPLETED	53	60	92

Reasons for withdrawal

Reasons for withdrawal
Measure	FTY720 0.5 mg Fingolimod (FTY720) 0.5 mg orally once a day for up to 12 months	FTY720 0.25 mg Fingolimod (FTY720) 0.25 mg orally once a day for up to 12 months	GA 20 mg Glatiramer acetate (GA) 20 mg s.c. once a day for up to 12 months
Overall Study Lack of Efficacy	1	6	13
Overall Study Abnormal laboratory value(s)	3	1	0
Overall Study Abnormal test procedure result(s)	0	1	0
Overall Study Administrative problems	1	2	5
Overall Study Adverse Event	16	18	20
Overall Study Lost to Follow-up	7	19	6
Overall Study Protocol Violation	4	0	2
Overall Study Subject no longer requires study drug	0	0	1
Overall Study Withdrawal by Subject	20	12	41
Overall Study missing Study Completion CRF	1	1	4

Baseline Characteristics

MS Study Evaluating Safety and Efficacy of Two Doses of Fingolimod Versus Copaxone

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	FTY720 0.5 mg n=352 Participants Fingolimod (FTY720) 0.5 mg orally once a day for up to 12 months	FTY720 0.25 mg n=370 Participants Fingolimod (FTY720) 0.25 mg orally once a day for up to 12 months	GA 20 mg n=342 Participants Glatiramer acetate (GA) 20 mg s.c. once a day for up to 12 months	Total n=1064 Participants Total of all reporting groups
Age, Continuous	40.3 Years STANDARD_DEVIATION 11.12 • n=5 Participants	38.9 Years STANDARD_DEVIATION 11.01 • n=7 Participants	39.6 Years STANDARD_DEVIATION 10.80 • n=5 Participants	39.6 Years STANDARD_DEVIATION 10.98 • n=4 Participants
Sex: Female, Male Female	264 Participants n=5 Participants	276 Participants n=7 Participants	252 Participants n=5 Participants	792 Participants n=4 Participants
Sex: Female, Male Male	88 Participants n=5 Participants	94 Participants n=7 Participants	90 Participants n=5 Participants	272 Participants n=4 Participants
Race/Ethnicity, Customized Caucasian	268 Participants n=5 Participants	279 Participants n=7 Participants	243 Participants n=5 Participants	790 Participants n=4 Participants
Race/Ethnicity, Customized Black	34 Participants n=5 Participants	43 Participants n=7 Participants	41 Participants n=5 Participants	118 Participants n=4 Participants
Race/Ethnicity, Customized Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race/Ethnicity, Customized Native American	8 Participants n=5 Participants	7 Participants n=7 Participants	9 Participants n=5 Participants	24 Participants n=4 Participants
Race/Ethnicity, Customized Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race/Ethnicity, Customized Other	42 Participants n=5 Participants	39 Participants n=7 Participants	49 Participants n=5 Participants	130 Participants n=4 Participants

PRIMARY outcome

Timeframe: up to 12 months

Population: Full-analysis set: All subjects who were randomly assigned and took at least 1 dose of study drug. Following the intent-to-treat principle, subjects were grouped according to the assigned treatment at randomization. Efficacy analyses were performed using the full analysis set unless otherwise notified.

Outcome measures

Outcome measures
Measure	FTY720 0.5 mg n=345 Participants Fingolimod (FTY720) 0.5 mg orally once a day for up to 12 months	FTY720 0.25 mg n=366 Participants Fingolimod (FTY720) 0.25 mg orally once a day for up to 12 months	GA 20 mg n=324 Participants Glatiramer acetate (GA) 20 mg s.c. once a day for up to 12 months
Confirmed Annualized Relapse Rate	0.153 relapses/year Interval 0.111 to 0.212	0.221 relapses/year Interval 0.168 to 0.29	0.258 relapses/year Interval 0.196 to 0.341

SECONDARY outcome

Timeframe: At 12 months/end of study

Inflammatory activity based on MRI measurement of new/newly enlarged T2 lesion count.

Outcome measures

Outcome measures
Measure	FTY720 0.5 mg n=345 Participants Fingolimod (FTY720) 0.5 mg orally once a day for up to 12 months	FTY720 0.25 mg n=366 Participants Fingolimod (FTY720) 0.25 mg orally once a day for up to 12 months	GA 20 mg n=324 Participants Glatiramer acetate (GA) 20 mg s.c. once a day for up to 12 months
New or Newly Enlarging T2 Lesions	2.6 Lesions Standard Deviation 5.42	3.3 Lesions Standard Deviation 6.94	5.7 Lesions Standard Deviation 10.71

SECONDARY outcome

Timeframe: At 12 months/end of study

Inflammatory activity based on MRI measurement of new/newly enlarged T2 lesion count.

Outcome measures

Outcome measures
Measure	FTY720 0.5 mg n=345 Participants Fingolimod (FTY720) 0.5 mg orally once a day for up to 12 months	FTY720 0.25 mg n=366 Participants Fingolimod (FTY720) 0.25 mg orally once a day for up to 12 months	GA 20 mg n=324 Participants Glatiramer acetate (GA) 20 mg s.c. once a day for up to 12 months
Number of Participants Free of New/Newly Enlarged T2 Lesions	156 Participants	155 Participants	96 Participants

SECONDARY outcome

Timeframe: Baseline, 12 months/end of study

Inflammatory activity based on MRI measurement of new/newly enlarged T2 lesion volume

Outcome measures

Outcome measures
Measure	FTY720 0.5 mg n=345 Participants Fingolimod (FTY720) 0.5 mg orally once a day for up to 12 months	FTY720 0.25 mg n=366 Participants Fingolimod (FTY720) 0.25 mg orally once a day for up to 12 months	GA 20 mg n=324 Participants Glatiramer acetate (GA) 20 mg s.c. once a day for up to 12 months
Change From Baseline in T2 Lesion Volume	-0.14 cubic centimeters (cc) Standard Deviation 1.583	-0.05 cubic centimeters (cc) Standard Deviation 2.340	0.42 cubic centimeters (cc) Standard Deviation 2.305

SECONDARY outcome

Timeframe: At 12 months/end of study

Inflammatory activity based on MRI measurement of Gd enhancing T1 lesion count

Outcome measures

Outcome measures
Measure	FTY720 0.5 mg n=345 Participants Fingolimod (FTY720) 0.5 mg orally once a day for up to 12 months	FTY720 0.25 mg n=366 Participants Fingolimod (FTY720) 0.25 mg orally once a day for up to 12 months	GA 20 mg n=324 Participants Glatiramer acetate (GA) 20 mg s.c. once a day for up to 12 months
Gd Enhancing T1 Lesion Count	0.4 lesions Standard Deviation 1.57	0.4 lesions Standard Deviation 1.56	0.9 lesions Standard Deviation 3.67

SECONDARY outcome

Timeframe: Baseline, 12 months/end of study

Inflammatory activity based on MRI measurement of Gd enhancing T1 lesion count

Outcome measures

Outcome measures
Measure	FTY720 0.5 mg n=345 Participants Fingolimod (FTY720) 0.5 mg orally once a day for up to 12 months	FTY720 0.25 mg n=366 Participants Fingolimod (FTY720) 0.25 mg orally once a day for up to 12 months	GA 20 mg n=324 Participants Glatiramer acetate (GA) 20 mg s.c. once a day for up to 12 months
Gd Enhancing T1 Lesion Volume Baseline	0.31 cubic centimeter Standard Deviation 1.067	0.32 cubic centimeter Standard Deviation 1.421	0.22 cubic centimeter Standard Deviation 0.841
Gd Enhancing T1 Lesion Volume Month 12/end of study	0.06 cubic centimeter Standard Deviation 0.215	0.05 cubic centimeter Standard Deviation 0.181	0.12 cubic centimeter Standard Deviation 0.450

SECONDARY outcome

Timeframe: 12 months

Based on MRI measures of new T1 hypointense lesions

Outcome measures

Outcome measures
Measure	FTY720 0.5 mg n=345 Participants Fingolimod (FTY720) 0.5 mg orally once a day for up to 12 months	FTY720 0.25 mg n=366 Participants Fingolimod (FTY720) 0.25 mg orally once a day for up to 12 months	GA 20 mg n=324 Participants Glatiramer acetate (GA) 20 mg s.c. once a day for up to 12 months
Percentage of Patients Free of New T1 Hypointense Lesions	55.3 Percentage	52.1 Percentage	44.3 Percentage

SECONDARY outcome

Timeframe: 6 months, 12 months/end of study

Treatment Satisfaction Questionnaire for Medication (TSQM) was developed and validated as a general measure for treatment satisfaction. Each scale score was calculated by summing individual items and then transformed to a 0-100 scale. Higher summary scores indicate better satisfaction with study drug.

Outcome measures

Outcome measures
Measure	FTY720 0.5 mg n=345 Participants Fingolimod (FTY720) 0.5 mg orally once a day for up to 12 months	FTY720 0.25 mg n=366 Participants Fingolimod (FTY720) 0.25 mg orally once a day for up to 12 months	GA 20 mg n=324 Participants Glatiramer acetate (GA) 20 mg s.c. once a day for up to 12 months
Change From Baseline in TSQM Scales Convenience (Month 6)	30.7 score on a scale Standard Deviation 25.76	26.5 score on a scale Standard Deviation 25.93	4.4 score on a scale Standard Deviation 20.73
Change From Baseline in TSQM Scales Global Satisfaction (Month 6)	20.8 score on a scale Standard Deviation 28.15	23.4 score on a scale Standard Deviation 27.04	14.4 score on a scale Standard Deviation 25.42
Change From Baseline in TSQM Scales Global Satisfaction (Month 12)	19.2 score on a scale Standard Deviation 31.87	20.5 score on a scale Standard Deviation 32.21	9.4 score on a scale Standard Deviation 30.43
Change From Baseline in TSQM Scales Effectiveness (Month 6)	15.2 score on a scale Standard Deviation 25.96	18.2 score on a scale Standard Deviation 25.05	12.9 score on a scale Standard Deviation 23.43
Change From Baseline in TSQM Scales Effectiveness (Month 12)	16.8 score on a scale Standard Deviation 26.85	17.9 score on a scale Standard Deviation 28.29	8.0 score on a scale Standard Deviation 27.38
Change From Baseline in TSQM Scales Side Effects (Month 6)	16.9 score on a scale Standard Deviation 31.58	18.8 score on a scale Standard Deviation 30.63	9.3 score on a scale Standard Deviation 31.94
Change From Baseline in TSQM Scales Side Effects (Month 12)	16.2 score on a scale Standard Deviation 31.52	17.2 score on a scale Standard Deviation 32.52	7.6 score on a scale Standard Deviation 32.76
Change From Baseline in TSQM Scales Convenience (Month 12)	29.5 score on a scale Standard Deviation 24.42	26.5 score on a scale Standard Deviation 26.36	0.8 score on a scale Standard Deviation 25.72

SECONDARY outcome

Timeframe: Baseline, 12 months, end of study

Using a Central MRI vendor to ensure calibrated MRI scanning equipment across all sites, MRI scans were performed on subjects following the established parameters and transferred to the central vendor for review of quality and assessment/evaluation.

Outcome measures

Outcome measures
Measure	FTY720 0.5 mg n=345 Participants Fingolimod (FTY720) 0.5 mg orally once a day for up to 12 months	FTY720 0.25 mg n=366 Participants Fingolimod (FTY720) 0.25 mg orally once a day for up to 12 months	GA 20 mg n=324 Participants Glatiramer acetate (GA) 20 mg s.c. once a day for up to 12 months
Percent Brain Volume Change From Baseline	-0.652 Percentages of volume change Standard Deviation 0.7810	-0.636 Percentages of volume change Standard Deviation 0.8097	-0.561 Percentages of volume change Standard Deviation 0.7819

Adverse Events

Fingolimod 0.5 mg

Serious events: 25 serious events

Other events: 214 other events

Deaths: 0 deaths

FTY 0.25 mg

Serious events: 32 serious events

Other events: 245 other events

Deaths: 0 deaths

GA 20 mg

Serious events: 20 serious events

Other events: 190 other events

Deaths: 0 deaths

All@Patients

Serious events: 77 serious events

Other events: 649 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: 862-778-8300

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
Publication restrictions are in place

Restriction type: OTHER

Serious adverse events
Measure	Fingolimod 0.5 mg n=345 participants at risk Fingolimod (FTY720) 0.5 mg orally once a day for up to 12 months	FTY 0.25 mg n=366 participants at risk Fingolimod (FTY720) 0.25 mg orally once a day for up to 12 months	GA 20 mg n=324 participants at risk Glatiramer acetate (GA) 20 mg s.c. once a day for up to 12 months	All@Patients n=1035 participants at risk All patients in the trial
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.29% 1/345 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	0.27% 1/366 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	0.00% 0/324 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	0.19% 2/1035 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.
Blood and lymphatic system disorders Anaemia	0.29% 1/345 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	0.00% 0/366 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	0.00% 0/324 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	0.10% 1/1035 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/345 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	0.55% 2/366 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	0.00% 0/324 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	0.19% 2/1035 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.
Cardiac disorders Acute myocardial infarction	0.00% 0/345 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	0.00% 0/366 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	0.31% 1/324 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	0.10% 1/1035 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.
Cardiac disorders Angina pectoris	0.29% 1/345 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	0.27% 1/366 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	0.00% 0/324 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	0.19% 2/1035 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.
Cardiac disorders Atrioventricular block second degree	0.29% 1/345 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	0.00% 0/366 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	0.00% 0/324 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	0.10% 1/1035 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.
Cardiac disorders Bradycardia	0.00% 0/345 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	0.27% 1/366 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	0.00% 0/324 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	0.10% 1/1035 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.
Cardiac disorders Cardiac arrest	0.00% 0/345 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	0.00% 0/366 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	0.31% 1/324 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	0.10% 1/1035 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.
Cardiac disorders Coronary artery stenosis	0.00% 0/345 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	0.00% 0/366 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	0.31% 1/324 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	0.10% 1/1035 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.
Cardiac disorders Palpitations	0.00% 0/345 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	0.00% 0/366 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	0.31% 1/324 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	0.10% 1/1035 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.
Cardiac disorders Sinus bradycardia	0.29% 1/345 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	0.00% 0/366 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	0.00% 0/324 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	0.10% 1/1035 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.
Cardiac disorders Tachycardia	0.00% 0/345 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	0.27% 1/366 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	0.00% 0/324 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	0.10% 1/1035 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.
Cardiac disorders Ventricular fibrillation	0.00% 0/345 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	0.00% 0/366 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	0.31% 1/324 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	0.10% 1/1035 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.
Ear and labyrinth disorders Vertigo	0.00% 0/345 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	0.00% 0/366 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	0.31% 1/324 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	0.10% 1/1035 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.
Endocrine disorders Pituitary-dependent Cushing's syndrome	0.00% 0/345 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	0.27% 1/366 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	0.00% 0/324 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	0.10% 1/1035 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.
Gastrointestinal disorders Abdominal hernia	0.00% 0/345 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	0.27% 1/366 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	0.00% 0/324 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	0.10% 1/1035 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.
Gastrointestinal disorders Abdominal pain upper	0.29% 1/345 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	0.00% 0/366 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	0.00% 0/324 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	0.10% 1/1035 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.
Gastrointestinal disorders Hypoaesthesia oral	0.29% 1/345 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	0.00% 0/366 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	0.00% 0/324 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	0.10% 1/1035 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.
Gastrointestinal disorders Pancreatitis	0.29% 1/345 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	0.00% 0/366 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	0.31% 1/324 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	0.19% 2/1035 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.
General disorders Chest pain	0.29% 1/345 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	0.00% 0/366 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	0.00% 0/324 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	0.10% 1/1035 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.
General disorders Feeling cold	0.29% 1/345 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	0.00% 0/366 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	0.00% 0/324 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	0.10% 1/1035 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.
General disorders Gait disturbance	0.00% 0/345 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	0.55% 2/366 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	0.00% 0/324 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	0.19% 2/1035 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.
General disorders Non-cardiac chest pain	0.29% 1/345 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	0.00% 0/366 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	0.00% 0/324 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	0.10% 1/1035 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.
General disorders Pyrexia	0.29% 1/345 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	0.27% 1/366 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	0.00% 0/324 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	0.19% 2/1035 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.
Hepatobiliary disorders Cholecystitis	0.29% 1/345 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	0.27% 1/366 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	0.00% 0/324 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	0.19% 2/1035 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.
Hepatobiliary disorders Hepatic steatosis	0.29% 1/345 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	0.00% 0/366 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	0.00% 0/324 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	0.10% 1/1035 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.
Infections and infestations Appendicitis	0.00% 0/345 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	0.27% 1/366 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	0.00% 0/324 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	0.10% 1/1035 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.
Infections and infestations Arthritis bacterial	0.29% 1/345 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	0.00% 0/366 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	0.00% 0/324 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	0.10% 1/1035 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.
Infections and infestations Bronchitis	0.00% 0/345 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	0.27% 1/366 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	0.00% 0/324 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	0.10% 1/1035 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.
Infections and infestations Cellulitis	0.00% 0/345 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	0.27% 1/366 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	0.00% 0/324 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	0.10% 1/1035 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.
Infections and infestations Clostridium difficile colitis	0.29% 1/345 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	0.00% 0/366 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	0.00% 0/324 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	0.10% 1/1035 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.
Infections and infestations Device related sepsis	0.00% 0/345 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	0.00% 0/366 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	0.31% 1/324 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	0.10% 1/1035 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.
Infections and infestations Diverticulitis	0.00% 0/345 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	0.00% 0/366 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	0.31% 1/324 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	0.10% 1/1035 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.
Infections and infestations Extradural abscess	0.00% 0/345 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	0.27% 1/366 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	0.00% 0/324 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	0.10% 1/1035 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.
Infections and infestations Gastroenteritis	0.00% 0/345 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	0.27% 1/366 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	0.00% 0/324 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	0.10% 1/1035 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.
Infections and infestations Gastroenteritis viral	0.29% 1/345 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	0.00% 0/366 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	0.00% 0/324 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	0.10% 1/1035 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.
Infections and infestations Influenza	0.29% 1/345 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	0.00% 0/366 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	0.00% 0/324 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	0.10% 1/1035 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.
Infections and infestations Meningitis fungal	0.00% 0/345 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	0.27% 1/366 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	0.00% 0/324 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	0.10% 1/1035 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.
Infections and infestations Parainfluenzae virus infection	0.00% 0/345 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	0.27% 1/366 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	0.00% 0/324 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	0.10% 1/1035 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.
Infections and infestations Pneumonia	0.29% 1/345 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	0.00% 0/366 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	0.00% 0/324 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	0.10% 1/1035 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.

Other adverse events
Measure	Fingolimod 0.5 mg n=345 participants at risk Fingolimod (FTY720) 0.5 mg orally once a day for up to 12 months	FTY 0.25 mg n=366 participants at risk Fingolimod (FTY720) 0.25 mg orally once a day for up to 12 months	GA 20 mg n=324 participants at risk Glatiramer acetate (GA) 20 mg s.c. once a day for up to 12 months	All@Patients n=1035 participants at risk All patients in the trial
Blood and lymphatic system disorders Lymphopenia	6.7% 23/345 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	4.9% 18/366 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	0.31% 1/324 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	4.1% 42/1035 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.
Gastrointestinal disorders Diarrhoea	6.1% 21/345 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	6.3% 23/366 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	3.1% 10/324 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	5.2% 54/1035 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.
Gastrointestinal disorders Nausea	7.0% 24/345 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	8.2% 30/366 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	4.6% 15/324 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	6.7% 69/1035 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.
General disorders Fatigue	13.3% 46/345 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	12.6% 46/366 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	6.8% 22/324 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	11.0% 114/1035 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.
General disorders Injection site erythema	0.00% 0/345 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	0.00% 0/366 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	10.5% 34/324 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	3.3% 34/1035 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.
General disorders Injection site pain	0.00% 0/345 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	0.00% 0/366 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	11.1% 36/324 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	3.5% 36/1035 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.
General disorders Injection site pruritus	0.00% 0/345 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	0.00% 0/366 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	8.0% 26/324 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	2.5% 26/1035 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.
General disorders Injection site reaction	0.00% 0/345 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	0.00% 0/366 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	6.5% 21/324 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	2.0% 21/1035 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.
Infections and infestations Nasopharyngitis	6.7% 23/345 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	6.3% 23/366 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	4.3% 14/324 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	5.8% 60/1035 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.
Infections and infestations Upper respiratory tract infection	8.7% 30/345 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	9.6% 35/366 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	6.2% 20/324 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	8.2% 85/1035 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.
Infections and infestations Urinary tract infection	12.8% 44/345 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	11.7% 43/366 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	10.8% 35/324 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	11.8% 122/1035 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.
Investigations Alanine aminotransferase increased	5.8% 20/345 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	4.1% 15/366 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	1.2% 4/324 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	3.8% 39/1035 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.
Musculoskeletal and connective tissue disorders Arthralgia	4.3% 15/345 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	5.5% 20/366 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	4.0% 13/324 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	4.6% 48/1035 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.
Musculoskeletal and connective tissue disorders Back pain	4.9% 17/345 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	5.2% 19/366 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	5.6% 18/324 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	5.2% 54/1035 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.
Musculoskeletal and connective tissue disorders Pain in extremity	7.0% 24/345 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	6.6% 24/366 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	5.2% 17/324 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	6.3% 65/1035 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.
Nervous system disorders Dizziness	3.5% 12/345 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	7.4% 27/366 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	4.3% 14/324 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	5.1% 53/1035 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.
Nervous system disorders Headache	14.8% 51/345 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	13.7% 50/366 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	8.3% 27/324 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	12.4% 128/1035 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.
Psychiatric disorders Anxiety	3.8% 13/345 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	5.7% 21/366 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	2.8% 9/324 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	4.2% 43/1035 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.
Psychiatric disorders Depression	6.7% 23/345 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	5.2% 19/366 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	5.6% 18/324 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	5.8% 60/1035 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.
Psychiatric disorders Insomnia	3.5% 12/345 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	7.4% 27/366 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	2.8% 9/324 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	4.6% 48/1035 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.
Vascular disorders Hypertension	7.5% 26/345 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	9.3% 34/366 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	3.7% 12/324 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.	7.0% 72/1035 • Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.