Trial Outcomes & Findings for A Study of the Safety and Efficacy of Golimumab in Subjects With Active Ankylosing Spondylitis (NCT NCT00265083)

Last Updated: 2013-07-19

Results Overview

Number of patients who achieved a 20% improvement and at least 1 absolute improvement on a 0 to 10 cm scale from baseline to Week 14 in at least 3 of the 4 domains: patient global, total back pain, function or inflammation.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

356 participants

Primary outcome timeframe

Week 14

Results posted on

2013-07-19

Participant Flow

356 patients were randomly assigned to treatment groups at 42 sites (17 in North America, 16 in Europe and 9 in Asia). Consent was obtained from the first patient on 13 Dec 2005. The last patient completed the final visit of the 24-week reporting period on 15 May 2007. The last patient completed the final visit of the 5-year period on 17 Jan 2012.

Participant milestones

Participant milestones
Measure	Group 1: Placebo Placebo SC injections every 4 weeks (wks) from Week (Wk) 0 thru Wk 20 (unless early escape at Wk 16); golimumab - if early escape, 50 mg SC every 4 wks from Wk 16 up to 5 yrs; golimumab - 50 mg SC beginning Wk 24 up to 5 yrs (unless early escape); golimumab- Dr's discretion after unblinding, dose adjust from 50 to 100 mg.	Group 2: Golimumab 50 mg Golimumab 50 mg SC injections every 4 wks from Wk 0 thru 5 yrs (unless early escape at Wk 16); golimumab - If early escape, 100 mg SC every 4 wks beginning Wk 16 up to 5 yrs; golimumab - Dr's discretion after unblinding, dose adjust from 50 to 100 mg.	Group 3: Golimumab 100 mg Golimumab 100 mg SC injections every 4 wks from Wk 0 up to 5 yrs.
Overall Study STARTED	78	138	140
Overall Study COMPLETED	61	96	98
Overall Study NOT COMPLETED	17	42	42

Reasons for withdrawal

Reasons for withdrawal
Measure	Group 1: Placebo Placebo SC injections every 4 weeks (wks) from Week (Wk) 0 thru Wk 20 (unless early escape at Wk 16); golimumab - if early escape, 50 mg SC every 4 wks from Wk 16 up to 5 yrs; golimumab - 50 mg SC beginning Wk 24 up to 5 yrs (unless early escape); golimumab- Dr's discretion after unblinding, dose adjust from 50 to 100 mg.	Group 2: Golimumab 50 mg Golimumab 50 mg SC injections every 4 wks from Wk 0 thru 5 yrs (unless early escape at Wk 16); golimumab - If early escape, 100 mg SC every 4 wks beginning Wk 16 up to 5 yrs; golimumab - Dr's discretion after unblinding, dose adjust from 50 to 100 mg.	Group 3: Golimumab 100 mg Golimumab 100 mg SC injections every 4 wks from Wk 0 up to 5 yrs.
Overall Study Adverse Event	5	13	15
Overall Study Lost to Follow-up	3	4	4
Overall Study Unsatisfactory therapeutic effect	8	13	14
Overall Study Other	1	12	9

Baseline Characteristics

A Study of the Safety and Efficacy of Golimumab in Subjects With Active Ankylosing Spondylitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group I: Placebo n=78 Participants Placebo SC injections every 4 weeks (wks) from Week (Wk) 0 thru Wk 20 (unless early escape at Wk 16); golimumab - if early escape, 50 mg SC every 4 wks from Wk 16 up to 5 yrs; golimumab - 50 mg SC beginning Wk 24 up to 5 yrs (unless early escape); golimumab- Dr's discretion after unblinding, dose adjust from 50 to 100 mg.	Group II: Golimumab 50 mg n=138 Participants Golimumab 50 mg SC injections every 4 wks from Wk 0 thru 5 yrs (unless early escape at Wk 16); golimumab - If early escape, 100 mg SC every 4 wks beginning Wk 16 up to 5 yrs; golimumab - Dr's discretion after unblinding, dose adjust from 50 to 100 mg.	Group III: Golimumab 100 mg n=140 Participants Golimumab 100 mg SC injections every 4 wks from Wk 0 up to 5 yrs.	Total n=356 Participants Total of all reporting groups
Age Continuous	40.6 years STANDARD_DEVIATION 12.71 • n=5 Participants	39.2 years STANDARD_DEVIATION 12.46 • n=7 Participants	38.6 years STANDARD_DEVIATION 11.30 • n=5 Participants	39.3 years STANDARD_DEVIATION 12.06 • n=4 Participants
Sex: Female, Male Female	23 Participants n=5 Participants	36 Participants n=7 Participants	42 Participants n=5 Participants	101 Participants n=4 Participants
Sex: Female, Male Male	55 Participants n=5 Participants	102 Participants n=7 Participants	98 Participants n=5 Participants	255 Participants n=4 Participants

PRIMARY outcome

Timeframe: Week 14

Population: Intent to treat (ITT). Patients considered non-responder if used any pre-specified prohibited medications or discontinued subcutaneous (SC) study agent due to lack of efficacy. Missing ASAS components at Week 14 were imputed by Last Observation Carried Forward (LOCF) unless all ASAS components are missing in which case considered non-responders.

Outcome measures

Outcome measures
Measure	Group I: Placebo n=78 Participants Placebo SC injections every 4 weeks (wks) from Week (Wk) 0 thru Wk 20 (unless early escape at Wk 16); golimumab - if early escape, 50 mg SC every 4 wks from Wk 16 up to 5 yrs; golimumab - 50 mg SC beginning Wk 24 up to 5 yrs (unless early escape); golimumab- Dr's discretion after unblinding, dose adjust from 50 to 100 mg.	Group II: Golimumab 50 mg n=138 Participants Golimumab 50 mg SC injections every 4 wks from Wk 0 thru 5 yrs (unless early escape at Wk 16); golimumab - If early escape, 100 mg SC every 4 wks beginning Wk 16 up to 5 yrs; golimumab - Dr's discretion after unblinding, dose adjust from 50 to 100 mg.	Group III: Golimumab 100 mg n=140 Participants Golimumab 100 mg SC injections every 4 wks from Wk 0 up to 5 yrs.	Combined: Groups II & III n=278 Participants Combines Group II (golimumab 50 mg) and Group III (golimumab 100 mg).
Assessment in Ankylosing Spondylitis 20 Responders at Week 14	17 Participants	82 Participants	84 Participants	166 Participants

SECONDARY outcome

Timeframe: Week 24

Population: ITT. Patients (pts) considered non-responder if used any pre-specified prohibited medications or discontinued SC study agent due to lack of efficacy. Missing ASAS components were imputed by LOCF unless all ASAS components are missing in which case considered non-responders. Wk 16 ASAS response was used for pts with change in study treatment.

Number of patients who achieved a 20% improvement and at least 1 absolute improvement on a 0 to 10 cm scale from baseline to Week 24 at least 3 of the 4 domains: patient global, total back pain, function or inflammation.

Outcome measures

Outcome measures
Measure	Group I: Placebo n=78 Participants Placebo SC injections every 4 weeks (wks) from Week (Wk) 0 thru Wk 20 (unless early escape at Wk 16); golimumab - if early escape, 50 mg SC every 4 wks from Wk 16 up to 5 yrs; golimumab - 50 mg SC beginning Wk 24 up to 5 yrs (unless early escape); golimumab- Dr's discretion after unblinding, dose adjust from 50 to 100 mg.	Group II: Golimumab 50 mg n=138 Participants Golimumab 50 mg SC injections every 4 wks from Wk 0 thru 5 yrs (unless early escape at Wk 16); golimumab - If early escape, 100 mg SC every 4 wks beginning Wk 16 up to 5 yrs; golimumab - Dr's discretion after unblinding, dose adjust from 50 to 100 mg.	Group III: Golimumab 100 mg n=140 Participants Golimumab 100 mg SC injections every 4 wks from Wk 0 up to 5 yrs.	Combined: Groups II & III n=278 Participants Combines Group II (golimumab 50 mg) and Group III (golimumab 100 mg).
Assessment in Ankylosing Spondylitis 20 Responders at Week 24	18 P a r t i c ip an t s	77 P a r t i c ip an t s	92 P a r t i c ip an t s	169 P a r t i c ip an t s

SECONDARY outcome

Timeframe: From Baseline to Week 14

Population: Intent to treat (ITT). Patients considered non-change from baseline in BASFI if used any pre-specified prohibited medications or discontinued SC study agent due to lack of efficacy. Missing value of change from baseline in BASFI at Week 14 was imputed by Last Observation Carried Forward (LOCF).

The Bath Ankylosing Spondylitis Functional Index (BASFI) is calculated as the mean of 10 VAS, each of length 0 to 10 cm. Eight of the scales relate to functional capacity of patients while the other 2 relate to a patient's ability to cope with everyday life. Change from baseline is Wk 14 value minus baseline value.

Outcome measures

Outcome measures
Measure	Group I: Placebo n=78 Participants Placebo SC injections every 4 weeks (wks) from Week (Wk) 0 thru Wk 20 (unless early escape at Wk 16); golimumab - if early escape, 50 mg SC every 4 wks from Wk 16 up to 5 yrs; golimumab - 50 mg SC beginning Wk 24 up to 5 yrs (unless early escape); golimumab- Dr's discretion after unblinding, dose adjust from 50 to 100 mg.	Group II: Golimumab 50 mg n=138 Participants Golimumab 50 mg SC injections every 4 wks from Wk 0 thru 5 yrs (unless early escape at Wk 16); golimumab - If early escape, 100 mg SC every 4 wks beginning Wk 16 up to 5 yrs; golimumab - Dr's discretion after unblinding, dose adjust from 50 to 100 mg.	Group III: Golimumab 100 mg n=140 Participants Golimumab 100 mg SC injections every 4 wks from Wk 0 up to 5 yrs.	Combined: Groups II & III n=278 Participants Combines Group II (golimumab 50 mg) and Group III (golimumab 100 mg).
Summary of Change From Baseline in Bath Ankylosing Spondylitis Functional Index at Week 14	0.095 Change from baseline in BASFI Index Interval -1.05 to 1.12	-1.375 Change from baseline in BASFI Index Interval -3.13 to -0.12	-1.495 Change from baseline in BASFI Index Interval -2.985 to -0.06	-1.420 Change from baseline in BASFI Index Interval -3.07 to -0.08

SECONDARY outcome

Timeframe: From Baseline to Week 14

Population: Intent to treat (ITT). Patients considered non-change from baseline in BASMI if used any pre-specified prohibited medications or discontinued SC study agent due to lack of efficacy. Missing value of change from baseline in BASMI at Week 14 was imputed by Last Observation Carried Forward (LOCF).

The Bath Ankylosing Spondylitis Metrology Index (BASMI) is the sum of scores comprised of 5 measures (0=mild, 1=moderate \& 2=severe): Tragus-to-wall; Lumbar flexion; Cervical rotation; Lumbar side flexion; Intermalleolar distance. BASMI ranges from 0 to 10. Change from baseline is Wk 14 value minus baseline value.

Outcome measures

Outcome measures
Measure	Group I: Placebo n=78 Participants Placebo SC injections every 4 weeks (wks) from Week (Wk) 0 thru Wk 20 (unless early escape at Wk 16); golimumab - if early escape, 50 mg SC every 4 wks from Wk 16 up to 5 yrs; golimumab - 50 mg SC beginning Wk 24 up to 5 yrs (unless early escape); golimumab- Dr's discretion after unblinding, dose adjust from 50 to 100 mg.	Group II: Golimumab 50 mg n=138 Participants Golimumab 50 mg SC injections every 4 wks from Wk 0 thru 5 yrs (unless early escape at Wk 16); golimumab - If early escape, 100 mg SC every 4 wks beginning Wk 16 up to 5 yrs; golimumab - Dr's discretion after unblinding, dose adjust from 50 to 100 mg.	Group III: Golimumab 100 mg n=140 Participants Golimumab 100 mg SC injections every 4 wks from Wk 0 up to 5 yrs.	Combined: Groups II & III n=278 Participants Combines Group II (golimumab 50 mg) and Group III (golimumab 100 mg).
Summary of Change From Baseline in Bath Ankylosing Spondylitis Metrology Index at Week 14	-0.28 Change from baseline in BASMI Index Standard Deviation 1.015	-0.36 Change from baseline in BASMI Index Standard Deviation 1.112	-0.49 Change from baseline in BASMI Index Standard Deviation 1.296	-0.43 Change from baseline in BASMI Index Standard Deviation 1.208

Adverse Events

Group 1: Golimumab 50 mg

Serious events: 27 serious events

Other events: 147 other events

Deaths: 0 deaths

Group 2: Golimumab 100 mg

Serious events: 26 serious events

Other events: 113 other events

Deaths: 0 deaths

Group 3: Golimumab 50 and 100 mg

Serious events: 19 serious events

Other events: 76 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Director, Clinical Research

Centocor Research and Development, Inc.

Phone: 1-800-457-6399

Results disclosure agreements

Principal investigator is a sponsor employee Generally, the only disclosure restriction on the PI is that the sponsor has 60 days to review results communications prior to public release and can embargo communications regarding trial results for a period that does not exceed 180 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
Publication restrictions are in place

Restriction type: OTHER

Serious adverse events
Measure	Group 1: Golimumab 50 mg n=158 participants at risk Subjects who were treated with Golimumab and received Golimumab 50 mg injections only.	Group 2: Golimumab 100 mg n=118 participants at risk Subjects who were treated with Golimumab and received Golimumab 100 mg injections only.	Group 3: Golimumab 50 and 100 mg n=77 participants at risk Subjects who were treated with Golimumab and received at least one injection of both Golimumab 50 mg and Golimumab 100 mg.
Cardiac disorders Cardiac Failure	0.00% 0/158 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	0.00% 0/118 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	1.3% 1/77 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
Cardiac disorders Coronary Artery Disease	0.00% 0/158 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	0.00% 0/118 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	1.3% 1/77 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
Cardiac disorders Hypertensive Heart Disease	0.00% 0/158 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	0.00% 0/118 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	1.3% 1/77 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
Cardiac disorders Myocardial Infarction	0.63% 1/158 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	0.00% 0/118 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	1.3% 1/77 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
Congenital, familial and genetic disorders Atrial Septal Defect	0.63% 1/158 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	0.00% 0/118 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	0.00% 0/77 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
Congenital, familial and genetic disorders Cryptorchism	0.63% 1/158 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	0.00% 0/118 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	0.00% 0/77 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
Gastrointestinal disorders Abdominal Pain	1.3% 2/158 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	0.00% 0/118 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	0.00% 0/77 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
Gastrointestinal disorders Abdominal Pain Upper	0.63% 1/158 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	0.00% 0/118 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	0.00% 0/77 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
Gastrointestinal disorders Crohn's Disease	0.00% 0/158 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	0.00% 0/118 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	1.3% 1/77 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
Gastrointestinal disorders Diverticulum Intestinal	0.00% 0/158 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	0.00% 0/118 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	1.3% 1/77 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
Gastrointestinal disorders Duodenal Ulcer	0.63% 1/158 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	0.00% 0/118 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	0.00% 0/77 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
Gastrointestinal disorders Enterocolitis	0.63% 1/158 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	0.00% 0/118 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	0.00% 0/77 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
Gastrointestinal disorders Gastrooesophageal Reflux Disease	0.00% 0/158 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	0.00% 0/118 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	2.6% 2/77 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
Gastrointestinal disorders Ileus	0.63% 1/158 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	0.00% 0/118 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	0.00% 0/77 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
Gastrointestinal disorders Inguinal Hernia	0.00% 0/158 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	0.00% 0/118 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	1.3% 1/77 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
Gastrointestinal disorders Intestinal Perforation	0.00% 0/158 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	0.00% 0/118 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	1.3% 1/77 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
Gastrointestinal disorders Lower Gastrointestinal Haemorrhage	0.63% 1/158 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	0.00% 0/118 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	0.00% 0/77 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
Gastrointestinal disorders Malocclusion	0.63% 1/158 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	0.00% 0/118 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	0.00% 0/77 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
Gastrointestinal disorders Mouth Haemorrhage	0.63% 1/158 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	0.00% 0/118 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	0.00% 0/77 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
Gastrointestinal disorders Oesophageal Stenosis	0.00% 0/158 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	0.85% 1/118 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	0.00% 0/77 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
Gastrointestinal disorders Pancreatitis	0.00% 0/158 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	0.00% 0/118 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	1.3% 1/77 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
Gastrointestinal disorders Small Intestinal Obstruction	0.63% 1/158 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	0.00% 0/118 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	0.00% 0/77 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
Gastrointestinal disorders Subileus	0.63% 1/158 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	0.00% 0/118 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	0.00% 0/77 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
General disorders Chest Pain	0.00% 0/158 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	1.7% 2/118 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	0.00% 0/77 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
General disorders Device Occlusion	0.00% 0/158 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	0.85% 1/118 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	0.00% 0/77 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
General disorders Generalised Oedema	0.00% 0/158 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	0.00% 0/118 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	1.3% 1/77 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
Hepatobiliary disorders Biliary Colic	0.63% 1/158 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	0.00% 0/118 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	0.00% 0/77 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
Hepatobiliary disorders Cholelithiasis	1.3% 2/158 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	0.00% 0/118 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	0.00% 0/77 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
Hepatobiliary disorders Hepatic Steatosis	0.00% 0/158 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	0.85% 1/118 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	0.00% 0/77 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
Hepatobiliary disorders Hepatitis	0.00% 0/158 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	0.85% 1/118 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	0.00% 0/77 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
Hepatobiliary disorders Hepatitis Toxic	0.63% 1/158 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	0.00% 0/118 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	0.00% 0/77 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
Infections and infestations Anal Abscess	0.00% 0/158 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	0.00% 0/118 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	1.3% 1/77 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
Infections and infestations Bursitis Infective	0.00% 0/158 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	0.00% 0/118 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	1.3% 1/77 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
Infections and infestations Cellulitis	0.00% 0/158 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	0.85% 1/118 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	0.00% 0/77 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
Infections and infestations Cellulitis Staphylococcal	0.00% 0/158 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	0.00% 0/118 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	1.3% 1/77 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
Infections and infestations Clostridial Infection	0.63% 1/158 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	0.00% 0/118 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	0.00% 0/77 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
Infections and infestations Coccidioidomycosis	0.63% 1/158 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	0.00% 0/118 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	0.00% 0/77 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
Infections and infestations Device Related Infection	0.00% 0/158 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	0.85% 1/118 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	0.00% 0/77 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
Infections and infestations Diverticulitis	0.63% 1/158 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	0.00% 0/118 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	0.00% 0/77 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
Infections and infestations Furuncle	0.00% 0/158 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	0.85% 1/118 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	0.00% 0/77 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.

Other adverse events
Measure	Group 1: Golimumab 50 mg n=158 participants at risk Subjects who were treated with Golimumab and received Golimumab 50 mg injections only.	Group 2: Golimumab 100 mg n=118 participants at risk Subjects who were treated with Golimumab and received Golimumab 100 mg injections only.	Group 3: Golimumab 50 and 100 mg n=77 participants at risk Subjects who were treated with Golimumab and received at least one injection of both Golimumab 50 mg and Golimumab 100 mg.
Eye disorders Dry Eye	0.63% 1/158 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	2.5% 3/118 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	5.2% 4/77 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
Eye disorders Iritis	4.4% 7/158 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	5.9% 7/118 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	3.9% 3/77 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
Eye disorders Uveitis	4.4% 7/158 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	8.5% 10/118 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	0.00% 0/77 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
Gastrointestinal disorders Abdominal Discomfort	1.3% 2/158 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	4.2% 5/118 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	6.5% 5/77 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
Gastrointestinal disorders Abdominal Pain	5.1% 8/158 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	3.4% 4/118 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	2.6% 2/77 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
Gastrointestinal disorders Abdominal Pain Lower	1.3% 2/158 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	0.00% 0/118 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	5.2% 4/77 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
Gastrointestinal disorders Abdominal Pain Upper	7.6% 12/158 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	7.6% 9/118 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	6.5% 5/77 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
Gastrointestinal disorders Dental Caries	1.3% 2/158 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	5.1% 6/118 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	1.3% 1/77 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
Gastrointestinal disorders Diarrhoea	13.9% 22/158 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	13.6% 16/118 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	14.3% 11/77 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
Gastrointestinal disorders Dyspepsia	6.3% 10/158 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	9.3% 11/118 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	2.6% 2/77 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
Gastrointestinal disorders Gastritis	5.1% 8/158 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	3.4% 4/118 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	1.3% 1/77 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
Gastrointestinal disorders Nausea	10.1% 16/158 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	20.3% 24/118 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	11.7% 9/77 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
Gastrointestinal disorders Toothache	1.9% 3/158 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	5.9% 7/118 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	3.9% 3/77 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
Gastrointestinal disorders Vomiting	5.7% 9/158 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	6.8% 8/118 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	5.2% 4/77 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
General disorders Chest Pain	4.4% 7/158 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	3.4% 4/118 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	6.5% 5/77 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
General disorders Fatigue	15.8% 25/158 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	25.4% 30/118 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	13.0% 10/77 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
General disorders Injection Site Erythema	5.1% 8/158 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	10.2% 12/118 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	13.0% 10/77 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
General disorders Injection Site Swelling	1.9% 3/158 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	2.5% 3/118 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	6.5% 5/77 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
General disorders Oedema Peripheral	5.1% 8/158 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	5.9% 7/118 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	5.2% 4/77 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
General disorders Pyrexia	8.2% 13/158 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	9.3% 11/118 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	5.2% 4/77 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
Hepatobiliary disorders Hepatic Steatosis	1.9% 3/158 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	6.8% 8/118 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	2.6% 2/77 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
Immune system disorders Seasonal Allergy	2.5% 4/158 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	3.4% 4/118 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	5.2% 4/77 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
Infections and infestations Bronchitis	10.8% 17/158 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	10.2% 12/118 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	13.0% 10/77 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
Infections and infestations Cellulitis	4.4% 7/158 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	5.1% 6/118 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	2.6% 2/77 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
Infections and infestations Ear Infection	1.3% 2/158 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	5.9% 7/118 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	1.3% 1/77 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
Infections and infestations Gastroenteritis	5.7% 9/158 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	6.8% 8/118 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	2.6% 2/77 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
Infections and infestations Gastroenteritis Viral	0.63% 1/158 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	5.1% 6/118 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	2.6% 2/77 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
Infections and infestations Herpes Zoster	1.9% 3/158 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	3.4% 4/118 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	7.8% 6/77 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
Infections and infestations Influenza	6.3% 10/158 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	11.0% 13/118 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	13.0% 10/77 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
Infections and infestations Lower Respiratory Tract Infection	0.63% 1/158 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	3.4% 4/118 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	5.2% 4/77 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
Infections and infestations Nasopharyngitis	31.0% 49/158 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	37.3% 44/118 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	35.1% 27/77 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
Infections and infestations Oral Herpes	5.1% 8/158 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	4.2% 5/118 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	7.8% 6/77 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
Infections and infestations Pharyngitis	5.7% 9/158 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	5.9% 7/118 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	3.9% 3/77 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
Infections and infestations Rhinitis	5.7% 9/158 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	5.1% 6/118 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	5.2% 4/77 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
Infections and infestations Sinusitis	11.4% 18/158 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	16.1% 19/118 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	16.9% 13/77 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
Infections and infestations Tooth Abscess	2.5% 4/158 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	3.4% 4/118 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	5.2% 4/77 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
Infections and infestations Tooth Infection	3.8% 6/158 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	5.9% 7/118 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	0.00% 0/77 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
Infections and infestations Upper Respiratory Tract Infection	38.0% 60/158 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	35.6% 42/118 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	33.8% 26/77 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
Infections and infestations Urinary Tract Infection	3.8% 6/158 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	11.0% 13/118 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	9.1% 7/77 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
Infections and infestations Vaginal Infection	1.3% 2/158 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	0.00% 0/118 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.	5.2% 4/77 • Up to 5 years (end of study) The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.