Trial Outcomes & Findings for A Study to Investigate the Use of Golimumab (Simponi®) in Participants With Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis (P06554) (NCT NCT01313858)

Last Updated: 2016-11-01

Results Overview

The CGI is a non-disease-specific evaluation of participants' overall health status assessed on a 10 mm visual analogue scale (VAS) ranging from "0" (free of complaints) to "10" (strong discomfort). The closer the score to 0, the better the health status.

Recruitment status

COMPLETED

Target enrollment

1613 participants

Primary outcome timeframe

Baseline (BL; Month 0), Month 3, Month 6, Month 9, Month 12, Month 15, Month 18, Month 21, Month 24

Results posted on

2016-11-01

Participant Flow

Participant milestones

Participant milestones
Measure	Participants With Rheumatoid Arthritis Simponi®-naïve participants with rheumatoid arthritis given Simponi® 50 mg once a month as a subcutaneous injection. Combination use with methotrexate was recommended.	Participants With Psoriatic Arthritis Simponi®-naïve participants with psoriatic arthritis given Simponi® 50 mg once a month as a subcutaneous injection.	Participants With Ankylosing Spondylitis Simponi®-naïve participants with ankylosing spondylitis given Simponi® 50 mg once a month as a subcutaneous injection.
Overall Study STARTED	524	546	543
Overall Study COMPLETED	238	276	305
Overall Study NOT COMPLETED	286	270	238

Reasons for withdrawal

Reasons for withdrawal
Measure	Participants With Rheumatoid Arthritis Simponi®-naïve participants with rheumatoid arthritis given Simponi® 50 mg once a month as a subcutaneous injection. Combination use with methotrexate was recommended.	Participants With Psoriatic Arthritis Simponi®-naïve participants with psoriatic arthritis given Simponi® 50 mg once a month as a subcutaneous injection.	Participants With Ankylosing Spondylitis Simponi®-naïve participants with ankylosing spondylitis given Simponi® 50 mg once a month as a subcutaneous injection.
Overall Study Premature Treatment Termination	251	219	191
Overall Study Lost to Follow-up	35	51	47

Baseline Characteristics

A Study to Investigate the Use of Golimumab (Simponi®) in Participants With Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis (P06554)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Participants With Rheumatoid Arthritis n=474 Participants Simponi®-naïve participants with rheumatoid arthritis given Simponi® 50 mg once a month as a subcutaneous injection. Combination use with methotrexate was recommended.	Participants With Psoriatic Arthritis n=501 Participants Simponi®-naïve participants with psoriatic arthritis given Simponi® 50 mg once a month as a subcutaneous injection.	Participants With Ankylosing Spondylitis n=483 Participants Simponi®-naïve participants with ankylosing spondylitis given Simponi® 50 mg once a month as a subcutaneous injection.	Total n=1458 Participants Total of all reporting groups
Age, Continuous	54.9 Years STANDARD_DEVIATION 13.38 • n=5 Participants	50.3 Years STANDARD_DEVIATION 12.07 • n=7 Participants	43.6 Years STANDARD_DEVIATION 12.29 • n=5 Participants	49.6 Years STANDARD_DEVIATION 13.39 • n=4 Participants
Sex: Female, Male Female	345 Participants n=5 Participants	271 Participants n=7 Participants	162 Participants n=5 Participants	778 Participants n=4 Participants
Sex: Female, Male Male	129 Participants n=5 Participants	230 Participants n=7 Participants	321 Participants n=5 Participants	680 Participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline (BL; Month 0), Month 3, Month 6, Month 9, Month 12, Month 15, Month 18, Month 21, Month 24

Population: The mITT population consists of all participants who were treated with Simponi® and have a baseline assessment and at least one additional visit, regardless of any protocol violations during the study.

Outcome measures

Outcome measures
Measure	Participants With Rheumatoid Arthritis n=474 Participants Simponi®-naïve participants with rheumatoid arthritis given Simponi® 50 mg once a month as a subcutaneous injection. Combination use with methotrexate was recommended.	Participants With Psoriatic Arthritis n=501 Participants Simponi®-naïve participants with psoriatic arthritis given Simponi® 50 mg once a month as a subcutaneous injection.	Participants With Ankylosing Spondylitis n=483 Participants Simponi®-naïve participants with ankylosing spondylitis given Simponi® 50 mg once a month as a subcutaneous injection.
Clinical Global Impression (CGI) Disease Status BL	5.7 Units on a scale Standard Deviation 2.21 • Interval 3.69 to 6.74	5.5 Units on a scale Standard Deviation 2.17 • Interval 2.77 to 6.01	5.7 Units on a scale Standard Deviation 2.19 • Interval 3.69 to 6.74
Clinical Global Impression (CGI) Disease Status Month 3	3.4 Units on a scale Standard Deviation 2.27 • Interval 4.1 to 7.33	3.2 Units on a scale Standard Deviation 2.25 • Interval 2.71 to 6.08	2.9 Units on a scale Standard Deviation 2.13 • Interval 4.1 to 7.33
Clinical Global Impression (CGI) Disease Status Month 6	3.1 Units on a scale Standard Deviation 2.25 • Interval 4.13 to 7.58	2.8 Units on a scale Standard Deviation 2.19 • Interval 3.8 to 7.44	2.5 Units on a scale Standard Deviation 2.09 • Interval 4.13 to 7.58
Clinical Global Impression (CGI) Disease Status Month 9	2.7 Units on a scale Standard Deviation 1.99 • Interval 4.5 to 8.08	2.6 Units on a scale Standard Deviation 2.07 • Interval 4.97 to 8.77	2.4 Units on a scale Standard Deviation 1.87 • Interval 4.5 to 8.08
Clinical Global Impression (CGI) Disease Status Month 12	2.8 Units on a scale Standard Deviation 2.11 • Interval 6.21 to 9.82	2.4 Units on a scale Standard Deviation 2.01 • Interval 3.98 to 7.89	2.3 Units on a scale Standard Deviation 1.94 • Interval 6.21 to 9.82
Clinical Global Impression (CGI) Disease Status Month 15	2.5 Units on a scale Standard Deviation 1.89	2.3 Units on a scale Standard Deviation 1.96	2.2 Units on a scale Standard Deviation 1.85
Clinical Global Impression (CGI) Disease Status Month 18	2.4 Units on a scale Standard Deviation 1.97	2.2 Units on a scale Standard Deviation 1.86	2.2 Units on a scale Standard Deviation 1.91
Clinical Global Impression (CGI) Disease Status Month 21	2.5 Units on a scale Standard Deviation 1.99	2.1 Units on a scale Standard Deviation 1.84	2.2 Units on a scale Standard Deviation 1.78
Clinical Global Impression (CGI) Disease Status Month 24	2.2 Units on a scale Standard Deviation 1.84	2.1 Units on a scale Standard Deviation 1.95	2.1 Units on a scale Standard Deviation 2.01

PRIMARY outcome

Timeframe: Baseline and Months 3, 6, 9, 12, 15, 18, 21, 24

The FFbH is a participant questionnaire assessing disability/functional impairment. Ability to perform 18 activities of daily living are scored on a 3 point scale (2=Yes, 1=Yes but with effort, and 0=No or with assistance) and summed. Remaining functional capacity is calculated as the percent of the maximum number of score points (FFbH\[%\] = (Attained score\*100)/(2\*n) where n is the number of completed responses) with range from 0 = total loss of functional capacity to 100 = maximal functional capacity. Increase from baseline in FFbH score signifies improvement. The FFbH is similar to Health Assessment Questionnaire (HAQ) but is more widely used in Germany.

Outcome measures

Outcome measures
Measure	Participants With Rheumatoid Arthritis n=474 Participants Simponi®-naïve participants with rheumatoid arthritis given Simponi® 50 mg once a month as a subcutaneous injection. Combination use with methotrexate was recommended.	Participants With Psoriatic Arthritis n=501 Participants Simponi®-naïve participants with psoriatic arthritis given Simponi® 50 mg once a month as a subcutaneous injection.	Participants With Ankylosing Spondylitis n=483 Participants Simponi®-naïve participants with ankylosing spondylitis given Simponi® 50 mg once a month as a subcutaneous injection.
Change From Baseline in FFbH (Funktionsfragebogen Hannover) Questionnaire Score Month 12 (n=218;247;247)	5.70 Units on a scale Standard Deviation 1.79	7.86 Units on a scale Standard Deviation 1.73	8.34 Units on a scale Standard Deviation 1.48
Change From Baseline in FFbH (Funktionsfragebogen Hannover) Questionnaire Score Month 3 (n=348;361;375)	5.29 Units on a scale Standard Deviation 1.56 • Interval 2.23 to 8.34	5.82 Units on a scale Standard Deviation 1.54	8.66 Units on a scale Standard Deviation 1.31
Change From Baseline in FFbH (Funktionsfragebogen Hannover) Questionnaire Score Month 6 (n=263;310;297)	5.71 Units on a scale Standard Deviation 1.69 • Interval 2.4 to 9.3	6.31 Units on a scale Standard Deviation 1.61	10.01 Units on a scale Standard Deviation 1.40
Change From Baseline in FFbH (Funktionsfragebogen Hannover) Questionnaire Score Month 9 (n=226;265;262)	5.78 Units on a scale Standard Deviation 1.77	7.07 Units on a scale Standard Deviation 1.69	9.67 Units on a scale Standard Deviation 1.45
Change From Baseline in FFbH (Funktionsfragebogen Hannover) Questionnaire Score Month 15 (n=188;222;234)	5.63 Units on a scale Standard Deviation 1.89	6.64 Units on a scale Standard Deviation 1.79	9.04 Units on a scale Standard Deviation 1.50
Change From Baseline in FFbH (Funktionsfragebogen Hannover) Questionnaire Score Month 18 (n=168;211;216)	6.98 Units on a scale Standard Deviation 1.96	8.99 Units on a scale Standard Deviation 1.82	8.79 Units on a scale Standard Deviation 1.54
Change From Baseline in FFbH (Funktionsfragebogen Hannover) Questionnaire Score Month 21 (n=166;198;200)	5.43 Units on a scale Standard Deviation 1.97	9.18 Units on a scale Standard Deviation 1.86	7.95 Units on a scale Standard Deviation 1.59
Change From Baseline in FFbH (Funktionsfragebogen Hannover) Questionnaire Score Month 24 (n=167;198;211)	7.42 Units on a scale Standard Deviation 1.97	7.71 Units on a scale Standard Deviation 1.86	9.51 Units on a scale Standard Deviation 1.56

PRIMARY outcome

Timeframe: Baseline and Months 3, 6, 12, 18, 24

The FACIT-F scale assesses self-reported fatigue and its impact upon daily activities and function. 13 items consisting of fatigue, weakness, listlessness, tiredness, trouble with starting things, trouble with finishing things, energy, activity, sleep, eating, help doing activities, frustration, and social activities are scored on a scale of 0 (not at all) to 4 (very much), except energy and activity which are reversed scored. Individual item scores are then summed to provide the final FACIT-F score with range from 0 (lowest) to 52 (highest quality of life). Increase from baseline in FACIT-F score signifies improvement.

Outcome measures

Outcome measures
Measure	Participants With Rheumatoid Arthritis n=474 Participants Simponi®-naïve participants with rheumatoid arthritis given Simponi® 50 mg once a month as a subcutaneous injection. Combination use with methotrexate was recommended.	Participants With Psoriatic Arthritis n=501 Participants Simponi®-naïve participants with psoriatic arthritis given Simponi® 50 mg once a month as a subcutaneous injection.	Participants With Ankylosing Spondylitis n=483 Participants Simponi®-naïve participants with ankylosing spondylitis given Simponi® 50 mg once a month as a subcutaneous injection.
Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score Month 3 (n=344;356;368)	2.85 Units on a scale Standard Deviation 0.79 • Interval 3.69 to 6.74	4.39 Units on a scale Standard Deviation 0.83 • Interval 2.77 to 6.01	5.21 Units on a scale Standard Deviation 0.78 • Interval 3.69 to 6.74
Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score Month 6 (n=264;311;300)	3.71 Units on a scale Standard Deviation 0.85 • Interval 4.1 to 7.33	4.40 Units on a scale Standard Deviation 0.86 • Interval 2.71 to 6.08	5.71 Units on a scale Standard Deviation 0.82 • Interval 4.1 to 7.33
Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score Month 12 (n=215;242;243)	4.81 Units on a scale Standard Deviation 0.91 • Interval 4.13 to 7.58	5.62 Units on a scale Standard Deviation 0.93 • Interval 3.8 to 7.44	5.86 Units on a scale Standard Deviation 0.88 • Interval 4.13 to 7.58
Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score Month 18 (n=167;212;216)	5.05 Units on a scale Standard Deviation 0.99 • Interval 4.5 to 8.08	6.87 Units on a scale Standard Deviation 0.97 • Interval 4.97 to 8.77	6.29 Units on a scale Standard Deviation 0.91 • Interval 4.5 to 8.08
Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score Month 24 (n=162;196;211)	5.99 Units on a scale Standard Deviation 1.00 • Interval 6.21 to 9.82	5.94 Units on a scale Standard Deviation 1.00 • Interval 3.98 to 7.89	8.01 Units on a scale Standard Deviation 0.92 • Interval 6.21 to 9.82

PRIMARY outcome

Timeframe: Baseline and Months 6, 12, 18, 24

The EQ-5D-3L is a health profile questionnaire that assesses quality of life along 5 dimensions. Participants rate 5 aspects of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) by choosing from 3 answering options (1=no problems; 2=some problems; 3=extreme problems). The summed score ranges from 1-15 with "1" corresponding to no problems and "15" corresponding to severe problems in the 5 dimensions. Decrease from baseline in EQ-5D-3L signifies improvement.

Outcome measures

Outcome measures
Measure	Participants With Rheumatoid Arthritis n=474 Participants Simponi®-naïve participants with rheumatoid arthritis given Simponi® 50 mg once a month as a subcutaneous injection. Combination use with methotrexate was recommended.	Participants With Psoriatic Arthritis n=501 Participants Simponi®-naïve participants with psoriatic arthritis given Simponi® 50 mg once a month as a subcutaneous injection.	Participants With Ankylosing Spondylitis n=483 Participants Simponi®-naïve participants with ankylosing spondylitis given Simponi® 50 mg once a month as a subcutaneous injection.
Change From Baseline in EuroQol- 5 Dimension 3 Level Version (EQ-5D-3L) Questionnaire Score Month 6 (n=254;302;293)	-0.69 Units on a scale Standard Deviation 0.15 • Interval 3.69 to 6.74	-1.07 Units on a scale Standard Deviation 0.14 • Interval 2.77 to 6.01	-1.18 Units on a scale Standard Deviation 0.14 • Interval 3.69 to 6.74
Change From Baseline in EuroQol- 5 Dimension 3 Level Version (EQ-5D-3L) Questionnaire Score Month 12 (n=211;236;242)	-0.97 Units on a scale Standard Deviation 0.16 • Interval 4.1 to 7.33	-1.35 Units on a scale Standard Deviation 0.15 • Interval 2.71 to 6.08	-1.24 Units on a scale Standard Deviation 0.14 • Interval 4.1 to 7.33
Change From Baseline in EuroQol- 5 Dimension 3 Level Version (EQ-5D-3L) Questionnaire Score Month 18 (n=161;206;211)	-1.11 Units on a scale Standard Deviation 0.17 • Interval 4.13 to 7.58	-1.35 Units on a scale Standard Deviation 0.16 • Interval 3.8 to 7.44	-1.25 Units on a scale Standard Deviation 0.15 • Interval 4.13 to 7.58
Change From Baseline in EuroQol- 5 Dimension 3 Level Version (EQ-5D-3L) Questionnaire Score Month 24 (n=162;191;210)	-1.08 Units on a scale Standard Deviation 0.17 • Interval 4.5 to 8.08	-1.29 Units on a scale Standard Deviation 0.17 • Interval 4.97 to 8.77	-1.51 Units on a scale Standard Deviation 0.15 • Interval 4.5 to 8.08

PRIMARY outcome

Timeframe: Up to 24 months

Population: The safety population consists of all participants with at least one injection of Simponi®.

An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.

Outcome measures

Outcome measures
Measure	Participants With Rheumatoid Arthritis n=524 Participants Simponi®-naïve participants with rheumatoid arthritis given Simponi® 50 mg once a month as a subcutaneous injection. Combination use with methotrexate was recommended.	Participants With Psoriatic Arthritis n=546 Participants Simponi®-naïve participants with psoriatic arthritis given Simponi® 50 mg once a month as a subcutaneous injection.	Participants With Ankylosing Spondylitis n=543 Participants Simponi®-naïve participants with ankylosing spondylitis given Simponi® 50 mg once a month as a subcutaneous injection.
Number of Participants Who Experienced at Least One Adverse Event	320 Participants	309 Participants	281 Participants

PRIMARY outcome

Timeframe: Up to 24 months

Population: The safety population consists of all participants with at least one injection of Simponi®.

A serious adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure that results in death, life-threatening adverse event, permanent or significant disability / unfitness for work, hospital treatment (i.e., admission to hospital) or prolongation of a patient's length of stay, or congenital deformity or birth defect.

Outcome measures

Outcome measures
Measure	Participants With Rheumatoid Arthritis n=524 Participants Simponi®-naïve participants with rheumatoid arthritis given Simponi® 50 mg once a month as a subcutaneous injection. Combination use with methotrexate was recommended.	Participants With Psoriatic Arthritis n=546 Participants Simponi®-naïve participants with psoriatic arthritis given Simponi® 50 mg once a month as a subcutaneous injection.	Participants With Ankylosing Spondylitis n=543 Participants Simponi®-naïve participants with ankylosing spondylitis given Simponi® 50 mg once a month as a subcutaneous injection.
Number of Participants Who Experienced at Least One Serious Adverse Event	75 Participants	70 Participants	59 Participants

Adverse Events

All Participants

Serious events: 204 serious events

Other events: 315 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	All Participants n=1613 participants at risk Simponi®-naïve participants with rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis given Simponi® 50 mg once a month as a subcutaneous injection.
Infections and infestations PYELONEPHRITIS	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Infections and infestations RESPIRATORY TRACT INFECTION	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Infections and infestations SALPINGO-OOPHORITIS	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Infections and infestations SEPSIS	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Infections and infestations SINOBRONCHITIS	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Infections and infestations SUBCUTANEOUS ABSCESS	0.25% 4/1613 • Number of events 4 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Infections and infestations URINARY TRACT INFECTION	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Injury, poisoning and procedural complications ANKLE FRACTURE	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Injury, poisoning and procedural complications CLAVICLE FRACTURE	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Injury, poisoning and procedural complications CRANIOCEREBRAL INJURY	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Injury, poisoning and procedural complications FALL	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Injury, poisoning and procedural complications FEMORAL NECK FRACTURE	0.12% 2/1613 • Number of events 2 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Injury, poisoning and procedural complications FEMUR FRACTURE	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Injury, poisoning and procedural complications JOINT DISLOCATION	0.12% 2/1613 • Number of events 2 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Injury, poisoning and procedural complications JOINT INJURY	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Injury, poisoning and procedural complications LACERATION	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Injury, poisoning and procedural complications LIGAMENT RUPTURE	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Injury, poisoning and procedural complications LOWER LIMB FRACTURE	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Injury, poisoning and procedural complications LUMBAR VERTEBRAL FRACTURE	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Injury, poisoning and procedural complications PERIPROSTHETIC FRACTURE	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Injury, poisoning and procedural complications RIB FRACTURE	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Injury, poisoning and procedural complications ROAD TRAFFIC ACCIDENT	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Injury, poisoning and procedural complications SKULL FRACTURE	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Blood and lymphatic system disorders ANAEMIA	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Blood and lymphatic system disorders LEUKOPENIA	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Blood and lymphatic system disorders NORMOCHROMIC NORMOCYTIC ANAEMIA	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Blood and lymphatic system disorders THROMBOCYTOPENIA	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Cardiac disorders ACUTE MYOCARDIAL INFARCTION	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Cardiac disorders ANGINA PECTORIS	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Cardiac disorders ANGINA UNSTABLE	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Cardiac disorders ATRIAL FIBRILLATION	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Cardiac disorders CARDIOVASCULAR INSUFFICIENCY	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Cardiac disorders CORONARY ARTERY DISEASE	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Cardiac disorders MYOCARDIAL INFARCTION	0.31% 5/1613 • Number of events 5 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Cardiac disorders MYOCARDIAL ISCHAEMIA	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Cardiac disorders SINOATRIAL BLOCK	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Cardiac disorders TACHYARRHYTHMIA	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Ear and labyrinth disorders ACUTE VESTIBULAR SYNDROME	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Ear and labyrinth disorders EXOSTOSIS OF EXTERNAL EAR CANAL	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Ear and labyrinth disorders HYPOACUSIS	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Eye disorders EXOPHTHALMOS	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Eye disorders EYELID OEDEMA	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Eye disorders PAROPHTHALMIA	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Eye disorders RETINAL DETACHMENT	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Gastrointestinal disorders ABDOMINAL ADHESIONS	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Gastrointestinal disorders ABDOMINAL DISCOMFORT	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Gastrointestinal disorders ABDOMINAL PAIN	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Gastrointestinal disorders ABDOMINAL PAIN UPPER	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Gastrointestinal disorders COLITIS	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Gastrointestinal disorders CONSTIPATION	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Gastrointestinal disorders DYSPHAGIA	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Gastrointestinal disorders ENTERITIS	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Gastrointestinal disorders GASTROOESOPHAGEAL REFLUX DISEASE	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Gastrointestinal disorders ILEUS	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Gastrointestinal disorders INGUINAL HERNIA	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Gastrointestinal disorders MELAENA	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Gastrointestinal disorders NAUSEA	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Gastrointestinal disorders OESOPHAGEAL VARICES HAEMORRHAGE	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Gastrointestinal disorders SUBILEUS	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Gastrointestinal disorders SWOLLEN TONGUE	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
General disorders CHEST DISCOMFORT	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
General disorders CHILLS	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
General disorders CONDITION AGGRAVATED	0.12% 2/1613 • Number of events 2 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
General disorders DEATH	0.25% 4/1613 • Number of events 4 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
General disorders DRUG INEFFECTIVE	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
General disorders FACIAL PAIN	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
General disorders FATIGUE	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
General disorders MASS	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
General disorders PAIN	0.12% 2/1613 • Number of events 2 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
General disorders PYREXIA	0.25% 4/1613 • Number of events 4 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Hepatobiliary disorders HEPATIC CYST	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Immune system disorders HYPERSENSITIVITY	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Infections and infestations ATYPICAL PNEUMONIA	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Infections and infestations BRONCHITIS	0.12% 2/1613 • Number of events 2 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Infections and infestations BRONCHOPNEUMONIA	0.12% 2/1613 • Number of events 2 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Infections and infestations CELLULITIS	0.12% 2/1613 • Number of events 2 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Infections and infestations CHLAMYDIAL INFECTION	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Infections and infestations DIVERTICULITIS	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Infections and infestations ENCEPHALITIC INFECTION	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Infections and infestations ERYSIPELAS	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Infections and infestations FEBRILE INFECTION	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Infections and infestations GASTROENTERITIS	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Infections and infestations KIDNEY INFECTION	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Infections and infestations LOBAR PNEUMONIA	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Infections and infestations PERITONITIS	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Infections and infestations PNEUMONIA	0.43% 7/1613 • Number of events 7 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Infections and infestations PULMONARY SEPSIS	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Infections and infestations PULMONARY TUBERCULOSIS	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Injury, poisoning and procedural complications SPLENIC RUPTURE	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Investigations ANTI-CYCLIC CITRULLINATED PEPTIDE ANTIBODY POSITIVE	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Investigations COLONOSCOPY	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Investigations GAMMA-GLUTAMYLTRANSFERASE INCREASED	0.12% 2/1613 • Number of events 2 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Investigations HAEMOGLOBIN DECREASED	0.06% 1/1613 • Number of events 2 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Investigations INVESTIGATION	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Investigations PLATELET COUNT INCREASED	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Metabolism and nutrition disorders DECREASED APPETITE	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Metabolism and nutrition disorders DIABETES MELLITUS INADEQUATE CONTROL	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Metabolism and nutrition disorders HYPOKALAEMIA	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Musculoskeletal and connective tissue disorders ANKYLOSING SPONDYLITIS	0.19% 3/1613 • Number of events 3 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Musculoskeletal and connective tissue disorders ARTHRITIS	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Musculoskeletal and connective tissue disorders ARTHROFIBROSIS	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Musculoskeletal and connective tissue disorders BACK PAIN	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Musculoskeletal and connective tissue disorders FACET JOINT SYNDROME	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Musculoskeletal and connective tissue disorders HAND DEFORMITY	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Musculoskeletal and connective tissue disorders INTERVERTEBRAL DISC PROTRUSION	0.25% 4/1613 • Number of events 4 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Musculoskeletal and connective tissue disorders JAW CYST	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Musculoskeletal and connective tissue disorders JOINT EFFUSION	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Musculoskeletal and connective tissue disorders JOINT SWELLING	0.12% 2/1613 • Number of events 2 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Musculoskeletal and connective tissue disorders MYALGIA	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Musculoskeletal and connective tissue disorders OSTEOARTHRITIS	0.25% 4/1613 • Number of events 4 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Musculoskeletal and connective tissue disorders PSORIATIC ARTHROPATHY	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Musculoskeletal and connective tissue disorders RHEUMATOID ARTHRITIS	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Musculoskeletal and connective tissue disorders ROTATOR CUFF SYNDROME	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Musculoskeletal and connective tissue disorders SYNOVITIS	0.12% 2/1613 • Number of events 3 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Musculoskeletal and connective tissue disorders VERTEBRAL FORAMINAL STENOSIS	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BRAIN NEOPLASM	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BREAST CANCER	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) CHOLESTEATOMA	0.12% 2/1613 • Number of events 2 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) CHRONIC MYELOID LEUKAEMIA	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) FIBROMA	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) GASTROINTESTINAL STROMAL TUMOUR	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LIP AND/OR ORAL CAVITY CANCER	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) MELANOCYTIC NAEVUS	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) METASTASES TO BONE	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) NON-HODGKIN'S LYMPHOMA	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) OESOPHAGEAL CARCINOMA	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) PROSTATE CANCER	0.12% 2/1613 • Number of events 3 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) PROSTATIC ADENOMA	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) RENAL CELL CARCINOMA	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) SALIVARY GLAND NEOPLASM	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Nervous system disorders BURNING SENSATION	0.06% 1/1613 • Number of events 2 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Nervous system disorders CARPAL TUNNEL SYNDROME	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Nervous system disorders CEREBELLAR INFARCTION	0.19% 3/1613 • Number of events 3 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Nervous system disorders CEREBRAL INFARCTION	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Nervous system disorders CEREBRAL ISCHAEMIA	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Nervous system disorders CEREBROVASCULAR ACCIDENT	0.25% 4/1613 • Number of events 4 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Nervous system disorders CEREBROVASCULAR DISORDER	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Nervous system disorders CUBITAL TUNNEL SYNDROME	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Nervous system disorders DEMYELINATION	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Nervous system disorders DIZZINESS	0.25% 4/1613 • Number of events 4 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Nervous system disorders FACIAL PARESIS	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Nervous system disorders HEADACHE	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Nervous system disorders MONOPARESIS	0.12% 2/1613 • Number of events 2 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Nervous system disorders SCIATICA	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Nervous system disorders SYNCOPE	0.25% 4/1613 • Number of events 4 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Nervous system disorders TRANSIENT ISCHAEMIC ATTACK	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Psychiatric disorders BURNOUT SYNDROME	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Psychiatric disorders DEPRESSION	0.12% 2/1613 • Number of events 3 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Psychiatric disorders MAJOR DEPRESSION	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Renal and urinary disorders CALCULUS URETERIC	0.12% 2/1613 • Number of events 2 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Renal and urinary disorders NEPHROLITHIASIS	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Renal and urinary disorders NEUROGENIC BLADDER	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Renal and urinary disorders RENAL FAILURE	0.12% 2/1613 • Number of events 2 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Reproductive system and breast disorders EPIDIDYMITIS	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Reproductive system and breast disorders MENORRHAGIA	0.19% 3/1613 • Number of events 3 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Reproductive system and breast disorders VAGINAL EROSION	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Respiratory, thoracic and mediastinal disorders ALVEOLITIS	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Respiratory, thoracic and mediastinal disorders BRONCHIECTASIS	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Respiratory, thoracic and mediastinal disorders DYSPNOEA	0.25% 4/1613 • Number of events 4 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Respiratory, thoracic and mediastinal disorders HAEMOPTYSIS	0.12% 2/1613 • Number of events 3 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Respiratory, thoracic and mediastinal disorders PNEUMOTHORAX	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Respiratory, thoracic and mediastinal disorders PULMONARY EMBOLISM	0.12% 2/1613 • Number of events 2 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Skin and subcutaneous tissue disorders ECZEMA	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Skin and subcutaneous tissue disorders NIGHT SWEATS	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Skin and subcutaneous tissue disorders PSORIASIS	0.12% 2/1613 • Number of events 2 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Skin and subcutaneous tissue disorders PUSTULAR PSORIASIS	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Skin and subcutaneous tissue disorders SKIN ULCER	0.12% 2/1613 • Number of events 2 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Surgical and medical procedures AUTONOMIC GANGLIONECTOMY	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Surgical and medical procedures BLADDER OPERATION	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Surgical and medical procedures BURSA REMOVAL	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Surgical and medical procedures CARDIAC OPERATION	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Surgical and medical procedures CHOLECYSTECTOMY	0.12% 2/1613 • Number of events 2 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Surgical and medical procedures CHOLESTEATOMA REMOVAL	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Surgical and medical procedures DRUG THERAPY CHANGED	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Surgical and medical procedures ENDOMETRIAL ABLATION	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Surgical and medical procedures FOOT OPERATION	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Surgical and medical procedures GALLBLADDER OPERATION	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Surgical and medical procedures HIP ARTHROPLASTY	0.19% 3/1613 • Number of events 3 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Surgical and medical procedures HOSPITALISATION	0.68% 11/1613 • Number of events 11 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Surgical and medical procedures HYSTERECTOMY	0.12% 2/1613 • Number of events 2 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Surgical and medical procedures JOINT ARTHROPLASTY	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Surgical and medical procedures KNEE ARTHROPLASTY	0.31% 5/1613 • Number of events 5 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Surgical and medical procedures KNEE OPERATION	0.12% 2/1613 • Number of events 2 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Surgical and medical procedures LAXATIVE SUPPORTIVE CARE	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Surgical and medical procedures LIMB OPERATION	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Surgical and medical procedures POLYPECTOMY	0.06% 1/1613 • Number of events 2 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Surgical and medical procedures PROSTHESIS IMPLANTATION	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Surgical and medical procedures RADIOACTIVE IODINE THERAPY	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Surgical and medical procedures SHOULDER ARTHROPLASTY	0.12% 2/1613 • Number of events 2 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Surgical and medical procedures SHOULDER OPERATION	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Surgical and medical procedures SPINAL DECOMPRESSION	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Surgical and medical procedures SPINAL FUSION SURGERY	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Surgical and medical procedures SPINAL OPERATION	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Surgical and medical procedures SYNOVECTOMY	0.25% 4/1613 • Number of events 6 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Surgical and medical procedures TENDON SHEATH INCISION	0.12% 2/1613 • Number of events 2 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Surgical and medical procedures TENOTOMY	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Surgical and medical procedures TOE OPERATION	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Surgical and medical procedures VARICOSE VEIN OPERATION	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Surgical and medical procedures VASCULAR GRAFT	0.12% 2/1613 • Number of events 2 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Surgical and medical procedures WRIST SURGERY	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Vascular disorders DEEP VEIN THROMBOSIS	0.12% 2/1613 • Number of events 2 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Vascular disorders HYPERTENSION	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Vascular disorders HYPERTENSIVE CRISIS	0.12% 2/1613 • Number of events 2 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Vascular disorders LYMPHOEDEMA	0.12% 2/1613 • Number of events 2 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Vascular disorders PERIPHERAL ARTERIAL OCCLUSIVE DISEASE	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
Vascular disorders VENOUS INSUFFICIENCY	0.06% 1/1613 • Number of events 1 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.

Other adverse events

Other adverse events
Measure	All Participants n=1613 participants at risk Simponi®-naïve participants with rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis given Simponi® 50 mg once a month as a subcutaneous injection.
General disorders DRUG INEFFECTIVE	19.5% 315/1613 • Number of events 315 • Up to 24 months Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place