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. Author manuscript; available in PMC: 2014 May 28.
Published in final edited form as: Arthritis Rheum. 2012 Sep;64(9):2824–2835. doi: 10.1002/art.34498

Table 3.

Safety Summary by Treatment Group.

IE (244) IT (132) SE (255) ST (124) Total (755)
Participants with any event (AE or SAE) 193(79.1) 101(76.5) 187(73.3) 92(74.2) 573(75.9)
 With event: Mean (SD) number of events 3.6 (3.0) 3.3 (2.4) 4.1 (3.1) 3.4 (2.9) 3.7(2.9)
 Range of events 1-22 1-11 1-18 1-13 1-22
Participants with a Serious Adverse Event 35(14.3) 18(13.6) 32(12.5) 16(12.9) 101(13.4)
 With SAE:   Mean (SD) number of events 1.3(0.6) 1.3(0.6) 1.2(0.4) 1.3(0.5) 1.3(0.5)
 Range of events 1-3 1-3 1-2 1-2 1-3
Deaths* 1 1 2 0 4
Organ Systems of SAE (including deaths)** 44 24 38 21 127
 Blood and lymphatic system 1 1 0 1 3(2.4)
16(12.6)
 Cardiac 5 2 4 5
 Eye 0 0 0 1 1(<1)
 Gastrointestinal 2 5 0 0 7(5.5)
 General and administration site 1 0 2 0 3(2.4)
 Immune system 1 0 0 0 1(<1)
 Infections and infestations*** 9 4 7 3 23(18.1)
 Injury and poisoning 2 0 1 1 4(3.1)
 Investigations 1 1 1 2 5(3.9)
 Metabolism and nutrition 0 0 0 2 2(1.6)
 Musculoskeletal and connective tissue 1 0 4 0 5(3.9)
 Neoplasms benign and malignant**** 5 1 0 1 7(5.5)
 Nervous system 2 1 3 2 8(6.3)
 Pregnancy, puerperium and perinatal 0 1 1 0 2(1.6)
 Psychiatric 3 0 0 1 4(3.1)
 Reproductive system and breast 0 0 3 0 3(2.4)
 Respiratory, thoracic and mediastinal 5 0 3 1 9(7.1)
 Surgical and medical procedures 6 5 7 1 19(15.0)
 Vascular 0 3 2 0 5(3.9)
*

Three deaths due to cardiac disorders: general (unattended death), coronary heart failure, ventricular septal defect; one due to respiratory failure.

**

Multiple events per subject; organ system will not necessarily total the sum of the individuals with events as a participant can report more than one event; percents shown are percent of events within a system out of number of events within treatment group.

***

Twenty-three serious infections were reported (9 in the IE group, 4 IT, 7 SE, 3 ST): 9 Pneumonia (4 IE, 1IT, 4 SE, 2 ST), 3 cellulitis (all IE), and 2 bronchitis (all IT); all other infections 1 per type (3 IE, 1 IT, 3 SE, 2 ST).

****

Seven malignant diseases were reported (5 in IE, 1 IT, and 1 ST): 2 breast cancer (1 in IT), 3 lung cancer (1 in ST), 1 prostate cancer, and 2 renal carcinoma. None of the reproductive or breast system disorders were breast cancer related.

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