Table 4.

SAEs over 48-week treatment period (SP1 SAF)

Primary system organ class preferred term	SDZ-ADL N = 177; n (%)	‘ref-ADL/switched SDZ-ADL’ N = 176; n (%)
Any primary system organ class	7 (4.0)	10 (5.7)
Infections and infestations	2 (1.1)	3 (1.7)
Pneumonia	0	2 (1.1)
Bronchitis	0	1 (0.6)
Diverticulitis	1 (0.6)	0
Pneumonia bacterial	1 (0.6)	0
Gastrointestinal disorders	1 (0.6)	3 (1.7)
Constipation	1 (0.6)	0
Diarrhea	0	1 (0.6)
Pancreatitis acute	0	1 (0.6)
Upper gastrointestinal hemorrhage	0	1 (0.6)
Hepatobiliary disorders	2 (1.1)	0
Cholecystitis	1 (0.6)	0
Hepatitis	1 (0.6)	0
Injury, poisoning and procedural complications	1 (0.6)	1 (0.6)
Lumbar vertebral fracture	1 (0.6)	0
Humerus fracture	0	1 (0.6)
Nervous system disorders	1 (0.6)	1 (0.6)
Encephalopathy	1 (0.6)	0
Epilepsy	0	1 (0.6)
Hemianopia homonymous	0	1 (0.6)
Intracranial pressure increased	0	1 (0.6)
Musculoskeletal and connective tissue disorders	1 (0.6)	0
Back pain	1 (0.6)	0
Neoplasms benign, malignant and unspecified (including cysts and polyps)	0	2 (1.1)
Brain neoplasm benign	0	1 (0.6)
Uterine leiomyoma	0	1 (0.6)
Cardiac disorders	0	1 (0.6)
Angina pectoris	0	1 (0.6)
Metabolism and nutrition disorders	0	1 (0.6)
Hyponatremia	0	1 (0.6)
Reproductive system and breast disorders	0	1 (0.6)
Uterine prolapse	0	1 (0.6)

SP1 SAF study period 1 safety set: all patients who received at least one dose of study drug, whether randomized or not, ref-ADL reference adalimumab, SAEs serious adverse events, SDZ-ADL Sandoz adalimumab