Table 3.
Summary of treatment emergent adverse events (> 2%) during SP1 (SP1 SAF) and SP2 (SP2 SAF)
| Primary system organ class preferred term |
Study Period 1 | Study Period 2 (Switch-in period) | ||
|---|---|---|---|---|
| SDZ-ADL N = 177 n (%) |
ref-ADL N = 176 n (%) |
‘Continued SDZ-ADL’ N = 159 n (%) |
‘ref-ADL to SDZ-ADL’ N = 166 n (%) |
|
| Any primary system organ class | 109 (61.6) | 106 (60.2) | 58 (36.5) | 54 (32.5) |
| Infections and infestations | 63 (35.6) | 65 (36.9) | 25 (15.7) | 27 (16.3) |
| Viral upper respiratory tract infection | 26 (14.7) | 16 (9.1) | 4 (2.5) | 4 (2.4) |
| Upper respiratory tract infection | 12 (6.8) | 7 (4.0) | 4 (2.5) | 3 (1.8) |
| Pharyngitis | 9 (5.1) | 10 (5.7) | 1 (0.6) | 3 (1.8) |
| Bronchitis | 4 (2.3) | 8 (4.5) | 1 (0.6) | 5 (3.0) |
| Urinary tract infection | 4 (2.3) | 6 (3.4) | 2 (1.3) | 3 (1.8) |
| Sinusitis | 5 (2.8) | 3 (1.7) | 0 | 2 (1.2) |
| Oral herpes | 4 (2.3) | 3 (1.7) | 1 (0.6) | 0 |
| Influenza | 3 (1.7) | 5 (2.8) | 1 (0.6) | 0 |
| Gastroenteritis | 2 (1.1) | 4 (2.3) | 0 | 1 (0.6) |
| Musculoskeletal and connective tissue disorders | 21 (11.9) | 14 (8.0) | 7 (4.4) | 4 (2.4) |
| Arthralgia | 8 (4.5) | 0 | 2 (1.3) | 0 |
| Rheumatoid arthritis | 3 (1.7) | 1 (0.6) | 5 (3.1) | 2 (1.2) |
| Back pain | 4 (2.3) | 3 (1.7) | 0 | 0 |
| Gastrointestinal disorders | 21 (11.9) | 17 (9.7) | 3 (1.9) | 4 (2.4) |
| Diarrhea | 4 (2.3) | 7 (4.0) | 0 | 1 (0.6) |
| Nausea | 5 (2.8) | 1 (0.6) | 0 | 0 |
| General disorders and administration site conditions | 15 (8.5) | 14 (8.0) | 2 (1.3) | 2 (1.2) |
| Injection site erythema | 2 (1.1) | 6 (3.4) | 1 (0.6) | 2 (1.2) |
| Fatigue | 5 (2.8) | 0 | 0 | 1 (0.6) |
| Nervous system disorders | 13 (7.3) | 12 (6.8) | 5 (3.1) | 4 (2.4) |
| Headache | 7 (4.0) | 5 (2.8) | 2 (1.3) | 2 (1.2) |
| Investigations | 7 (4.0) | 8 (4.5) | 6 (3.8) | 5 (3.0) |
| Transaminases increased | 0 | 3 (1.7) | 1 (0.6) | 1 (0.6) |
| Skin and subcutaneous tissue disorders | 12 (6.8) | 9 (5.1) | 3 (1.9) | 1 (0.6) |
| Urticaria | 0 | 3 (1.7) | 0 | 1 (0.6) |
| Injury, poisoning and procedural complications | 9 (5.1) | 8 (4.5) | 4 (2.5) | 4 (2.4) |
| Fall | 2 (1.1) | 3 (1.7) | 0 | 1 (0.6) |
| Respiratory, thoracic and mediastinal disorders | 10 (5.6) | 4 (2.3) | 4 (2.5) | 1 (0.6) |
| Cough | 2 (1.1) | 1 (0.6) | 3 (1.9) | 0 |
| Metabolism and nutrition disorders | 6 (3.4) | 5 (2.8) | 3 (1.9) | 0 |
| Hypercholesterolemia | 3 (1.7) | 3 (1.7) | 2 (1.3) | 0 |
| Vascular disorders | 7 (4.0) | 4 (2.3) | 2 (1.3) | 4 (2.4) |
| Hypertension | 5 (2.8) | 3 (1.7) | 2 (1.3) | 1 (0.6) |
| Blood and lymphatic system disorders | 5 (2.8) | 1 (0.6) | 5 (3.1) | 2 (1.2) |
| Neutropenia | 3 (1.7) | 0 | 2 (1.3) | 1 (0.6) |
| Leukopenia | 2 (1.1) | 0 | 2 (1.3) | 0 |
| Cardiac disorders | 1 (0.6) | 4 (2.3) | 2 (1.3) | 2 (1.2) |
| Eye disorders | 4 (2.3) | 3 (1.7) | 1 (0.6) | 0 |
| Hepatobiliary disorders | 4 (2.3) | 1 (0.6) | 1 (0.6) | 1 (0.6) |
| Psychiatric disorders | 2 (1.1) | 1 (0.6) | 2 (1.3) | 1 (0.6) |
| Renal and urinary disorders | 3 (1.7) | 1 (0.6) | 2 (1.3) | 0 |
SP1 SAF study period 1 safety set: all patients who received at least one dose of study drug, whether randomized or not, SP2 SAF study period 2 safety set: all patients in the study period 1 safety analysis set who entered study period 2 and received at least 1 dose of study drug in study period 2, ref-ADL reference adalimumab, SDZ-ADL Sandoz adalimumab