Summary of patients with TEAE
| Patients with TEAE* in part 1 | Subcutaneous golimumab (N=3357), n (%) |
|---|---|
| One or more TEAE | 1881 (56.0) |
| TEAE possibly or probably related to study medication | 943 (28.1) |
| TEAE leading to early withdrawal | 145 (4.3) |
| Deaths | 6 (0.2)† |
| Injection site reactions | 23 (0.7) |
| Clinically significant abnormal lab values | 163 (4.9) |
| Serious TEAE | 190 (5.7) |
| Infections and infestations | 58 (1.7) |
| Injury, poisoning and procedural complications | 26 (0.8) |
| Musculoskeletal and connective tissue disorders | 25 (0.7) |
| Cardiac disorders | 15 (0.4) |
| Neoplasms benign, malignant and unspecified (including cysts and polyps) | 15 (0.4) |
| Respiratory, thoracic and mediastinal disorders | 15 (0.4) |
| Gastrointestinal disorders | 14 (0.4) |
| Nervous system disorders | 11 (0.3) |
| General disorders and administration site conditions | 10 (0.3) |
| Vascular disorders | 9 (0.3) |
| Renal and urinary disorders | 7 (0.2) |
| Metabolism and nutrition disorders | 6 (0.2) |
| Hepatobiliary disorders | 4 (0.1) |
| Skin and subcutaneous tissue disorders | 4 (0.1) |
| Surgical and medical procedures | 4 (0.1) |
| Blood and lymphatic system disorders | 3 (0.1) |
| Immune system disorders | 3 (0.1) |
| Investigations | 3 (0.1) |
| Psychiatric disorders | 3 (0.1) |
| Reproductive system and breast disorders | 3 (0.1) |
| Eye disorders | 2 (0.1) |
| Ear and labyrinth disorders | 1 (0.03) |
| Patients with TEAE in part 2 | IV+SC golimumab (N=245) n (%) | Subcutaneous golimumab (N=255) n (%) |
|---|---|---|
| One or more TEAE | 133 (54.3) | 127 (49.8) |
| TEAE possibly or probably related to study medication | 65 (26.5) | 57 (22.4) |
| TEAE leading to early withdrawal | 12 (4.9) | 6 (2.4) |
| Deaths | 1 (0.4) | 0 |
| Injection site reactions | 1 (0.4) | 0 |
| Clinically significant abnormal lab values | 13 (5.3) | 16 (6.3) |
| Serious TEAE | 17 (6.9) | 6 (2.4) |
| Infections and infestations | 5 (2.0) | 2 (0.8) |
| Musculoskeletal and connective tissue disorders | 3 (1.2) | 0 |
| Injury, poisoning, and procedural complications | 3 (1.2) | 1 (0.4) |
| Respiratory, thoracic and mediastinal disorders | 2 (0.8) | 0 |
| Gastrointestinal disorders | 2 (0.8) | 0 |
| Hepatobiliary disorders | 1 (0.4) | 0 |
| General disorders and administration site conditions | 1 (0.4) | 0 |
| Cardiac disorders | 1 (0.4) | 0 |
| Neoplasms benign, malignant and unspecified | 1 (0.4) | 2 (0.8) |
| Nervous system disorders | 1 (0.4) | 0 |
| Skin and subcutaneous tissue disorders | 0 | 1 (0.4) |
| Investigations | 0 | 1 (0.4) |
*A TEAE was defined as an adverse event occurring during the treatment period if it started on or after the first dose of study medication, and up to 30 days after the last dose of study medication, or if it was present before the first dose of study medication, but increased in severity during the treatment period.
†Four additional events that led to death occurred in patients more than 30 days after their last dose of study medication.
IV+SC, intravenous plus subcutaneous; TEAE, treatment-emergent adverse event.