TABLE 4.
Safety Endpoints During Induction: AEs of Special Interest in Relation to Corticosteroid Use in the Overall Population in GEMINI 2 and GEMINI 3 With Placebo and Vedolizumab Stratified by Corticosteroid Use
| GEMINI 2 | GEMINI 3 | |||||||
|---|---|---|---|---|---|---|---|---|
| Placebo (n = 148) | Vedolizumab (n = 220) | Placebo (n = 207) | Vedolizumab (n = 209) | |||||
| MedDRA organ class | CS n = 65 | No CS n = 81 | CS n = 100 | No CS n = 119 | CS n = 108 | No CS n = 97 | CS n = 111 | No CS n = 97 |
| Patients with ≥1 AE, n (%) | 41 (63) | 45 (56) | 59 (59) | 64 (54) | 62 (57) | 62 (64) | 61 (55) | 57 (59) |
| Gastrointestinal disorders | 12 (18) | 22 (27) | 24 (24) | 29 (24) | 20 (19) | 29 (30) | 16 (14) | 22 (23) |
| Infections and infestations | 13 (20) | 13 (16) | 20 (20) | 14 (12) | 16 (15) | 20 (21) | 23 (21) | 16 (16) |
| Musculoskeletal and connective tissue disorders | 8 (12) | 8 (10) | 7 (7) | 17 (14) | 15 (14) | 9 (9) | 11 (10) | 15 (15) |
| Skin and subcutaneous tissue disorders | 3 (5) | 6 (7) | 6 (6) | 8 (7) | 4 (4) | 9 (9) | 9 (8) | 10 (10) |
| Blood and lymphatic system disorders | 4 (6) | 5 (6) | 6 (6) | 3 (3) | 2 (2) | 1 (1) | 5 (5) | 4 (4) |
| Metabolism and nutrition disorders | 4 (6) | 1 (1) | 3 (3) | 3 (3) | 0 (0) | 3 (3) | 6 (5) | 2 (2) |
| Psychiatric disorders | 3 (5) | 1 (1) | 2 (2) | 2 (2) | 7 (6) | 6 (6) | 1 (<1) | 2 (2) |
| Immune system disorders (atopic disorders and seasonal allergy) | 1 (2) | 0 (0) | 0 (0) | 1 (<1) | 1 (<1) | 0 (0) | 1 (<1) | 0 (0) |
| Endocrine disorders (cushingoid) | 0 (0) | 0 (0) | 1 (1) | 1 (<1) | 1 (<1) | 0 (0) | 1 (<1) | 0 (0) |
Note: No direct relation is attributed to corticosteroid use because this was not recorded during the trial (only AEs deemed related to study treatment were specifically recorded).
MedDRA, Medical Dictionary for Regulatory Activities; CS, corticosteroid.