Distribution of patient-and HCP-reported ADRs
| Patient | HCP | p-value | ||||
|---|---|---|---|---|---|---|
| High Level Group Term | Burden (1-5) | Reports (%) | HCP contact (%) | Reports (%) | All patient vs HCP reports | HCP contact vs HCP reports |
| Administration site reactions | 1.7 | 402 (20.3) | 93 (11.1) | 20 (2.9) | <.001 | <.001 |
| Infections - pathogen unspecified | 2.9 | 229 (11.6) | 130 (15.5) | 93 (13.7) | 0.153 | 0.344 |
| Epidermal and dermal conditions | 2.6 | 218 (11.0) | 96 (11.4) | 111 (16.3) | <.001 | 0.007 |
| General system disorders NEC | 2.8 | 175 (8.9) | 82 (9.8) | 52 (7.7) | 0.382 | 0.172 |
| Gastrointestinal signs and symptoms | 2.4 | 81 (4.1) | 17 (2.0) | 29 (4.3) | 0.824 | 0.015 |
| Respiratory disorders NEC | 2.4 | 77 (3.9) | 33 (3.9) | 26 (3.8) | 1.0 | 1.0 |
| Headaches | 2.9 | 55 (2.8) | 23 (2.7) | 19 (2.8) | 1.0 | 1.0 |
| Joint disorders | 3.3 | 55 (2.8) | 32 (3.8) | 3 (0.4) | 0.093 | 0.006 |
| Respiratory tract signs and symptoms | 2.2 | 47 (2.4) | 22 (2.6) | 7 (1.0) | 0.039 | 0.036 |
| Skin appendage conditions | 3.0 | 44 (2.2) | 14 (1.7) | 12 (1.8) | 0.538 | 1.0 |
| Musculoskeletal and connective tissue disorders NEC | 3.1 | 40 (2.0) | 16 (1.9) | 4 (0.6) | 0.009 | 0.039 |
| Oral soft tissue conditions | 2.4 | 33 (1.7) | 12 (1.4) | 7 (1.0) | 0.277 | 0.644 |
| Gastrointestinal motility and defaecation conditions | 2.6 | 29 (1.5) | 12 (1.4) | 16 (2.4) | 0.123 | 0.186 |
| Ocular infections, irritations and inflammations | 3.1 | 29 (1.5) | 22 (2.6) | 4 (0.6) | 0.106 | 0.002 |
| Therapeutic and nontherapeutic effects (excl toxicity) | 2.9 | 27 (1.4) | 16 (1.9) | 3 (0.4) | 0.057 | 0.010 |
| Other | 2.9 | 436 (22.1) | 221 (26.3) | 273 (40.2) | <.001 | <.001 |