Table 4.
EAIRs of BTK inhibitor or concomitant drug class-associated TEAEs by preferred term
| Total | Cont’d | Total | |||||||
| Placebo (n=271) |
Evobrutinib (n=861) |
Placebo (n=271) |
Evobrutinib (n=861) |
||||||
| n (%) | EAIR | n (%) | EAIR | n (%) | EAIR | n (%) | EAIR | ||
| Cardiac disorders | Infections | ||||||||
| Tachycardia | 0 (0.0) | – | 1 (0.1) | 0.2 | Serious infections and infestations | 3 (1.1) | 2.1 | 14 (1.6) | 2.7 |
| Ventricular arrhythmia | 0 (0.0) | – | 1 (0.1) | 0.2 | Herpes zoster | 3 (1.1) | 2.1 | 9 (1.0) | 1.8 |
| Coronary artery disease | 0 (0.0) | – | 1 (0.1) | 0.2 | Immune system disorders | ||||
| Haemorrhage-related TEAEs | Hypersensitivity | 1 (0.4) | 0.7 | 3 (0.3) | 0.6 | ||||
| Bleeding* | 7 (2.6) | 2.4 | 13 (1.5) | 0.6 | Musculoskeletal and connective tissue disorders | ||||
| Bruising† | 1 (0.4) | 0.7 | 5 (0.6) | 0.5 | Osteonecrosis | 1 (0.4) | 0.7 | 3 (0.3) | 0.6 |
| Vascular disorders | Liver-related TEAEs | ||||||||
| Hypertension | 1 (0.4) | 0.7 | 19 (2.2) | 3.7 | ALT increase‡ | 4 (1.5) | 2.8 | 25 (2.9) | 4.8 |
| Neoplasms | AST increase‡ | 1 (0.4) | 0.7 | 18 (2.1) | 3.5 | ||||
| Neoplasms benign, malignant and unspecified (SOC) | 5 (1.8) | 3.5 | 7 (0.8) | 1.4 | Pancreas-related TEAEs | ||||
| Anogenital warts | 1 (0.4) | 0.7 | 2 (0.2) | 0.4 | Amylase increase | 10 (3.7) | 7.0 | 26 (3.0) | 5.1 |
| Fibrous histiocytoma | 1 (0.4) | 0.7 | 0 (0.0) | – | Lipase increase‡ | 4 (1.5) | 2.8 | 17 (2.0) | 4.0 |
| Lipoma | 1 (0.4) | 0.7 | 0 (0.0) | – | Leucopenia-related TEAEs | ||||
| Lung neoplasm | 1 (0.4) | 0.7 | 0 (0.0) | – | Lymphopenia‡ | 10 (3.7) | 7.2 | 16 (1.9) | 3.1 |
| Oral papilloma | 0 (0.0) | – | 1 (0.1) | 0.2 | Neutropenia‡ | 6 (2.2) | 4.2 | 10 (1.2) | 1.9 |
| Papillary thyroid cancer | 1 (0.4) | 0.7 | 0 (0.0) | – | Thrombocytopenia-related TEAEs | ||||
| Skin papilloma | 0 (0.0) | – | 1 (0.1) | 0.2 | Thrombocytopenia‡ | 0 (0.0) | – | 2 (0.2) | 0.4 |
| Thyroid adenoma | 0 (0.0) | – | 1 (0.1) | 0.2 | |||||
| Uterine leiomyoma | 0 (0.0) | – | 2 (0.2) | 0.4 | |||||
*Defined by medical concept as epistaxis, haematoma, haematoma muscle, haemorrhagic diathesis.
†Defined by medical concept as ecchymosis and petechiae.
‡The event with the highest severity for a patient during the treatment period and meeting the AESI definition was included in the summary.
AESI, adverse event of special interest; EAIR, exposure-adjusted incidence rates; MS, multiple sclerosis; RA, rheumatoid arthritis; SLE, systemic lupus erythematosus; SOC, system organ class; TEAEs, treatment-emergent adverse events.