Table 4

EAIRs of BTK inhibitor or concomitant drug class-associated TEAEs by preferred term

TotalCont’dTotal
Placebo
(n=271)
Evobrutinib
(n=861)
Placebo
(n=271)
Evobrutinib
(n=861)
n (%)EAIRn (%)EAIRn (%)EAIRn (%)EAIR
Cardiac disordersInfections
 Tachycardia0 (0.0)1 (0.1)0.2 Serious infections and infestations3 (1.1)2.114 (1.6)2.7
 Ventricular arrhythmia0 (0.0)1 (0.1)0.2 Herpes zoster3 (1.1)2.19 (1.0)1.8
 Coronary artery disease0 (0.0)1 (0.1)0.2Immune system disorders
Haemorrhage-related TEAEs Hypersensitivity1 (0.4)0.73 (0.3)0.6
 Bleeding*7 (2.6)2.413 (1.5)0.6Musculoskeletal and connective tissue disorders
 Bruising†1 (0.4)0.75 (0.6)0.5 Osteonecrosis1 (0.4)0.73 (0.3)0.6
Vascular disordersLiver-related TEAEs
 Hypertension1 (0.4)0.719 (2.2)3.7 ALT increase‡4 (1.5)2.825 (2.9)4.8
Neoplasms AST increase‡1 (0.4)0.718 (2.1)3.5
 Neoplasms benign, malignant and unspecified (SOC)5 (1.8)3.57 (0.8)1.4Pancreas-related TEAEs
  Anogenital warts1 (0.4)0.72 (0.2)0.4 Amylase increase10 (3.7)7.026 (3.0)5.1
  Fibrous histiocytoma1 (0.4)0.70 (0.0) Lipase increase‡4 (1.5)2.817 (2.0)4.0
  Lipoma1 (0.4)0.70 (0.0)Leucopenia-related TEAEs
  Lung neoplasm1 (0.4)0.70 (0.0) Lymphopenia‡10 (3.7)7.216 (1.9)3.1
  Oral papilloma0 (0.0)1 (0.1)0.2 Neutropenia‡6 (2.2)4.210 (1.2)1.9
  Papillary thyroid cancer1 (0.4)0.70 (0.0)Thrombocytopenia-related TEAEs
  Skin papilloma0 (0.0)1 (0.1)0.2 Thrombocytopenia‡0 (0.0)2 (0.2)0.4
  Thyroid adenoma0 (0.0)1 (0.1)0.2
  Uterine leiomyoma0 (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.