Any secukinumab dose (N=510) | |
---|---|
Total exposure, patient-years | 968.9 |
Minimum–maximum exposure (days) | 1–1530 |
Death, n (%) | 0 |
AEs by EAIR: AE per 100 Patient-years (95% Cl) | |
Any AE | 159.2 (144.4, 175.1) |
Any SAE | 5.4 (4.0, 7.1) |
Frequent AEs1 | |
Nasopharyngitis | 13.6 (11.2, 16.5) |
Diarrhoea | 6.4 (4.9, 8.3) |
Headache | 6.7 (5.1, 8.7) |
Upper respiratory tract infection | 4.3 (3.1, 5.9) |
AEs of special interest | |
Candida infections | 0.8 (0.4, 1.6) |
Serious infections | 0.7 (0.3, 1.5) |
Inflammatory Bowel Disease | 0.4 (0.1, 1.1) |
Crohn's disease | 0.2 (0.0, 0.7) |
Ulcerative colitis | 0.2 (0.0, 0.7) |
MACE | 0.4 (0.1, 1.1) |
Neutropenia | 1.2 (0.6, 2.1) |
Uveitis | 1.6 (0.9, 2.6) |
1AEs that occurred in Any secukinumab group with an IR >4.0 during the entire safety period. AE, adverse event; CI, confidence interval; EAIR, exposure adjusted incidence rate per 100 patient-years; MACE, major adverse cardiac events; N, number of patients in the analysis; n, number of patients with event; SAE, serious adverse event.