Table 3 Serious adverse events under therapy with Benepali®
System Organ Class term | Preferred Term (PT) | n=83 | Number of SAE | 145 exposure years |
|---|---|---|---|---|
n (%) | AE rate per 100 exposure years (95% CI) | |||
Infections and infestations | 1 (1.2%) | 1 | 0.69 (0.02–3.84) | |
Urospesis | 1 (1.2%) | 1 | 0.69 (0.02–3.84) | |
Pregnancy, puerperium and perinatal conditions | 2 (2.4%) | 2 | 1.38 (0.17–4.98) | |
Hyperemesis gravidarum | 1 (1.2%) | 1 | 0.69 (0.02–3.84) | |
Premature birth | 1 (1.2%) | 1 | 0.69 (0.02–3.84) | |
Respiratory, thoracic, and mediastinal disorders | 1 (1.2%) | 1 | 0.69 (0.02–3.84) | |
Asthma | 1 (1.2%) | 1 | 0.69 (0.02–3.84) | |
Surgical and medical procedures | 5 (6.0%) | 6 | 4.14 (1.52–9.01) | |
Ankle operation | 1 (1.3%) | 1 | 0.69 (0.02–3.84) | |
Parathyroidectomy | 1 (1.3%) | 1 | 0.69 (0.02–3.84) | |
Renal stone removal | 1 (1.3%) | 1 | 0.69 (0.02–3.84) | |
Sinus operation | 1 (1.3%) | 1 | 0.69 (0.02–3.84) | |
Synovectomy | 1 (1.3%) | 1 | 0.69 (0.02–3.84) | |
Tooth extraction | 1 (1.3%) | 1 | 0.69 (0.02–3.84) |