Table 2.
Description of the cohort of case reports
| Total 186 (100%) |
Training 93 (100%) |
Validation 93 (100%) |
|
|---|---|---|---|
| Expert assessment | |||
| Poor | 30 (16.1%) | 9 (9.7%) | 21 (22.6%) |
| Moderate | 35 (18.8%) | 14 (15.1%) | 21 (22.6%) |
| Good | 55 (29.6%) | 30 (32.3%) | 25 (26.9%) |
| Excellent | 66 (35.5%) | 40 (43.0%) | 26 (28.0%) |
| Source | |||
| Spontaneous reports | 25 (13.4%) | 17 (18.3%) | 8 (8.6%) |
| Literature reports | 23 (12.4%) | 9 (9.7%) | 14 (15.1%) |
| TIS (UK) | 28 (15.1%) | 10 (10.8%) | 18 (19.4%) |
| TIS (Switzerland) | 27 (14.5%) | 17 (18.3%) | 10 (10.8%) |
| The Dutch Pregnancy Drug Register | 30 (16.1%) | 12 (12.9%) | 18 (19.4%) |
| Gilenya pregnancy registry | 28 (15.1%) | 15 (16.1%) | 13 (14.0%) |
| Enhanced PV programme | 25 (13.4%) | 13 (14.0%) | 12 (12.9%) |
| Clinical scenario | |||
| Pregnancy loss | 33 (17.7%) | 19 (20.4%) | 14 (15.1%) |
| Congenital anomalies or chromosomal defects | 37 (19.9%) | 18 (19.4%) | 19 (20.4%) |
| Foetal or neo-natal complications | 35 (18.8%) | 18 (19.4%) | 17 (18.3%) |
| Infant or child complications | 3 (1.6%) | 0 | 3 (3.2%) |
| Maternal pregnancy-related complications | 33 (17.7%) | 18 (19.4%) | 15 (16.1%) |
| No adverse outcomes or complications | 43 (23.1%) | 19 (20.4%) | 24 (25.8%) |
| Other | 2 (1.1%) | 1 (1.1%) | 1 (1.1%) |
PV pharmacovigilance, TIS Teratology Information Services