TABLE 3.
SOC a | Signal | Frequency of drug-event pair | ROR b (95%CI) |
---|---|---|---|
Pregnancy, Puerperium and Perinatal Conditions | Abortion | 3 | 5.2 (1.7–16.1) |
Foetal death | 7 | 6.3 (3.0–13.3) | |
Premature delivery | 11 | 2.0 (1.1–3.6) | |
Premature labor | 4 | 4.2 (1.6–11.1) | |
Injury, Poisoning and Procedural Complications | Maternal drugs affecting foetus | 3 | 10.8 (3.4–33.7) |
Maternal exposure during pregnancy | 70 | 2.3 (1.8–2.9) |
System Organ Class.
Reporting Odds Ratio.