Caliper validation of the submitted claim (drug=valproic acid, AE=Neural tube defect). BELOW_DEDUP_THRESHOLD — 7 raw reports matched the reaction term, but only 4 unique cases remained after dedup; genuine signal-density limitation (the term was found, there just isn't enough independent evidence yet).
BELOW_DEDUP_THRESHOLD — 7 raw reports matched the reaction term, but only 4 unique cases remained after dedup; genuine signal-density limitation (the term was found, there just isn't enough independent evidence yet).| MedDRA PT | n |
|---|---|
| DRUG INTERACTION | 4 |
| NEURAL TUBE DEFECT | 4 |
| Foetal exposure during pregnancy | 3 |
| Neural tube defect | 3 |
| Arnold-Chiari malformation | 1 |
| Cerebral ventricle dilatation | 1 |
| Spina bifida | 1 |