Person who experienced the adverse event (patient)
| Event ID | CASE | I F COD | FOLL SEQ | IMAGE | EVENT DT | MFR DT | FDA DT | REPT COD | MFR NUM | MFR SNDR | AGE | AGE COD | GNDR COD | E SUB | WT | WT COD | REPT DT | OCCP COD | DEATH DT | TO MFR | CONFID | REPORTER COUNTRY |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 8016628 | 8317516 | I | 8016628-6 | 20111220 | 20111231 | EXP | PHHY2011JP111311 | SANDOZ,INC. | 32 | YR | Y | 20111231 | OT | JAPAN |
Drug(s) used by person
| Event ID | DRUG SEQ | ROLE COD | DRUGNAME | VAL VBM | ROUTE | DOSE VBM | DECHAL | RECHAL | LOT NUM | EXP DT | NDA NUM |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 8016628 | 1018419911 | SS | CYCLOSPORINE | 1 | TRANSPLACENTAL | MATERNAL DOSE: 60 MG | |||||
| 8016628 | 1018419912 | PS | HYDRALAZINE HYDROCHLORIDE | 1 | TRANSPLACENTAL | 083241 | |||||
| 8016628 | 1018419914 | C | PREDNISOLONE | 1 | |||||||
| 8016628 | 1018419913 | SS | HYDRALAZINE HYDROCHLORIDE | 1 | TRANSPLACENTAL | MATERNAL DOSE: 6 MG |
Indications of drugs used
| no results found |
Outcome of event
| Event ID | OUTC COD |
|---|---|
| 8016628 | HO |
Reactions reported
| Event ID | PT |
|---|---|
| 8016628 | FOETAL EXPOSURE DURING PREGNANCY |
| 8016628 | LOW BIRTH WEIGHT BABY |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |