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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 4631674 | 5930609 | I | 4631674-8 | 20050401 | 20050407 | EXP | 2005-BP-05406RO | ROXANE LABORATORIES, INC. | UNK | N | 20050404 | FRANCE |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 4631674 | 1005863321 | PS | METHOTREXATE | 1 | INTRA-UTERINE | 7.5 MG/WEEK (MATERNAL EXPOSURE) , IU; 8.3 GESTATIONAL WEEKS | D | D | 40054 | ||
| 4631674 | 1005890839 | SS | SULFASALAZINE | 1 | INTRA-UTERINE | 3 G/D (MATERNAL EXPOSURE), IU; 8.3 GESTATIONAL WEEKS | D | D |
Indications of drugs used
| no results found |
Outcome of event
| Event ID | OUTC COD |
|---|---|
| 4631674 | CA |
| 4631674 | OT |
Reactions reported
| Event ID | PT |
|---|---|
| 4631674 | ABORTION INDUCED |
| 4631674 | ABORTION SPONTANEOUS |
| 4631674 | CAESAREAN SECTION |
| 4631674 | DRUG EXPOSURE DURING PREGNANCY |
| 4631674 | HAEMANGIOMA |
| 4631674 | JAUNDICE NEONATAL |
| 4631674 | NEONATAL RESPIRATORY DISTRESS SYNDROME |
| 4631674 | PREMATURE LABOUR |
| 4631674 | TALIPES |
Reporting Sources (this data is often not reported and may therefore be missing here)
| Event ID | RPSR COD |
|---|---|
| 4631674 | FGN |
| 4631674 | LIT |
| 4631674 | SDY |
Therapies reported
| Event ID | DRUG SEQ | START DT | END DT | DUR | DUR COD |
|---|---|---|---|---|---|
| 4631674 | 1005863321 | 8 | WK | ||
| 4631674 | 1005890839 | 8 | WK |