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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 4365385 | 4079355 | F | 1 | 4365385-3 | 20030610 | 20040514 | 20040525 | EXP | MEST00304000083 | SOLVAY PHARMACEUTICALS, INC | 30 | YR | M | N | 70 | KG | 20040520 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 4365385 | 1004893143 | PS | ROWASA | 1 | ORAL | SEE IMAGE | Y | D | 19618 | ||
| 4365385 | 1004906298 | C | PREDNISOLONE | 1 | ORAL | 20 MG DAILY PO | Y | D |
Indications of drugs used
| Event ID | DRUG SEQ | INDI PT |
|---|---|---|
| 4365385 | 1004893143 | CROHN'S DISEASE |
| 4365385 | 1004906298 | CROHN'S DISEASE |
Outcome of event
| Event ID | OUTC COD |
|---|---|
| 4365385 | HO |
Reactions reported
| Event ID | PT |
|---|---|
| 4365385 | HEPATITIS |
| 4365385 | INFLAMMATION |
| 4365385 | INTERSTITIAL LUNG DISEASE |
Reporting Sources (this data is often not reported and may therefore be missing here)
| Event ID | RPSR COD |
|---|---|
| 4365385 | FGN |
| 4365385 | OTH |
Therapies reported
| Event ID | DRUG SEQ | START DT | END DT | DUR | DUR COD |
|---|---|---|---|---|---|
| 4365385 | 1004893143 | 20030301 | 20030101 | ||
| 4365385 | 1004893143 | 20030601 | 20030613 | ||
| 4365385 | 1004906298 | 20030613 |