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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 5584616 | 6711487 | F | 1 | 5584616-5 | 20071218 | 20080103 | EXP | 2007BM000196 | BIOMARIN PHARMACEUTICALS INC. | 22 | YR | F | N | 20071227 | MD | IRAN (ISLAMIC REPUBLIC OF) |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 5584616 | 1009373327 | PS | PREDNISOLONE | 1 | 20 MG;QD;10MG;QD | Y | N | 75117 | |||
| 5584616 | 1009388535 | SS | AZATHIOPRINE SODIUM | 1 | 50 MG;QD; | Y | N | ||||
| 5584616 | 1009388536 | C | AMINOSALICYLATE SODIUM | 2 |
Indications of drugs used
| Event ID | DRUG SEQ | INDI PT |
|---|---|---|
| 5584616 | 1009373327 | COLITIS ULCERATIVE |
| 5584616 | 1009388535 | COLITIS ULCERATIVE |
Outcome of event
| Event ID | OUTC COD |
|---|---|
| 5584616 | HO |
Reactions reported
| Event ID | PT |
|---|---|
| 5584616 | BLOOD POTASSIUM DECREASED |
| 5584616 | BLOOD PRESSURE SYSTOLIC DECREASED |
| 5584616 | COMA |
| 5584616 | CONDITION AGGRAVATED |
| 5584616 | DIARRHOEA HAEMORRHAGIC |
| 5584616 | DYSENTERY |
| 5584616 | ENCEPHALITIS HERPES |
| 5584616 | HAEMOGLOBIN DECREASED |
Reporting Sources (this data is often not reported and may therefore be missing here)
| Event ID | RPSR COD |
|---|---|
| 5584616 | FGN |
| 5584616 | HP |
| 5584616 | LIT |
Therapies reported
| Event ID | DRUG SEQ | START DT | END DT | DUR | DUR COD |
|---|---|---|---|---|---|
| 5584616 | 1009373327 | 1 | YR | ||
| 5584616 | 1009373327 | 2 | YR | ||
| 5584616 | 1009388535 | 1 | YR |