Person who experienced the adverse event (patient)
| Event ID | CASEID | CASEVERSION | I F COD | EVENT DT | MFR DT | INIT FDA DT | FDA DT | REPT COD | AUTH NUM | MFR NUM | MFR SNDR | LIT REF | AGE | AGE COD | AGE GRP | GNDR COD | E SUB | WT | WT COD | REPT DT | TO MFR | OCCP COD | REPORTER COUNTRY | OCCR COUNTRY |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122251468 | 12225146 | 8 | F | 20160316 | 20160915 | 20160331 | 20160921 | EXP | AU-SA-2016SA055954 | AVENTIS | 51.00 | YR | A | M | Y | 65.00000 | KG | 20160921 | OT | AU | AU |
Drug(s) used by person
| Event ID | CASEID | DRUG SEQ | ROLE COD | DRUGNAME | PROD AI | VAL VBM | ROUTE | DOSE VBM | CUM DOSE CHR | CUM DOSE UNIT | DECHAL | RECHAL | LOT NUM | EXP DT | NDA NUM | DOSE AMT | DOSE UNIT | DOSE FORM | DOSE FREQ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122251468 | 12225146 | 1 | PS | FABRAZYME | AGALSIDASE BETA | 1 | Intravenous drip | Y | E5008Y05 | 103979 | 1.05 | MG/KG | POWDER FOR SOLUTION FOR INFUSION | QOW | |||||
| 122251468 | 12225146 | 2 | SS | FABRAZYME | AGALSIDASE BETA | 1 | Intravenous drip | Y | UNKNOWN | 103979 | 1.05 | MG/KG | POWDER FOR SOLUTION FOR INFUSION | QOW | |||||
| 122251468 | 12225146 | 3 | C | PREDNISOLONE. | PREDNISOLONE | 1 | 0 | 5 | MG | TABLET | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 122251468 | 12225146 | 1 | Fabry's disease |
| 122251468 | 12225146 | 2 | Fabry's disease |
| 122251468 | 12225146 | 3 | Premedication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 122251468 | 12225146 | HO |
| 122251468 | 12225146 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 122251468 | 12225146 | Arthritis infective | |
| 122251468 | 12225146 | Atrial fibrillation | |
| 122251468 | 12225146 | Cholelithiasis | |
| 122251468 | 12225146 | Joint swelling | |
| 122251468 | 12225146 | Malaise | |
| 122251468 | 12225146 | Shock | |
| 122251468 | 12225146 | Vomiting |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| Event ID | CASEID | DSG DRUG SEQ | START DT | END DT | DUR | DUR COD |
|---|---|---|---|---|---|---|
| 122251468 | 12225146 | 1 | 2000 | 20160316 | 0 | |
| 122251468 | 12225146 | 2 | 20160330 | 0 |