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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127085961 | 12708596 | 1 | I | 20160823 | 20160901 | 20160901 | EXP | NO-SA-2016SA156502 | AVENTIS | 0.00 | A | M | Y | 0.00000 | 20160901 | CN | NO | NO |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127085961 | 12708596 | 1 | PS | CEREZYME | IMIGLUCERASE | 1 | Intravenous drip | 14 VIALS PER INFUSION PER MONTH DOSE:40 UNIT(S)/KILOGRAM BODYWEIGHT | U | UNKNOWN | 20367 | POWDER FOR SOLUTION FOR INFUSION | |||||||
| 127085961 | 12708596 | 2 | SS | CEREZYME | IMIGLUCERASE | 1 | Intravenous drip | DOSE:15 UNIT(S)/KILOGRAM BODYWEIGHT | U | UNKNOWN | 20367 | POWDER FOR SOLUTION FOR INFUSION |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127085961 | 12708596 | 1 | Gaucher's disease |
| 127085961 | 12708596 | 2 | Gaucher's disease |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127085961 | 12708596 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127085961 | 12708596 | Gallbladder disorder | |
| 127085961 | 12708596 | Incorrect dose administered | |
| 127085961 | 12708596 | Liver disorder | |
| 127085961 | 12708596 | Splenomegaly |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |