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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121546125 | 12154612 | 5 | F | 2014 | 20160628 | 20160307 | 20160708 | EXP | PE-SA-2016SA042508 | AVENTIS | 23.00 | YR | A | F | Y | 0.00000 | 20160708 | MD | PE | PE |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121546125 | 12154612 | 1 | PS | CEREZYME | IMIGLUCERASE | 1 | Intravenous drip | DOSE:2800 UNIT(S) | UNKNOWN | 20367 | POWDER FOR SOLUTION FOR INFUSION | QOW | |||||||
| 121546125 | 12154612 | 2 | SS | CEREZYME | IMIGLUCERASE | 1 | Intravenous drip | DOSE:2800 UNIT(S) | UNKNOWN | 20367 | POWDER FOR SOLUTION FOR INFUSION | QOW |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 121546125 | 12154612 | 1 | Gaucher's disease type I |
| 121546125 | 12154612 | 2 | Gaucher's disease type I |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 121546125 | 12154612 | DS |
| 121546125 | 12154612 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 121546125 | 12154612 | Abdominal pain | |
| 121546125 | 12154612 | Bone pain | |
| 121546125 | 12154612 | Condition aggravated | |
| 121546125 | 12154612 | Decreased activity | |
| 121546125 | 12154612 | General physical health deterioration | |
| 121546125 | 12154612 | Hepatosplenomegaly | |
| 121546125 | 12154612 | Poor venous access | |
| 121546125 | 12154612 | Road traffic accident | |
| 121546125 | 12154612 | Vaginal haemorrhage |
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 |
|---|---|---|---|---|---|---|
| 121546125 | 12154612 | 1 | 1999 | 201510 | 0 | |
| 121546125 | 12154612 | 2 | 20160507 | 0 |