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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122623605 | 12262360 | 5 | F | 20160212 | 20160812 | 20160413 | 20160819 | EXP | PE-SA-2016SA069682 | AVENTIS | 11.00 | YR | C | M | Y | 20.00000 | KG | 20160819 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122623605 | 12262360 | 1 | PS | CEREZYME | IMIGLUCERASE | 1 | Intravenous drip | 4 VILAS/INFUSION (1600 U) | UNKNOWN | 20367 | 60 | IU/KG | POWDER FOR SOLUTION FOR INFUSION | QOW |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 122623605 | 12262360 | 1 | Gaucher's disease type I |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 122623605 | 12262360 | HO |
| 122623605 | 12262360 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 122623605 | 12262360 | Acute respiratory failure | |
| 122623605 | 12262360 | Diarrhoea | |
| 122623605 | 12262360 | Ear haemorrhage | |
| 122623605 | 12262360 | Epistaxis | |
| 122623605 | 12262360 | Fungal infection | |
| 122623605 | 12262360 | Irritability | |
| 122623605 | 12262360 | Platelet count decreased | |
| 122623605 | 12262360 | Pyrexia | |
| 122623605 | 12262360 | Seizure | |
| 122623605 | 12262360 | Somnolence | |
| 122623605 | 12262360 | Vomiting | |
| 122623605 | 12262360 | White blood cell count decreased |
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 |
|---|---|---|---|---|---|---|
| 122623605 | 12262360 | 1 | 20141107 | 0 |