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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 104090275 | 10409027 | 5 | F | 20150625 | 20160923 | 20140826 | 20160930 | EXP | US-SA-2014SA111595 | AVENTIS | 7.00 | MON | I | F | Y | 0.00000 | 20160930 | MD | US | US |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 104090275 | 10409027 | 1 | PS | LUMIZYME | ALGLUCOSIDASE ALFA | 1 | Intravenous (not otherwise specified) | C3178Y02 | 125291 | 24.1 | MG | POWDER FOR SOLUTION FOR INFUSION | QOW |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 104090275 | 10409027 | 1 | Glycogen storage disease type II |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 104090275 | 10409027 | HO |
| 104090275 | 10409027 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 104090275 | 10409027 | Cardiac disorder | |
| 104090275 | 10409027 | Infusion related reaction | |
| 104090275 | 10409027 | Respiratory tract infection | |
| 104090275 | 10409027 | Upper respiratory tract infection |
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 |
|---|---|---|---|---|---|---|
| 104090275 | 10409027 | 1 | 20140724 | 0 |