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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 80037782 | 8003778 | 2 | F | 200907 | 20160809 | 20110623 | 20160815 | EXP | US-SHIRE-SPV1-2009-01534 | SHIRE | 13.79 | YR | M | Y | 30.40000 | KG | 20160815 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 80037782 | 8003778 | 1 | PS | Idursulfase | IDURSULFASE | 1 | Intravenous drip | 0.5 MG/KG, 1X/WEEK | 125151 | .5 | MG/KG | CONCENTRATE FOR SOLUTION FOR INFUSION | /wk | ||||||
| 80037782 | 8003778 | 2 | SS | PREDNISOLONE. | PREDNISOLONE | 1 | Intravenous (not otherwise specified) | 30 UNK (UNITS NOT REPORTED), OTHER(FOUR TIMES) | U | U | 0 | ||||||||
| 80037782 | 8003778 | 3 | C | CETRIZINE | CETIRIZINE HYDROCHLORIDE | 1 | Oral | 5.0 UNK, OTHER(FOUR TIMES) | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 80037782 | 8003778 | 1 | Mucopolysaccharidosis II |
| 80037782 | 8003778 | 2 | Premedication |
| 80037782 | 8003778 | 3 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 80037782 | 8003778 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 80037782 | 8003778 | Anxiety | |
| 80037782 | 8003778 | Arthralgia | |
| 80037782 | 8003778 | Dizziness | |
| 80037782 | 8003778 | Flushing | |
| 80037782 | 8003778 | Lethargy | |
| 80037782 | 8003778 | Mental status changes | |
| 80037782 | 8003778 | Pyrexia | |
| 80037782 | 8003778 | Weight bearing difficulty |
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 |
|---|---|---|---|---|---|---|
| 80037782 | 8003778 | 1 | 20061005 | 0 | ||
| 80037782 | 8003778 | 2 | 20070208 | 0 | ||
| 80037782 | 8003778 | 3 | 20070405 | 0 |