Person who experienced the adverse event (patient)
| Event ID | CASE | I F COD | FOLL SEQ | IMAGE | EVENT DT | MFR DT | FDA DT | REPT COD | MFR NUM | MFR SNDR | AGE | AGE COD | GNDR COD | E SUB | WT | WT COD | REPT DT | OCCP COD | DEATH DT | TO MFR | CONFID | REPORTER COUNTRY |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 6843034 | 6973320 | F | 8 | 6843034-X | 20090226 | 20100624 | 20100709 | EXP | FABR-1000697 | GENZYME | 17 | YR | M | N | 55 | KG | 20100708 | MD | JAPAN |
Drug(s) used by person
| Event ID | DRUG SEQ | ROLE COD | DRUGNAME | VAL VBM | ROUTE | DOSE VBM | DECHAL | RECHAL | LOT NUM | EXP DT | NDA NUM |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 6843034 | 1014132666 | PS | FABRAZYME | 1 | INTRAVENOUS | 0.5 MG/KG, ONCE, INTRAVENOUS, 70 MG, ONCE, INTRAVENOUS, 0.2 MG/KG, ONCE, INTRAVENOUS | D | D | |||
| 6843034 | 1014234336 | SS | REPLAGAL (AGALSIDASE ALFA) | 2 |
Indications of drugs used
| Event ID | DRUG SEQ | INDI PT |
|---|---|---|
| 6843034 | 1014132666 | FABRY'S DISEASE |
Outcome of event
| Event ID | OUTC COD |
|---|---|
| 6843034 | OT |
Reactions reported
| Event ID | PT |
|---|---|
| 6843034 | BODY TEMPERATURE INCREASED |
| 6843034 | ECZEMA |
| 6843034 | EOSINOPHIL PERCENTAGE INCREASED |
| 6843034 | FEELING HOT |
Reporting Sources (this data is often not reported and may therefore be missing here)
| Event ID | RPSR COD |
|---|---|
| 6843034 | CR |
| 6843034 | FGN |
| 6843034 | HP |
| 6843034 | OTH |
Therapies reported
| Event ID | DRUG SEQ | START DT | END DT | DUR | DUR COD |
|---|---|---|---|---|---|
| 6843034 | 1014132666 | 20090224 | 20090224 | ||
| 6843034 | 1014132666 | 20090306 | 20090306 | ||
| 6843034 | 1014132666 | 20090421 | 20090421 | ||
| 6843034 | 1014132666 | 20090507 | 20090507 |