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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121243555 | 12124355 | 5 | F | 201602 | 20160917 | 20160229 | 20160922 | EXP | CA-SA-2016SA039263 | AVENTIS | 46.00 | YR | A | F | Y | 80.00000 | KG | 20160922 | MD | CA | CA |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121243555 | 12124355 | 1 | PS | FABRAZYME | AGALSIDASE BETA | 1 | Intravenous drip | Y | E4025Y07 | 103979 | 1 | MG/KG | POWDER FOR SOLUTION FOR INFUSION | QOW | |||||
| 121243555 | 12124355 | 2 | SS | FABRAZYME | AGALSIDASE BETA | 1 | Intravenous drip | Y | E5004Y05 | 103979 | 1 | MG/KG | POWDER FOR SOLUTION FOR INFUSION | QOW | |||||
| 121243555 | 12124355 | 3 | SS | FABRAZYME | AGALSIDASE BETA | 1 | Intravenous drip | Y | E4025Y13 | 103979 | 1 | MG/KG | POWDER FOR SOLUTION FOR INFUSION | QOW | |||||
| 121243555 | 12124355 | 4 | SS | FABRAZYME | AGALSIDASE BETA | 1 | Intravenous drip | Y | E5020Y02 | 103979 | 1 | MG/KG | POWDER FOR SOLUTION FOR INFUSION | QOW | |||||
| 121243555 | 12124355 | 5 | SS | FABRAZYME | AGALSIDASE BETA | 1 | Intravenous drip | Y | E5023Y013 | 103979 | 1 | MG/KG | POWDER FOR SOLUTION FOR INFUSION | QOW | |||||
| 121243555 | 12124355 | 6 | SS | FABRAZYME | AGALSIDASE BETA | 1 | Intravenous drip | Y | E5020Y08 | 103979 | 1 | MG/KG | POWDER FOR SOLUTION FOR INFUSION | QOW | |||||
| 121243555 | 12124355 | 7 | SS | TOPIRAMATE. | TOPIRAMATE | 1 | Unknown | Y | UNKNOWN | 0 | 50 | MG | QD | ||||||
| 121243555 | 12124355 | 8 | SS | TOPIRAMATE. | TOPIRAMATE | 1 | Unknown | Y | UNKNOWN | 0 | |||||||||
| 121243555 | 12124355 | 9 | C | REACTINE | CETIRIZINE HYDROCHLORIDE | 1 | Oral | 0 | 10 | MG | |||||||||
| 121243555 | 12124355 | 10 | C | TYLENOL | ACETAMINOPHEN | 1 | Oral | 0 | 500 | MG | |||||||||
| 121243555 | 12124355 | 11 | C | PLAVIX | CLOPIDOGREL BISULFATE | 1 | 0 | 75 | MG | QD | |||||||||
| 121243555 | 12124355 | 12 | C | VITAMIN B12 | CYANOCOBALAMIN | 1 | DOSE: 1000 MICRO | 0 | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 121243555 | 12124355 | 1 | Fabry's disease |
| 121243555 | 12124355 | 2 | Fabry's disease |
| 121243555 | 12124355 | 3 | Fabry's disease |
| 121243555 | 12124355 | 4 | Fabry's disease |
| 121243555 | 12124355 | 5 | Fabry's disease |
| 121243555 | 12124355 | 6 | Fabry's disease |
| 121243555 | 12124355 | 9 | Premedication |
| 121243555 | 12124355 | 10 | Premedication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 121243555 | 12124355 | DS |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 121243555 | 12124355 | Constipation | |
| 121243555 | 12124355 | Delayed sleep phase | |
| 121243555 | 12124355 | Eye disorder | |
| 121243555 | 12124355 | Fatigue | |
| 121243555 | 12124355 | Feeling abnormal | |
| 121243555 | 12124355 | Irritability | |
| 121243555 | 12124355 | Malaise | |
| 121243555 | 12124355 | Pain in extremity | |
| 121243555 | 12124355 | Paraesthesia |
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 |
|---|---|---|---|---|---|---|
| 121243555 | 12124355 | 1 | 20120627 | 0 | ||
| 121243555 | 12124355 | 2 | 20120627 | 0 | ||
| 121243555 | 12124355 | 3 | 20120627 | 0 | ||
| 121243555 | 12124355 | 4 | 20120627 | 0 | ||
| 121243555 | 12124355 | 5 | 20120627 | 0 | ||
| 121243555 | 12124355 | 6 | 20120627 | 0 | ||
| 121243555 | 12124355 | 7 | 20160203 | 20160228 | 0 |