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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127003451 | 12700345 | 1 | I | 20151203 | 20151203 | 20160830 | 20160830 | PER | US-SA-2015SA209027 | AVENTIS | 45.00 | YR | A | M | Y | 72.10000 | KG | 20160830 | PH | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127003451 | 12700345 | 1 | PS | FABRAZYME | AGALSIDASE BETA | 1 | Intravenous drip | Y | E431Y03 | 103979 | 80 | MG | POWDER FOR SOLUTION FOR INFUSION | QOW | |||||
| 127003451 | 12700345 | 2 | SS | FABRAZYME | AGALSIDASE BETA | 1 | Intravenous drip | Y | E4326Y01 | 103979 | 80 | MG | POWDER FOR SOLUTION FOR INFUSION | QOW | |||||
| 127003451 | 12700345 | 3 | SS | FABRAZYME | AGALSIDASE BETA | 1 | Intravenous drip | Y | C4336Y01 | 103979 | 80 | MG | POWDER FOR SOLUTION FOR INFUSION | QOW | |||||
| 127003451 | 12700345 | 4 | SS | FABRAZYME | AGALSIDASE BETA | 1 | Intravenous drip | DOSE- 15 MG IN 55 CC | Y | UNK | 103979 | POWDER FOR SOLUTION FOR INFUSION | QOW | ||||||
| 127003451 | 12700345 | 5 | SS | FABRAZYME | AGALSIDASE BETA | 1 | Intravenous drip | Y | C4364Y01 | 103979 | 80 | MG | POWDER FOR SOLUTION FOR INFUSION | QOW | |||||
| 127003451 | 12700345 | 6 | SS | FABRAZYME | AGALSIDASE BETA | 1 | Intravenous drip | Y | E431Y03 | 103979 | 80 | MG | POWDER FOR SOLUTION FOR INFUSION | QOW | |||||
| 127003451 | 12700345 | 7 | SS | FABRAZYME | AGALSIDASE BETA | 1 | Intravenous drip | Y | E5001Y02 | 103979 | 80 | MG | POWDER FOR SOLUTION FOR INFUSION | QOW | |||||
| 127003451 | 12700345 | 8 | C | AMLODIPINE | AMLODIPINE BESYLATE | 1 | 0 | 10 | MG | QD | |||||||||
| 127003451 | 12700345 | 9 | C | COREG | CARVEDILOL | 1 | 0 | 25 | MG | BID | |||||||||
| 127003451 | 12700345 | 10 | C | EPOETIN NOS | ERYTHROPOIETIN | 1 | DOSE:10000 UNIT(S) | 0 | /wk | ||||||||||
| 127003451 | 12700345 | 11 | C | EPOETIN NOS | ERYTHROPOIETIN | 1 | DOSE:10000 UNIT(S) | 0 | /wk | ||||||||||
| 127003451 | 12700345 | 12 | C | ISOSORBIDE MONONITRATE. | ISOSORBIDE MONONITRATE | 1 | 0 | 30 | MG | QD | |||||||||
| 127003451 | 12700345 | 13 | C | RENVELA | SEVELAMER CARBONATE | 1 | 0 | 800 | MG | TID | |||||||||
| 127003451 | 12700345 | 14 | C | OXYCODONE | OXYCODONE | 1 | 0 | 15 | MG | ||||||||||
| 127003451 | 12700345 | 15 | C | TYLENOL | ACETAMINOPHEN | 1 | 0 | ||||||||||||
| 127003451 | 12700345 | 16 | C | LOPERAMIDE | LOPERAMIDE | 1 | 0 | ||||||||||||
| 127003451 | 12700345 | 17 | C | ZANTAC | RANITIDINE HYDROCHLORIDE | 1 | 0 | ||||||||||||
| 127003451 | 12700345 | 18 | C | BENADRYL | DIPHENHYDRAMINE HYDROCHLORIDE | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127003451 | 12700345 | 1 | Fabry's disease |
| 127003451 | 12700345 | 2 | Fabry's disease |
| 127003451 | 12700345 | 3 | Fabry's disease |
| 127003451 | 12700345 | 4 | Fabry's disease |
| 127003451 | 12700345 | 5 | Fabry's disease |
| 127003451 | 12700345 | 6 | Fabry's disease |
| 127003451 | 12700345 | 7 | Fabry's disease |
| 127003451 | 12700345 | 8 | Hypertension |
| 127003451 | 12700345 | 9 | Hypertension |
| 127003451 | 12700345 | 10 | Anaemia |
| 127003451 | 12700345 | 11 | Renal failure |
| 127003451 | 12700345 | 12 | Hypertension |
| 127003451 | 12700345 | 14 | Pain |
| 127003451 | 12700345 | 15 | Premedication |
| 127003451 | 12700345 | 16 | Premedication |
| 127003451 | 12700345 | 17 | Premedication |
| 127003451 | 12700345 | 18 | Premedication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127003451 | 12700345 | Abdominal pain | |
| 127003451 | 12700345 | Blood pressure abnormal | |
| 127003451 | 12700345 | Blood pressure increased | |
| 127003451 | 12700345 | Body temperature decreased | |
| 127003451 | 12700345 | Chest discomfort | |
| 127003451 | 12700345 | Chills | |
| 127003451 | 12700345 | Dyspnoea | |
| 127003451 | 12700345 | Flatulence | |
| 127003451 | 12700345 | Hyperhidrosis | |
| 127003451 | 12700345 | Nausea |
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 |
|---|---|---|---|---|---|---|
| 127003451 | 12700345 | 1 | 20150430 | 20150709 | 0 | |
| 127003451 | 12700345 | 2 | 20150430 | 20150709 | 0 | |
| 127003451 | 12700345 | 3 | 20151008 | 20151203 | 0 | |
| 127003451 | 12700345 | 5 | 20150723 | 20150723 | 0 | |
| 127003451 | 12700345 | 6 | 20150723 | 20150723 | 0 | |
| 127003451 | 12700345 | 7 | 20151008 | 20151203 | 0 | |
| 127003451 | 12700345 | 8 | 201508 | 0 | ||
| 127003451 | 12700345 | 9 | 201504 | 0 | ||
| 127003451 | 12700345 | 12 | 20160116 | 0 | ||
| 127003451 | 12700345 | 14 | 201410 | 0 |