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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122993267 | 12299326 | 7 | F | 201312 | 20160914 | 20160425 | 20160921 | EXP | AU-SA-2016SA040173 | AVENTIS | 52.00 | YR | A | M | Y | 60.00000 | KG | 20160921 | MD | AU | AU |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122993267 | 12299326 | 1 | PS | FABRAZYME | AGALSIDASE BETA | 1 | Intravenous drip | EXPIRY DATE: E5002Y1 (AUG) ; E5020Y03 (NOV) | E5004Y12 | 103979 | .91 | MG/KG | POWDER FOR SOLUTION FOR INFUSION | QOW | |||||
| 122993267 | 12299326 | 2 | SS | FABRAZYME | AGALSIDASE BETA | 1 | Intravenous drip | EXPIRY DATE: E5002Y1 (AUG) ; E5020Y03 (NOV) | E5002Y04 | 103979 | .91 | MG/KG | POWDER FOR SOLUTION FOR INFUSION | QOW | |||||
| 122993267 | 12299326 | 3 | SS | FABRAZYME | AGALSIDASE BETA | 1 | Intravenous drip | EXPIRY DATE: E5002Y1 (AUG) ; E5020Y03 (NOV) | E5002Y1E | 103979 | .91 | MG/KG | POWDER FOR SOLUTION FOR INFUSION | QOW | |||||
| 122993267 | 12299326 | 4 | SS | FABRAZYME | AGALSIDASE BETA | 1 | Intravenous drip | EXPIRY DATE: E5002Y1 (AUG) ; E5020Y03 (NOV) | E5020Y03 | 103979 | .91 | MG/KG | POWDER FOR SOLUTION FOR INFUSION | QOW | |||||
| 122993267 | 12299326 | 5 | SS | FABRAZYME | AGALSIDASE BETA | 1 | Intravenous drip | EXPIRY DATE: E5002Y1 (AUG) ; E5020Y03 (NOV) | E5002Y14 | 103979 | .91 | MG/KG | POWDER FOR SOLUTION FOR INFUSION | QOW | |||||
| 122993267 | 12299326 | 6 | SS | FABRAZYME | AGALSIDASE BETA | 1 | Intravenous drip | EXPIRY DATE: E5002Y1 (AUG) ; E5020Y03 (NOV) | E5023Y1E | 103979 | .91 | MG/KG | POWDER FOR SOLUTION FOR INFUSION | QOW | |||||
| 122993267 | 12299326 | 7 | SS | FABRAZYME | AGALSIDASE BETA | 1 | Intravenous drip | EXPIRY DATE: E5002Y1 (AUG) ; E5020Y03 (NOV) | E5020Y10 | 103979 | .91 | MG/KG | POWDER FOR SOLUTION FOR INFUSION | QOW | |||||
| 122993267 | 12299326 | 8 | SS | TACROLIMUS. | TACROLIMUS | 1 | Unknown | U | UNKNOWN | 0 | |||||||||
| 122993267 | 12299326 | 9 | C | ASPIRIN. | ASPIRIN | 1 | 0 | 100 | MG | QD | |||||||||
| 122993267 | 12299326 | 10 | C | CALCITRIOL. | CALCITRIOL | 1 | 0 | .25 | UG | QD | |||||||||
| 122993267 | 12299326 | 11 | C | ESCITALOPRAM | ESCITALOPRAM OXALATE | 1 | 0 | 2 | MG | QD | |||||||||
| 122993267 | 12299326 | 12 | C | ESCITALOPRAM | ESCITALOPRAM OXALATE | 1 | 0 | 10 | MG | QD | |||||||||
| 122993267 | 12299326 | 13 | C | DILTIAZEM. | DILTIAZEM | 1 | 0 | 180 | MG | QD | |||||||||
| 122993267 | 12299326 | 14 | C | FAMOTIDINE. | FAMOTIDINE | 1 | 0 | 2 | MG | QD | |||||||||
| 122993267 | 12299326 | 15 | C | FISH OIL | FISH OIL | 1 | 0 | 1 | G | QD | |||||||||
| 122993267 | 12299326 | 16 | C | LEVETIRACETAM. | LEVETIRACETAM | 1 | 0 | 500 | MG | BID | |||||||||
| 122993267 | 12299326 | 17 | C | LEVETIRACETAM. | LEVETIRACETAM | 1 | 0 | 250 | MG | ||||||||||
| 122993267 | 12299326 | 18 | C | PANADEINE FORTE | ACETAMINOPHENCODEINE PHOSPHATE | 1 | 0 | ||||||||||||
| 122993267 | 12299326 | 19 | C | PANTOPRAZOLE | PANTOPRAZOLE SODIUM | 1 | 0 | 20 | MG | QD | |||||||||
| 122993267 | 12299326 | 20 | C | PRAVASTATIN. | PRAVASTATIN | 1 | 0 | 20 | MG | QD | |||||||||
| 122993267 | 12299326 | 21 | C | PREDNISOLONE. | PREDNISOLONE | 1 | 0 | 5 | MG | QD | |||||||||
| 122993267 | 12299326 | 22 | C | PREDNISOLONE. | PREDNISOLONE | 1 | 0 | 7.5 | MG | QD | |||||||||
| 122993267 | 12299326 | 23 | C | PROMETHAZINE | PROMETHAZINEPROMETHAZINE HYDROCHLORIDE | 1 | 0 | 25 | MG | ||||||||||
| 122993267 | 12299326 | 24 | C | MYCOPHENOLATE MOFETIL. | MYCOPHENOLATE MOFETIL | 1 | 0 | 250 | MG | BID | |||||||||
| 122993267 | 12299326 | 25 | C | MYCOPHENOLATE MOFETIL. | MYCOPHENOLATE MOFETIL | 1 | 0 | 500 | MG | BID | |||||||||
| 122993267 | 12299326 | 26 | C | VALCYTE | VALGANCICLOVIR HYDROCHLORIDE | 1 | 0 | ||||||||||||
| 122993267 | 12299326 | 27 | C | VALCYTE | VALGANCICLOVIR HYDROCHLORIDE | 1 | 0 | 450 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 122993267 | 12299326 | 1 | Fabry's disease |
| 122993267 | 12299326 | 2 | Fabry's disease |
| 122993267 | 12299326 | 3 | Fabry's disease |
| 122993267 | 12299326 | 4 | Fabry's disease |
| 122993267 | 12299326 | 5 | Fabry's disease |
| 122993267 | 12299326 | 6 | Fabry's disease |
| 122993267 | 12299326 | 7 | Fabry's disease |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 122993267 | 12299326 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 122993267 | 12299326 | Abdominal distension | |
| 122993267 | 12299326 | Aortic stenosis | |
| 122993267 | 12299326 | Apraxia | |
| 122993267 | 12299326 | Ataxia | |
| 122993267 | 12299326 | Azotaemia | |
| 122993267 | 12299326 | Balint's syndrome | |
| 122993267 | 12299326 | Basal cell carcinoma | |
| 122993267 | 12299326 | Blindness cortical | |
| 122993267 | 12299326 | Body temperature decreased | |
| 122993267 | 12299326 | Bradycardia | |
| 122993267 | 12299326 | Cardiac disorder | |
| 122993267 | 12299326 | Cardiac valve disease | |
| 122993267 | 12299326 | Colitis | |
| 122993267 | 12299326 | Condition aggravated | |
| 122993267 | 12299326 | Contusion | |
| 122993267 | 12299326 | Cough | |
| 122993267 | 12299326 | Cytomegalovirus infection | |
| 122993267 | 12299326 | Device related infection | |
| 122993267 | 12299326 | Diarrhoea | |
| 122993267 | 12299326 | Diastolic dysfunction | |
| 122993267 | 12299326 | Emphysema | |
| 122993267 | 12299326 | Fibrosis | |
| 122993267 | 12299326 | Fistula | |
| 122993267 | 12299326 | Fungal skin infection | |
| 122993267 | 12299326 | Haemoglobin decreased | |
| 122993267 | 12299326 | Hepatitis | |
| 122993267 | 12299326 | Left ventricular hypertrophy | |
| 122993267 | 12299326 | Liver function test abnormal | |
| 122993267 | 12299326 | Localised infection | |
| 122993267 | 12299326 | Neuralgia | |
| 122993267 | 12299326 | Pain | |
| 122993267 | 12299326 | Pleural fibrosis | |
| 122993267 | 12299326 | Resting tremor | |
| 122993267 | 12299326 | Sensory disturbance | |
| 122993267 | 12299326 | Visual agnosia | |
| 122993267 | 12299326 | Visual impairment |
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 |
|---|---|---|---|---|---|---|
| 122993267 | 12299326 | 1 | 201312 | 0 | ||
| 122993267 | 12299326 | 2 | 201312 | 0 | ||
| 122993267 | 12299326 | 3 | 201312 | 0 | ||
| 122993267 | 12299326 | 4 | 201312 | 0 | ||
| 122993267 | 12299326 | 5 | 201312 | 0 | ||
| 122993267 | 12299326 | 6 | 201312 | 0 | ||
| 122993267 | 12299326 | 7 | 201312 | 0 | ||
| 122993267 | 12299326 | 27 | 201507 | 0 |