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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 119135624 | 11913562 | 4 | F | 20151128 | 20160802 | 20160113 | 20160812 | EXP | JP-ALXN-A201600005AA | ALEXION | 66.00 | YR | M | Y | 59.00000 | KG | 20160812 | MD | JP | JP |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 119135624 | 11913562 | 1 | PS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 900 MG, QW | 3600 | MG | AD6547B01 | 125166 | 900 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | /wk | |||
| 119135624 | 11913562 | 2 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 900 MG, QW | 3600 | MG | AD7700B01 | 125166 | 900 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | /wk | |||
| 119135624 | 11913562 | 3 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 1200 MG, Q2W | 3600 | MG | AD7700B01 | 125166 | 1200 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | |||
| 119135624 | 11913562 | 4 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 1200 MG, Q2W | 3600 | MG | AE3116D01 | 125166 | 1200 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | |||
| 119135624 | 11913562 | 5 | C | FEBURIC | FEBUXOSTAT | 1 | Oral | 10 MG, QD | 50 | MG | 0 | 10 | MG | TABLET | QD | ||||
| 119135624 | 11913562 | 6 | C | CEFTRIAXONE NA | CEFTRIAXONE | 1 | Intravenous drip | 2 G, QD | 0 | 2 | G | INJECTION | QD | ||||||
| 119135624 | 11913562 | 7 | C | AVELOX | MOXIFLOXACIN HYDROCHLORIDE | 1 | Oral | 400 MG, QD | 0 | 400 | MG | TABLET | QD | ||||||
| 119135624 | 11913562 | 8 | C | PARIET | RABEPRAZOLE SODIUM | 1 | Oral | 10 MG, QD | 0 | 10 | MG | TABLET | QD | ||||||
| 119135624 | 11913562 | 9 | C | FAMOTIDINE. | FAMOTIDINE | 1 | Oral | 20 MG, QD | 340 | MG | 0 | 20 | MG | TABLET | QD | ||||
| 119135624 | 11913562 | 10 | C | AMIODARONE HYDROCHLORIDE. | AMIODARONE HYDROCHLORIDE | 1 | Oral | 100 MG, QD | 0 | 100 | MG | TABLET | QD | ||||||
| 119135624 | 11913562 | 11 | C | SPIRONOLACTONE. | SPIRONOLACTONE | 1 | Oral | 2.5 MG, QD | 0 | 2.5 | MG | QD | |||||||
| 119135624 | 11913562 | 12 | C | SLOW-K | POTASSIUM CHLORIDE | 1 | Oral | 1200 MG, BID | 0 | 1200 | MG | BID | |||||||
| 119135624 | 11913562 | 13 | C | SLOW-K | POTASSIUM CHLORIDE | 1 | Oral | 600 MG, BID | 0 | 600 | MG | BID | |||||||
| 119135624 | 11913562 | 14 | C | MONILAC | LACTULOSE | 1 | Oral | 10 ML, TID | 0 | 10 | ML | SYRUP | TID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 119135624 | 11913562 | 1 | Haemolytic uraemic syndrome |
| 119135624 | 11913562 | 5 | Hyperuricaemia |
| 119135624 | 11913562 | 6 | Urinary tract infection |
| 119135624 | 11913562 | 7 | Infection prophylaxis |
| 119135624 | 11913562 | 8 | Gastritis |
| 119135624 | 11913562 | 9 | Gastritis |
| 119135624 | 11913562 | 10 | Tachycardia |
| 119135624 | 11913562 | 11 | Product used for unknown indication |
| 119135624 | 11913562 | 12 | Product used for unknown indication |
| 119135624 | 11913562 | 14 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 119135624 | 11913562 | OT |
| 119135624 | 11913562 | HO |
| 119135624 | 11913562 | LT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 119135624 | 11913562 | Cardiac failure congestive | |
| 119135624 | 11913562 | Hepatic failure | |
| 119135624 | 11913562 | Infection | |
| 119135624 | 11913562 | Liver disorder | |
| 119135624 | 11913562 | Pneumonia | |
| 119135624 | 11913562 | Renal impairment | |
| 119135624 | 11913562 | Ventricular tachycardia |
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 |
|---|---|---|---|---|---|---|
| 119135624 | 11913562 | 1 | 20151127 | 0 | ||
| 119135624 | 11913562 | 2 | 20151218 | 0 | ||
| 119135624 | 11913562 | 3 | 20151225 | 0 | ||
| 119135624 | 11913562 | 5 | 20151215 | 20151219 | 0 | |
| 119135624 | 11913562 | 6 | 20151128 | 20151129 | 0 | |
| 119135624 | 11913562 | 7 | 20151130 | 20151217 | 0 | |
| 119135624 | 11913562 | 8 | 20151127 | 20151202 | 0 | |
| 119135624 | 11913562 | 9 | 20151203 | 20160103 | 0 | |
| 119135624 | 11913562 | 10 | 20160119 | 20160512 | 0 | |
| 119135624 | 11913562 | 11 | 20160129 | 20160418 | 0 | |
| 119135624 | 11913562 | 12 | 20160202 | 20160204 | 0 | |
| 119135624 | 11913562 | 13 | 20160205 | 20160208 | 0 | |
| 119135624 | 11913562 | 14 | 20160210 | 20160211 | 0 |