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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 112737548 | 11273754 | 8 | F | 20150202 | 20160729 | 20150715 | 20160809 | EXP | JP-ALEXION PHARMACEUTICALS INC.-A201502558 | ALEXION | 67.00 | YR | F | Y | 41.00000 | KG | 20160809 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 112737548 | 11273754 | 1 | PS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 900 MG, QW | 12869.291 | MG | Y | U | AC4114B02 | 125166 | 900 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | /wk | |
| 112737548 | 11273754 | 2 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 600 MG, SINGLE | 12869.291 | MG | Y | U | 125166 | 600 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QD | ||
| 112737548 | 11273754 | 3 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 900 MG, QW | 12869.291 | MG | Y | U | 125166 | 900 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | /wk | ||
| 112737548 | 11273754 | 4 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 1200 MG, Q2W | 12869.291 | MG | Y | U | AC6839D01 | 125166 | 1200 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | |
| 112737548 | 11273754 | 5 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 1200 MG, EVERY 3 WEEKS | 12869.291 | MG | Y | U | 125166 | 1200 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | |||
| 112737548 | 11273754 | 6 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 900 MG, EVERY 3 WEEKS | 12869.291 | MG | Y | U | AD6547B01 | 125166 | 900 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | ||
| 112737548 | 11273754 | 7 | C | PURSENNID /00142207/ | SENNOSIDES A AND B | 1 | Oral | 0 | |||||||||||
| 112737548 | 11273754 | 8 | C | NESP | DARBEPOETIN ALFA | 1 | Intravenous (not otherwise specified) | 120 ?G, QW | 0 | 120 | UG | INJECTION | /wk | ||||||
| 112737548 | 11273754 | 9 | C | FESIN /00023550/ | IRON SUCROSE | 1 | Intravenous (not otherwise specified) | 40 MG, TIW | 0 | 40 | MG | TIW | |||||||
| 112737548 | 11273754 | 10 | C | SOL-MELCORT | METHYLPREDNISOLONE SODIUM SUCCINATE | 1 | Intravenous drip | 1 G, QD | 3 | G | 0 | 1 | G | QD | |||||
| 112737548 | 11273754 | 11 | C | BAKTAR | SULFAMETHOXAZOLETRIMETHOPRIM | 1 | Oral | 4 G, QD | 56 | G | 0 | 4 | G | QD | |||||
| 112737548 | 11273754 | 12 | C | PREDONINE | PREDNISOLONEPREDNISOLONE ACETATEPREDNISOLONE SODIUM SUCCINATE | 1 | Oral | 7.5MG TAPERING, QD | 0 | QD | |||||||||
| 112737548 | 11273754 | 13 | C | CEFEPIME | CEFEPIME HYDROCHLORIDE | 1 | Intravenous drip | 1 G, QD | 11 | G | 0 | 1 | G | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 112737548 | 11273754 | 1 | Haemolytic uraemic syndrome |
| 112737548 | 11273754 | 7 | Faecaloma |
| 112737548 | 11273754 | 8 | Nephrogenic anaemia |
| 112737548 | 11273754 | 9 | Iron deficiency anaemia |
| 112737548 | 11273754 | 10 | Haemolytic uraemic syndrome |
| 112737548 | 11273754 | 11 | Prophylaxis |
| 112737548 | 11273754 | 12 | Anti-glomerular basement membrane antibody |
| 112737548 | 11273754 | 13 | Prophylaxis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 112737548 | 11273754 | HO |
| 112737548 | 11273754 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 112737548 | 11273754 | Clostridium difficile colitis | |
| 112737548 | 11273754 | Condition aggravated | |
| 112737548 | 11273754 | Cytomegalovirus infection | |
| 112737548 | 11273754 | Cytopenia | |
| 112737548 | 11273754 | Device related infection | |
| 112737548 | 11273754 | Enterococcal infection | |
| 112737548 | 11273754 | Immunosuppression | |
| 112737548 | 11273754 | Inappropriate schedule of drug administration | |
| 112737548 | 11273754 | Nausea | |
| 112737548 | 11273754 | Pneumonia | |
| 112737548 | 11273754 | Purpura | |
| 112737548 | 11273754 | Skin erosion | |
| 112737548 | 11273754 | Venous thrombosis | |
| 112737548 | 11273754 | Vomiting |
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 |
|---|---|---|---|---|---|---|
| 112737548 | 11273754 | 1 | 20150117 | 20150117 | 0 | |
| 112737548 | 11273754 | 2 | 20150121 | 20150121 | 0 | |
| 112737548 | 11273754 | 3 | 20150124 | 20150206 | 0 | |
| 112737548 | 11273754 | 4 | 20150213 | 20150619 | 0 | |
| 112737548 | 11273754 | 5 | 20150710 | 20150710 | 0 | |
| 112737548 | 11273754 | 6 | 20150731 | 0 | ||
| 112737548 | 11273754 | 8 | 20150202 | 0 | ||
| 112737548 | 11273754 | 9 | 20150706 | 20150724 | 0 | |
| 112737548 | 11273754 | 10 | 20150120 | 20150122 | 0 | |
| 112737548 | 11273754 | 11 | 20150120 | 20150202 | 0 | |
| 112737548 | 11273754 | 12 | 20150203 | 20150512 | 0 | |
| 112737548 | 11273754 | 13 | 20150116 | 20150126 | 0 |