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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125085132 | 12508513 | 2 | F | 20160621 | 20160729 | 20160629 | 20160810 | EXP | BR-ALEXION PHARMACEUTICALS INC-A201604823 | ALEXION | 41.94 | YR | F | Y | 56.00000 | KG | 20160810 | CN | BR | BR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125085132 | 12508513 | 1 | PS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 900 MG, UNK | 125166 | 900 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | |||||||
| 125085132 | 12508513 | 2 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 1200 UNK, UNK | 125166 | 1200 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125085132 | 12508513 | 1 | Haemolytic uraemic syndrome |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125085132 | 12508513 | OT |
| 125085132 | 12508513 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125085132 | 12508513 | Blood lactate dehydrogenase increased | |
| 125085132 | 12508513 | Condition aggravated | |
| 125085132 | 12508513 | Graft versus host disease in gastrointestinal tract | |
| 125085132 | 12508513 | Intestinal haemorrhage | |
| 125085132 | 12508513 | Microangiopathy | |
| 125085132 | 12508513 | Schistocytosis | |
| 125085132 | 12508513 | Septic shock | |
| 125085132 | 12508513 | Thrombocytopenia |
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 |
|---|---|---|---|---|---|---|
| 125085132 | 12508513 | 1 | 20160617 | 0 | ||
| 125085132 | 12508513 | 2 | 20160715 | 0 |