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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125439044 | 12543904 | 4 | F | 20160715 | 20160825 | 20160711 | 20160901 | EXP | BR-ALEXION PHARMACEUTICALS INC-A201605007 | ALEXION | 37.00 | YR | F | Y | 0.00000 | 20160901 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125439044 | 12543904 | 1 | PS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 900 MG, UNK | 125166 | 900 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | |||||||
| 125439044 | 12543904 | 2 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 1200 MG, EVERY 15 DAYS | 125166 | 1200 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | |||||||
| 125439044 | 12543904 | 3 | C | MYCOPHENOLATE | MYCOPHENOLIC ACID | 1 | Unknown | N | 0 | ||||||||||
| 125439044 | 12543904 | 4 | C | TACROLIMUS. | TACROLIMUS | 1 | Unknown | N | 0 | ||||||||||
| 125439044 | 12543904 | 5 | C | CIPROFLOXACIN. | CIPROFLOXACIN | 1 | Unknown | 0 | |||||||||||
| 125439044 | 12543904 | 6 | C | METRONIDAZOLE. | METRONIDAZOLE | 1 | Unknown | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125439044 | 12543904 | 1 | Haemolytic uraemic syndrome |
| 125439044 | 12543904 | 3 | Immunosuppression |
| 125439044 | 12543904 | 4 | Immunosuppression |
| 125439044 | 12543904 | 5 | Bacterial infection |
| 125439044 | 12543904 | 6 | Bacterial infection |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125439044 | 12543904 | HO |
| 125439044 | 12543904 | DE |
| 125439044 | 12543904 | OT |
| 125439044 | 12543904 | LT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125439044 | 12543904 | Blood creatinine increased | |
| 125439044 | 12543904 | Blood lactate dehydrogenase increased | |
| 125439044 | 12543904 | Blood urea increased | |
| 125439044 | 12543904 | Drug ineffective | |
| 125439044 | 12543904 | Encephalitis | |
| 125439044 | 12543904 | Haematocrit decreased | |
| 125439044 | 12543904 | Haemoglobin decreased | |
| 125439044 | 12543904 | Haptoglobin decreased | |
| 125439044 | 12543904 | Kidney transplant rejection | |
| 125439044 | 12543904 | Renal impairment | |
| 125439044 | 12543904 | Septic shock | |
| 125439044 | 12543904 | Shock | |
| 125439044 | 12543904 | 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 |
|---|---|---|---|---|---|---|
| 125439044 | 12543904 | 1 | 20160624 | 0 | ||
| 125439044 | 12543904 | 2 | 20160708 | 20160715 | 0 |