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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116827979 | 11682797 | 9 | F | 2015 | 20160711 | 20151029 | 20160715 | EXP | US-ALEXION PHARMACEUTICALS INC-A201504118 | ALEXION | 0.00 | F | Y | 0.00000 | 20160715 | CN | US | US |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116827979 | 11682797 | 1 | PS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | UNK | Y | T2-AD3636B01 | 125166 | CONCENTRATE FOR SOLUTION FOR INFUSION | |||||||
| 116827979 | 11682797 | 2 | SS | SOLIRIS | ECULIZUMAB | 1 | UNK | Y | T2-AD4285B01 | 125166 | CONCENTRATE FOR SOLUTION FOR INFUSION | ||||||||
| 116827979 | 11682797 | 3 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 1200 MG, UNK | Y | T2-AE0884B01R | 125166 | 1200 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | |||||
| 116827979 | 11682797 | 4 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 900 MG, QW | Y | 125166 | 900 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | /wk | |||||
| 116827979 | 11682797 | 5 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 1200 MG, Q2W | Y | 125166 | 1200 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | |||||
| 116827979 | 11682797 | 6 | C | DIPRIVAN | PROPOFOL | 1 | Unknown | 0 | |||||||||||
| 116827979 | 11682797 | 7 | C | LEVOPHED | NOREPINEPHRINE BITARTRATE | 1 | Unknown | UNK | 0 | ||||||||||
| 116827979 | 11682797 | 8 | C | EPOGEN | ERYTHROPOIETIN | 1 | Unknown | UNK UNK, QW | 0 | /wk | |||||||||
| 116827979 | 11682797 | 9 | C | RITUXAN | RITUXIMAB | 1 | Intravenous (not otherwise specified) | UNK, QW/EVERY FRIDAY | 0 | /wk | |||||||||
| 116827979 | 11682797 | 10 | C | PREDNISONE. | PREDNISONE | 1 | Unknown | UNK, TAPPERING OFF | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 116827979 | 11682797 | 1 | Haemolytic uraemic syndrome |
| 116827979 | 11682797 | 6 | Product used for unknown indication |
| 116827979 | 11682797 | 7 | Product used for unknown indication |
| 116827979 | 11682797 | 8 | Product used for unknown indication |
| 116827979 | 11682797 | 9 | Product used for unknown indication |
| 116827979 | 11682797 | 10 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 116827979 | 11682797 | OT |
| 116827979 | 11682797 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 116827979 | 11682797 | Acute kidney injury | |
| 116827979 | 11682797 | Altered state of consciousness | |
| 116827979 | 11682797 | Anger | |
| 116827979 | 11682797 | Blood creatinine abnormal | |
| 116827979 | 11682797 | Blood lactate dehydrogenase increased | |
| 116827979 | 11682797 | Cerebrovascular accident | |
| 116827979 | 11682797 | Encephalopathy | |
| 116827979 | 11682797 | General physical health deterioration | |
| 116827979 | 11682797 | Haematocrit decreased | |
| 116827979 | 11682797 | Haemoglobin decreased | |
| 116827979 | 11682797 | Headache | |
| 116827979 | 11682797 | Hemiparesis | |
| 116827979 | 11682797 | Hemiplegia | |
| 116827979 | 11682797 | Hypoaesthesia | |
| 116827979 | 11682797 | Memory impairment | |
| 116827979 | 11682797 | Mobility decreased | |
| 116827979 | 11682797 | Paraesthesia | |
| 116827979 | 11682797 | Posterior reversible encephalopathy syndrome | |
| 116827979 | 11682797 | Renal impairment | |
| 116827979 | 11682797 | Respiratory failure | |
| 116827979 | 11682797 | Thrombocytopenic purpura | |
| 116827979 | 11682797 | Urine output increased |
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 |
|---|---|---|---|---|---|---|
| 116827979 | 11682797 | 5 | 20151123 | 0 |