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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127453642 | 12745364 | 2 | F | 20120623 | 20160906 | 20160915 | 20160919 | EXP | FR-ALEXION-A201201498 | ALEXION | 30.84 | YR | F | Y | 54.10000 | KG | 20160919 | OT | FR | FR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127453642 | 12745364 | 1 | PS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 900 MG, QW | 125166 | 900 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | /wk | ||||||
| 127453642 | 12745364 | 2 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 1200 MG, Q2W | 125166 | 1200 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | ||||||
| 127453642 | 12745364 | 3 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | UNK | 125166 | CONCENTRATE FOR SOLUTION FOR INFUSION | |||||||||
| 127453642 | 12745364 | 4 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 900 MG, QW FOR 2 WEEKS | 125166 | CONCENTRATE FOR SOLUTION FOR INFUSION | /wk | ||||||||
| 127453642 | 12745364 | 5 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | UNK UNK, Q2W | 125166 | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | ||||||||
| 127453642 | 12745364 | 6 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 1500 MG, Q2W | 125166 | 1500 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | ||||||
| 127453642 | 12745364 | 7 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 1200 MG, QW | 125166 | 1200 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | /wk | ||||||
| 127453642 | 12745364 | 8 | C | APROVEL | IRBESARTAN | 1 | Unknown | UNK | 0 | ||||||||||
| 127453642 | 12745364 | 9 | C | AMLOR | AMLODIPINE BESYLATE | 1 | Unknown | 0 | |||||||||||
| 127453642 | 12745364 | 10 | C | ERYTHROPOETIN | ERYTHROPOIETIN | 1 | Unknown | 0 | |||||||||||
| 127453642 | 12745364 | 11 | C | ERYTHROPOETIN | ERYTHROPOIETIN | 1 | Unknown | UNK | 0 | ||||||||||
| 127453642 | 12745364 | 12 | C | TRANDATE | LABETALOL HYDROCHLORIDE | 1 | Unknown | UNK | 0 | ||||||||||
| 127453642 | 12745364 | 13 | C | ORACILLINE /00001801/ | PENICILLIN V | 1 | Unknown | 0 | |||||||||||
| 127453642 | 12745364 | 14 | C | UVEDOSE | CHOLECALCIFEROL | 1 | Unknown | 0 | |||||||||||
| 127453642 | 12745364 | 15 | C | TRIATEC /00885601/ | RAMIPRIL | 1 | Unknown | 0 | |||||||||||
| 127453642 | 12745364 | 16 | C | LUTERAN | CHLORMADINONE ACETATE | 1 | Unknown | 0 | |||||||||||
| 127453642 | 12745364 | 17 | C | SODIUM BICARBONATE. | SODIUM BICARBONATE | 1 | Unknown | 0 | |||||||||||
| 127453642 | 12745364 | 18 | C | ARANESP | DARBEPOETIN ALFA | 1 | Unknown | 0 | |||||||||||
| 127453642 | 12745364 | 19 | C | LOXEN /00639802/ | NICARDIPINE | 1 | Unknown | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127453642 | 12745364 | 1 | Haemolytic uraemic syndrome |
| 127453642 | 12745364 | 8 | Hypertension |
| 127453642 | 12745364 | 9 | Hypertension |
| 127453642 | 12745364 | 10 | Aplastic anaemia |
| 127453642 | 12745364 | 12 | Hypertension |
| 127453642 | 12745364 | 13 | Product used for unknown indication |
| 127453642 | 12745364 | 14 | Product used for unknown indication |
| 127453642 | 12745364 | 15 | Product used for unknown indication |
| 127453642 | 12745364 | 16 | Contraception |
| 127453642 | 12745364 | 17 | Product used for unknown indication |
| 127453642 | 12745364 | 18 | Product used for unknown indication |
| 127453642 | 12745364 | 19 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127453642 | 12745364 | HO |
| 127453642 | 12745364 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127453642 | 12745364 | Anaemia | |
| 127453642 | 12745364 | Blood creatinine increased | |
| 127453642 | 12745364 | Blood lactate dehydrogenase increased | |
| 127453642 | 12745364 | Exposure during pregnancy | |
| 127453642 | 12745364 | HELLP syndrome | |
| 127453642 | 12745364 | Haemoglobin decreased | |
| 127453642 | 12745364 | Haemolysis | |
| 127453642 | 12745364 | Haptoglobin decreased | |
| 127453642 | 12745364 | Hepatic enzyme increased | |
| 127453642 | 12745364 | Hypertension | |
| 127453642 | 12745364 | Incorrect dose administered | |
| 127453642 | 12745364 | Metrorrhagia | |
| 127453642 | 12745364 | Postpartum haemorrhage | |
| 127453642 | 12745364 | Proteinuria | |
| 127453642 | 12745364 | Retroplacental haematoma | |
| 127453642 | 12745364 | Uterine haemorrhage |
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 |
|---|---|---|---|---|---|---|
| 127453642 | 12745364 | 1 | 20110708 | 0 | ||
| 127453642 | 12745364 | 8 | 2011 | 0 | ||
| 127453642 | 12745364 | 12 | 2011 | 0 |