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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123433683 | 12343368 | 3 | F | 201604 | 20160715 | 20160506 | 20160726 | EXP | CA-ALEXION PHARMACEUTICALS INC.-A201603186 | ALEXION | 36.33 | YR | F | Y | 85.00000 | KG | 20160726 | MD | CA | CA |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123433683 | 12343368 | 1 | PS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 1200 MG, SINGLE | 125166 | 1200 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QD | ||||||
| 123433683 | 12343368 | 2 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 1200 MG, SINGLE | 125166 | 1200 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QD | ||||||
| 123433683 | 12343368 | 3 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 1200 MG, SINGLE | 125166 | 1200 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QD | ||||||
| 123433683 | 12343368 | 4 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 1200 MG, SINGLE | 125166 | 1200 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QD | ||||||
| 123433683 | 12343368 | 5 | C | WARFARIN | WARFARIN | 1 | Unknown | 0 | |||||||||||
| 123433683 | 12343368 | 6 | C | HEPARIN | HEPARIN SODIUM | 1 | Intravenous (not otherwise specified) | 0 | |||||||||||
| 123433683 | 12343368 | 7 | C | PREDNISONE. | PREDNISONE | 1 | Unknown | 75 MG, QD | 0 | 75 | MG | QD | |||||||
| 123433683 | 12343368 | 8 | C | RITUXIMAB | RITUXIMAB | 1 | Unknown | UNK | 0 | ||||||||||
| 123433683 | 12343368 | 9 | C | CYCLOPHOSPHAMIDE. | CYCLOPHOSPHAMIDE | 1 | Unknown | UNK | 0 | ||||||||||
| 123433683 | 12343368 | 10 | C | AZATHIOPRINE. | AZATHIOPRINE | 1 | Unknown | UNK | 0 | ||||||||||
| 123433683 | 12343368 | 11 | C | HYDRALAZINE | HYDRALAZINE HYDROCHLORIDE | 1 | Unknown | 0 | |||||||||||
| 123433683 | 12343368 | 12 | C | VORICONAZOLE. | VORICONAZOLE | 1 | Unknown | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123433683 | 12343368 | 1 | Antiphospholipid syndrome |
| 123433683 | 12343368 | 5 | Anticoagulant therapy |
| 123433683 | 12343368 | 6 | Anticoagulant therapy |
| 123433683 | 12343368 | 7 | Product used for unknown indication |
| 123433683 | 12343368 | 8 | Immunosuppression |
| 123433683 | 12343368 | 9 | Immunosuppression |
| 123433683 | 12343368 | 10 | Immunosuppression |
| 123433683 | 12343368 | 11 | Cardiac failure |
| 123433683 | 12343368 | 12 | Antiphospholipid syndrome |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 123433683 | 12343368 | HO |
| 123433683 | 12343368 | OT |
| 123433683 | 12343368 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123433683 | 12343368 | Bacteraemia | |
| 123433683 | 12343368 | Cerebrovascular accident | |
| 123433683 | 12343368 | Cytomegalovirus viraemia | |
| 123433683 | 12343368 | Haemodynamic instability | |
| 123433683 | 12343368 | Haemolysis | |
| 123433683 | 12343368 | Hepatic failure | |
| 123433683 | 12343368 | Hypotension | |
| 123433683 | 12343368 | Meningitis viral | |
| 123433683 | 12343368 | Sepsis |
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 |
|---|---|---|---|---|---|---|
| 123433683 | 12343368 | 1 | 20160326 | 20160326 | 0 | |
| 123433683 | 12343368 | 2 | 20160401 | 20160401 | 0 | |
| 123433683 | 12343368 | 3 | 20160408 | 20160408 | 0 | |
| 123433683 | 12343368 | 4 | 20160415 | 20160415 | 0 | |
| 123433683 | 12343368 | 8 | 201510 | 0 | ||
| 123433683 | 12343368 | 9 | 201602 | 0 | ||
| 123433683 | 12343368 | 10 | 201511 | 201602 | 0 |