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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118608802 | 11860880 | 2 | F | 20151214 | 20160627 | 20151222 | 20160707 | EXP | ES-ALEXION PHARMACEUTICALS INC-A201505224 | ALEXION | 64.74 | YR | F | Y | 0.00000 | 20160707 | CN | ES | ES |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118608802 | 11860880 | 1 | PS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 900 MG, QW | 900 | MG | 125166 | 900 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | /wk | ||||
| 118608802 | 11860880 | 2 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 1200 MG, Q2W | 900 | MG | P0003903 | 125166 | 1200 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 118608802 | 11860880 | 1 | Off label use |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 118608802 | 11860880 | OT |
| 118608802 | 11860880 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 118608802 | 11860880 | Cerebrovascular accident | |
| 118608802 | 11860880 | Off label use |
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 |
|---|---|---|---|---|---|---|
| 118608802 | 11860880 | 1 | 20140924 | 201410 | 0 | |
| 118608802 | 11860880 | 2 | 201410 | 201511 | 0 |