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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124970232 | 12497023 | 2 | F | 20151217 | 20160719 | 20160624 | 20160728 | EXP | CO-ALEXION-A201604645 | ALEXION | 43.37 | YR | M | Y | 60.00000 | KG | 20160728 | CN | CO | CO |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124970232 | 12497023 | 1 | PS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 600 MG, QW | 125166 | 600 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | /wk | ||||||
| 124970232 | 12497023 | 2 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 900 MG, Q2W | AE1235B05 | 125166 | 900 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | |||||
| 124970232 | 12497023 | 3 | C | PREDNISOLONE. | PREDNISOLONE | 1 | Oral | 50 MG, QD | 0 | 50 | MG | QD | |||||||
| 124970232 | 12497023 | 4 | C | CYCLOSPORIN | CYCLOSPORINE | 1 | Oral | 100 MG, Q8H | 0 | 100 | MG | Q8H | |||||||
| 124970232 | 12497023 | 5 | C | ZANTAC | RANITIDINE HYDROCHLORIDE | 1 | Oral | 50 MG, Q8H | 0 | 50 | MG | Q8H | |||||||
| 124970232 | 12497023 | 6 | C | DANAZOL. | DANAZOL | 1 | Oral | 200 MG, Q8H | 0 | 200 | MG | Q8H |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124970232 | 12497023 | 1 | Paroxysmal nocturnal haemoglobinuria |
| 124970232 | 12497023 | 3 | Aplastic anaemia |
| 124970232 | 12497023 | 4 | Aplastic anaemia |
| 124970232 | 12497023 | 5 | Aplastic anaemia |
| 124970232 | 12497023 | 6 | Aplastic anaemia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124970232 | 12497023 | OT |
| 124970232 | 12497023 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124970232 | 12497023 | Abscess oral | |
| 124970232 | 12497023 | Decreased immune responsiveness | |
| 124970232 | 12497023 | Drug ineffective | |
| 124970232 | 12497023 | Gingivitis | |
| 124970232 | 12497023 | 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 |
|---|---|---|---|---|---|---|
| 124970232 | 12497023 | 1 | 20151111 | 20151202 | 0 | |
| 124970232 | 12497023 | 2 | 20151209 | 0 | ||
| 124970232 | 12497023 | 3 | 20160501 | 0 | ||
| 124970232 | 12497023 | 4 | 20160501 | 0 | ||
| 124970232 | 12497023 | 5 | 20160501 | 0 | ||
| 124970232 | 12497023 | 6 | 20160501 | 0 |