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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123495322 | 12349532 | 2 | F | 20160422 | 20160729 | 20160510 | 20160810 | EXP | US-ALEXION PHARMACEUTICALS INC-A201603238 | ALEXION | 0.00 | M | Y | 0.00000 | 20160810 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123495322 | 12349532 | 1 | PS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | U | T2-AE0884B01R | 125166 | CONCENTRATE FOR SOLUTION FOR INFUSION | ||||||||
| 123495322 | 12349532 | 2 | SS | CYCLOSPORINE. | CYCLOSPORINE | 1 | Unknown | 75MG DAILY QD IN THE EVENING, | U | 0 | 75 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123495322 | 12349532 | 1 | Paroxysmal nocturnal haemoglobinuria |
| 123495322 | 12349532 | 2 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 123495322 | 12349532 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123495322 | 12349532 | Chromaturia | |
| 123495322 | 12349532 | Dyspnoea exertional | |
| 123495322 | 12349532 | Haemoglobin decreased | |
| 123495322 | 12349532 | Platelet count decreased |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |