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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 99256304 | 9925630 | 4 | F | 201409 | 20160912 | 20140226 | 20160920 | EXP | US-ALEXION PHARMACEUTICALS INC.-A201305086 | ALEXION | 0.00 | Y | 0.00000 | 20160920 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 99256304 | 9925630 | 1 | PS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | UNK | T2-AC0985B01 | 125166 | CONCENTRATE FOR SOLUTION FOR INFUSION | ||||||||
| 99256304 | 9925630 | 2 | SS | AZACITIDINE. | AZACITIDINE | 1 | Intravenous (not otherwise specified) | UNK, 5 DAYS A WEEK | 0 | ||||||||||
| 99256304 | 9925630 | 3 | SS | AZACITIDINE. | AZACITIDINE | 1 | Intravenous (not otherwise specified) | UNK, Q3 WEEKS | 0 | ||||||||||
| 99256304 | 9925630 | 4 | C | NEUPOGEN | FILGRASTIM | 1 | Unknown | 0 | |||||||||||
| 99256304 | 9925630 | 5 | C | CYCLOSPORIN A | CYCLOSPORINE | 1 | Unknown | UNK | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 99256304 | 9925630 | 1 | Paroxysmal nocturnal haemoglobinuria |
| 99256304 | 9925630 | 2 | Myelodysplastic syndrome |
| 99256304 | 9925630 | 5 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 99256304 | 9925630 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 99256304 | 9925630 | Aplastic anaemia | |
| 99256304 | 9925630 | Constipation | |
| 99256304 | 9925630 | Dry skin | |
| 99256304 | 9925630 | Fatigue | |
| 99256304 | 9925630 | Myelodysplastic syndrome | |
| 99256304 | 9925630 | Oedema peripheral | |
| 99256304 | 9925630 | Platelet count decreased |
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 |
|---|---|---|---|---|---|---|
| 99256304 | 9925630 | 2 | 201409 | 0 | ||
| 99256304 | 9925630 | 3 | 201409 | 0 | ||
| 99256304 | 9925630 | 5 | 201310 | 0 |