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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 106763367 | 10676336 | 7 | F | 20160909 | 20141226 | 20160919 | EXP | US-ALEXION PHARMACEUTICALS INC-A201404820 | ALEXION | 0.00 | M | Y | 0.00000 | 20160919 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 106763367 | 10676336 | 1 | PS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 600 MG, UNK | U | T3-AD3745B01 | 125166 | 600 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | |||||
| 106763367 | 10676336 | 2 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 900 MG, UNK | U | 125166 | 900 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 106763367 | 10676336 | 1 | Paroxysmal nocturnal haemoglobinuria |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 106763367 | 10676336 | HO |
| 106763367 | 10676336 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 106763367 | 10676336 | Appendicitis | |
| 106763367 | 10676336 | Asthenia | |
| 106763367 | 10676336 | Chest pain | |
| 106763367 | 10676336 | Condition aggravated | |
| 106763367 | 10676336 | Cyst | |
| 106763367 | 10676336 | Dizziness | |
| 106763367 | 10676336 | Drug hypersensitivity | |
| 106763367 | 10676336 | Fatigue | |
| 106763367 | 10676336 | Lethargy | |
| 106763367 | 10676336 | Neutrophil count decreased | |
| 106763367 | 10676336 | Pyrexia | |
| 106763367 | 10676336 | Rash | |
| 106763367 | 10676336 | Red blood cell count decreased | |
| 106763367 | 10676336 | Throat tightness | |
| 106763367 | 10676336 | White blood cell 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 |
|---|---|---|---|---|---|---|
| 106763367 | 10676336 | 2 | 20141209 | 0 |