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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1015727711 | 10157277 | 11 | F | 20140411 | 20160902 | 20140507 | 20160909 | EXP | US-ALEXION-A201401638 | ALEXION | 57.94 | YR | F | Y | 0.00000 | 20160909 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1015727711 | 10157277 | 1 | PS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 900 MG, Q2W | U | T2-AB5118D, T3-AB5117C, T3-AB5118D, | 125166 | 900 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | ||||
| 1015727711 | 10157277 | 2 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 900 MG, Q2W | U | AB7975C, AB7974C | 125166 | 900 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | ||||
| 1015727711 | 10157277 | 3 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | UNK | U | T3-AB7975C | 125166 | CONCENTRATE FOR SOLUTION FOR INFUSION | |||||||
| 1015727711 | 10157277 | 4 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | UNK | U | T3-AB7974C | 125166 | CONCENTRATE FOR SOLUTION FOR INFUSION | |||||||
| 1015727711 | 10157277 | 5 | SS | SOLIRIS | ECULIZUMAB | 1 | UNK | U | 125166 | CONCENTRATE FOR SOLUTION FOR INFUSION | |||||||||
| 1015727711 | 10157277 | 6 | C | EXJADE | DEFERASIROX | 1 | Unknown | UNK | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 1015727711 | 10157277 | 1 | Paroxysmal nocturnal haemoglobinuria |
| 1015727711 | 10157277 | 6 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 1015727711 | 10157277 | HO |
| 1015727711 | 10157277 | OT |
| 1015727711 | 10157277 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 1015727711 | 10157277 | Aplastic anaemia | |
| 1015727711 | 10157277 | Balance disorder | |
| 1015727711 | 10157277 | Blood bilirubin increased | |
| 1015727711 | 10157277 | Blood creatinine increased | |
| 1015727711 | 10157277 | Blood lactate dehydrogenase increased | |
| 1015727711 | 10157277 | Chromaturia | |
| 1015727711 | 10157277 | Drug ineffective | |
| 1015727711 | 10157277 | Gait disturbance | |
| 1015727711 | 10157277 | Haemoglobin abnormal | |
| 1015727711 | 10157277 | Haemoglobin decreased | |
| 1015727711 | 10157277 | Headache | |
| 1015727711 | 10157277 | Hepatic steatosis | |
| 1015727711 | 10157277 | Joint instability | |
| 1015727711 | 10157277 | Platelet count decreased | |
| 1015727711 | 10157277 | Staphylococcal infection |
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 |
|---|---|---|---|---|---|---|
| 1015727711 | 10157277 | 1 | 20140224 | 0 |