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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 103635746 | 10363574 | 6 | F | 201407 | 20160809 | 20140805 | 20160816 | EXP | AU-ALEXION PHARMACEUTICALS INC.-A201402962 | ALEXION | 24.08 | YR | F | Y | 0.00000 | 20160816 | CN | AU | AU |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 103635746 | 10363574 | 1 | PS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 600 MG, QW | 125166 | 600 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | /wk | ||||||
| 103635746 | 10363574 | 2 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 900 MG, Q2W | 125166 | 900 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 103635746 | 10363574 | 1 | Paroxysmal nocturnal haemoglobinuria |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 103635746 | 10363574 | HO |
| 103635746 | 10363574 | OT |
| 103635746 | 10363574 | DS |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 103635746 | 10363574 | Abdominal discomfort | |
| 103635746 | 10363574 | Abdominal distension | |
| 103635746 | 10363574 | Abdominal pain | |
| 103635746 | 10363574 | Bacterial infection | |
| 103635746 | 10363574 | Blood lactate dehydrogenase increased | |
| 103635746 | 10363574 | Chills | |
| 103635746 | 10363574 | Deafness | |
| 103635746 | 10363574 | Device kink | |
| 103635746 | 10363574 | Dizziness | |
| 103635746 | 10363574 | Fluid retention | |
| 103635746 | 10363574 | Haemoglobinuria | |
| 103635746 | 10363574 | Jaundice | |
| 103635746 | 10363574 | Nasopharyngitis | |
| 103635746 | 10363574 | Nausea | |
| 103635746 | 10363574 | Neck pain | |
| 103635746 | 10363574 | Ocular icterus | |
| 103635746 | 10363574 | Peripheral swelling | |
| 103635746 | 10363574 | Pyrexia | |
| 103635746 | 10363574 | Shunt occlusion | |
| 103635746 | 10363574 | Shunt stenosis | |
| 103635746 | 10363574 | Tinnitus | |
| 103635746 | 10363574 | Vertigo | |
| 103635746 | 10363574 | Viral infection | |
| 103635746 | 10363574 | Vomiting |
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 |
|---|---|---|---|---|---|---|
| 103635746 | 10363574 | 1 | 201312 | 0 |