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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124572705 | 12457270 | 5 | F | 201606 | 20160629 | 20160610 | 20160711 | EXP | PL-ALEXION PHARMACEUTICALS INC-A201604273 | ALEXION | 19.95 | YR | M | Y | 60.50000 | KG | 20160711 | CN | PL | PL |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124572705 | 12457270 | 1 | PS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 600 MG, QW | 125166 | 600 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | /wk | ||||||
| 124572705 | 12457270 | 2 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 600 MG, QW | 125166 | 600 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | /wk | ||||||
| 124572705 | 12457270 | 3 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 600 MG, UNK | 125166 | 600 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | |||||||
| 124572705 | 12457270 | 4 | C | PARACETAMOL | ACETAMINOPHEN | 1 | Unknown | 0 | |||||||||||
| 124572705 | 12457270 | 5 | C | ENCORTON /00044701/ | PREDNISONE | 1 | Unknown | 20 MG, UNK | 0 | 20 | MG | ||||||||
| 124572705 | 12457270 | 6 | C | HEPARIN | HEPARIN SODIUM | 1 | Unknown | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124572705 | 12457270 | 1 | Paroxysmal nocturnal haemoglobinuria |
| 124572705 | 12457270 | 4 | Pain |
| 124572705 | 12457270 | 5 | Product used for unknown indication |
| 124572705 | 12457270 | 6 | Anticoagulant therapy |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124572705 | 12457270 | LT |
| 124572705 | 12457270 | HO |
| 124572705 | 12457270 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124572705 | 12457270 | Activities of daily living impaired | |
| 124572705 | 12457270 | Asthenia | |
| 124572705 | 12457270 | Gait disturbance | |
| 124572705 | 12457270 | General physical health deterioration | |
| 124572705 | 12457270 | Haemolysis | |
| 124572705 | 12457270 | Hypotension | |
| 124572705 | 12457270 | Malaise | |
| 124572705 | 12457270 | Renal failure | |
| 124572705 | 12457270 | Thrombosis | |
| 124572705 | 12457270 | 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 |
|---|---|---|---|---|---|---|
| 124572705 | 12457270 | 1 | 20160511 | 20160511 | 0 | |
| 124572705 | 12457270 | 2 | 20160518 | 20160518 | 0 | |
| 124572705 | 12457270 | 3 | 20160615 | 0 |