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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126655143 | 12665514 | 3 | F | 20160817 | 20160907 | 20160818 | 20160914 | PER | US-ALEXION-A201606005 | ALEXION | 0.00 | M | Y | 0.00000 | 20160914 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126655143 | 12665514 | 1 | PS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 1200 MG, Q2W | Y | U | 125166 | 1200 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | ||||
| 126655143 | 12665514 | 2 | C | TYLENOL | ACETAMINOPHEN | 1 | Unknown | UNK | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126655143 | 12665514 | 1 | Paroxysmal nocturnal haemoglobinuria |
| 126655143 | 12665514 | 2 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126655143 | 12665514 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126655143 | 12665514 | Dyspnoea | |
| 126655143 | 12665514 | Feeling drunk | |
| 126655143 | 12665514 | Haemolysis | |
| 126655143 | 12665514 | Head discomfort | |
| 126655143 | 12665514 | Heart rate increased | |
| 126655143 | 12665514 | Incorrect dose administered | |
| 126655143 | 12665514 | Infusion related reaction | |
| 126655143 | 12665514 | Insomnia | |
| 126655143 | 12665514 | Liver iron concentration increased | |
| 126655143 | 12665514 | Malaise |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |