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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121064793 | 12106479 | 3 | F | 20060503 | 20160809 | 20160223 | 20160817 | EXP | IL-ALEXION-A201502660 | ALEXION | 49.97 | YR | M | Y | 0.00000 | 20160817 | CN | IL | IL |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121064793 | 12106479 | 1 | PS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 300 MG, QW | Y | 125166 | 300 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | /wk | |||||
| 121064793 | 12106479 | 2 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 300 MG, Q2W | Y | 125166 | 300 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 121064793 | 12106479 | 1 | Paroxysmal nocturnal haemoglobinuria |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 121064793 | 12106479 | OT |
| 121064793 | 12106479 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 121064793 | 12106479 | Blood lactate dehydrogenase increased | |
| 121064793 | 12106479 | Deep vein thrombosis | |
| 121064793 | 12106479 | Drug ineffective | |
| 121064793 | 12106479 | Haemolysis | |
| 121064793 | 12106479 | Incorrect dose administered | |
| 121064793 | 12106479 | Pseudomonas infection | |
| 121064793 | 12106479 | Pyrexia |
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 |
|---|---|---|---|---|---|---|
| 121064793 | 12106479 | 1 | 20150503 | 0 |