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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 110921975 | 11092197 | 5 | F | 201504 | 20160707 | 20150506 | 20160713 | EXP | JP-ALEXION-A201501449 | ALEXION | 61.00 | YR | F | Y | 44.00000 | KG | 20160713 | MD | JP | JP |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 110921975 | 11092197 | 1 | PS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 600 MG, QW | 103782.781 | MG | Y | 125166 | 600 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | /wk | |||
| 110921975 | 11092197 | 2 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 900 MG, Q2W | 103782.781 | MG | Y | 125166 | 900 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | |||
| 110921975 | 11092197 | 3 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 600 MG, Q2W | 103782.781 | MG | Y | AC6839D01 | 125166 | 600 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | ||
| 110921975 | 11092197 | 4 | C | DIFLUCAN | FLUCONAZOLE | 1 | Oral | 100 MG, QD | 0 | 100 | MG | QD | |||||||
| 110921975 | 11092197 | 5 | C | WARFARIN | WARFARIN | 1 | Oral | 3 MG, QD | 0 | 3 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 110921975 | 11092197 | 1 | Paroxysmal nocturnal haemoglobinuria |
| 110921975 | 11092197 | 4 | Product used for unknown indication |
| 110921975 | 11092197 | 5 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 110921975 | 11092197 | OT |
| 110921975 | 11092197 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 110921975 | 11092197 | Condition aggravated | |
| 110921975 | 11092197 | Extravascular haemolysis | |
| 110921975 | 11092197 | Pneumonia | |
| 110921975 | 11092197 | Underdose |
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 |
|---|---|---|---|---|---|---|
| 110921975 | 11092197 | 1 | 20101028 | 20101118 | 0 | |
| 110921975 | 11092197 | 2 | 20101124 | 20150414 | 0 | |
| 110921975 | 11092197 | 3 | 20150428 | 0 | ||
| 110921975 | 11092197 | 4 | 20150114 | 0 | ||
| 110921975 | 11092197 | 5 | 200601 | 20120507 | 0 |