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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125236331 | 12523633 | 1 | I | 201512 | 20160623 | 20160704 | 20160704 | EXP | JP-ALXN-A201604717AA | ALEXION | 78.00 | YR | F | Y | 85.00000 | KG | 20160704 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125236331 | 12523633 | 1 | PS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 600 MG, QW | 125166 | 600 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | /wk | ||||||
| 125236331 | 12523633 | 2 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 900 MG, Q2W | 125166 | 900 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | ||||||
| 125236331 | 12523633 | 3 | C | NEXIUM | ESOMEPRAZOLE MAGNESIUM | 1 | Oral | 1 DF, DAILY | 0 | CAPSULE | QD | ||||||||
| 125236331 | 12523633 | 4 | C | REBAMIPIDE | REBAMIPIDE | 1 | Oral | 3 DF, DAILY | 0 | TABLET | QD | ||||||||
| 125236331 | 12523633 | 5 | C | REBAMIPIDE | REBAMIPIDE | 1 | Oral | 1 DF, DAILY | 0 | TABLET | QD | ||||||||
| 125236331 | 12523633 | 6 | C | VASOLAN /00014302/ | VERAPAMIL HYDROCHLORIDE | 1 | Oral | 1 DF, DAILY | 0 | TABLET | QD | ||||||||
| 125236331 | 12523633 | 7 | C | VASOLAN /00014302/ | VERAPAMIL HYDROCHLORIDE | 1 | Oral | 3 DF, DAILY | 0 | TABLET | QD | ||||||||
| 125236331 | 12523633 | 8 | C | WARFARIN | WARFARIN | 1 | Oral | 3 DF, DAILY | 0 | TABLET | QD | ||||||||
| 125236331 | 12523633 | 9 | C | WARFARIN | WARFARIN | 1 | Oral | 3 DF, DAILY | 0 | TABLET | QD | ||||||||
| 125236331 | 12523633 | 10 | C | RENIVACE | ENALAPRIL | 1 | Oral | 1 DF, DAILY | 0 | TABLET | QD | ||||||||
| 125236331 | 12523633 | 11 | C | PREDONINE | PREDNISOLONEPREDNISOLONE ACETATEPREDNISOLONE SODIUM SUCCINATE | 1 | Unknown | 20 MG, DAILY | 0 | 20 | MG | QD | |||||||
| 125236331 | 12523633 | 12 | C | PREDONINE | PREDNISOLONEPREDNISOLONE ACETATEPREDNISOLONE SODIUM SUCCINATE | 1 | Unknown | 10 MG, UNK | 0 | 10 | MG | ||||||||
| 125236331 | 12523633 | 13 | C | PREDONINE | PREDNISOLONEPREDNISOLONE ACETATEPREDNISOLONE SODIUM SUCCINATE | 1 | Unknown | 5 MG, UNK | 0 | 5 | MG | ||||||||
| 125236331 | 12523633 | 14 | C | FOLIAMIN | FOLIC ACID | 1 | Unknown | 5 MG, DAILY | 0 | 5 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125236331 | 12523633 | 1 | Paroxysmal nocturnal haemoglobinuria |
| 125236331 | 12523633 | 3 | Product used for unknown indication |
| 125236331 | 12523633 | 4 | Product used for unknown indication |
| 125236331 | 12523633 | 6 | Product used for unknown indication |
| 125236331 | 12523633 | 8 | Product used for unknown indication |
| 125236331 | 12523633 | 10 | Product used for unknown indication |
| 125236331 | 12523633 | 11 | Product used for unknown indication |
| 125236331 | 12523633 | 14 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125236331 | 12523633 | OT |
| 125236331 | 12523633 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125236331 | 12523633 | Breast cancer | |
| 125236331 | 12523633 | Nasopharyngitis |
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 |
|---|---|---|---|---|---|---|
| 125236331 | 12523633 | 1 | 20130529 | 20130621 | 0 | |
| 125236331 | 12523633 | 2 | 20130628 | 0 | ||
| 125236331 | 12523633 | 3 | 20130501 | 0 | ||
| 125236331 | 12523633 | 4 | 20130501 | 0 | ||
| 125236331 | 12523633 | 5 | 20130501 | 0 | ||
| 125236331 | 12523633 | 6 | 20130501 | 0 | ||
| 125236331 | 12523633 | 8 | 20130501 | 20130306 | 0 | |
| 125236331 | 12523633 | 9 | 20130312 | 0 | ||
| 125236331 | 12523633 | 10 | 20150814 | 0 | ||
| 125236331 | 12523633 | 11 | 20130525 | 20130530 | 0 | |
| 125236331 | 12523633 | 12 | 20160531 | 20160606 | 0 | |
| 125236331 | 12523633 | 13 | 20160607 | 0 | ||
| 125236331 | 12523633 | 14 | 20130626 | 0 |