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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125366472 | 12536647 | 2 | F | 201507 | 20160726 | 20160707 | 20160808 | EXP | NZ-ALEXION PHARMACEUTICALS INC-A201504027 | ALEXION | 28.87 | YR | F | Y | 0.00000 | 20160808 | CN | NZ | NZ |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125366472 | 12536647 | 1 | PS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | UNK | Y | 125166 | CONCENTRATE FOR SOLUTION FOR INFUSION | ||||||||
| 125366472 | 12536647 | 2 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 900 MG, Q2W | Y | 125166 | 900 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | |||||
| 125366472 | 12536647 | 3 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 1200 MG, Q2W | Y | AD9299B03 | 125166 | 1200 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | ||||
| 125366472 | 12536647 | 4 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 900 MG, Q2W | Y | 125166 | 900 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | |||||
| 125366472 | 12536647 | 5 | C | WARFARIN | WARFARIN | 1 | Unknown | UNK | 0 | ||||||||||
| 125366472 | 12536647 | 6 | C | WARFARIN | WARFARIN | 1 | Unknown | UNK | 0 | ||||||||||
| 125366472 | 12536647 | 7 | C | CLEXANE | ENOXAPARIN SODIUM | 1 | Unknown | 100 MG, UNK | 0 | 100 | MG | ||||||||
| 125366472 | 12536647 | 8 | C | HEPARIN | HEPARIN SODIUM | 1 | Unknown | UNK | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125366472 | 12536647 | 1 | Paroxysmal nocturnal haemoglobinuria |
| 125366472 | 12536647 | 5 | Product used for unknown indication |
| 125366472 | 12536647 | 7 | Product used for unknown indication |
| 125366472 | 12536647 | 8 | Anticoagulant therapy |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125366472 | 12536647 | OT |
| 125366472 | 12536647 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125366472 | 12536647 | Exposure during breast feeding | |
| 125366472 | 12536647 | Exposure during pregnancy | |
| 125366472 | 12536647 | Haemoglobin abnormal | |
| 125366472 | 12536647 | Haemolysis | |
| 125366472 | 12536647 | Incorrect dose administered | |
| 125366472 | 12536647 | Mastitis | |
| 125366472 | 12536647 | Retained placenta or membranes |
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 |
|---|---|---|---|---|---|---|
| 125366472 | 12536647 | 1 | 200912 | 0 | ||
| 125366472 | 12536647 | 3 | 20160323 | 20160601 | 0 | |
| 125366472 | 12536647 | 4 | 20160615 | 0 | ||
| 125366472 | 12536647 | 5 | 20150908 | 0 | ||
| 125366472 | 12536647 | 7 | 20150910 | 20160428 | 0 | |
| 125366472 | 12536647 | 8 | 20160428 | 0 |