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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122915373 | 12291537 | 3 | F | 20140716 | 20160810 | 20160421 | 20160817 | EXP | CO-ALEXION PHARMACEUTICALS INC-A201602835 | ALEXION | 36.50 | YR | M | Y | 140.00000 | KG | 20160817 | CN | CO | CO |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122915373 | 12291537 | 1 | PS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 600 MG, QW | 125166 | 600 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | /wk | ||||||
| 122915373 | 12291537 | 2 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 900 MG, Q2W | AE1235B05 | 125166 | 900 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | |||||
| 122915373 | 12291537 | 3 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 1200 MG, Q2W | 125166 | 1200 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | ||||||
| 122915373 | 12291537 | 4 | C | PREDNISOLONE. | PREDNISOLONE | 1 | Unknown | UNK | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 122915373 | 12291537 | 1 | Paroxysmal nocturnal haemoglobinuria |
| 122915373 | 12291537 | 4 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 122915373 | 12291537 | HO |
| 122915373 | 12291537 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 122915373 | 12291537 | Asthenia | |
| 122915373 | 12291537 | Fatigue | |
| 122915373 | 12291537 | Haemoglobinuria | |
| 122915373 | 12291537 | Haemolysis | |
| 122915373 | 12291537 | Incorrect dose administered | |
| 122915373 | 12291537 | Jaundice | |
| 122915373 | 12291537 | Myalgia |
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 |
|---|---|---|---|---|---|---|
| 122915373 | 12291537 | 1 | 20130430 | 20130521 | 0 | |
| 122915373 | 12291537 | 2 | 20130528 | 20140617 | 0 | |
| 122915373 | 12291537 | 3 | 20140716 | 0 |