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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126811551 | 12681155 | 1 | I | 20090107 | 20160302 | 20160824 | 20160824 | EXP | GB-ALEXION PHARMACEUTICALS INC-A201601666 | ALEXION | 25.76 | YR | F | Y | 0.00000 | 20160824 | OT | GB | GB |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126811551 | 12681155 | 1 | PS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | UNK | 125166 | CONCENTRATE FOR SOLUTION FOR INFUSION | |||||||||
| 126811551 | 12681155 | 2 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 1200 MG, Q2W | P0004002 | 125166 | 1200 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | |||||
| 126811551 | 12681155 | 3 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 1200 MG, Q2W | P0004708 | 125166 | 1200 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | |||||
| 126811551 | 12681155 | 4 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 1200 MG, Q2W | P0004801 | 125166 | 1200 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | |||||
| 126811551 | 12681155 | 5 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 900 MG, Q2W | 125166 | 900 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | ||||||
| 126811551 | 12681155 | 6 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 1200 MG, UNK | P0004801 | 125166 | 1200 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | ||||||
| 126811551 | 12681155 | 7 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 1500 MG, Q2W | P0005002R | 125166 | 1500 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126811551 | 12681155 | 1 | Paroxysmal nocturnal haemoglobinuria |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126811551 | 12681155 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126811551 | 12681155 | Abortion spontaneous | |
| 126811551 | 12681155 | Body temperature increased | |
| 126811551 | 12681155 | Exposure during pregnancy | |
| 126811551 | 12681155 | Incorrect dose administered |
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 |
|---|---|---|---|---|---|---|
| 126811551 | 12681155 | 2 | 20090107 | 0 | ||
| 126811551 | 12681155 | 3 | 20090107 | 0 | ||
| 126811551 | 12681155 | 4 | 20090107 | 0 | ||
| 126811551 | 12681155 | 5 | 20090107 | 0 |