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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 109682896 | 10968289 | 6 | F | 20150312 | 20160627 | 20150330 | 20160706 | EXP | CO-ALEXION PHARMACEUTICALS INC-A201501161 | ALEXION | 29.66 | YR | F | Y | 75.00000 | KG | 20160706 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 109682896 | 10968289 | 1 | PS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 900 MG, QW | 59793.6055 | MG | AD9299B07 | 125166 | 900 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | /wk | |||
| 109682896 | 10968289 | 2 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 1200 MG, Q12D | 59793.6055 | MG | AC4050B14 | 125166 | 1200 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | ||||
| 109682896 | 10968289 | 3 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 1200 MG, Q12D | 59793.6055 | MG | AD9299B07 | 125166 | 1200 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 109682896 | 10968289 | 1 | Haemolytic uraemic syndrome |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 109682896 | 10968289 | OT |
| 109682896 | 10968289 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 109682896 | 10968289 | Abdominal pain | |
| 109682896 | 10968289 | Blood lactate dehydrogenase increased | |
| 109682896 | 10968289 | Diarrhoea | |
| 109682896 | 10968289 | Gastroenteritis | |
| 109682896 | 10968289 | Haemoglobin abnormal | |
| 109682896 | 10968289 | Haemolytic uraemic syndrome | |
| 109682896 | 10968289 | Inappropriate schedule of drug administration | |
| 109682896 | 10968289 | Muscle spasms | |
| 109682896 | 10968289 | Platelet count abnormal |
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 |
|---|---|---|---|---|---|---|
| 109682896 | 10968289 | 1 | 20141009 | 20141031 | 0 | |
| 109682896 | 10968289 | 2 | 20141107 | 0 | ||
| 109682896 | 10968289 | 3 | 20141107 | 0 |