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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125994124 | 12599412 | 4 | F | 201607 | 20160829 | 20160727 | 20160902 | EXP | CA-ALEXION PHARMACEUTICALS INC-A201605377 | ALEXION | 14.53 | YR | M | Y | 53.60000 | KG | 20160902 | CN | CA | CA |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125994124 | 12599412 | 1 | PS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 900 MG, QW | 125166 | 900 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | /wk | ||||||
| 125994124 | 12599412 | 2 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 1200 MG, Q2W | 00017E | 125166 | 1200 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | |||||
| 125994124 | 12599412 | 3 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 1200 MG, Q2W | 00020C | 125166 | 1200 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | |||||
| 125994124 | 12599412 | 4 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 1200 MG, Q2W | AB7976C | 125166 | 1200 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | |||||
| 125994124 | 12599412 | 5 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 1200 MG, Q2W | AE7317B04 | 125166 | 1200 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125994124 | 12599412 | 1 | Haemolytic uraemic syndrome |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125994124 | 12599412 | OT |
| 125994124 | 12599412 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125994124 | 12599412 | Blood bilirubin increased | |
| 125994124 | 12599412 | Blood creatinine increased | |
| 125994124 | 12599412 | Blood urea increased | |
| 125994124 | 12599412 | Eye colour change | |
| 125994124 | 12599412 | Haemoglobin decreased | |
| 125994124 | 12599412 | Haemolytic anaemia | |
| 125994124 | 12599412 | Jaundice | |
| 125994124 | 12599412 | Limb injury | |
| 125994124 | 12599412 | Renal impairment | |
| 125994124 | 12599412 | Syncope | |
| 125994124 | 12599412 | Yellow skin |
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 |
|---|---|---|---|---|---|---|
| 125994124 | 12599412 | 1 | 20120331 | 20120420 | 0 | |
| 125994124 | 12599412 | 2 | 20120427 | 0 | ||
| 125994124 | 12599412 | 3 | 20120427 | 0 | ||
| 125994124 | 12599412 | 4 | 20120427 | 0 | ||
| 125994124 | 12599412 | 5 | 20120427 | 0 |