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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124533604 | 12453360 | 4 | F | 20160530 | 20160913 | 20160609 | 20160920 | EXP | BR-ALEXION PHARMACEUTICALS INC-A201604190 | ALEXION | 61.00 | YR | F | Y | 0.00000 | 20160920 | CN | BR | BR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124533604 | 12453360 | 1 | PS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 600 MG, QW | Y | 125166 | 600 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | /wk | |||||
| 124533604 | 12453360 | 2 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 900 MG, Q2W | Y | 125166 | 900 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | |||||
| 124533604 | 12453360 | 3 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 600 MG, QW | Y | 125166 | 600 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | /wk | |||||
| 124533604 | 12453360 | 4 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 900 MG, QW | Y | 125166 | 900 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | /wk | |||||
| 124533604 | 12453360 | 5 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 900 MG, Q2W | Y | 125166 | 900 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124533604 | 12453360 | 1 | Paroxysmal nocturnal haemoglobinuria |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124533604 | 12453360 | HO |
| 124533604 | 12453360 | OT |
| 124533604 | 12453360 | LT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124533604 | 12453360 | Chest pain | |
| 124533604 | 12453360 | Fatigue | |
| 124533604 | 12453360 | Gait disturbance | |
| 124533604 | 12453360 | Headache | |
| 124533604 | 12453360 | Oedema peripheral | |
| 124533604 | 12453360 | Pain | |
| 124533604 | 12453360 | Pharyngitis | |
| 124533604 | 12453360 | Pulmonary embolism | |
| 124533604 | 12453360 | Syncope | |
| 124533604 | 12453360 | Thyroid mass | |
| 124533604 | 12453360 | Tonsillitis |
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 |
|---|---|---|---|---|---|---|
| 124533604 | 12453360 | 1 | 20151228 | 20160118 | 0 | |
| 124533604 | 12453360 | 2 | 20160125 | 20160321 | 0 | |
| 124533604 | 12453360 | 3 | 20160627 | 0 | ||
| 124533604 | 12453360 | 5 | 20160725 | 0 |