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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123561873 | 12356187 | 3 | F | 20160401 | 20160728 | 20160511 | 20160809 | EXP | BR-ALEXION PHARMACEUTICALS INC-A201602601 | ALEXION | 35.93 | YR | M | Y | 0.00000 | 20160809 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123561873 | 12356187 | 1 | PS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 600 MG, UNK | 125166 | 600 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | |||||||
| 123561873 | 12356187 | 2 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 600 MG, UNK | 125166 | 600 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | |||||||
| 123561873 | 12356187 | 3 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 900 MG, SINGLE | 125166 | 900 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QD | ||||||
| 123561873 | 12356187 | 4 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 900 MG, UNK | 125166 | 900 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123561873 | 12356187 | 1 | Paroxysmal nocturnal haemoglobinuria |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 123561873 | 12356187 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123561873 | 12356187 | Chikungunya virus infection | |
| 123561873 | 12356187 | Chromaturia | |
| 123561873 | 12356187 | Condition aggravated | |
| 123561873 | 12356187 | Incorrect dose administered | |
| 123561873 | 12356187 | Malaise | |
| 123561873 | 12356187 | Paroxysmal nocturnal haemoglobinuria | |
| 123561873 | 12356187 | Viral infection | |
| 123561873 | 12356187 | Vision blurred |
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 |
|---|---|---|---|---|---|---|
| 123561873 | 12356187 | 1 | 20121229 | 0 | ||
| 123561873 | 12356187 | 2 | 20130131 | 201604 | 0 | |
| 123561873 | 12356187 | 4 | 201605 | 0 |