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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125576091 | 12557609 | 1 | I | 20160617 | 20160706 | 20160714 | 20160714 | EXP | BR-ALEXION-A201605140 | ALEXION | 33.33 | YR | F | Y | 0.00000 | 20160714 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125576091 | 12557609 | 1 | PS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 600 MG, UNK | Y | 125166 | 600 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | ||||||
| 125576091 | 12557609 | 2 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 900 MG, UNK | Y | 125166 | 900 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | ||||||
| 125576091 | 12557609 | 3 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 300 MG, UNK | Y | 125166 | 300 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | ||||||
| 125576091 | 12557609 | 4 | C | PEN-VE-ORAL | PENICILLIN V POTASSIUM | 1 | Oral | UNK | 0 | ||||||||||
| 125576091 | 12557609 | 5 | C | MAREVAN | WARFARIN SODIUM | 1 | Oral | UNK | 0 | ||||||||||
| 125576091 | 12557609 | 6 | C | GRANULOKINE | FILGRASTIM | 1 | Unknown | UNK | 0 | ||||||||||
| 125576091 | 12557609 | 7 | C | BACTRIM | SULFAMETHOXAZOLETRIMETHOPRIM | 1 | Unknown | UNK | 0 | ||||||||||
| 125576091 | 12557609 | 8 | C | FLUCONAZOLE. | FLUCONAZOLE | 1 | Unknown | UNK | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125576091 | 12557609 | 1 | Paroxysmal nocturnal haemoglobinuria |
| 125576091 | 12557609 | 4 | Infection prophylaxis |
| 125576091 | 12557609 | 5 | Anticoagulant therapy |
| 125576091 | 12557609 | 6 | Aplasia |
| 125576091 | 12557609 | 7 | Infection prophylaxis |
| 125576091 | 12557609 | 8 | Infection prophylaxis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125576091 | 12557609 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125576091 | 12557609 | Abdominal pain | |
| 125576091 | 12557609 | Chromaturia | |
| 125576091 | 12557609 | Haemoglobinuria | |
| 125576091 | 12557609 | Haemolysis | |
| 125576091 | 12557609 | 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 |
|---|---|---|---|---|---|---|
| 125576091 | 12557609 | 1 | 20121220 | 20130110 | 0 | |
| 125576091 | 12557609 | 2 | 20130117 | 0 | ||
| 125576091 | 12557609 | 3 | 20160617 | 0 |