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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127555011 | 12755501 | 1 | I | 20160523 | 20160908 | 20160916 | 20160916 | EXP | BR-ALEXION PHARMACEUTICALS INC-A201606827 | ALEXION | 29.08 | YR | F | Y | 0.00000 | 20160916 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127555011 | 12755501 | 1 | PS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 600 MG, FOR FOUR WEEKS | P0004601 | 125166 | 600 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | ||||||
| 127555011 | 12755501 | 2 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 900 MG, Q2W | 125166 | 900 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | ||||||
| 127555011 | 12755501 | 3 | C | PREDNISONE. | PREDNISONE | 1 | Oral | UNK | 0 | ||||||||||
| 127555011 | 12755501 | 4 | C | CLEXANE | ENOXAPARIN SODIUM | 1 | Subcutaneous | UNK | 0 | ||||||||||
| 127555011 | 12755501 | 5 | C | PEN V /00001801/ | 2 | Oral | UNK | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127555011 | 12755501 | 1 | Paroxysmal nocturnal haemoglobinuria |
| 127555011 | 12755501 | 3 | Aplasia |
| 127555011 | 12755501 | 4 | Anticoagulant therapy |
| 127555011 | 12755501 | 5 | Antibiotic prophylaxis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127555011 | 12755501 | HO |
| 127555011 | 12755501 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127555011 | 12755501 | Condition aggravated | |
| 127555011 | 12755501 | Deep vein thrombosis | |
| 127555011 | 12755501 | Haemoglobinuria | |
| 127555011 | 12755501 | Haemolysis | |
| 127555011 | 12755501 | Ocular icterus | |
| 127555011 | 12755501 | Pain in extremity | |
| 127555011 | 12755501 | Pruritus |
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 |
|---|---|---|---|---|---|---|
| 127555011 | 12755501 | 1 | 20141105 | 20141226 | 0 |