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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127591121 | 12759112 | 1 | I | 20110623 | 20160909 | 20160919 | 20160919 | EXP | US-ALEXION-A201606803 | ALEXION | 0.00 | M | Y | 0.00000 | 20160919 | CN | US | US |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127591121 | 12759112 | 1 | PS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 900 MG, UNK | 125166 | 900 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | |||||||
| 127591121 | 12759112 | 2 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | UNK, Q2W | 125166 | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | ||||||||
| 127591121 | 12759112 | 3 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | UNK, Q3W | 125166 | CONCENTRATE FOR SOLUTION FOR INFUSION | Q3W |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127591121 | 12759112 | 1 | Paroxysmal nocturnal haemoglobinuria |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127591121 | 12759112 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127591121 | 12759112 | Dysphagia | |
| 127591121 | 12759112 | Dyspnoea | |
| 127591121 | 12759112 | Hepatic steatosis | |
| 127591121 | 12759112 | Hepatitis | |
| 127591121 | 12759112 | Inappropriate schedule of drug administration | |
| 127591121 | 12759112 | Rash |
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 |
|---|---|---|---|---|---|---|
| 127591121 | 12759112 | 1 | 20080717 | 0 | ||
| 127591121 | 12759112 | 3 | 20160908 | 0 |