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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126850012 | 12685001 | 2 | F | 201606 | 20160825 | 20160825 | 20160831 | EXP | US-ALEXION-A201606096 | ALEXION | 0.00 | M | Y | 0.00000 | 20160831 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126850012 | 12685001 | 1 | PS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 1200 MG, Q2W | U | 125166 | 1200 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | |||||
| 126850012 | 12685001 | 2 | SS | CELLCEPT | MYCOPHENOLATE MOFETILMYCOPHENOLATE MOFETIL HYDROCHLORIDE | 1 | Unknown | HIGHEST DOSE | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126850012 | 12685001 | 1 | Haemolytic uraemic syndrome |
| 126850012 | 12685001 | 2 | Scleroderma |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126850012 | 12685001 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126850012 | 12685001 | Adverse reaction | |
| 126850012 | 12685001 | Decreased appetite | |
| 126850012 | 12685001 | Diarrhoea | |
| 126850012 | 12685001 | Fatigue | |
| 126850012 | 12685001 | Hypophagia | |
| 126850012 | 12685001 | Hypotension | |
| 126850012 | 12685001 | Malaise | |
| 126850012 | 12685001 | Nausea | |
| 126850012 | 12685001 | Viral infection | |
| 126850012 | 12685001 | Vomiting |
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 |
|---|---|---|---|---|---|---|
| 126850012 | 12685001 | 1 | 20160526 | 0 |