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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 109519538 | 10951953 | 8 | F | 20150323 | 20160906 | 20150325 | 20160912 | EXP | US-ALEXION PHARMACEUTICALS INC-A201500958 | ALEXION | 0.00 | M | Y | 0.00000 | 20160912 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 109519538 | 10951953 | 1 | PS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | UNK, Q2W | T3-AD3636B01 | 125166 | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | |||||||
| 109519538 | 10951953 | 2 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | UNK,Q4W | 125166 | CONCENTRATE FOR SOLUTION FOR INFUSION | |||||||||
| 109519538 | 10951953 | 3 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | UNK,Q3W | 125166 | CONCENTRATE FOR SOLUTION FOR INFUSION |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 109519538 | 10951953 | 1 | Haemolytic uraemic syndrome |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 109519538 | 10951953 | DE |
| 109519538 | 10951953 | HO |
| 109519538 | 10951953 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 109519538 | 10951953 | Blood creatinine increased | |
| 109519538 | 10951953 | Blood lactate dehydrogenase increased | |
| 109519538 | 10951953 | Dyspnoea | |
| 109519538 | 10951953 | Graft versus host disease in skin | |
| 109519538 | 10951953 | Inappropriate schedule of drug administration | |
| 109519538 | 10951953 | Lethargy | |
| 109519538 | 10951953 | Pneumonia | |
| 109519538 | 10951953 | Pyrexia | |
| 109519538 | 10951953 | Thrombotic microangiopathy |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |