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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126586412 | 12658641 | 2 | F | 20160731 | 20160906 | 20160817 | 20160913 | EXP | BR-ALEXION PHARMACEUTICALS INC-A201605987 | ALEXION | 0.00 | F | Y | 0.00000 | 20160913 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126586412 | 12658641 | 1 | PS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 900 MG, UNK | U | 125166 | 900 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | ||||||
| 126586412 | 12658641 | 2 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 1200 MG, Q2W | U | 125166 | 1200 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | |||||
| 126586412 | 12658641 | 3 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 900 MG, 2 EXTRA DOSES | U | 125166 | 900 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | ||||||
| 126586412 | 12658641 | 4 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 900 MG, EXTRA DOSE | U | 125166 | 900 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | ||||||
| 126586412 | 12658641 | 5 | C | TACROLIMUS. | TACROLIMUS | 1 | Unknown | 2 MG, QD | 0 | 2 | MG | QD | |||||||
| 126586412 | 12658641 | 6 | C | THYMOGLOBULIN | LAPINE T-LYMPHOCYTE IMMUNE GLOBULIN | 1 | Unknown | UNK | 0 | ||||||||||
| 126586412 | 12658641 | 7 | C | MYFORTIC | MYCOPHENOLATE SODIUM | 1 | Unknown | 1440 MG, QD | 0 | 1440 | MG | QD | |||||||
| 126586412 | 12658641 | 8 | C | PREDNISONE. | PREDNISONE | 1 | Unknown | 20 MG, QD | 0 | 20 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126586412 | 12658641 | 1 | Haemolytic uraemic syndrome |
| 126586412 | 12658641 | 5 | Transplant |
| 126586412 | 12658641 | 6 | Transplant |
| 126586412 | 12658641 | 7 | Transplant |
| 126586412 | 12658641 | 8 | Transplant |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126586412 | 12658641 | OT |
| 126586412 | 12658641 | HO |
| 126586412 | 12658641 | LT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126586412 | 12658641 | Blood lactate dehydrogenase increased | |
| 126586412 | 12658641 | Haemolysis | |
| 126586412 | 12658641 | Hypertension | |
| 126586412 | 12658641 | Inappropriate schedule of drug administration | |
| 126586412 | 12658641 | Muscle spasms | |
| 126586412 | 12658641 | Renal disorder | |
| 126586412 | 12658641 | Reticulocyte count increased |
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 |
|---|---|---|---|---|---|---|
| 126586412 | 12658641 | 1 | 20140430 | 20140519 | 0 | |
| 126586412 | 12658641 | 2 | 20140529 | 0 | ||
| 126586412 | 12658641 | 4 | 20160908 | 0 |