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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126555742 | 12655574 | 2 | F | 20150528 | 20160915 | 20160816 | 20160922 | EXP | AU-ALEXION-A201605878 | ALEXION | 54.00 | YR | M | Y | 0.00000 | 20160922 | CN | AU | AU |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126555742 | 12655574 | 1 | PS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 900 MG, UNK | Y | 125166 | 900 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | ||||||
| 126555742 | 12655574 | 2 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 1200 MG, Q2W | Y | 125166 | 1200 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | |||||
| 126555742 | 12655574 | 3 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | UNK | Y | 125166 | CONCENTRATE FOR SOLUTION FOR INFUSION | ||||||||
| 126555742 | 12655574 | 4 | C | BASILIXIMAB | BASILIXIMAB | 1 | Unknown | 20 MG DAY 0 AND 4 | 0 | ||||||||||
| 126555742 | 12655574 | 5 | C | PREDNISOLONE. | PREDNISOLONE | 1 | Unknown | WEANING TO 10 MG BY MONTH 3 | 0 | ||||||||||
| 126555742 | 12655574 | 6 | C | MYCOPHENOLATE SODIUM | MYCOPHENOLATE SODIUM | 1 | Unknown | 720 MG, BID | 0 | 720 | MG | BID | |||||||
| 126555742 | 12655574 | 7 | C | TACROLIMUS. | TACROLIMUS | 1 | Unknown | UNK | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126555742 | 12655574 | 1 | Haemolytic uraemic syndrome |
| 126555742 | 12655574 | 4 | Renal transplant |
| 126555742 | 12655574 | 5 | Immunosuppression |
| 126555742 | 12655574 | 6 | Immunosuppression |
| 126555742 | 12655574 | 7 | Immunosuppression |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126555742 | 12655574 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126555742 | 12655574 | Blood lactate dehydrogenase increased | |
| 126555742 | 12655574 | Haptoglobin decreased | |
| 126555742 | 12655574 | Platelet count decreased | |
| 126555742 | 12655574 | Thrombotic microangiopathy | |
| 126555742 | 12655574 | Transplant rejection |
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 |
|---|---|---|---|---|---|---|
| 126555742 | 12655574 | 1 | 201410 | 0 |