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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 98676172 | 9867617 | 2 | F | 20160810 | 20140204 | 20160819 | EXP | US-ALEXION PHARMACEUTICALS INC.-A201304744 | ALEXION | 0.00 | F | Y | 0.00000 | 20160819 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 98676172 | 9867617 | 1 | PS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 900 MG, 4 WEEKS | T3-AB3859C | 125166 | 900 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | ||||||
| 98676172 | 9867617 | 2 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 1200 MG, ON 5TH WEEK | 125166 | 1200 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | |||||||
| 98676172 | 9867617 | 3 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 300 MG, UNK | 125166 | 300 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | |||||||
| 98676172 | 9867617 | 4 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 1200 MG, Q2W | 125166 | 1200 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | ||||||
| 98676172 | 9867617 | 5 | C | RITUXAN | RITUXIMAB | 1 | Unknown | UNK | 0 | ||||||||||
| 98676172 | 9867617 | 6 | C | MYCOPHENOLATE MOFETIL. | MYCOPHENOLATE MOFETIL | 1 | Unknown | 360 MG, BID | 0 | 360 | MG | BID | |||||||
| 98676172 | 9867617 | 7 | C | PREDNISONE. | PREDNISONE | 1 | Unknown | 5 MG, QD | 0 | 5 | MG | QD | |||||||
| 98676172 | 9867617 | 8 | C | BELATACEPT | BELATACEPT | 1 | Unknown | 450 MG, QMONTH | 0 | 450 | MG | /month | |||||||
| 98676172 | 9867617 | 9 | C | CIPROFLOXACIN. | CIPROFLOXACIN | 1 | Unknown | 500 MG, QD | 0 | 500 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 98676172 | 9867617 | 1 | Haemolytic uraemic syndrome |
| 98676172 | 9867617 | 5 | Product used for unknown indication |
| 98676172 | 9867617 | 6 | Immunosuppression |
| 98676172 | 9867617 | 7 | Immunosuppression |
| 98676172 | 9867617 | 8 | Immunosuppression |
| 98676172 | 9867617 | 9 | Prophylaxis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 98676172 | 9867617 | OT |
| 98676172 | 9867617 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 98676172 | 9867617 | Acute kidney injury | |
| 98676172 | 9867617 | Blood creatinine increased | |
| 98676172 | 9867617 | Chills | |
| 98676172 | 9867617 | Diarrhoea | |
| 98676172 | 9867617 | Haemoglobin decreased | |
| 98676172 | 9867617 | Haemolysis | |
| 98676172 | 9867617 | Haemolytic uraemic syndrome | |
| 98676172 | 9867617 | Headache | |
| 98676172 | 9867617 | Plasmapheresis | |
| 98676172 | 9867617 | Platelet count decreased | |
| 98676172 | 9867617 | Pyrexia | |
| 98676172 | 9867617 | Thrombocytopenia | |
| 98676172 | 9867617 | Thrombotic microangiopathy |
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 |
|---|---|---|---|---|---|---|
| 98676172 | 9867617 | 1 | 20120928 | 20121019 | 0 | |
| 98676172 | 9867617 | 2 | 20130117 | 0 |