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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126689191 | 12668919 | 1 | I | 20160810 | 20160819 | 20160819 | EXP | AU-ALEXION PHARMACEUTICALS INC-A201606019 | ALEXION | 45.00 | YR | M | Y | 0.00000 | 20160819 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126689191 | 12668919 | 1 | PS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 900 MG, QW | U | 125166 | 900 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | /wk | |||||
| 126689191 | 12668919 | 2 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 1200 MG, Q2W | U | 125166 | 1200 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | |||||
| 126689191 | 12668919 | 3 | C | EVEROLIMUS | EVEROLIMUS | 1 | Unknown | UNK | 0 | ||||||||||
| 126689191 | 12668919 | 4 | C | MYCOPHENOLATE MOFETIL. | MYCOPHENOLATE MOFETIL | 1 | Unknown | 1 G, BID | 0 | 1 | G | BID | |||||||
| 126689191 | 12668919 | 5 | C | MYCOPHENOLATE MOFETIL. | MYCOPHENOLATE MOFETIL | 1 | Unknown | 250 MG, BID | 0 | 250 | MG | BID | |||||||
| 126689191 | 12668919 | 6 | C | MYCOPHENOLATE MOFETIL. | MYCOPHENOLATE MOFETIL | 1 | Unknown | 500 MG, BID | 0 | 500 | MG | BID | |||||||
| 126689191 | 12668919 | 7 | C | PREDNISOLONE. | PREDNISOLONE | 1 | Unknown | 20 MG, QD | 0 | 20 | MG | QD | |||||||
| 126689191 | 12668919 | 8 | C | ASPIRIN /00002701/ | ASPIRIN | 1 | Unknown | 100 MG, QD | 0 | 100 | MG | QD | |||||||
| 126689191 | 12668919 | 9 | C | ENOXAPARIN | ENOXAPARIN | 1 | Unknown | 40 MG, QD | 0 | 40 | MG | QD | |||||||
| 126689191 | 12668919 | 10 | C | ENOXAPARIN | ENOXAPARIN | 1 | 0 | ||||||||||||
| 126689191 | 12668919 | 11 | C | DARBEPOETIN ALFA | DARBEPOETIN ALFA | 1 | Unknown | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126689191 | 12668919 | 1 | Thrombotic microangiopathy |
| 126689191 | 12668919 | 2 | Off label use |
| 126689191 | 12668919 | 3 | Immunosuppression |
| 126689191 | 12668919 | 4 | Immunosuppression |
| 126689191 | 12668919 | 7 | Immunosuppression |
| 126689191 | 12668919 | 8 | Thrombosis prophylaxis |
| 126689191 | 12668919 | 9 | Thrombosis prophylaxis |
| 126689191 | 12668919 | 10 | Deep vein thrombosis |
| 126689191 | 12668919 | 11 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126689191 | 12668919 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126689191 | 12668919 | Beta-2 glycoprotein antibody positive | |
| 126689191 | 12668919 | Blood lactate dehydrogenase increased | |
| 126689191 | 12668919 | Bone marrow failure | |
| 126689191 | 12668919 | Cardiolipin antibody positive | |
| 126689191 | 12668919 | Deep vein thrombosis | |
| 126689191 | 12668919 | Diarrhoea | |
| 126689191 | 12668919 | Gastrooesophageal reflux disease | |
| 126689191 | 12668919 | Haemolysis | |
| 126689191 | 12668919 | Off label use | |
| 126689191 | 12668919 | Pancytopenia | |
| 126689191 | 12668919 | Renal cortical necrosis | |
| 126689191 | 12668919 | Vomiting |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |