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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127558131 | 12755813 | 1 | I | 20150311 | 20160916 | 20160916 | EXP | AU-009507513-1503AUS005971 | MERCK | 51.00 | YR | F | Y | 0.00000 | 20160916 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127558131 | 12755813 | 1 | PS | MONTELUKAST SODIUM. | MONTELUKAST SODIUM | 1 | UNK | 20829 | TABLET | ||||||||||
| 127558131 | 12755813 | 2 | SS | MONTELUKAST SODIUM. | MONTELUKAST SODIUM | 1 | 20829 | TABLET | |||||||||||
| 127558131 | 12755813 | 3 | SS | CYCLOSPORINE. | CYCLOSPORINE | 1 | U | 0 | |||||||||||
| 127558131 | 12755813 | 4 | SS | CYCLOSPORINE. | CYCLOSPORINE | 1 | U | 0 | |||||||||||
| 127558131 | 12755813 | 5 | SS | AZATHIOPRINE. | AZATHIOPRINE | 1 | U | 0 | |||||||||||
| 127558131 | 12755813 | 6 | SS | AZATHIOPRINE. | AZATHIOPRINE | 1 | U | 0 | |||||||||||
| 127558131 | 12755813 | 7 | SS | CYCLOPHOSPHAMIDE. | CYCLOPHOSPHAMIDE | 1 | U | 0 | |||||||||||
| 127558131 | 12755813 | 8 | SS | CYCLOPHOSPHAMIDE. | CYCLOPHOSPHAMIDE | 1 | U | 0 | |||||||||||
| 127558131 | 12755813 | 9 | SS | DAPSONE. | DAPSONE | 1 | U | 0 | |||||||||||
| 127558131 | 12755813 | 10 | SS | DAPSONE. | DAPSONE | 1 | U | 0 | |||||||||||
| 127558131 | 12755813 | 11 | SS | METHOTREXATE. | METHOTREXATE | 1 | U | 0 | TABLET | ||||||||||
| 127558131 | 12755813 | 12 | SS | METHOTREXATE. | METHOTREXATE | 1 | U | 0 | TABLET | ||||||||||
| 127558131 | 12755813 | 13 | SS | PLAQUENIL | HYDROXYCHLOROQUINE SULFATE | 1 | U | 0 | |||||||||||
| 127558131 | 12755813 | 14 | SS | PLAQUENIL | HYDROXYCHLOROQUINE SULFATE | 1 | U | 0 | |||||||||||
| 127558131 | 12755813 | 15 | SS | PREDNISONE. | PREDNISONE | 1 | AT A VARIABLE DOSE OF 10 TO 25 MG DAILY | 0 | TABLET | QD | |||||||||
| 127558131 | 12755813 | 16 | SS | PREDNISONE. | PREDNISONE | 1 | 0 | TABLET | |||||||||||
| 127558131 | 12755813 | 17 | C | GLOBULIN, IMMUNE | HUMAN IMMUNOGLOBULIN G | 1 | 0 | ||||||||||||
| 127558131 | 12755813 | 18 | C | GLOBULIN, IMMUNE | HUMAN IMMUNOGLOBULIN G | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127558131 | 12755813 | 1 | Urticaria |
| 127558131 | 12755813 | 2 | Angioedema |
| 127558131 | 12755813 | 3 | Urticaria |
| 127558131 | 12755813 | 4 | Angioedema |
| 127558131 | 12755813 | 5 | Urticaria |
| 127558131 | 12755813 | 6 | Angioedema |
| 127558131 | 12755813 | 7 | Urticaria |
| 127558131 | 12755813 | 8 | Angioedema |
| 127558131 | 12755813 | 9 | Urticaria |
| 127558131 | 12755813 | 10 | Angioedema |
| 127558131 | 12755813 | 11 | Angioedema |
| 127558131 | 12755813 | 12 | Urticaria |
| 127558131 | 12755813 | 13 | Urticaria |
| 127558131 | 12755813 | 14 | Angioedema |
| 127558131 | 12755813 | 15 | Urticaria |
| 127558131 | 12755813 | 16 | Angioedema |
| 127558131 | 12755813 | 17 | Urticaria |
| 127558131 | 12755813 | 18 | Angioedema |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127558131 | 12755813 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127558131 | 12755813 | Cushing's syndrome | |
| 127558131 | 12755813 | Diabetes mellitus | |
| 127558131 | 12755813 | Drug dependence | |
| 127558131 | 12755813 | Hypertension | |
| 127558131 | 12755813 | Ill-defined disorder | |
| 127558131 | 12755813 | Off label use | |
| 127558131 | 12755813 | Treatment failure |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |