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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127456931 | 12745693 | 1 | I | 20160902 | 20160915 | 20160915 | EXP | US-APOTEX-2016AP011385 | APOTEX | 66.00 | YR | M | Y | 0.00000 | 20160915 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127456931 | 12745693 | 1 | PS | MYCOPHENOLATE MOFETIL. | MYCOPHENOLATE MOFETIL | 1 | Unknown | U | U | 90499 | TABLET | ||||||||
| 127456931 | 12745693 | 2 | SS | TACROLIMUS. | TACROLIMUS | 1 | Unknown | UNK | U | U | 0 | ||||||||
| 127456931 | 12745693 | 3 | SS | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | Unknown | U | U | 0 | |||||||||
| 127456931 | 12745693 | 4 | SS | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | U | U | 0 | ||||||||||
| 127456931 | 12745693 | 5 | SS | ANTITHYMOCYTE IMMUNOGLOBULIN (RABBIT) | LAPINE T-LYMPHOCYTE IMMUNE GLOBULIN | 1 | Unknown | UNK | U | U | 0 | ||||||||
| 127456931 | 12745693 | 6 | SS | ANTITHYMOCYTE IMMUNOGLOBULIN (RABBIT) | LAPINE T-LYMPHOCYTE IMMUNE GLOBULIN | 1 | Unknown | TOTAL OF 500 MG (5 MG/KG) | U | U | 0 | ||||||||
| 127456931 | 12745693 | 7 | SS | PREDNISONE. | PREDNISONE | 1 | Unknown | 3 MONTH DOSE; 1.5MG/KG | U | U | 0 | ||||||||
| 127456931 | 12745693 | 8 | SS | PREDNISONE. | PREDNISONE | 1 | Unknown | AT 2 MONTHS, TAPERING, 3 MONTHS DOSE IS STATED | U | U | 0 | ||||||||
| 127456931 | 12745693 | 9 | C | ACICLOVIR | ACYCLOVIR | 1 | Unknown | U | U | 0 | |||||||||
| 127456931 | 12745693 | 10 | C | CLOTRIMAZOLE. | CLOTRIMAZOLE | 1 | Unknown | U | U | 0 | |||||||||
| 127456931 | 12745693 | 11 | C | SULFAMETHOXAZOLE AND TRIMETHOPRIM | SULFAMETHOXAZOLETRIMETHOPRIM | 1 | Unknown | U | 0 | ||||||||||
| 127456931 | 12745693 | 12 | C | SULFAMETHOXAZOLE AND TRIMETHOPRIM | SULFAMETHOXAZOLETRIMETHOPRIM | 1 | Oral | UNK | U | 0 | |||||||||
| 127456931 | 12745693 | 13 | C | MEROPENEM. | MEROPENEM | 1 | U | U | 0 | ||||||||||
| 127456931 | 12745693 | 14 | C | DAPSONE. | DAPSONE | 1 | Unknown | U | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127456931 | 12745693 | 1 | Immunosuppressant drug therapy |
| 127456931 | 12745693 | 2 | Immunosuppressant drug therapy |
| 127456931 | 12745693 | 3 | Immunosuppressant drug therapy |
| 127456931 | 12745693 | 4 | Evidence based treatment |
| 127456931 | 12745693 | 5 | Immunosuppressant drug therapy |
| 127456931 | 12745693 | 7 | Immunosuppression |
| 127456931 | 12745693 | 9 | Prophylaxis |
| 127456931 | 12745693 | 10 | Prophylaxis |
| 127456931 | 12745693 | 11 | Prophylaxis |
| 127456931 | 12745693 | 12 | Whipple's disease |
| 127456931 | 12745693 | 13 | Antibiotic therapy |
| 127456931 | 12745693 | 14 | Antibiotic therapy |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127456931 | 12745693 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127456931 | 12745693 | Graft versus host disease | |
| 127456931 | 12745693 | Graft versus host disease in gastrointestinal tract | |
| 127456931 | 12745693 | Graft versus host disease in skin | |
| 127456931 | 12745693 | Whipple's disease |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |