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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127609951 | 12760995 | 1 | I | 20131216 | 20160919 | 20160919 | EXP | US-ROCHE-1322162 | ROCHE | SHAH A, CHEN J AND FRIDELL J INCIDENCE AND OUTCOMES OF CYTOMEGALOVIRUS IN PANCREAS TRANSPLANTATION WITH STEROID-FREE IMMUNOSUPPRESSION. CLINICAL TRANSPLANTATION 2015;29 (12):1221-1229. | 0.00 | Y | 0.00000 | 20160920 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127609951 | 12760995 | 1 | PS | GANCICLOVIR. | GANCICLOVIR | 1 | Intravenous (not otherwise specified) | U | 19661 | POWDER FOR INFUSION | |||||||||
| 127609951 | 12760995 | 2 | SS | VALGANCICLOVIR. | VALGANCICLOVIR | 1 | Oral | 450-900 MG | U | 22257 | ORAL SOLUTION | QD | |||||||
| 127609951 | 12760995 | 3 | SS | VALGANCICLOVIR. | VALGANCICLOVIR | 1 | Oral | U | 22257 | ORAL SOLUTION | |||||||||
| 127609951 | 12760995 | 4 | SS | MYCOPHENOLATE MOFETIL. | MYCOPHENOLATE MOFETIL | 1 | Oral | U | 50722 | 500 | MG | BID | |||||||
| 127609951 | 12760995 | 5 | SS | ANTI-THYMOCYTE GLOBULIN (RABBIT) NOS | LAPINE T-LYMPHOCYTE IMMUNE GLOBULIN | 1 | Unknown | 1 MG/KG/DOSE/D FOR FIVE DOSES, | U | 0 | |||||||||
| 127609951 | 12760995 | 6 | SS | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | Intravenous (not otherwise specified) | U | 0 | 125 | MG | ||||||||
| 127609951 | 12760995 | 7 | SS | TACROLIMUS. | TACROLIMUS | 1 | Unknown | U | 0 | ||||||||||
| 127609951 | 12760995 | 8 | SS | SIROLIMUS. | SIROLIMUS | 1 | Unknown | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127609951 | 12760995 | 1 | Antiviral prophylaxis |
| 127609951 | 12760995 | 2 | Antiviral prophylaxis |
| 127609951 | 12760995 | 4 | Prophylaxis |
| 127609951 | 12760995 | 5 | Prophylaxis |
| 127609951 | 12760995 | 6 | Prophylaxis |
| 127609951 | 12760995 | 7 | Prophylaxis |
| 127609951 | 12760995 | 8 | Prophylaxis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127609951 | 12760995 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127609951 | 12760995 | Cytomegalovirus viraemia | |
| 127609951 | 12760995 | Drug resistance |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |