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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 115387923 | 11538792 | 3 | F | 20160822 | 20150923 | 20160829 | EXP | JP-ROCHE-1636076 | ROCHE | , SHINODA K, TAMAKI S, KONO H, ASANUMA H, NAKAGAWA K AND OYA M SUCCESSFUL LOW-DOSE LEFLUNOMIDE TREATMENT FOR GANCICLOVIR-RESISTANT CYTOMEGALOVIRUS INFECTION WITH HIGH-LEVEL ANTIGENEMIA IN A KIDNEY TRANSPLANT: A CASE REPORT AND LITERATURE REVIEW. JOURNAL OF CLINICAL VIROLOGY: THE OFFICIAL PUBLICATION OF THE PAN AMERICAN SOCIETY FOR CLINICAL VIROLOGY 2016;82:133-138. | 52.00 | YR | F | Y | 0.00000 | 20160829 | MD | JP | JP |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 115387923 | 11538792 | 1 | PS | CELLCEPT | MYCOPHENOLATE MOFETILMYCOPHENOLATE MOFETIL HYDROCHLORIDE | 1 | Oral | 50722 | CAPSULE | ||||||||||
| 115387923 | 11538792 | 2 | SS | CELLCEPT | MYCOPHENOLATE MOFETILMYCOPHENOLATE MOFETIL HYDROCHLORIDE | 1 | Oral | 50722 | CAPSULE | ||||||||||
| 115387923 | 11538792 | 3 | SS | CELLCEPT | MYCOPHENOLATE MOFETILMYCOPHENOLATE MOFETIL HYDROCHLORIDE | 1 | Oral | 50722 | CAPSULE | ||||||||||
| 115387923 | 11538792 | 4 | SS | GANCICLOVIR. | GANCICLOVIR | 1 | Unknown | U | 19661 | ||||||||||
| 115387923 | 11538792 | 5 | SS | GANCICLOVIR. | GANCICLOVIR | 1 | Unknown | U | 19661 | ||||||||||
| 115387923 | 11538792 | 6 | SS | EVEROLIMUS | EVEROLIMUS | 1 | Unknown | U | 0 | ||||||||||
| 115387923 | 11538792 | 7 | SS | TACROLIMUS HYDRATE | TACROLIMUS | 1 | Unknown | DOSAGE IS UNCERTAIN. | 0 | ||||||||||
| 115387923 | 11538792 | 8 | SS | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | Unknown | U | 0 | ||||||||||
| 115387923 | 11538792 | 9 | SS | BASILIXIMAB | BASILIXIMAB | 1 | Unknown | DOSAGE IS UNCERTAIN. | U | 0 | |||||||||
| 115387923 | 11538792 | 10 | SS | CYCLOSPORINE. | CYCLOSPORINE | 1 | Unknown | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 115387923 | 11538792 | 1 | Prophylaxis against transplant rejection |
| 115387923 | 11538792 | 4 | Cytomegalovirus infection |
| 115387923 | 11538792 | 6 | Prophylaxis against transplant rejection |
| 115387923 | 11538792 | 7 | Prophylaxis against transplant rejection |
| 115387923 | 11538792 | 8 | Prophylaxis against transplant rejection |
| 115387923 | 11538792 | 9 | Prophylaxis against transplant rejection |
| 115387923 | 11538792 | 10 | Prophylaxis against transplant rejection |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 115387923 | 11538792 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 115387923 | 11538792 | Cytomegalovirus infection | |
| 115387923 | 11538792 | Pathogen resistance | |
| 115387923 | 11538792 | Renal impairment |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |