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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125788101 | 12578810 | 1 | I | 20090820 | 20151228 | 20160721 | 20160721 | EXP | US-STRIDES ARCOLAB LIMITED-2015SP002534 | STRIDES | CHON WJ, KADAMBI PV, XU C, BECKER YT, WITKOWSKI P, PURSELL K, KANE B, JOSEPHSONA MA. USE OF LEFLUNOMIDE IN RENAL TRANSPLANT RECIPIENTS WITH GANCICLOVIR RESISTANT/REFRACTORY CYTOMEGALOVIRUS INFECTION: A CASE SERIES FROM THE UNIVERSITY OF CHICAGO.. CASE REPORTS IN NEPHROLOGY AND DIALYSIS. 2015;5(1):96-105 | 0.00 | Y | 0.00000 | 20160721 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125788101 | 12578810 | 1 | PS | MYCOPHENOLATE MOFETIL. | MYCOPHENOLATE MOFETIL | 1 | UNK | U | U | 90055 | |||||||||
| 125788101 | 12578810 | 2 | SS | TACROLIMUS. | TACROLIMUS | 1 | UNK | U | U | 0 | |||||||||
| 125788101 | 12578810 | 3 | SS | PREDNISOLONE. | PREDNISOLONE | 1 | UNK | U | U | 0 | |||||||||
| 125788101 | 12578810 | 4 | SS | DACLIZUMAB | DACLIZUMAB | 1 | UNK | 0 | |||||||||||
| 125788101 | 12578810 | 5 | C | VALGANCICLOVIR. | VALGANCICLOVIR | 1 | Oral | UNK | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125788101 | 12578810 | 1 | Immunosuppression |
| 125788101 | 12578810 | 2 | Immunosuppression |
| 125788101 | 12578810 | 3 | Immunosuppression |
| 125788101 | 12578810 | 4 | Immunosuppression |
| 125788101 | 12578810 | 5 | Antiviral prophylaxis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125788101 | 12578810 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125788101 | 12578810 | Cytomegalovirus viraemia | |
| 125788101 | 12578810 | Diarrhoea | |
| 125788101 | 12578810 | Malaise |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |