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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126096372 | 12609637 | 2 | F | 20160816 | 20160801 | 20160829 | EXP | FR-ACCORD-042639 | ACCORD | LEVAVASSEUR M, DARRAS S, MORTIER L, GOEMINNE C, AUFFRET M, BERTRAND M. DRUG INTERACTION BETWEEN DABRAFENIB AND IMMUNOSUPPRESSIVE DRUGS: ABOUT ONE CASE. MELANOMA RES. 2016 JUL 8. | 47.00 | YR | M | Y | 0.00000 | 20160829 | MD | FR | FR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126096372 | 12609637 | 1 | PS | TACROLIMUS. | TACROLIMUS | 1 | DECREASED TACROLIMUS 4 MG/DAY?DABRAFENIB WAS STOPPED SO DOSES OF TACROLIMUS WAS GRADUALLY DECREAS | 91195 | 5 | MG | |||||||||
| 126096372 | 12609637 | 2 | I | DABRAFENIB | DABRAFENIB | 1 | REINTRODUCE DABRAFENIB AT A FULL?DOSE AND TO INCREASE THE DOSAGE OF IMMUNOSUPPRESSANTS | 0 | 300 | MG | |||||||||
| 126096372 | 12609637 | 3 | I | EVEROLIMUS | EVEROLIMUS | 1 | DABRAFENIB WAS STOPPED SO DOSES OF EVEROLIMUS WAS GRADUALLY DECREASED.??INCREASED DOSE OF 10 MG/DA | 0 | 1.5 | MG | |||||||||
| 126096372 | 12609637 | 4 | C | PREDNISONE. | PREDNISONE | 1 | 0 | 10 | MG | ||||||||||
| 126096372 | 12609637 | 5 | C | MYCOPHENOLIC ACID. | MYCOPHENOLIC ACID | 1 | 0 | 2 | G | ||||||||||
| 126096372 | 12609637 | 6 | C | VEMURAFENIB | VEMURAFENIB | 1 | 0 | 1920 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126096372 | 12609637 | 1 | Heart transplant |
| 126096372 | 12609637 | 2 | Product used for unknown indication |
| 126096372 | 12609637 | 3 | Heart transplant |
| 126096372 | 12609637 | 4 | Heart transplant |
| 126096372 | 12609637 | 5 | Heart transplant |
| 126096372 | 12609637 | 6 | Metastatic malignant melanoma |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126096372 | 12609637 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126096372 | 12609637 | Disease progression | |
| 126096372 | 12609637 | Drug interaction |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| Event ID | CASEID | DSG DRUG SEQ | START DT | END DT | DUR | DUR COD |
|---|---|---|---|---|---|---|
| 126096372 | 12609637 | 3 | 201301 | 0 |