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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
127170511 | 12717051 | 1 | I | 20160223 | 20160830 | 20160906 | 20160906 | EXP | CO-ASTELLAS-2016US034224 | ASTELLAS | 30.27 | YR | M | Y | 59.00000 | KG | 20160906 | CN | US | CO |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
127170511 | 12717051 | 1 | PS | TACROLIMUS. | TACROLIMUS | 1 | Oral | 5967 | MG | Y | 204096 | 13 | MG | MODIFIED-RELEASE CAPSULE, HARD | QD | ||||
127170511 | 12717051 | 2 | SS | TACROLIMUS. | TACROLIMUS | 1 | Oral | 5967 | MG | U | 204096 | 8 | MG | MODIFIED-RELEASE CAPSULE, HARD | QD | ||||
127170511 | 12717051 | 3 | SS | TACROLIMUS. | TACROLIMUS | 1 | Oral | 5967 | MG | 204096 | 9 | MG | MODIFIED-RELEASE CAPSULE, HARD | QD |
Indications of drugs used
Event ID | CASEID | INDI DRUG SEQ | INDI PT |
---|---|---|---|
127170511 | 12717051 | 1 | Renal transplant |
Outcome of event
Event ID | CASEID | OUTC COD |
---|---|---|
127170511 | 12717051 | HO |
127170511 | 12717051 | OT |
Reactions reported
Event ID | CASEID | DRUG REC ACT | PT |
---|---|---|---|
127170511 | 12717051 | Generalised oedema | |
127170511 | 12717051 | Immunosuppressant drug level increased | |
127170511 | 12717051 | Kidney transplant rejection |
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 |
---|---|---|---|---|---|---|
127170511 | 12717051 | 1 | 20141122 | 20160224 | 0 | |
127170511 | 12717051 | 2 | 20160225 | 0 |