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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118638163 | 11863816 | 3 | F | 20150430 | 20160830 | 20151223 | 20160906 | EXP | FR-ASTELLAS-2015US047638 | ASTELLAS | 58.00 | YR | F | Y | 50.00000 | KG | 20160906 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118638163 | 11863816 | 1 | PS | TACROLIMUS. | TACROLIMUS | 1 | Unknown | 4 MG, ONCE DAILY DOSE (1 HOUR BEFORE OR 2 HOURS AFTER MEAL) | 105 | MG | 204096 | 4 | MG | MODIFIED-RELEASE CAPSULE, HARD | QD | ||||
| 118638163 | 11863816 | 2 | SS | TACROLIMUS. | TACROLIMUS | 1 | Oral | 105 | MG | 204096 | 3 | MG | MODIFIED-RELEASE CAPSULE, HARD | QD | |||||
| 118638163 | 11863816 | 3 | SS | TACROLIMUS. | TACROLIMUS | 1 | Oral | 105 | MG | U | 204096 | 3 | MG | MODIFIED-RELEASE CAPSULE, HARD | QD | ||||
| 118638163 | 11863816 | 4 | SS | TACROLIMUS. | TACROLIMUS | 1 | Oral | 105 | MG | U | 204096 | 2.5 | MG | MODIFIED-RELEASE CAPSULE, HARD | QD | ||||
| 118638163 | 11863816 | 5 | SS | TACROLIMUS. | TACROLIMUS | 1 | Oral | 105 | MG | U | 204096 | 3.5 | MG | MODIFIED-RELEASE CAPSULE, HARD | QD | ||||
| 118638163 | 11863816 | 6 | SS | TACROLIMUS. | TACROLIMUS | 1 | Oral | 105 | MG | 204096 | 3 | MG | MODIFIED-RELEASE CAPSULE, HARD | QD | |||||
| 118638163 | 11863816 | 7 | C | MYFORTIC | MYCOPHENOLATE SODIUM | 1 | Oral | U | 0 | 360 | MG | FORMULATION UNKNOWN | TID | ||||||
| 118638163 | 11863816 | 8 | C | CORTANCYL | PREDNISONE | 1 | Oral | U | 0 | 5 | MG | FORMULATION UNKNOWN | QD | ||||||
| 118638163 | 11863816 | 9 | C | ZELITREX | VALACYCLOVIR HYDROCHLORIDE | 1 | Oral | U | 0 | 1500 | MG | FORMULATION UNKNOWN | TID | ||||||
| 118638163 | 11863816 | 10 | C | INEXIUM /01479302/ | ESOMEPRAZOLE MAGNESIUM | 1 | Oral | U | 0 | 40 | MG | FORMULATION UNKNOWN | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 118638163 | 11863816 | 1 | Transplant rejection |
| 118638163 | 11863816 | 7 | Transplant rejection |
| 118638163 | 11863816 | 8 | Transplant rejection |
| 118638163 | 11863816 | 9 | Prophylaxis |
| 118638163 | 11863816 | 10 | Prophylaxis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 118638163 | 11863816 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 118638163 | 11863816 | BK virus infection | |
| 118638163 | 11863816 | Bronchitis | |
| 118638163 | 11863816 | Cytomegalovirus infection | |
| 118638163 | 11863816 | Diarrhoea | |
| 118638163 | 11863816 | Hypertension |
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 |
|---|---|---|---|---|---|---|
| 118638163 | 11863816 | 1 | 20150428 | 0 | ||
| 118638163 | 11863816 | 2 | 20150512 | 20150615 | 0 | |
| 118638163 | 11863816 | 3 | 20150616 | 20150720 | 0 | |
| 118638163 | 11863816 | 4 | 20150721 | 20151012 | 0 | |
| 118638163 | 11863816 | 5 | 20151013 | 20160215 | 0 | |
| 118638163 | 11863816 | 6 | 20160216 | 0 |