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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127071601 | 12707160 | 1 | I | 20150530 | 20160421 | 20160901 | 20160901 | EXP | FR-ASTELLAS-2016US015886 | ASTELLAS | 54.00 | YR | F | Y | 0.00000 | 20160901 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127071601 | 12707160 | 1 | PS | TACROLIMUS. | TACROLIMUS | 1 | Oral | 329 | MG | 204096 | 5 | MG | MODIFIED-RELEASE CAPSULE, HARD | QD | |||||
| 127071601 | 12707160 | 2 | SS | TACROLIMUS. | TACROLIMUS | 1 | Oral | 329 | MG | 204096 | 3 | MG | MODIFIED-RELEASE CAPSULE, HARD | QD | |||||
| 127071601 | 12707160 | 3 | SS | TACROLIMUS. | TACROLIMUS | 1 | Oral | 329 | MG | 204096 | 4 | MG | MODIFIED-RELEASE CAPSULE, HARD | QD | |||||
| 127071601 | 12707160 | 4 | SS | TACROLIMUS. | TACROLIMUS | 1 | Oral | 329 | MG | 204096 | 3 | MG | MODIFIED-RELEASE CAPSULE, HARD | QD | |||||
| 127071601 | 12707160 | 5 | SS | TACROLIMUS. | TACROLIMUS | 1 | Oral | 329 | MG | 204096 | 5 | MG | MODIFIED-RELEASE CAPSULE, HARD | QD | |||||
| 127071601 | 12707160 | 6 | SS | TACROLIMUS. | TACROLIMUS | 1 | Oral | 329 | MG | 204096 | 6 | MG | MODIFIED-RELEASE CAPSULE, HARD | QD | |||||
| 127071601 | 12707160 | 7 | SS | TACROLIMUS. | TACROLIMUS | 1 | Oral | 329 | MG | 204096 | 8 | MG | MODIFIED-RELEASE CAPSULE, HARD | QD | |||||
| 127071601 | 12707160 | 8 | SS | TACROLIMUS. | TACROLIMUS | 1 | Oral | 329 | MG | 204096 | 9 | MG | MODIFIED-RELEASE CAPSULE, HARD | QD | |||||
| 127071601 | 12707160 | 9 | SS | TACROLIMUS. | TACROLIMUS | 1 | Oral | 329 | MG | 204096 | 11 | MG | MODIFIED-RELEASE CAPSULE, HARD | QD | |||||
| 127071601 | 12707160 | 10 | SS | TACROLIMUS. | TACROLIMUS | 1 | Oral | 329 | MG | 204096 | 10 | MG | MODIFIED-RELEASE CAPSULE, HARD | QD | |||||
| 127071601 | 12707160 | 11 | SS | CELLCEPT | MYCOPHENOLATE MOFETILMYCOPHENOLATE MOFETIL HYDROCHLORIDE | 1 | Oral | 0 | 1500 | MG | FORMULATION UNKNOWN | QD | |||||||
| 127071601 | 12707160 | 12 | SS | CELLCEPT | MYCOPHENOLATE MOFETILMYCOPHENOLATE MOFETIL HYDROCHLORIDE | 1 | Oral | U | 0 | 750 | MG | FORMULATION UNKNOWN | BID | ||||||
| 127071601 | 12707160 | 13 | SS | CELLCEPT | MYCOPHENOLATE MOFETILMYCOPHENOLATE MOFETIL HYDROCHLORIDE | 1 | Oral | U | 0 | 1000 | MG | FORMULATION UNKNOWN | QD | ||||||
| 127071601 | 12707160 | 14 | SS | CORTANCYL | PREDNISONE | 1 | Oral | U | 0 | 10 | MG | FORMULATION UNKNOWN | QD | ||||||
| 127071601 | 12707160 | 15 | C | TAHOR | ATORVASTATIN CALCIUM | 1 | Unknown | U | 0 | 10 | MG | FORMULATION UNKNOWN | QD | ||||||
| 127071601 | 12707160 | 16 | C | PERINDOPRIL | PERINDOPRIL | 1 | Unknown | U | 0 | 4 | MG | FORMULATION UNKNOWN | QD | ||||||
| 127071601 | 12707160 | 17 | C | AMLODIPINE | AMLODIPINE BESYLATE | 1 | Unknown | U | 0 | 5 | MG | FORMULATION UNKNOWN | QD | ||||||
| 127071601 | 12707160 | 18 | C | EUPRESSYL /00631801/ | URAPIDIL | 1 | Unknown | U | 0 | 60 | MG | FORMULATION UNKNOWN | QD | ||||||
| 127071601 | 12707160 | 19 | C | BISOPROLOL | BISOPROLOL | 1 | Unknown | U | 0 | 1.25 | MG | FORMULATION UNKNOWN | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127071601 | 12707160 | 1 | Renal transplant |
| 127071601 | 12707160 | 2 | Immunosuppressant drug therapy |
| 127071601 | 12707160 | 11 | Immunosuppressant drug therapy |
| 127071601 | 12707160 | 14 | Immunosuppressant drug therapy |
| 127071601 | 12707160 | 15 | Dyslipidaemia |
| 127071601 | 12707160 | 16 | Hypertension |
| 127071601 | 12707160 | 17 | Hypertension |
| 127071601 | 12707160 | 18 | Hypertension |
| 127071601 | 12707160 | 19 | Hypertension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127071601 | 12707160 | OT |
| 127071601 | 12707160 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127071601 | 12707160 | Anaemia | |
| 127071601 | 12707160 | Blood disorder | |
| 127071601 | 12707160 | Diabetes mellitus | |
| 127071601 | 12707160 | Hypertension | |
| 127071601 | 12707160 | Pyelonephritis acute |
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 |
|---|---|---|---|---|---|---|
| 127071601 | 12707160 | 1 | 20150310 | 20150408 | 0 | |
| 127071601 | 12707160 | 2 | 20150409 | 20150507 | 0 | |
| 127071601 | 12707160 | 3 | 20150508 | 20150531 | 0 | |
| 127071601 | 12707160 | 4 | 20150601 | 20150607 | 0 | |
| 127071601 | 12707160 | 5 | 20150608 | 20150729 | 0 | |
| 127071601 | 12707160 | 6 | 20150730 | 20151218 | 0 | |
| 127071601 | 12707160 | 7 | 20151219 | 20160112 | 0 | |
| 127071601 | 12707160 | 8 | 20160113 | 20160302 | 0 | |
| 127071601 | 12707160 | 9 | 20160303 | 20160316 | 0 | |
| 127071601 | 12707160 | 10 | 20160317 | 0 | ||
| 127071601 | 12707160 | 11 | 201502 | 0 | ||
| 127071601 | 12707160 | 12 | 20150310 | 201506 | 0 | |
| 127071601 | 12707160 | 13 | 201506 | 0 | ||
| 127071601 | 12707160 | 14 | 20150310 | 201506 | 0 | |
| 127071601 | 12707160 | 15 | 201412 | 0 | ||
| 127071601 | 12707160 | 16 | 201501 | 201506 | 0 | |
| 127071601 | 12707160 | 17 | 201503 | 201508 | 0 | |
| 127071601 | 12707160 | 18 | 201508 | 0 | ||
| 127071601 | 12707160 | 19 | 201507 | 0 |