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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123985223 | 12398522 | 3 | F | 20151202 | 20160915 | 20160524 | 20160922 | EXP | FR-ASTELLAS-2016US013803 | ASTELLAS | 74.00 | YR | M | Y | 0.00000 | 20160922 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123985223 | 12398522 | 1 | PS | TACROLIMUS. | TACROLIMUS | 1 | Oral | STARTED 1MG, CHANGED TO 1.5 MG AND 2 MG, ONCE DAILY (DURING MEAL) | Y | 204096 | MODIFIED-RELEASE CAPSULE, HARD | QD | |||||||
| 123985223 | 12398522 | 2 | I | TACROLIMUS. | TACROLIMUS | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | D | 204096 | MODIFIED-RELEASE CAPSULE, HARD | ||||||||
| 123985223 | 12398522 | 3 | I | Mecir LP | TAMSULOSIN HYDROCHLORIDE | 1 | Oral | 0.4 MG, ONCE DAILY | 0 | .4 | MG | FORMULATION UNKNOWN | QD | ||||||
| 123985223 | 12398522 | 4 | C | Atorvastatin | ATORVASTATIN | 1 | Oral | D | U | 0 | 10 | MG | FORMULATION UNKNOWN | QD | |||||
| 123985223 | 12398522 | 5 | C | ATACAND | CANDESARTAN CILEXETIL | 1 | Unknown | D | U | 0 | 8 | MG | FORMULATION UNKNOWN | QD | |||||
| 123985223 | 12398522 | 6 | C | NEBIVOLOL. | NEBIVOLOL | 1 | Oral | D | U | 0 | 2.5 | MG | FORMULATION UNKNOWN | QD | |||||
| 123985223 | 12398522 | 7 | C | REPAGLINIDE. | REPAGLINIDE | 1 | Unknown | D | U | 0 | 11 | MG | FORMULATION UNKNOWN | QD | |||||
| 123985223 | 12398522 | 8 | C | LASILIX /00032601/ | FUROSEMIDE | 1 | Oral | D | U | 0 | 20 | MG | FORMULATION UNKNOWN | QD | |||||
| 123985223 | 12398522 | 9 | C | LASILIX /00032601/ | FUROSEMIDE | 1 | Unknown | D | U | 0 | 40 | MG | FORMULATION UNKNOWN | QD | |||||
| 123985223 | 12398522 | 10 | C | KARDEGIC | ASPIRIN LYSINE | 1 | Oral | D | U | 0 | 75 | MG | FORMULATION UNKNOWN | QD | |||||
| 123985223 | 12398522 | 11 | C | NOVONORM | REPAGLINIDE | 1 | Oral | 808 | MG | D | U | 0 | 4 | MG | FORMULATION UNKNOWN | BID | |||
| 123985223 | 12398522 | 12 | C | NOVONORM | REPAGLINIDE | 1 | Oral | 808 | MG | D | U | 0 | 11 | MG | FORMULATION UNKNOWN | QD | |||
| 123985223 | 12398522 | 13 | C | SPECIAFOLDINE | FOLIC ACID | 1 | Oral | D | U | 0 | 5 | MG | FORMULATION UNKNOWN | QD | |||||
| 123985223 | 12398522 | 14 | C | CELLCEPT | MYCOPHENOLATE MOFETILMYCOPHENOLATE MOFETIL HYDROCHLORIDE | 1 | Oral | D | U | 0 | 500 | MG | FORMULATION UNKNOWN | BID | |||||
| 123985223 | 12398522 | 15 | C | CANDESARTAN | CANDESARTAN | 1 | Oral | 980 | MG | D | U | 0 | 10 | MG | FORMULATION UNKNOWN | QD | |||
| 123985223 | 12398522 | 16 | C | TARDYFERON | FERROUS SULFATE | 1 | Oral | D | U | 0 | 80 | MG | FORMULATION UNKNOWN | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123985223 | 12398522 | 1 | Prophylaxis against transplant rejection |
| 123985223 | 12398522 | 2 | Renal transplant |
| 123985223 | 12398522 | 3 | Benign prostatic hyperplasia |
| 123985223 | 12398522 | 4 | Dyslipidaemia |
| 123985223 | 12398522 | 5 | Hypertension |
| 123985223 | 12398522 | 6 | Hypertension |
| 123985223 | 12398522 | 7 | Diabetes mellitus |
| 123985223 | 12398522 | 8 | Hypertension |
| 123985223 | 12398522 | 10 | Angiopathy |
| 123985223 | 12398522 | 11 | Diabetes mellitus |
| 123985223 | 12398522 | 13 | Folate deficiency |
| 123985223 | 12398522 | 14 | Renal transplant |
| 123985223 | 12398522 | 15 | Hypertension |
| 123985223 | 12398522 | 16 | Blood iron |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 123985223 | 12398522 | DS |
| 123985223 | 12398522 | OT |
| 123985223 | 12398522 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123985223 | 12398522 | Cognitive disorder | |
| 123985223 | 12398522 | Drug dose omission | |
| 123985223 | 12398522 | Drug interaction | |
| 123985223 | 12398522 | Transplant rejection | |
| 123985223 | 12398522 | Treatment noncompliance | |
| 123985223 | 12398522 | Vascular dementia |
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 |
|---|---|---|---|---|---|---|
| 123985223 | 12398522 | 1 | 20151104 | 20160106 | 0 | |
| 123985223 | 12398522 | 2 | 20160219 | 0 | ||
| 123985223 | 12398522 | 3 | 20151103 | 0 | ||
| 123985223 | 12398522 | 4 | 20150824 | 0 | ||
| 123985223 | 12398522 | 5 | 201511 | 201602 | 0 | |
| 123985223 | 12398522 | 6 | 20150824 | 0 | ||
| 123985223 | 12398522 | 7 | 201508 | 0 | ||
| 123985223 | 12398522 | 8 | 20150827 | 0 | ||
| 123985223 | 12398522 | 9 | 201603 | 0 | ||
| 123985223 | 12398522 | 10 | 20150824 | 0 | ||
| 123985223 | 12398522 | 11 | 20150824 | 20160219 | 0 | |
| 123985223 | 12398522 | 12 | 201508 | 0 | ||
| 123985223 | 12398522 | 13 | 20150824 | 0 | ||
| 123985223 | 12398522 | 14 | 20150810 | 0 | ||
| 123985223 | 12398522 | 15 | 20150827 | 20160219 | 0 | |
| 123985223 | 12398522 | 16 | 20150824 | 0 |