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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125662101 | 12566210 | 1 | I | 201605 | 20160705 | 20160718 | 20160718 | EXP | FR-ASTELLAS-2016US026042 | ASTELLAS | 75.39 | YR | M | Y | 0.00000 | 20160718 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125662101 | 12566210 | 1 | PS | Advagraf | TACROLIMUS | 1 | Oral | U | 204096 | 1 | MG | MODIFIED-RELEASE CAPSULE, HARD | TID | ||||||
| 125662101 | 12566210 | 2 | SS | CERTICAN | EVEROLIMUS | 1 | Oral | 0.5 MG, TWICE DAILY | U | 0 | .5 | MG | FORMULATION UNKNOWN | BID | |||||
| 125662101 | 12566210 | 3 | SS | MYFORTIC | MYCOPHENOLATE SODIUM | 1 | Oral | 0 | 360 | MG | FORMULATION UNKNOWN | BID | |||||||
| 125662101 | 12566210 | 4 | SS | CORTANCYL | PREDNISONE | 1 | Oral | U | 0 | 5 | MG | FORMULATION UNKNOWN | QD | ||||||
| 125662101 | 12566210 | 5 | C | KARDEGIC | ASPIRIN LYSINE | 1 | Oral | U | 0 | 75 | MG | FORMULATION UNKNOWN | QD | ||||||
| 125662101 | 12566210 | 6 | C | INEXIUM /01479302/ | ESOMEPRAZOLE MAGNESIUM | 1 | Oral | U | 0 | 20 | MG | FORMULATION UNKNOWN | QD | ||||||
| 125662101 | 12566210 | 7 | C | CARDENSIEL | BISOPROLOL FUMARATE | 1 | Oral | U | 0 | 2.5 | MG | FORMULATION UNKNOWN | QD | ||||||
| 125662101 | 12566210 | 8 | C | ACTONEL | RISEDRONATE SODIUM | 1 | Oral | 35 MG, PER WEEK | U | 0 | 35 | MG | FORMULATION UNKNOWN | /wk | |||||
| 125662101 | 12566210 | 9 | C | UVEDOSE | CHOLECALCIFEROL | 1 | Oral | 100000 IU, TWICE A MONTH | U | 0 | 100000 | IU | FORMULATION UNKNOWN |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125662101 | 12566210 | 1 | Renal transplant |
| 125662101 | 12566210 | 2 | Renal transplant |
| 125662101 | 12566210 | 3 | Product used for unknown indication |
| 125662101 | 12566210 | 4 | Renal transplant |
| 125662101 | 12566210 | 5 | Product used for unknown indication |
| 125662101 | 12566210 | 6 | Product used for unknown indication |
| 125662101 | 12566210 | 7 | Product used for unknown indication |
| 125662101 | 12566210 | 8 | Product used for unknown indication |
| 125662101 | 12566210 | 9 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125662101 | 12566210 | OT |
| 125662101 | 12566210 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125662101 | 12566210 | Brain abscess | |
| 125662101 | 12566210 | Cerebral artery embolism | |
| 125662101 | 12566210 | Endocarditis | |
| 125662101 | 12566210 | Fall | |
| 125662101 | 12566210 | Head injury | |
| 125662101 | 12566210 | Inappropriate schedule of drug administration | |
| 125662101 | 12566210 | Loss of consciousness | |
| 125662101 | 12566210 | Malaise | |
| 125662101 | 12566210 | Subdural haematoma |
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 |
|---|---|---|---|---|---|---|
| 125662101 | 12566210 | 2 | 20160513 | 0 | ||
| 125662101 | 12566210 | 3 | 20160513 | 0 | ||
| 125662101 | 12566210 | 5 | 20160525 | 0 |