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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122318932 | 12231893 | 2 | F | 20151027 | 20160816 | 20160401 | 20160822 | EXP | FR-ASTELLAS-2016US010572 | ASTELLAS | 64.00 | YR | M | Y | 0.00000 | 20160822 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122318932 | 12231893 | 1 | SS | TACROLIMUS. | TACROLIMUS | 1 | Unknown | 0 | 3 | MG | MODIFIED-RELEASE CAPSULE, HARD | QD | |||||||
| 122318932 | 12231893 | 2 | SS | TACROLIMUS. | TACROLIMUS | 1 | Unknown | 0 | 2 | MG | MODIFIED-RELEASE CAPSULE, HARD | QD | |||||||
| 122318932 | 12231893 | 3 | SS | TACROLIMUS. | TACROLIMUS | 1 | Unknown | 0 | 2.5 | MG | MODIFIED-RELEASE CAPSULE, HARD | QD | |||||||
| 122318932 | 12231893 | 4 | PS | PROGRAF | TACROLIMUSTACROLIMUS ANHYDROUS | 1 | Unknown | 1 MG, TWICE DAILY (1-0-1) | 50708 | 1 | MG | FORMULATION UNKNOWN | BID | ||||||
| 122318932 | 12231893 | 5 | C | NOVOMIX | INSULIN ASPART | 1 | Unknown | 32 U IN THE MORNING, 30 U AT NIGHT (TWICE DAILY) | U | 0 | 30 | IU | FORMULATION UNKNOWN | BID | |||||
| 122318932 | 12231893 | 6 | C | METFORMIN | METFORMIN HYDROCHLORIDE | 1 | Unknown | 425 MG, TWICE DAILY (1-0-1) | U | 0 | 425 | MG | FORMULATION UNKNOWN | BID | |||||
| 122318932 | 12231893 | 7 | C | CELLCEPT | MYCOPHENOLATE MOFETILMYCOPHENOLATE MOFETIL HYDROCHLORIDE | 1 | Unknown | U | 0 | 500 | MG | FORMULATION UNKNOWN | QID | ||||||
| 122318932 | 12231893 | 8 | C | CORTANCYL | PREDNISONE | 1 | Unknown | 20 MG, ONCE DAILY (1-0-0) | U | 0 | 20 | MG | FORMULATION UNKNOWN | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 122318932 | 12231893 | 1 | Liver transplant |
| 122318932 | 12231893 | 4 | Liver transplant |
| 122318932 | 12231893 | 5 | Diabetes mellitus |
| 122318932 | 12231893 | 6 | Diabetes mellitus |
| 122318932 | 12231893 | 7 | Prophylaxis against transplant rejection |
| 122318932 | 12231893 | 8 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 122318932 | 12231893 | OT |
| 122318932 | 12231893 | HO |
| 122318932 | 12231893 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 122318932 | 12231893 | Death | |
| 122318932 | 12231893 | Encephalopathy | |
| 122318932 | 12231893 | Hypertension | |
| 122318932 | 12231893 | Jaundice | |
| 122318932 | 12231893 | Overdose | |
| 122318932 | 12231893 | Renal failure | |
| 122318932 | 12231893 | Transplant rejection | |
| 122318932 | 12231893 | Underdose |
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 |
|---|---|---|---|---|---|---|
| 122318932 | 12231893 | 1 | 20150117 | 0 | ||
| 122318932 | 12231893 | 2 | 20150827 | 0 | ||
| 122318932 | 12231893 | 3 | 20151027 | 0 | ||
| 122318932 | 12231893 | 5 | 20141106 | 0 | ||
| 122318932 | 12231893 | 6 | 20141106 | 0 | ||
| 122318932 | 12231893 | 7 | 20141106 | 0 |