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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125841261 | 12584126 | 1 | I | 201512 | 20160715 | 20160722 | 20160722 | EXP | FR-ASTELLAS-2016US027588 | ASTELLAS | 58.92 | YR | M | Y | 0.00000 | 20160722 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125841261 | 12584126 | 1 | PS | Advagraf | TACROLIMUS | 1 | Oral | Y | 204096 | 16 | MG | MODIFIED-RELEASE CAPSULE, HARD | QD | ||||||
| 125841261 | 12584126 | 2 | SS | CORTANCYL | PREDNISONE | 1 | Oral | Y | 0 | 4 | MG | FORMULATION UNKNOWN | QD | ||||||
| 125841261 | 12584126 | 3 | SS | CELLCEPT | MYCOPHENOLATE MOFETILMYCOPHENOLATE MOFETIL HYDROCHLORIDE | 1 | Oral | 1000 MG (2 DF), ONCE DAILY | Y | 0 | 1000 | MG | FORMULATION UNKNOWN | QD | |||||
| 125841261 | 12584126 | 4 | C | AMLOR | AMLODIPINE BESYLATE | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 125841261 | 12584126 | 5 | C | APROVEL | IRBESARTAN | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 125841261 | 12584126 | 6 | C | LANTUS | INSULIN GLARGINE | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125841261 | 12584126 | 1 | Renal transplant |
| 125841261 | 12584126 | 2 | Renal transplant |
| 125841261 | 12584126 | 3 | Renal transplant |
| 125841261 | 12584126 | 4 | Hypertension |
| 125841261 | 12584126 | 5 | Hypertension |
| 125841261 | 12584126 | 6 | Type 1 diabetes mellitus |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125841261 | 12584126 | HO |
| 125841261 | 12584126 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125841261 | 12584126 | Abdominal wall abscess | |
| 125841261 | 12584126 | Abscess | |
| 125841261 | 12584126 | Chronic granulomatous disease | |
| 125841261 | 12584126 | Diarrhoea | |
| 125841261 | 12584126 | Escherichia pyelonephritis | |
| 125841261 | 12584126 | Inflammation | |
| 125841261 | 12584126 | Malacoplakia gastrointestinal | |
| 125841261 | 12584126 | Sepsis | |
| 125841261 | 12584126 | Tubulointerstitial nephritis |
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 |
|---|---|---|---|---|---|---|
| 125841261 | 12584126 | 1 | 20160106 | 0 | ||
| 125841261 | 12584126 | 2 | 20160301 | 0 | ||
| 125841261 | 12584126 | 3 | 20160106 | 0 |