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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125550471 | 12555047 | 1 | I | 20150530 | 20150615 | 20160714 | 20160714 | EXP | IN-ROCHE-1793816 | ROCHE | 40.00 | YR | M | Y | 0.00000 | 20160714 | CN | IN | IN |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125550471 | 12555047 | 1 | PS | CELLCEPT | MYCOPHENOLATE MOFETILMYCOPHENOLATE MOFETIL HYDROCHLORIDE | 1 | Oral | 500MG, TWO TIMES A DAY | 50723 | 500 | MG | TABLET | BID | ||||||
| 125550471 | 12555047 | 2 | C | PANGRAF | TACROLIMUS | 1 | Oral | 3-2.5 MG | 0 | ||||||||||
| 125550471 | 12555047 | 3 | C | RANTAC | RANITIDINE HYDROCHLORIDE | 1 | Oral | 150MG, TWO TIMES A DAY | 0 | 150 | MG | BID | |||||||
| 125550471 | 12555047 | 4 | C | FLUCONAZOLE. | FLUCONAZOLE | 1 | Oral | 50MG, ONCE A DAY | 0 | 50 | MG | QD | |||||||
| 125550471 | 12555047 | 5 | C | WYSOLONE | PREDNISOLONE | 1 | Oral | 20MG, ONCE A DAY | 0 | 20 | MG | QD | |||||||
| 125550471 | 12555047 | 6 | C | SEPTRAN (INDIA) | 2 | Oral | 0 | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125550471 | 12555047 | 1 | Prophylaxis against transplant rejection |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125550471 | 12555047 | OT |
| 125550471 | 12555047 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125550471 | 12555047 | Immunosuppressant drug level increased | |
| 125550471 | 12555047 | Infection | |
| 125550471 | 12555047 | Myocardial infarction |
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 |
|---|---|---|---|---|---|---|
| 125550471 | 12555047 | 1 | 20150319 | 0 | ||
| 125550471 | 12555047 | 2 | 20150319 | 0 | ||
| 125550471 | 12555047 | 3 | 20150319 | 0 | ||
| 125550471 | 12555047 | 4 | 20150319 | 0 | ||
| 125550471 | 12555047 | 5 | 20150319 | 0 | ||
| 125550471 | 12555047 | 6 | 20150319 | 0 |