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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126256091 | 12625609 | 1 | I | 20110610 | 20120217 | 20160805 | 20160805 | EXP | FR-ROCHE-1041457 | ROCHE | 29.46 | YR | F | Y | 0.00000 | 20160805 | MD | FR | DE |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126256091 | 12625609 | 1 | C | PROGRAF | TACROLIMUSTACROLIMUS ANHYDROUS | 1 | Unknown | 0 | 7 | MG | QD | ||||||||
| 126256091 | 12625609 | 2 | C | CORTANCYL | PREDNISONE | 1 | Unknown | 0 | 10 | MG | TABLET | QD | |||||||
| 126256091 | 12625609 | 3 | C | CELLCEPT | MYCOPHENOLATE MOFETILMYCOPHENOLATE MOFETIL HYDROCHLORIDE | 1 | Unknown | 0 | 2000 | MG | QD | ||||||||
| 126256091 | 12625609 | 4 | C | BACTRIM | SULFAMETHOXAZOLETRIMETHOPRIM | 1 | Buccal | 0 | 400 | MG | TABLET | QD | |||||||
| 126256091 | 12625609 | 5 | PS | Rituximab | RITUXIMAB | 1 | Intravenous (not otherwise specified) | 103705 | 375 | MG/M**2 | SOLUTION FOR INFUSION |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126256091 | 12625609 | 5 | Prophylaxis against transplant rejection |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126256091 | 12625609 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126256091 | 12625609 | Acute kidney injury | |
| 126256091 | 12625609 | Diarrhoea |
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 |
|---|---|---|---|---|---|---|
| 126256091 | 12625609 | 1 | 20110323 | 0 | ||
| 126256091 | 12625609 | 2 | 20110414 | 0 | ||
| 126256091 | 12625609 | 3 | 20110426 | 0 | ||
| 126256091 | 12625609 | 4 | 20110601 | 0 | ||
| 126256091 | 12625609 | 5 | 20110418 | 20110418 | 0 |