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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125351261 | 12535126 | 1 | I | 20160622 | 20160707 | 20160707 | EXP | US-CIPLA LTD.-2016US08455 | CIPLA | EL-KHOUEIRY AB, RAMANATHAN RK, YANG DY, ZHANG W, SHIBATA S, WRIGHT JJ ET AL.,. A RANDOMIZED PHASE II OF GEMCITABINE AND SORAFENIB VERSUS SORAFENIB ALONE IN PATIENTS WITH METASTATIC PANCREATIC CANCER. INVEST NEW DRUGS. 2012;30:1175 TO 1183 | 0.00 | Y | 0.00000 | 20160707 | CN | US | US |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125351261 | 12535126 | 1 | PS | GEMCITABINE | GEMCITABINEGEMCITABINE HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | 1000 MG/M2, AT A RATE OF 10 MG/M2/MIN, WEEKLY FOR 3 OUT OF 4 WEEKS | 78759 | 1000 | MG/M**2 | ||||||||
| 125351261 | 12535126 | 2 | SS | Sorafenib | SORAFENIB | 1 | Oral | 200 MG, BID, TWO TABLETS | 0 | 200 | MG | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125351261 | 12535126 | 1 | Pancreatic carcinoma metastatic |
| 125351261 | 12535126 | 2 | Pancreatic carcinoma metastatic |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125351261 | 12535126 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125351261 | 12535126 | Disease progression |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |