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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125558361 | 12555836 | 1 | I | 20140609 | 20160714 | 20160714 | EXP | IT-CIPLA LTD.-2014IT00546 | CIPLA | AGLIETTA M, BARONE C, SAWYER MB, MOORE MJ, MILLER WH JR, BAGALA C ET AL.,. A PHASE I DOSE-ESCALATION TRIAL OF TREMELIMUMAB (CP-675,206) IN COMBINATION WITH GEMCITABINE IN CHEMOTHERAPY-NAIVE PATIENTS WITH METASTATIC PANCREATIC CANCER. ANNALS OF ONCOLOGY. 2014;25 (9):1750 TO 1755 | 0.00 | Y | 0.00000 | 20160714 | OT | IT | IT |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125558361 | 12555836 | 1 | PS | GEMCITABINE | GEMCITABINEGEMCITABINE HYDROCHLORIDE | 1 | Unknown | 1000 MG/M2 ON DAYS 1, 8, AND 15 OF EACH 28-DAY CYCLES | U | U | 0 | 1000 | MG/M**2 | ||||||
| 125558361 | 12555836 | 2 | SS | Tremelimumab | TREMELIMUMAB | 1 | Intravenous (not otherwise specified) | 10 MG/KG, ON DAY 1 OF EACH 84 | U | U | 0 | 10 | MG/KG | INFUSION |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125558361 | 12555836 | 1 | Pancreatic carcinoma metastatic |
| 125558361 | 12555836 | 2 | Pancreatic carcinoma metastatic |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125558361 | 12555836 | DE |
| 125558361 | 12555836 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125558361 | 12555836 | Dehydration | |
| 125558361 | 12555836 | Diarrhoea |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |