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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127885001 | 12788500 | 1 | I | 2012 | 20160921 | 20160928 | 20160928 | EXP | DE-ASTELLAS-2016US037647 | ASTELLAS | 0.00 | F | Y | 0.00000 | 20160928 | CN | GB | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127885001 | 12788500 | 1 | PS | TARCEVA | ERLOTINIB HYDROCHLORIDE | 1 | Unknown | Y | 21743 | 100 | MG | FORMULATION UNKNOWN | |||||||
| 127885001 | 12788500 | 2 | SS | TARCEVA | ERLOTINIB HYDROCHLORIDE | 1 | Unknown | Y | 21743 | 100 | MG | FORMULATION UNKNOWN | |||||||
| 127885001 | 12788500 | 3 | SS | GEMCITABINE | GEMCITABINEGEMCITABINE HYDROCHLORIDE | 1 | Unknown | 750 MG/M2, DAY 1, 7, AND 14 OF 28 DAY CYCLE | Y | 0 | 750 | MG/M**2 | FORMULATION UNKNOWN | ||||||
| 127885001 | 12788500 | 4 | SS | GEMCITABINE | GEMCITABINEGEMCITABINE HYDROCHLORIDE | 1 | Unknown | 750 MG/M2, DAY 1, 7, AND 14 OF 28 DAY CYCLE | Y | 0 | 750 | MG/M**2 | FORMULATION UNKNOWN |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127885001 | 12788500 | 1 | Pancreatic carcinoma |
| 127885001 | 12788500 | 3 | Pancreatic carcinoma |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127885001 | 12788500 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127885001 | 12788500 | Chronic obstructive pulmonary disease | |
| 127885001 | 12788500 | Dyspnoea | |
| 127885001 | 12788500 | General physical health deterioration | |
| 127885001 | 12788500 | Nausea | |
| 127885001 | 12788500 | Nocturia | |
| 127885001 | 12788500 | Oedema peripheral | |
| 127885001 | 12788500 | Pancreatic mass |
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 |
|---|---|---|---|---|---|---|
| 127885001 | 12788500 | 1 | 20120130 | 20120619 | 0 | |
| 127885001 | 12788500 | 2 | 201301 | 201307 | 0 | |
| 127885001 | 12788500 | 3 | 20120130 | 20120619 | 0 | |
| 127885001 | 12788500 | 4 | 201301 | 201307 | 0 |