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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125501593 | 12550159 | 3 | F | 2011 | 20160728 | 20160712 | 20160802 | EXP | JP-ELI_LILLY_AND_COMPANY-JP201607002080 | ELI LILLY AND CO | 68.00 | YR | M | Y | 0.00000 | 20160801 | CN | JP | JP |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125501593 | 12550159 | 1 | PS | GEMZAR | GEMCITABINE HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | UNK | Y | U | 20509 | INJECTION | |||||||
| 125501593 | 12550159 | 2 | C | GEMCITABINE | GEMCITABINEGEMCITABINE HYDROCHLORIDE | 1 | Unknown | UNK | U | 0 | |||||||||
| 125501593 | 12550159 | 3 | C | TS-1 | GIMERACILOTERACILTEGAFUR | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125501593 | 12550159 | 1 | Pancreatic carcinoma |
| 125501593 | 12550159 | 2 | Pancreatic carcinoma |
| 125501593 | 12550159 | 3 | Pancreatic carcinoma |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125501593 | 12550159 | DE |
| 125501593 | 12550159 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125501593 | 12550159 | Anaemia | |
| 125501593 | 12550159 | Ascites | |
| 125501593 | 12550159 | Cholecystitis | |
| 125501593 | 12550159 | Cholelithiasis obstructive | |
| 125501593 | 12550159 | Malaise | |
| 125501593 | 12550159 | Metastases to lymph nodes |
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 |
|---|---|---|---|---|---|---|
| 125501593 | 12550159 | 1 | 2011 | 2011 | 0 | |
| 125501593 | 12550159 | 2 | 2012 | 0 |