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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126338382 | 12633838 | 2 | F | 20141215 | 20160818 | 20160809 | 20160826 | EXP | DE-ASTELLAS-2014US021587 | ASTELLAS | 68.00 | YR | M | Y | 0.00000 | 20160826 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126338382 | 12633838 | 1 | PS | Erlotinib | ERLOTINIB | 1 | Oral | 100 MG, ONCE DAILY, | 4200 | MG | Y | 21743 | 100 | MG | TABLET | QD | |||
| 126338382 | 12633838 | 2 | SS | Erlotinib | ERLOTINIB | 1 | Oral | 4200 | MG | 21743 | 100 | MG | TABLET | QD | |||||
| 126338382 | 12633838 | 3 | SS | GEMCITABINE | GEMCITABINEGEMCITABINE HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | 1000 MG/M2, ONCE WEEKLY, DATE OF LAST DOSE PRIOR YO SAE 15-DEC-2014 | 7000 | MG/M2 | U | 0 | 1000 | MG/M**2 | INFUSION | /wk |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126338382 | 12633838 | 1 | Pancreatic carcinoma |
| 126338382 | 12633838 | 3 | Pancreatic carcinoma |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126338382 | 12633838 | HO |
| 126338382 | 12633838 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126338382 | 12633838 | Abdominal pain | |
| 126338382 | 12633838 | Lipase increased | |
| 126338382 | 12633838 | Pancreatitis | |
| 126338382 | 12633838 | Pyrexia |
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 |
|---|---|---|---|---|---|---|
| 126338382 | 12633838 | 1 | 20141103 | 20141214 | 0 | |
| 126338382 | 12633838 | 3 | 20141103 | 20141215 | 0 |