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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 86772653 | 8677265 | 3 | F | 20110927 | 20160706 | 20120723 | 20160721 | EXP | US-ASTELLAS-2011US006349 | ASTELLAS | 62.00 | YR | F | Y | 0.00000 | 20160721 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 86772653 | 8677265 | 1 | PS | Erlotinib | ERLOTINIB | 1 | Oral | 21743 | 75 | MG | TABLET | QD | |||||||
| 86772653 | 8677265 | 2 | SS | Erlotinib | ERLOTINIB | 1 | Oral | 21743 | 75 | MG | TABLET | QD | |||||||
| 86772653 | 8677265 | 3 | SS | Erlotinib | ERLOTINIB | 1 | Oral | 21743 | 2100 | MG | TABLET | QD | |||||||
| 86772653 | 8677265 | 4 | SS | Erlotinib | ERLOTINIB | 1 | Oral | 21743 | 2100 | MG | TABLET | QD | |||||||
| 86772653 | 8677265 | 5 | SS | Erlotinib | ERLOTINIB | 1 | Oral | 21743 | 1500 | MG | TABLET | QD | |||||||
| 86772653 | 8677265 | 6 | SS | Erlotinib | ERLOTINIB | 1 | Oral | 21743 | 2100 | MG | TABLET | QD | |||||||
| 86772653 | 8677265 | 7 | SS | Erlotinib | ERLOTINIB | 1 | Oral | 21743 | 1575 | MG | TABLET | QD | |||||||
| 86772653 | 8677265 | 8 | SS | Erlotinib | ERLOTINIB | 1 | Oral | 21743 | 2100 | MG | TABLET | QD | |||||||
| 86772653 | 8677265 | 9 | SS | Erlotinib | ERLOTINIB | 1 | Oral | 21743 | 975 | MG | TABLET | QD | |||||||
| 86772653 | 8677265 | 10 | SS | Erlotinib | ERLOTINIB | 1 | Oral | U | 21743 | 2100 | MG | TABLET | QD | ||||||
| 86772653 | 8677265 | 11 | SS | GEMCITABINE | GEMCITABINEGEMCITABINE HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | 600 MG/M2, CYCLIC (DAY 1, 8, 15 OF 28 DAY CYCLE) | Y | 0 | 600 | MG/M**2 | FORMULATION UNKNOWN | ||||||
| 86772653 | 8677265 | 12 | SS | GEMCITABINE | GEMCITABINEGEMCITABINE HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | 600 MG/M2, CYCLIC (DAY 1, 8, 15) | U | 0 | 600 | MG/M**2 | FORMULATION UNKNOWN | ||||||
| 86772653 | 8677265 | 13 | SS | VISMODEGIB | VISMODEGIB | 1 | Oral | 0 | 150 | MG | CAPSULE | QD | |||||||
| 86772653 | 8677265 | 14 | SS | VISMODEGIB | VISMODEGIB | 1 | Oral | 0 | 150 | MG | CAPSULE | QD | |||||||
| 86772653 | 8677265 | 15 | SS | VISMODEGIB | VISMODEGIB | 1 | Oral | 0 | 4200 | MG | CAPSULE | QD | |||||||
| 86772653 | 8677265 | 16 | SS | VISMODEGIB | VISMODEGIB | 1 | Oral | 0 | 4200 | MG | CAPSULE | QD | |||||||
| 86772653 | 8677265 | 17 | SS | VISMODEGIB | VISMODEGIB | 1 | Oral | 0 | 3000 | MG | CAPSULE | QD | |||||||
| 86772653 | 8677265 | 18 | SS | VISMODEGIB | VISMODEGIB | 1 | Oral | 0 | 3300 | MG | CAPSULE | QD | |||||||
| 86772653 | 8677265 | 19 | SS | VISMODEGIB | VISMODEGIB | 1 | Oral | U | 0 | 4200 | MG | CAPSULE | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 86772653 | 8677265 | 1 | Cholangiocarcinoma |
| 86772653 | 8677265 | 11 | Cholangiocarcinoma |
| 86772653 | 8677265 | 13 | Cholangiocarcinoma |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 86772653 | 8677265 | HO |
| 86772653 | 8677265 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 86772653 | 8677265 | Abdominal pain | |
| 86772653 | 8677265 | Alanine aminotransferase increased | |
| 86772653 | 8677265 | Aspartate aminotransferase increased | |
| 86772653 | 8677265 | Bile duct obstruction | |
| 86772653 | 8677265 | Bile duct stenosis | |
| 86772653 | 8677265 | Bilirubin conjugated increased | |
| 86772653 | 8677265 | Blood alkaline phosphatase increased | |
| 86772653 | 8677265 | Blood bilirubin increased | |
| 86772653 | 8677265 | Cholangitis | |
| 86772653 | 8677265 | Device occlusion | |
| 86772653 | 8677265 | Duodenal stenosis | |
| 86772653 | 8677265 | Hypophosphataemia | |
| 86772653 | 8677265 | Neutrophil count decreased | |
| 86772653 | 8677265 | Off label use | |
| 86772653 | 8677265 | Pain | |
| 86772653 | 8677265 | 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 |
|---|---|---|---|---|---|---|
| 86772653 | 8677265 | 1 | 20110722 | 20110927 | 0 | |
| 86772653 | 8677265 | 2 | 20111006 | 20120710 | 0 | |
| 86772653 | 8677265 | 3 | 20111014 | 0 | ||
| 86772653 | 8677265 | 4 | 20110722 | 0 | ||
| 86772653 | 8677265 | 5 | 20110916 | 0 | ||
| 86772653 | 8677265 | 6 | 20111014 | 0 | ||
| 86772653 | 8677265 | 7 | 20120406 | 0 | ||
| 86772653 | 8677265 | 8 | 20120504 | 0 | ||
| 86772653 | 8677265 | 9 | 20120629 | 0 | ||
| 86772653 | 8677265 | 10 | 20120727 | 20120824 | 0 | |
| 86772653 | 8677265 | 11 | 20110722 | 20110923 | 0 | |
| 86772653 | 8677265 | 12 | 20111006 | 20120706 | 0 | |
| 86772653 | 8677265 | 13 | 20110722 | 20110927 | 0 | |
| 86772653 | 8677265 | 14 | 20111006 | 20120711 | 0 | |
| 86772653 | 8677265 | 15 | 20111014 | 0 | ||
| 86772653 | 8677265 | 16 | 20110722 | 0 | ||
| 86772653 | 8677265 | 17 | 20110916 | 0 | ||
| 86772653 | 8677265 | 18 | 20120406 | 0 | ||
| 86772653 | 8677265 | 19 | 20120504 | 20120824 | 0 |