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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125777811 | 12577781 | 1 | I | 20110927 | 20110930 | 20160721 | 20160721 | EXP | US-ROCHE-1003365 | ROCHE | 61.00 | YR | F | Y | 72.00000 | KG | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125777811 | 12577781 | 1 | PS | Vismodegib | VISMODEGIB | 1 | Oral | Y | Y | 203388 | 150 | MG | CAPSULE | QD | |||||
| 125777811 | 12577781 | 2 | SS | Vismodegib | VISMODEGIB | 1 | Oral | Y | Y | 203388 | 150 | MG | CAPSULE | QD | |||||
| 125777811 | 12577781 | 3 | SS | Vismodegib | VISMODEGIB | 1 | Oral | Y | Y | 203388 | 4200 | MG | CAPSULE | ||||||
| 125777811 | 12577781 | 4 | SS | Vismodegib | VISMODEGIB | 1 | Oral | Y | Y | 203388 | 4200 | MG | CAPSULE | ||||||
| 125777811 | 12577781 | 5 | SS | Vismodegib | VISMODEGIB | 1 | Oral | Y | Y | 203388 | 3000 | MG | CAPSULE | ||||||
| 125777811 | 12577781 | 6 | SS | Vismodegib | VISMODEGIB | 1 | Oral | Y | Y | 203388 | 3300 | MG | CAPSULE | ||||||
| 125777811 | 12577781 | 7 | SS | Vismodegib | VISMODEGIB | 1 | Oral | LAST TREATMENT DATE: 24/AUG/2012 | Y | Y | 203388 | 4200 | MG | CAPSULE | |||||
| 125777811 | 12577781 | 8 | SS | Erlotinib | ERLOTINIB | 1 | Oral | Y | Y | 53728 | 75 | MG | TABLET | QD | |||||
| 125777811 | 12577781 | 9 | SS | Erlotinib | ERLOTINIB | 1 | Oral | Y | Y | 53728 | 75 | MG | TABLET | QD | |||||
| 125777811 | 12577781 | 10 | SS | Erlotinib | ERLOTINIB | 1 | Oral | Y | Y | 53728 | 2100 | MG | TABLET | ||||||
| 125777811 | 12577781 | 11 | SS | Erlotinib | ERLOTINIB | 1 | Oral | Y | Y | 53728 | 2100 | MG | TABLET | ||||||
| 125777811 | 12577781 | 12 | SS | Erlotinib | ERLOTINIB | 1 | Oral | Y | Y | 53728 | 1500 | MG | TABLET | ||||||
| 125777811 | 12577781 | 13 | SS | Erlotinib | ERLOTINIB | 1 | Oral | Y | Y | 53728 | 2100 | MG | TABLET | ||||||
| 125777811 | 12577781 | 14 | SS | Erlotinib | ERLOTINIB | 1 | Oral | Y | Y | 53728 | 1575 | MG | TABLET | ||||||
| 125777811 | 12577781 | 15 | SS | Erlotinib | ERLOTINIB | 1 | Oral | Y | Y | 53728 | 2100 | MG | TABLET | ||||||
| 125777811 | 12577781 | 16 | SS | Erlotinib | ERLOTINIB | 1 | Oral | Y | Y | 53728 | 975 | MG | TABLET | ||||||
| 125777811 | 12577781 | 17 | SS | Erlotinib | ERLOTINIB | 1 | Oral | LAST TREATMENT DATE: 24/AUG/2012 | Y | Y | 53728 | 2100 | MG | TABLET | |||||
| 125777811 | 12577781 | 18 | SS | GEMCITABINE | GEMCITABINEGEMCITABINE HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | Y | Y | 0 | /wk | ||||||||
| 125777811 | 12577781 | 19 | SS | GEMCITABINE | GEMCITABINEGEMCITABINE HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | Y | Y | 0 | /wk |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125777811 | 12577781 | 1 | Cholangiocarcinoma |
| 125777811 | 12577781 | 8 | Cholangiocarcinoma |
| 125777811 | 12577781 | 18 | Cholangiocarcinoma |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125777811 | 12577781 | HO |
| 125777811 | 12577781 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125777811 | 12577781 | Abdominal pain | |
| 125777811 | 12577781 | Alanine aminotransferase increased | Alanine aminotransferase increased |
| 125777811 | 12577781 | Aspartate aminotransferase increased | |
| 125777811 | 12577781 | Bile duct stenosis | |
| 125777811 | 12577781 | Bilirubin conjugated increased | |
| 125777811 | 12577781 | Blood alkaline phosphatase increased | |
| 125777811 | 12577781 | Blood bilirubin increased | Blood bilirubin increased |
| 125777811 | 12577781 | Cholangitis | |
| 125777811 | 12577781 | Device occlusion | |
| 125777811 | 12577781 | Hypophosphataemia | |
| 125777811 | 12577781 | Neutrophil count decreased | |
| 125777811 | 12577781 | Pain |
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 |
|---|---|---|---|---|---|---|
| 125777811 | 12577781 | 1 | 20110722 | 20110927 | 0 | |
| 125777811 | 12577781 | 2 | 20111006 | 20120711 | 0 | |
| 125777811 | 12577781 | 3 | 20111014 | 0 | ||
| 125777811 | 12577781 | 4 | 20110722 | 0 | ||
| 125777811 | 12577781 | 5 | 20110916 | 0 | ||
| 125777811 | 12577781 | 6 | 20120406 | 0 | ||
| 125777811 | 12577781 | 7 | 20120504 | 20120824 | 0 | |
| 125777811 | 12577781 | 8 | 20110722 | 20110927 | 0 | |
| 125777811 | 12577781 | 9 | 20111006 | 20120710 | 0 | |
| 125777811 | 12577781 | 10 | 20111014 | 0 | ||
| 125777811 | 12577781 | 11 | 20110722 | 0 | ||
| 125777811 | 12577781 | 12 | 20110916 | 0 | ||
| 125777811 | 12577781 | 13 | 20111014 | 0 | ||
| 125777811 | 12577781 | 14 | 20120406 | 0 | ||
| 125777811 | 12577781 | 15 | 20120504 | 0 | ||
| 125777811 | 12577781 | 16 | 20120629 | 0 | ||
| 125777811 | 12577781 | 17 | 20120727 | 20120824 | 0 | |
| 125777811 | 12577781 | 18 | 20110722 | 20110923 | 0 | |
| 125777811 | 12577781 | 19 | 20111006 | 20120706 | 0 |