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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125916941 | 12591694 | 1 | I | 20120705 | 20120824 | 20160726 | 20160726 | EXP | US-ROCHE-1107824 | ROCHE | 57.00 | YR | F | Y | 61.40000 | KG | 20160726 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125916941 | 12591694 | 1 | PS | Vismodegib | VISMODEGIB | 1 | Oral | LAST DOSE ADMINISTERED ON: 09/JUL/2012 | 203388 | 1000 | MG | QD | |||||||
| 125916941 | 12591694 | 2 | SS | Vismodegib | VISMODEGIB | 1 | Oral | COURSE 2 | 203388 | 1000 | MG | ||||||||
| 125916941 | 12591694 | 3 | SS | Vismodegib | VISMODEGIB | 1 | Oral | COURSE 3 | 203388 | 1000 | MG | ||||||||
| 125916941 | 12591694 | 4 | SS | GEMCITABINE | GEMCITABINEGEMCITABINE HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | LAST DOSE ADMINISTERED ON: 25/JUN/2012 | 0 | 1000 | MG | ||||||||
| 125916941 | 12591694 | 5 | SS | GEMCITABINE | GEMCITABINEGEMCITABINE HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | COURSE 2 | 0 | 1000 | MG | ||||||||
| 125916941 | 12591694 | 6 | SS | GEMCITABINE | GEMCITABINEGEMCITABINE HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | COURSE 3 | 0 | 1000 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125916941 | 12591694 | 1 | Pancreatic carcinoma |
| 125916941 | 12591694 | 4 | Pancreatic carcinoma |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125916941 | 12591694 | OT |
| 125916941 | 12591694 | DE |
| 125916941 | 12591694 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125916941 | 12591694 | Alanine aminotransferase increased | |
| 125916941 | 12591694 | Aspartate aminotransferase increased | |
| 125916941 | 12591694 | Aspiration | |
| 125916941 | 12591694 | Death | |
| 125916941 | 12591694 | Dyspnoea | |
| 125916941 | 12591694 | Hyperkalaemia | |
| 125916941 | 12591694 | Oedema peripheral |
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 |
|---|---|---|---|---|---|---|
| 125916941 | 12591694 | 1 | 20120427 | 0 | ||
| 125916941 | 12591694 | 2 | 20120525 | 0 | ||
| 125916941 | 12591694 | 3 | 20120725 | 20120814 | 0 | |
| 125916941 | 12591694 | 4 | 20120427 | 0 | ||
| 125916941 | 12591694 | 5 | 20120525 | 0 | ||
| 125916941 | 12591694 | 6 | 20120725 | 20120814 | 0 |