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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125870101 | 12587010 | 1 | I | 20120507 | 20160706 | 20160725 | 20160725 | EXP | US-ROCHE-1799818 | ROCHE | 59.00 | YR | M | Y | 110.90000 | KG | 20160725 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125870101 | 12587010 | 1 | PS | Vismodegib | VISMODEGIB | 1 | Oral | 203388 | 500 | MG | |||||||||
| 125870101 | 12587010 | 2 | SS | Vismodegib | VISMODEGIB | 1 | Oral | 203388 | 500 | MG | |||||||||
| 125870101 | 12587010 | 3 | SS | Vismodegib | VISMODEGIB | 1 | Oral | 203388 | 1000 | MG | |||||||||
| 125870101 | 12587010 | 4 | SS | GEMCITABINE HYDROCHLORIDE. | GEMCITABINE HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | OVER 30 MINUTES ON DAYS 1, 8, AND 15, COURSE 1, ASSIGNED CODE: TAC1 | 0 | 1000 | MG | ||||||||
| 125870101 | 12587010 | 5 | SS | GEMCITABINE HYDROCHLORIDE. | GEMCITABINE HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | OVER 30 MINUTES ON DAYS 1, 8, AND 15, COURSE 1, ASSIGNED CODE: TAC1 | 0 | 500 | MG | ||||||||
| 125870101 | 12587010 | 6 | SS | GEMCITABINE HYDROCHLORIDE. | GEMCITABINE HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | OVER 30 MINUTES ON DAYS 1, 8, AND 15, COURSE 1, ASSIGNED CODE: TAC1 | 0 | 500 | MG | ||||||||
| 125870101 | 12587010 | 7 | SS | GEMCITABINE HYDROCHLORIDE. | GEMCITABINE HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | OVER 30 MINUTES ON DAYS 1, 8, AND 15, COURSE 1, ASSIGNED CODE: TAC1 | 0 | 500 | MG | ||||||||
| 125870101 | 12587010 | 8 | SS | GEMCITABINE HYDROCHLORIDE. | GEMCITABINE HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | OVER 30 MINUTES ON DAYS 1, 8, AND 15, COURSE 1, ASSIGNED CODE: TAC1 | 0 | 1000 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125870101 | 12587010 | 1 | Pancreatic carcinoma |
| 125870101 | 12587010 | 4 | Pancreatic carcinoma |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125870101 | 12587010 | DE |
| 125870101 | 12587010 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125870101 | 12587010 | Death | |
| 125870101 | 12587010 | Febrile neutropenia | |
| 125870101 | 12587010 | Neutrophil count decreased | |
| 125870101 | 12587010 | Platelet count decreased | |
| 125870101 | 12587010 | White blood cell count decreased |
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 |
|---|---|---|---|---|---|---|
| 125870101 | 12587010 | 1 | 20110815 | 0 | ||
| 125870101 | 12587010 | 2 | 20110912 | 0 | ||
| 125870101 | 12587010 | 3 | 20111010 | 20111010 | 0 | |
| 125870101 | 12587010 | 4 | 20110325 | 0 | ||
| 125870101 | 12587010 | 5 | 20110422 | 0 | ||
| 125870101 | 12587010 | 6 | 20110815 | 0 | ||
| 125870101 | 12587010 | 7 | 20110912 | 0 | ||
| 125870101 | 12587010 | 8 | 20111010 | 20111010 | 0 |