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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 98121063 | 9812106 | 3 | F | 20110523 | 20160706 | 20140111 | 20160725 | EXP | US-ROCHE-783279 | ROCHE | 65.39 | YR | M | Y | 91.80000 | KG | 20160725 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 98121063 | 9812106 | 1 | PS | Vismodegib | VISMODEGIB | 1 | Oral | CYCLE = 28 DAYS?DATE OF LAST DOSE PRIOR TO ADVERSE EVENT 1: 22/MAY/2011?DATE OF LAST DOSE PRIOR TO A | U | 203388 | CAPSULE | ||||||||
| 98121063 | 9812106 | 2 | SS | Vismodegib | VISMODEGIB | 1 | Oral | CYCLE = 28 DAYS | U | 203388 | 1000 | MG | CAPSULE | ||||||
| 98121063 | 9812106 | 3 | SS | GEMCITABINE | GEMCITABINEGEMCITABINE HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | 1000MG/M2 IV OVER 30 MINUTES ON DAYS 1, 8, 15 STARTING WITH CYCLE 2 (DAY 29) | U | 0 | 1000 | MG/M**2 | |||||||
| 98121063 | 9812106 | 4 | SS | GEMCITABINE | GEMCITABINEGEMCITABINE HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | 1000MG/M2 IV OVER 30 MINUTES ON DAYS 1, 8, 15 STARTING WITH CYCLE 2 (DAY 29) | U | 0 | 1000 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 98121063 | 9812106 | 1 | Adenocarcinoma pancreas |
| 98121063 | 9812106 | 3 | Adenocarcinoma pancreas |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 98121063 | 9812106 | OT |
| 98121063 | 9812106 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 98121063 | 9812106 | Cognitive disorder | |
| 98121063 | 9812106 | Dehydration | |
| 98121063 | 9812106 | Neutrophil count decreased | |
| 98121063 | 9812106 | 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 |
|---|---|---|---|---|---|---|
| 98121063 | 9812106 | 1 | 20110504 | 20110614 | 0 | |
| 98121063 | 9812106 | 2 | 20110601 | 20110614 | 0 |