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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 105183683 | 10518368 | 3 | F | 20100331 | 20160706 | 20141015 | 20160811 | EXP | US-ROCHE-698050 | ROCHE | 61.91 | YR | F | Y | 69.40000 | KG | 20160811 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 105183683 | 10518368 | 1 | PS | Erlotinib | ERLOTINIB | 1 | Oral | U | 53728 | 75 | MG | TABLET | QD | ||||||
| 105183683 | 10518368 | 2 | SS | Vismodegib | VISMODEGIB | 1 | Oral | U | 203388 | 150 | MG | CAPSULE | QD | ||||||
| 105183683 | 10518368 | 3 | SS | GEMCITABINE | GEMCITABINEGEMCITABINE HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | FORM: INJECTION FOR INFUSION, ON DAY 1, 8, 15, 22, 29, 36 AND 43 | U | 0 | 1000 | MG/M**2 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 105183683 | 10518368 | 1 | Colon cancer metastatic |
| 105183683 | 10518368 | 2 | Colon cancer metastatic |
| 105183683 | 10518368 | 3 | Colon cancer metastatic |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 105183683 | 10518368 | HO |
| 105183683 | 10518368 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 105183683 | 10518368 | Anaemia | |
| 105183683 | 10518368 | Cystitis | |
| 105183683 | 10518368 | Nausea | |
| 105183683 | 10518368 | Neutrophil count decreased | |
| 105183683 | 10518368 | Platelet count decreased | |
| 105183683 | 10518368 | Thrombocytopenia | |
| 105183683 | 10518368 | 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 |
|---|---|---|---|---|---|---|
| 105183683 | 10518368 | 1 | 20100322 | 20100331 | 0 | |
| 105183683 | 10518368 | 2 | 20100322 | 20100331 | 0 | |
| 105183683 | 10518368 | 3 | 20100322 | 20100331 | 0 |