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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126283551 | 12628355 | 1 | I | 20110519 | 20110526 | 20160808 | 20160808 | EXP | US-ROCHE-781932 | ROCHE | 51.00 | YR | M | Y | 73.10000 | KG | 20160808 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126283551 | 12628355 | 1 | PS | Vismodegib | VISMODEGIB | 1 | Oral | N | 203388 | ||||||||||
| 126283551 | 12628355 | 2 | SS | Vismodegib | VISMODEGIB | 1 | Oral | TOTAL DOSE AMOUNT: 450 MG | N | 203388 | |||||||||
| 126283551 | 12628355 | 3 | SS | Erlotinib | ERLOTINIB | 1 | Oral | 75 MG UID/QD | N | 53728 | |||||||||
| 126283551 | 12628355 | 4 | SS | Erlotinib | ERLOTINIB | 1 | Oral | TOTAL DOSE AMOUNT: 225 MG | N | 53728 | |||||||||
| 126283551 | 12628355 | 5 | SS | GEMCITABINE | GEMCITABINEGEMCITABINE HYDROCHLORIDE | 1 | Oral | 0 | 750 | MG/M**2 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126283551 | 12628355 | 1 | Adenocarcinoma of colon |
| 126283551 | 12628355 | 3 | Adenocarcinoma of colon |
| 126283551 | 12628355 | 5 | Adenocarcinoma of colon |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126283551 | 12628355 | HO |
| 126283551 | 12628355 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126283551 | 12628355 | Abdominal pain | |
| 126283551 | 12628355 | Colitis | |
| 126283551 | 12628355 | Large intestinal obstruction | |
| 126283551 | 12628355 | Nausea | |
| 126283551 | 12628355 | 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 |
|---|---|---|---|---|---|---|
| 126283551 | 12628355 | 2 | 20110518 | 20110521 | 0 | |
| 126283551 | 12628355 | 4 | 20110518 | 20110521 | 0 | |
| 126283551 | 12628355 | 5 | 20110420 | 20110515 | 0 |