{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"3"}]}],"title":"Grade 1"},{"categories":[{"measurements":[{"groupId":"OG000","value":"20"},{"groupId":"OG001","value":"24"}]}],"title":"Grade 2"},{"categories":[{"measurements":[{"groupId":"OG000","value":"100"},{"groupId":"OG001","value":"101"}]}],"title":"Grade 3"},{"categories":[{"measurements":[{"groupId":"OG000","value":"32"},{"groupId":"OG001","value":"27"}]}],"title":"Grade 4"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"3"}]}],"title":"Grade 5"}],"denoms":[{"counts":[{"groupId":"OG000","value":"160"},{"groupId":"OG001","value":"158"}],"units":"Participants"}],"description":"Assessed according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 which grades adverse event severity from 1=mild to 5=death. Summary data is provided in this outcome measure; see Adverse Events Module for specific adverse event data.","groups":[{"description":"Patients receive either gemcitabine hydrochloride or \\[starting 06-28-2016\\] allowable combination chemotherapy per standard of care for 5 months. Patients undergo CT, MRI, and/or x-ray imaging throughout the trial. Patients also undergo blood sample collection during screening and follow-up and undergo tissue sample collection at baseline.","id":"OG000","title":"Arm I (Gemcitabine Hydrochloride or Combination Chemotherapy)"},{"description":"\\[Closed to accrual 2-28-14.\\] Patients receive gemcitabine hydrochloride IV over 30 minutes once a week for 3 weeks then off 1 week and erlotinib hydrochloride PO once daily on days 1-28. Treatment repeats every 28 days for up to 5 courses in the absence of disease progression or unacceptable toxicity. Patients undergo CT, MRI, and/or x-ray imaging throughout the trial. Patients also undergo blood sample collection during screening and follow-up and undergo tissue sample collection at baseline.","id":"OG001","title":"Arm II (Gemcitabine Hydrochloride, Erlotinib Hydrochloride)"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Eligible participants randomized in Step 1 who started protocol treatment and were assessed for adverse events.","reportingStatus":"POSTED","timeFrame":"From step 1 randomization (gemcitabine vs. gemcitabine/erlotinib) to death or last follow-up. Maximum follow-up at the time of the phase II analysis was 6.2 years.","title":"Number of Participants by Highest Grade Adverse Event Reported (Phase II)","type":"SECONDARY","unitOfMeasure":"Participants"}