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NCT02966509 · ADVERSE EVENTS

Adverse events

Engagement of Patients With Advanced Cancer · Source last updated 2018-10-31

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame
Time frame for adverse event reporting was at 3, 6, 12, and 15 months
Other-event reporting threshold
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
A: Intervention Arm

All participants randomized to Arm A will receive the EPAC intervention as well as usual oncologic care. EPAC: Each patient will receive a lay health worker who will engage and educate patients on goals of care documentation and will continue to address goals of care for at least 6 months with patients after enrollment in the study.

0 / 1050 / 105Not reported / Not reported
B: Control Group Arm

All participants randomized to Arm B will receive usual oncologic care.

0 / 1080 / 108Not reported / Not reported

Group identifiers: EG000: A: Intervention Arm · EG001: B: Control Group Arm

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

    Other reported adverse events

    Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

      Complete source fields
      event Groups
      1. description
        All participants randomized to Arm A will receive the EPAC intervention as well as usual oncologic care. EPAC: Each patient will receive a lay health worker who will engage and educate patients on goals of care documentation and will continue to address goals of care for at least 6 months with patients after enrollment in the study.
        id
        EG000
        other Num Affected
        0
        other Num At Risk
        105
        serious Num Affected
        0
        serious Num At Risk
        105
        title
        A: Intervention Arm
      2. description
        All participants randomized to Arm B will receive usual oncologic care.
        id
        EG001
        other Num Affected
        0
        other Num At Risk
        108
        serious Num Affected
        0
        serious Num At Risk
        108
        title
        B: Control Group Arm
      frequency Threshold
      0
      time Frame
      Time frame for adverse event reporting was at 3, 6, 12, and 15 months

      Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

      Preserved source evidence · Not medical advice