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NCT03198754 · ADVERSE EVENTS

Adverse events

Programmed Environmental Illumination (PEI) of Hospital Rooms to Prevent/Reduce Cancer-Related Fatigue · Source last updated 2020-08-11

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
90 days
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Circadian Active Bright White Light (BWL)

PEI Experimental Light: Ambient Light Fixture delivery of circadian active bright white light (BWL) installed in the patient's hospital room will turn on automatically and illuminate the hospital room from 7 to 10 AM each morning.

0 / 380 / 380 / 38
Circadian Inactive Dim White Light (DWL)

Comparison Light: Ambient Light Fixture delivery of circadian inactive dim white light (DWL) installed in the patient's hospital room will turn on automatically and illuminate the hospital room from 7 to 10 AM each morning.

0 / 350 / 350 / 35

Group identifiers: EG000: Circadian Active Bright White Light (BWL) · EG001: Circadian Inactive Dim White Light (DWL)

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. deaths Num Affected
        0
        deaths Num At Risk
        38
        description
        PEI Experimental Light: Ambient Light Fixture delivery of circadian active bright white light (BWL) installed in the patient's hospital room will turn on automatically and illuminate the hospital room from 7 to 10 AM each morning.
        id
        EG000
        other Num Affected
        0
        other Num At Risk
        38
        serious Num Affected
        0
        serious Num At Risk
        38
        title
        Circadian Active Bright White Light (BWL)
      2. deaths Num Affected
        0
        deaths Num At Risk
        35
        description
        Comparison Light: Ambient Light Fixture delivery of circadian inactive dim white light (DWL) installed in the patient's hospital room will turn on automatically and illuminate the hospital room from 7 to 10 AM each morning.
        id
        EG001
        other Num Affected
        0
        other Num At Risk
        35
        serious Num Affected
        0
        serious Num At Risk
        35
        title
        Circadian Inactive Dim White Light (DWL)
      frequency Threshold
      5
      time Frame
      90 days

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

      Preserved source evidence · Not medical advice