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NCT02767388 · ADVERSE EVENTS

Adverse events

Electrophysiological Biomarkers of Chemotherapy-related Cognitive Impairment and Recovery · Source last updated 2023-09-29

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
Adverse events were monitored through study completion for each study participant.
Other-event reporting threshold
0%

This is a minimal risk study. To minimize risk, research personnel will frequently check in during all aspects of the protocol to ensure participant feels safe and comfortable. Breaks will be built into behavioral testing protocols, patients will be asked if they are experiencing any discomfort during the electrophysiological outfitting procedure, and patients will be guided through the simulator adaptation procedure to ensure that risk of nausea is minimized.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
HM - Chemotherapy

Study patients diagnosed with HM that are scheduled to receive chemotherapy treatment.

0 / 150 / 150 / 15
HM - No Chemotherapy

Study patients diagnosed with HM that are scheduled to receive non-chemotherapy treatment options.

0 / 150 / 150 / 15
Healthy Controls

Study participants that are demographically matched to HM study patients and meet all inclusion criteria

0 / 150 / 150 / 15

Group identifiers: EG000: HM - Chemotherapy · EG001: HM - No Chemotherapy · EG002: Healthy Controls

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
      description
      This is a minimal risk study. To minimize risk, research personnel will frequently check in during all aspects of the protocol to ensure participant feels safe and comfortable. Breaks will be built into behavioral testing protocols, patients will be asked if they are experiencing any discomfort during the electrophysiological outfitting procedure, and patients will be guided through the simulator adaptation procedure to ensure that risk of nausea is minimized.
      event Groups
      1. deaths Num Affected
        0
        deaths Num At Risk
        15
        description
        Study patients diagnosed with HM that are scheduled to receive chemotherapy treatment.
        id
        EG000
        other Num Affected
        0
        other Num At Risk
        15
        serious Num Affected
        0
        serious Num At Risk
        15
        title
        HM - Chemotherapy
      2. deaths Num Affected
        0
        deaths Num At Risk
        15
        description
        Study patients diagnosed with HM that are scheduled to receive non-chemotherapy treatment options.
        id
        EG001
        other Num Affected
        0
        other Num At Risk
        15
        serious Num Affected
        0
        serious Num At Risk
        15
        title
        HM - No Chemotherapy
      3. deaths Num Affected
        0
        deaths Num At Risk
        15
        description
        Study participants that are demographically matched to HM study patients and meet all inclusion criteria
        id
        EG002
        other Num Affected
        0
        other Num At Risk
        15
        serious Num Affected
        0
        serious Num At Risk
        15
        title
        Healthy Controls
      frequency Threshold
      0
      time Frame
      Adverse events were monitored through study completion for each study participant.

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

      Preserved source evidence · Not medical advice