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NCT03109873 · ADVERSE EVENTS

Adverse events

Metformin Hydrochloride in Affecting Cytokines and Exosomes in Patients With Head and Neck Cancer · Source last updated 2025-04-30

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
baseline through one year after completion of treatment
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Arm I (EBRT, Metformin Hydrochloride)

Patients undergo External Beam Radiation Therapy (EBRT). Beginning 1 week prior to start of EBRT, patients receive metformin hydrochloride PO QD for 3 days and BID thereafter until 2 weeks after completion of EBRT. External Beam Radiation Therapy: Undergo External Beam Radiation Therapy Metformin Hydrochloride: Given orally

0 / 54 / 50 / 5
Arm II (EBRT, Placebo)

Patients undergo External Beam Radiation Therapy (EBRT). Beginning 1 week prior to start of EBRT, patients receive placebo PO QD for 3 days and BID thereafter until 2 weeks after completion of EBRT. External Beam Radiation Therapy: Undergo External Beam Radiation Therapy Placebo: Given orally

0 / 43 / 40 / 4

Group identifiers: EG000: Arm I (EBRT, Metformin Hydrochloride) · EG001: Arm II (EBRT, Placebo)

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.

    1. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      notes
      Dry mouth
      organ System
      General disorders
      stats
      1. group Id
        EG000
        num Affected
        4
        num At Risk
        5
      2. group Id
        EG001
        num Affected
        2
        num At Risk
        4
      term
      Xerostomia
    2. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      stats
      1. group Id
        EG000
        num Affected
        4
        num At Risk
        5
      2. group Id
        EG001
        num Affected
        2
        num At Risk
        4
      term
      Dysphagia
    3. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      stats
      1. group Id
        EG000
        num Affected
        4
        num At Risk
        5
      2. group Id
        EG001
        num Affected
        3
        num At Risk
        4
      term
      Fatigue
    4. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      stats
      1. group Id
        EG000
        num Affected
        4
        num At Risk
        5
      2. group Id
        EG001
        num Affected
        3
        num At Risk
        4
      term
      Dysgeusia
    Complete source fields
    event Groups
    1. deaths Num Affected
      0
      deaths Num At Risk
      5
      description
      Patients undergo External Beam Radiation Therapy (EBRT). Beginning 1 week prior to start of EBRT, patients receive metformin hydrochloride PO QD for 3 days and BID thereafter until 2 weeks after completion of EBRT. External Beam Radiation Therapy: Undergo External Beam Radiation Therapy Metformin Hydrochloride: Given orally
      id
      EG000
      other Num Affected
      4
      other Num At Risk
      5
      serious Num Affected
      0
      serious Num At Risk
      5
      title
      Arm I (EBRT, Metformin Hydrochloride)
    2. deaths Num Affected
      0
      deaths Num At Risk
      4
      description
      Patients undergo External Beam Radiation Therapy (EBRT). Beginning 1 week prior to start of EBRT, patients receive placebo PO QD for 3 days and BID thereafter until 2 weeks after completion of EBRT. External Beam Radiation Therapy: Undergo External Beam Radiation Therapy Placebo: Given orally
      id
      EG001
      other Num Affected
      3
      other Num At Risk
      4
      serious Num Affected
      0
      serious Num At Risk
      4
      title
      Arm II (EBRT, Placebo)
    frequency Threshold
    5
    other Events
    1. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      notes
      Dry mouth
      organ System
      General disorders
      stats
      1. group Id
        EG000
        num Affected
        4
        num At Risk
        5
      2. group Id
        EG001
        num Affected
        2
        num At Risk
        4
      term
      Xerostomia
    2. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      stats
      1. group Id
        EG000
        num Affected
        4
        num At Risk
        5
      2. group Id
        EG001
        num Affected
        2
        num At Risk
        4
      term
      Dysphagia
    3. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      stats
      1. group Id
        EG000
        num Affected
        4
        num At Risk
        5
      2. group Id
        EG001
        num Affected
        3
        num At Risk
        4
      term
      Fatigue
    4. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      stats
      1. group Id
        EG000
        num Affected
        4
        num At Risk
        5
      2. group Id
        EG001
        num Affected
        3
        num At Risk
        4
      term
      Dysgeusia
    time Frame
    baseline through one year after completion of treatment

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

    Preserved source evidence · Not medical advice