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NCT02062632 · ADVERSE EVENTS

Adverse events

Doxepin Hydrochloride in Treating Esophageal Pain in Patients With Thoracic Cancer Receiving Radiation Therapy to the Thorax With or Without Chemotherapy · Source last updated 2019-10-01

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
Up to 4 hours after treatment on day 3
Other-event reporting threshold
0%

Since only one patient was accrued and completed the study on one arm, patient confidentiality prevents the reporting of results per intervention. Therefore, the study results are only reported for the first study period (before crossover) and only for a single intervention (placebo).Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Placebo

Patients receive placebo oral solution (swish, gargle for 30 seconds, and slowly swallow) on day 1.

0 / 32 / 30 / 3

Group identifiers: EG000: 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
      SYSTEMATIC_ASSESSMENT
      organ System
      Ear and labyrinth disorders
      source Vocabulary
      MedDRA 12
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        3
        num Events
        1
      term
      Tinnitus
    2. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      MedDRA 12
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        3
        num Events
        1
      term
      Constipation
    3. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      MedDRA 12
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        3
        num Events
        1
      term
      Esophagitis
    4. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      MedDRA 12
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        3
        num Events
        2
      term
      Nausea
    5. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      MedDRA 12
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        3
        num Events
        2
      term
      Fatigue
    6. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Nervous system disorders
      source Vocabulary
      MedDRA 12
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        3
        num Events
        1
      term
      Dizziness
    7. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Nervous system disorders
      source Vocabulary
      MedDRA 12
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        3
        num Events
        1
      term
      Somnolence
    Complete source fields
    description
    Since only one patient was accrued and completed the study on one arm, patient confidentiality prevents the reporting of results per intervention. Therefore, the study results are only reported for the first study period (before crossover) and only for a single intervention (placebo).Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
    event Groups
    1. deaths Num Affected
      0
      deaths Num At Risk
      3
      description
      Patients receive placebo oral solution (swish, gargle for 30 seconds, and slowly swallow) on day 1.
      id
      EG000
      other Num Affected
      2
      other Num At Risk
      3
      serious Num Affected
      0
      serious Num At Risk
      3
      title
      Placebo
    frequency Threshold
    0
    other Events
    1. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Ear and labyrinth disorders
      source Vocabulary
      MedDRA 12
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        3
        num Events
        1
      term
      Tinnitus
    2. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      MedDRA 12
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        3
        num Events
        1
      term
      Constipation
    3. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      MedDRA 12
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        3
        num Events
        1
      term
      Esophagitis
    4. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      MedDRA 12
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        3
        num Events
        2
      term
      Nausea
    5. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      MedDRA 12
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        3
        num Events
        2
      term
      Fatigue
    6. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Nervous system disorders
      source Vocabulary
      MedDRA 12
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        3
        num Events
        1
      term
      Dizziness
    7. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Nervous system disorders
      source Vocabulary
      MedDRA 12
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        3
        num Events
        1
      term
      Somnolence
    time Frame
    Up to 4 hours after treatment on day 3

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

    Preserved source evidence · Not medical advice