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NCT01156142 · ADVERSE EVENTS

Adverse events

Doxepin Hydrochloride in Treating Oral Mucositis Pain in Patients With Head and Neck Cancer Undergoing Radiation Therapy With or Without Chemotherapy · Source last updated 2017-08-09

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 are assessed during the Active Monitoring Phase at the following time points: at time Dose 1 of study treatment is administered, at time of Dose 2 crossover, during the Optional Continuation Phase, and at the end of the study. All adverse events are collected during the first day; up to 9 days.
Other-event reporting threshold
0%

The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. All graded adverse events are reported.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Arm I (Doxepin-Placebo)

Patients receive (10 mg/mL x 2.5 mL) 25 mg doxepin hydrochloride (diluted to 5 mL with 2.5 mL of sterile water for irrigation, or sterile water for injection, or distilled water) oral rinse (swish, gargle, and spit) over 1 minute on day 1. Patients may crossover to arm II on day 2.

0 / 7410 / 74Not reported / Not reported
Arm II (Placebo-Doxepin)

Patients receive 2.5 mL placebo (diluted to 5 mL with 2.5 mL of sterile water for irrigation, or sterile water for injection, or distilled water) oral rinse (swish, gargle, and spit) over 1 minute on day 1. Patients may crossover to arm I on day 2.

0 / 758 / 75Not reported / Not reported

Group identifiers: EG000: Arm I (Doxepin-Placebo) · EG001: Arm II (Placebo-Doxepin)

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
      Gastrointestinal disorders
      source Vocabulary
      MedDRA 9
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        74
        num Events
        1
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        75
        num Events
        0
      term
      Diarrhea
    2. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      MedDRA 9
      stats
      1. group Id
        EG000
        num Affected
        3
        num At Risk
        74
        num Events
        4
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        75
        num Events
        0
      term
      Dry mouth
    3. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      MedDRA 9
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        74
        num Events
        1
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        75
        num Events
        0
      term
      Dysphagia
    4. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      MedDRA 9
      stats
      1. group Id
        EG000
        num Affected
        4
        num At Risk
        74
        num Events
        9
      2. group Id
        EG001
        num Affected
        6
        num At Risk
        75
        num Events
        12
      term
      Mucositis oral
    5. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      MedDRA 9
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        74
        num Events
        1
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        75
        num Events
        2
      term
      Nausea
    6. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      MedDRA 9
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        74
        num Events
        5
      2. group Id
        EG001
        num Affected
        2
        num At Risk
        75
        num Events
        2
      term
      Oral pain
    7. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      MedDRA 9
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        74
        num Events
        1
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        75
        num Events
        0
      term
      Salivary duct inflammation
    8. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      MedDRA 9
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        74
        num Events
        0
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        75
        num Events
        2
      term
      Vomiting
    9. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      MedDRA 9
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        74
        num Events
        1
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        75
        num Events
        0
      term
      Fatigue
    10. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Metabolism and nutrition disorders
      source Vocabulary
      MedDRA 9
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        74
        num Events
        1
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        75
        num Events
        0
      term
      Anorexia
    11. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Metabolism and nutrition disorders
      source Vocabulary
      MedDRA 9
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        74
        num Events
        0
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        75
        num Events
        2
      term
      Dehydration
    12. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Nervous system disorders
      source Vocabulary
      MedDRA 9
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        74
        num Events
        0
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        75
        num Events
        1
      term
      Lethargy
    Complete source fields
    description
    The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. All graded adverse events are reported.
    event Groups
    1. description
      Patients receive (10 mg/mL x 2.5 mL) 25 mg doxepin hydrochloride (diluted to 5 mL with 2.5 mL of sterile water for irrigation, or sterile water for injection, or distilled water) oral rinse (swish, gargle, and spit) over 1 minute on day 1. Patients may crossover to arm II on day 2.
      id
      EG000
      other Num Affected
      10
      other Num At Risk
      74
      serious Num Affected
      0
      serious Num At Risk
      74
      title
      Arm I (Doxepin-Placebo)
    2. description
      Patients receive 2.5 mL placebo (diluted to 5 mL with 2.5 mL of sterile water for irrigation, or sterile water for injection, or distilled water) oral rinse (swish, gargle, and spit) over 1 minute on day 1. Patients may crossover to arm I on day 2.
      id
      EG001
      other Num Affected
      8
      other Num At Risk
      75
      serious Num Affected
      0
      serious Num At Risk
      75
      title
      Arm II (Placebo-Doxepin)
    frequency Threshold
    0
    other Events
    1. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      MedDRA 9
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        74
        num Events
        1
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        75
        num Events
        0
      term
      Diarrhea
    2. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      MedDRA 9
      stats
      1. group Id
        EG000
        num Affected
        3
        num At Risk
        74
        num Events
        4
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        75
        num Events
        0
      term
      Dry mouth
    3. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      MedDRA 9
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        74
        num Events
        1
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        75
        num Events
        0
      term
      Dysphagia
    4. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      MedDRA 9
      stats
      1. group Id
        EG000
        num Affected
        4
        num At Risk
        74
        num Events
        9
      2. group Id
        EG001
        num Affected
        6
        num At Risk
        75
        num Events
        12
      term
      Mucositis oral
    5. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      MedDRA 9
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        74
        num Events
        1
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        75
        num Events
        2
      term
      Nausea
    6. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      MedDRA 9
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        74
        num Events
        5
      2. group Id
        EG001
        num Affected
        2
        num At Risk
        75
        num Events
        2
      term
      Oral pain
    7. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      MedDRA 9
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        74
        num Events
        1
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        75
        num Events
        0
      term
      Salivary duct inflammation
    8. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      MedDRA 9
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        74
        num Events
        0
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        75
        num Events
        2
      term
      Vomiting
    9. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      MedDRA 9
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        74
        num Events
        1
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        75
        num Events
        0
      term
      Fatigue
    10. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Metabolism and nutrition disorders
      source Vocabulary
      MedDRA 9
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        74
        num Events
        1
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        75
        num Events
        0
      term
      Anorexia
    11. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Metabolism and nutrition disorders
      source Vocabulary
      MedDRA 9
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        74
        num Events
        0
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        75
        num Events
        2
      term
      Dehydration
    12. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Nervous system disorders
      source Vocabulary
      MedDRA 9
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        74
        num Events
        0
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        75
        num Events
        1
      term
      Lethargy
    time Frame
    Adverse events are assessed during the Active Monitoring Phase at the following time points: at time Dose 1 of study treatment is administered, at time of Dose 2 crossover, during the Optional Continuation Phase, and at the end of the study. All adverse events are collected during the first day; up to 9 days.

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