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NCT02123511 · ADVERSE EVENTS

Adverse events

Acetylcysteine Rinse in Reducing Saliva Thickness and Mucositis in Patients With Head and Neck Cancer Undergoing Radiation Therapy · Source last updated 2019-04-30

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
Adverse events are collected weekly during radiotherapy management visits
Other-event reporting threshold
0%

Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the AE form at least once. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.

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

Patients receive a placebo oral rinse and gargle or swish for 60 seconds and then spit 5 times per day beginning within 3 days of the initiation of radiotherapy to 14 days following completion of radiotherapy.

5 / 1715 / 170 / 17
Arm B (Rincinol)

Patients receive acetylcysteine oral rinse and gargle or swish for 60 seconds then spit 5 times per day beginning within 3 days of the initiation of radiotherapy to 14 days following completion of radiotherapy.

0 / 1614 / 160 / 16

Group identifiers: EG000: Arm A (Placebo) · EG001: Arm B (Rincinol)

Serious 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 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
      num Events
      0
    term
    Dysphagia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
      num Events
      0
    term
    Nausea
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
      num Events
      0
    term
    Oral hemorrhage
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
      num Events
      0
    term
    Oral pain
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
      num Events
      0
    term
    Lung infection
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
      num Events
      0
    term
    White blood cell decreased
  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
      17
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
      num Events
      0
    term
    Dysgeusia

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 12
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      17
      num Events
      8
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      16
      num Events
      6
    term
    Abdominal pain
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
      num Events
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
      num Events
      0
    term
    Dry mouth
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
      num Events
      1
    term
    Dysphagia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      17
      num Events
      6
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      16
      num Events
      3
    term
    Mucositis oral
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      17
      num Events
      28
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      16
      num Events
      13
    term
    Nausea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      17
      num Events
      10
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      16
      num Events
      7
    term
    Oral hemorrhage
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      17
      num Events
      47
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      16
      num Events
      31
    term
    Oral pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
      num Events
      0
    term
    Creatinine increased
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
      num Events
      0
    term
    Weight loss
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
      num Events
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
      num Events
      0
    term
    Dysgeusia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      17
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
      num Events
      1
    term
    Cough
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
      num Events
      0
    term
    Hoarseness
Complete source fields
description
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the AE form at least once. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
event Groups
  1. deaths Num Affected
    0
    deaths Num At Risk
    17
    description
    Patients receive a placebo oral rinse and gargle or swish for 60 seconds and then spit 5 times per day beginning within 3 days of the initiation of radiotherapy to 14 days following completion of radiotherapy.
    id
    EG000
    other Num Affected
    15
    other Num At Risk
    17
    serious Num Affected
    5
    serious Num At Risk
    17
    title
    Arm A (Placebo)
  2. deaths Num Affected
    0
    deaths Num At Risk
    16
    description
    Patients receive acetylcysteine oral rinse and gargle or swish for 60 seconds then spit 5 times per day beginning within 3 days of the initiation of radiotherapy to 14 days following completion of radiotherapy.
    id
    EG001
    other Num Affected
    14
    other Num At Risk
    16
    serious Num Affected
    0
    serious Num At Risk
    16
    title
    Arm B (Rincinol)
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      17
      num Events
      8
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      16
      num Events
      6
    term
    Abdominal pain
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
      num Events
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
      num Events
      0
    term
    Dry mouth
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
      num Events
      1
    term
    Dysphagia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      17
      num Events
      6
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      16
      num Events
      3
    term
    Mucositis oral
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      17
      num Events
      28
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      16
      num Events
      13
    term
    Nausea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      17
      num Events
      10
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      16
      num Events
      7
    term
    Oral hemorrhage
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      17
      num Events
      47
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      16
      num Events
      31
    term
    Oral pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
      num Events
      0
    term
    Creatinine increased
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
      num Events
      0
    term
    Weight loss
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
      num Events
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
      num Events
      0
    term
    Dysgeusia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      17
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
      num Events
      1
    term
    Cough
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
      num Events
      0
    term
    Hoarseness
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
      num Events
      0
    term
    Dysphagia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
      num Events
      0
    term
    Nausea
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
      num Events
      0
    term
    Oral hemorrhage
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
      num Events
      0
    term
    Oral pain
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
      num Events
      0
    term
    Lung infection
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
      num Events
      0
    term
    White blood cell decreased
  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
      17
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
      num Events
      0
    term
    Dysgeusia
time Frame
Adverse events are collected weekly during radiotherapy management visits

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