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NCT00293462 · ADVERSE EVENTS

Adverse events

GM-CSF Mouthwash for Preventing and Treating Mucositis in Patients Undergoing Radiation Therapy for Head and Neck Cancer · Source last updated 2021-07-30

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
Up to 3 months
Other-event reporting threshold
3%

Serious Adverse Events and adverse events were collected in the safety population which is comprised of all participants who were both randomized and received at least one dose of the study medication. Number of participants at risk represents the number of participants who received study medications.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Arm I: GM-CSF Group (GG)

Arm I: Patients receive oral sargramostim (GM-CSF) mouthwash, holding it in their mouths and swallowing it in intervals over 1 hour once daily. Treatment continues during 6-7 weeks of radiotherapy and until the mucositis heals.

1 / 2918 / 291 / 29
Arm II: Salt & Soda Group (SS)

Arm II: Patients receive oral salt and soda mouthwash, holding it and swallowing it in intervals over 1 hour once daily. Treatment continues during 6-7 weeks of radiotherapy and until the mucositis heals.

2 / 2826 / 280 / 28
Arm III: Salt & Soda Switched to GM-CSF (SG)

Arm II patients are split, with Arm III being switched to GM-CSF when they develop mucositis.

2 / 2827 / 280 / 28

Group identifiers: EG000: Arm I: GM-CSF Group (GG) · EG001: Arm II: Salt & Soda Group (SS) · EG002: Arm III: Salt & Soda Switched to GM-CSF (SG)

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
    notes
    Other (withdrawal symptoms-opioid)
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      29
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      28
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      28
      num Events
      1
    term
    Other
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Mucositis Oral:Hypersensitivity Reaction from Salt and Soda Mouthwash
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      29
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      28
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      28
      num Events
      0
    term
    Mucositis Oral
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      29
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      28
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      28
      num Events
      0
    term
    Lower gastrointestinal hemorrhage
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      29
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      28
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      28
      num Events
      1
    term
    Thromboembolic event
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Reactive oral mucositis : Due to the timing of the adverse event (AE), the study team determined that the reactive oral mucositis is unlikely to be related to radiation therapy and was part of the salt and soda group.
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      29
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      28
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      28
      num Events
      0
    term
    Allergic reaction

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
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      29
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      28
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      28
      num Events
      0
    term
    Transfusion
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      29
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      28
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      28
      num Events
      1
    term
    Anemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      29
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      28
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      28
      num Events
      1
    term
    Febrile neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Sinus tachycardia due to Acetaminophen-codeine medication.
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      29
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      28
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      28
      num Events
      0
    term
    Sinus Tachycardia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      29
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      28
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      28
      num Events
      0
    term
    Stomach pain
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      29
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      28
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      28
      num Events
      1
    term
    Constipation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      29
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      28
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      28
      num Events
      1
    term
    Fatigue
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    (Shoulder and neck area)
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      29
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      28
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      28
      num Events
      1
    term
    Pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    (Withdraweal symptoms-opioid)
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      29
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      28
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      28
      num Events
      1
    term
    Other
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    (Right foot)
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      29
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      28
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      28
      num Events
      1
    term
    Wound infection
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      29
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      28
      num Events
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      28
      num Events
      0
    term
    Sinusitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    (left parotid gland)
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      29
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      28
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      28
      num Events
      1
    term
    Infection
Complete source fields
description
Serious Adverse Events and adverse events were collected in the safety population which is comprised of all participants who were both randomized and received at least one dose of the study medication. Number of participants at risk represents the number of participants who received study medications.
event Groups
  1. deaths Num Affected
    1
    deaths Num At Risk
    29
    description
    Arm I: Patients receive oral sargramostim (GM-CSF) mouthwash, holding it in their mouths and swallowing it in intervals over 1 hour once daily. Treatment continues during 6-7 weeks of radiotherapy and until the mucositis heals.
    id
    EG000
    other Num Affected
    18
    other Num At Risk
    29
    serious Num Affected
    1
    serious Num At Risk
    29
    title
    Arm I: GM-CSF Group (GG)
  2. deaths Num Affected
    0
    deaths Num At Risk
    28
    description
    Arm II: Patients receive oral salt and soda mouthwash, holding it and swallowing it in intervals over 1 hour once daily. Treatment continues during 6-7 weeks of radiotherapy and until the mucositis heals.
    id
    EG001
    other Num Affected
    26
    other Num At Risk
    28
    serious Num Affected
    2
    serious Num At Risk
    28
    title
    Arm II: Salt & Soda Group (SS)
  3. deaths Num Affected
    0
    deaths Num At Risk
    28
    description
    Arm II patients are split, with Arm III being switched to GM-CSF when they develop mucositis.
    id
    EG002
    other Num Affected
    27
    other Num At Risk
    28
    serious Num Affected
    2
    serious Num At Risk
    28
    title
    Arm III: Salt & Soda Switched to GM-CSF (SG)
frequency Threshold
3
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      29
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      28
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      28
      num Events
      0
    term
    Transfusion
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      29
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      28
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      28
      num Events
      1
    term
    Anemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      29
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      28
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      28
      num Events
      1
    term
    Febrile neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Sinus tachycardia due to Acetaminophen-codeine medication.
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      29
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      28
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      28
      num Events
      0
    term
    Sinus Tachycardia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      29
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      28
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      28
      num Events
      0
    term
    Stomach pain
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      29
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      28
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      28
      num Events
      1
    term
    Constipation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      29
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      28
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      28
      num Events
      1
    term
    Fatigue
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    (Shoulder and neck area)
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      29
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      28
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      28
      num Events
      1
    term
    Pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    (Withdraweal symptoms-opioid)
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      29
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      28
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      28
      num Events
      1
    term
    Other
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    (Right foot)
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      29
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      28
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      28
      num Events
      1
    term
    Wound infection
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      29
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      28
      num Events
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      28
      num Events
      0
    term
    Sinusitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    (left parotid gland)
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      29
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      28
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      28
      num Events
      1
    term
    Infection
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Other (withdrawal symptoms-opioid)
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      29
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      28
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      28
      num Events
      1
    term
    Other
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Mucositis Oral:Hypersensitivity Reaction from Salt and Soda Mouthwash
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      29
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      28
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      28
      num Events
      0
    term
    Mucositis Oral
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      29
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      28
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      28
      num Events
      0
    term
    Lower gastrointestinal hemorrhage
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      29
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      28
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      28
      num Events
      1
    term
    Thromboembolic event
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Reactive oral mucositis : Due to the timing of the adverse event (AE), the study team determined that the reactive oral mucositis is unlikely to be related to radiation therapy and was part of the salt and soda group.
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      29
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      28
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      28
      num Events
      0
    term
    Allergic reaction
time Frame
Up to 3 months

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Preserved source evidence · Not medical advice