Skip to content
Triangle logo TriangleGet started
← Full study record

NCT04162873 · ADVERSE EVENTS

Adverse events

Celecoxib Through Surgery and Radiation Therapy for the Treatment of Advanced Head and Neck Cancer · Source last updated 2025-02-12

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
Collection of adverse events began on the first dose of study medication until the end of treatment visit (or until a new cancer treatment is initiated). Adverse events were collected for up to 5 months.
Other-event reporting threshold
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Celecoxib Arm

Patients received celecoxib PO or via feeding tube BID starting 1 to 7 days prior to surgery and continued until the completion of radiation therapy (up to 6 months in total) in the absence of disease progression or unacceptable toxicity. Celecoxib: Given PO or via feeding tube Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies

2 / 55 / 50 / 5
Placebo Arm

Patients received placebo PO or via feeding tube BID starting 1 to 7 days prior to surgery and continued until the completion of radiation therapy (up to 6 months in total) in the absence of disease progression or unacceptable toxicity. Placebo: Given PO or via feeding tube Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies

1 / 77 / 70 / 7

Group identifiers: EG000: Celecoxib Arm · EG001: Placebo Arm

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
    Vascular disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Hypotension
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Injury, poisoning and procedural complications - Other, specify
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
      num Events
      1
    term
    Postoperative hemorrhage
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Syncope
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Thromboembolic event
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Wound dehiscence

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
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
      num Events
      1
    term
    Abdominal distension
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Allergic reaction
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      5
      num Events
      5
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      7
      num Events
      3
    term
    Anemia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
      num Events
      2
    term
    Anorexia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Anxiety
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Bone pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
      num Events
      1
    term
    Bruising
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      5
      num Events
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Constipation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
      num Events
      1
    term
    Creatinine increased
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Depression
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      7
      num Events
      2
    term
    Dermatitis radiation
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      5
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Diarrhea
Complete source fields
event Groups
  1. deaths Num Affected
    0
    deaths Num At Risk
    5
    description
    Patients received celecoxib PO or via feeding tube BID starting 1 to 7 days prior to surgery and continued until the completion of radiation therapy (up to 6 months in total) in the absence of disease progression or unacceptable toxicity. Celecoxib: Given PO or via feeding tube Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies
    id
    EG000
    other Num Affected
    5
    other Num At Risk
    5
    serious Num Affected
    2
    serious Num At Risk
    5
    title
    Celecoxib Arm
  2. deaths Num Affected
    0
    deaths Num At Risk
    7
    description
    Patients received placebo PO or via feeding tube BID starting 1 to 7 days prior to surgery and continued until the completion of radiation therapy (up to 6 months in total) in the absence of disease progression or unacceptable toxicity. Placebo: Given PO or via feeding tube Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies
    id
    EG001
    other Num Affected
    7
    other Num At Risk
    7
    serious Num Affected
    1
    serious Num At Risk
    7
    title
    Placebo Arm
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
      num Events
      1
    term
    Abdominal distension
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Allergic reaction
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      5
      num Events
      5
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      7
      num Events
      3
    term
    Anemia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
      num Events
      2
    term
    Anorexia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Anxiety
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Bone pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
      num Events
      1
    term
    Bruising
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      5
      num Events
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Constipation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
      num Events
      1
    term
    Creatinine increased
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Depression
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      7
      num Events
      2
    term
    Dermatitis radiation
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      5
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Diarrhea
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Hypotension
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Injury, poisoning and procedural complications - Other, specify
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
      num Events
      1
    term
    Postoperative hemorrhage
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Syncope
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Thromboembolic event
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Wound dehiscence
time Frame
Collection of adverse events began on the first dose of study medication until the end of treatment visit (or until a new cancer treatment is initiated). Adverse events were collected for up to 5 months.

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

Preserved source evidence · Not medical advice