Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00064298 · ADVERSE EVENTS

Adverse events

Fruit and Vegetable Extracts in Treating Patients With Stage I-IV, Stage IVA/IVB Head and Neck Cancer · Source last updated 2021-09-28

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
12 weeks
Other-event reporting threshold
4.4%

Sample size is number of participants with follow-up toxicity data recorded.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Arm I - JuicePlus

Patients receive oral fruit and vegetable extracts twice daily. fruit and vegetable extracts: Given orally

2 / 6821 / 68Not reported / Not reported
Arm II - Control

Patients receive oral placebo twice daily. placebo: Given orally

2 / 5916 / 59Not reported / Not reported

Group identifiers: EG000: Arm I - JuicePlus · EG001: Arm II - Control

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
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      68
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      59
      num Events
      0
    term
    Dehydration
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      68
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      59
      num Events
      0
    term
    Headache
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      68
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      59
      num Events
      0
    term
    Pain
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      68
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      59
      num Events
      1
    term
    Ataxia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      68
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      59
      num Events
      1
    term
    Fatigue
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      68
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      59
      num Events
      1
    term
    Mood Change

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
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      68
      num Events
      5
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      59
      num Events
      5
    term
    Diarrhea
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      68
      num Events
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      59
      num Events
      0
    term
    Dysphagia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      68
      num Events
      7
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      59
      num Events
      7
    term
    Fatigue
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      68
      num Events
      0
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      59
      num Events
      4
    term
    Gas
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      68
      num Events
      7
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      59
      num Events
      12
    term
    Heartburn
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      68
      num Events
      1
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      59
      num Events
      3
    term
    Nausea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      68
      num Events
      3
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      59
      num Events
      3
    term
    Pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      68
      num Events
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      59
      num Events
      0
    term
    SOB
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      68
      num Events
      11
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      59
      num Events
      2
    term
    Taste Alteration
Complete source fields
description
Sample size is number of participants with follow-up toxicity data recorded.
event Groups
  1. description
    Patients receive oral fruit and vegetable extracts twice daily. fruit and vegetable extracts: Given orally
    id
    EG000
    other Num Affected
    21
    other Num At Risk
    68
    serious Num Affected
    2
    serious Num At Risk
    68
    title
    Arm I - JuicePlus
  2. description
    Patients receive oral placebo twice daily. placebo: Given orally
    id
    EG001
    other Num Affected
    16
    other Num At Risk
    59
    serious Num Affected
    2
    serious Num At Risk
    59
    title
    Arm II - Control
frequency Threshold
4.4
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      68
      num Events
      5
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      59
      num Events
      5
    term
    Diarrhea
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      68
      num Events
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      59
      num Events
      0
    term
    Dysphagia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      68
      num Events
      7
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      59
      num Events
      7
    term
    Fatigue
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      68
      num Events
      0
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      59
      num Events
      4
    term
    Gas
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      68
      num Events
      7
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      59
      num Events
      12
    term
    Heartburn
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      68
      num Events
      1
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      59
      num Events
      3
    term
    Nausea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      68
      num Events
      3
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      59
      num Events
      3
    term
    Pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      68
      num Events
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      59
      num Events
      0
    term
    SOB
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      68
      num Events
      11
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      59
      num Events
      2
    term
    Taste Alteration
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      68
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      59
      num Events
      0
    term
    Dehydration
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      68
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      59
      num Events
      0
    term
    Headache
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      68
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      59
      num Events
      0
    term
    Pain
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      68
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      59
      num Events
      1
    term
    Ataxia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      68
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      59
      num Events
      1
    term
    Fatigue
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      68
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      59
      num Events
      1
    term
    Mood Change
time Frame
12 weeks

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

Preserved source evidence · Not medical advice