Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00656513 · ADVERSE EVENTS

Adverse events

Acupuncture-Like Transcutaneous Electrical Nerve Stimulation (ALTENS) or Pilocarpine in Treating Early Dry Mouth in Patients Undergoing Radiation Therapy for Head and Neck Cancer · Source last updated 2019-11-19

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
Not reported
Other-event reporting threshold
5%

Adverse events are reported for all eligible patients who started protocol treatment. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
ALTENS: Phase II

Acupuncture-like transcutaneous electrical nerve stimulation (ALTENS) twice weekly for 12 weeks via a Codetron unit

1 / 477 / 47Not reported / Not reported
Pilocarpine: Phase III

5mg pilocarpine by mouth 3 times a day for 12 weeks

0 / 7351 / 73Not reported / Not reported
ALTENS: Phase III

Acupuncture-like transcutaneous electrical nerve stimulation (ALTENS) twice weekly for 12 weeks via a Codetron unit

1 / 7227 / 72Not reported / Not reported

Group identifiers: EG000: ALTENS: Phase II · EG001: Pilocarpine: Phase III · EG002: ALTENS: Phase III

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
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      73
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      72
    term
    Gastrointestinal disorder
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      73
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      72
    term
    Appendicitis perforated

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
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      73
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      72
    term
    Tinnitus
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      73
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      72
    term
    Vision blurred
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      73
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      72
    term
    Constipation
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      73
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      72
    term
    Diarrhea
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      73
    3. group Id
      EG002
      num Affected
      18
      num At Risk
      72
    term
    Dry mouth
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      73
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      72
    term
    Dysphagia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      73
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      72
    term
    Chills
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      73
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      72
    term
    Fatigue
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      73
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      72
    term
    Localized edema [head and neck]
  10. assessment Type
    NON_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
      47
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      73
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      72
    term
    Neck pain
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      73
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      72
    term
    Dizziness
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      73
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      72
    term
    Headache
Complete source fields
description
Adverse events are reported for all eligible patients who started protocol treatment. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
event Groups
  1. description
    Acupuncture-like transcutaneous electrical nerve stimulation (ALTENS) twice weekly for 12 weeks via a Codetron unit
    id
    EG000
    other Num Affected
    7
    other Num At Risk
    47
    serious Num Affected
    1
    serious Num At Risk
    47
    title
    ALTENS: Phase II
  2. description
    5mg pilocarpine by mouth 3 times a day for 12 weeks
    id
    EG001
    other Num Affected
    51
    other Num At Risk
    73
    serious Num Affected
    0
    serious Num At Risk
    73
    title
    Pilocarpine: Phase III
  3. description
    Acupuncture-like transcutaneous electrical nerve stimulation (ALTENS) twice weekly for 12 weeks via a Codetron unit
    id
    EG002
    other Num Affected
    27
    other Num At Risk
    72
    serious Num Affected
    1
    serious Num At Risk
    72
    title
    ALTENS: Phase III
frequency Threshold
5
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      73
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      72
    term
    Tinnitus
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      73
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      72
    term
    Vision blurred
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      73
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      72
    term
    Constipation
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      73
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      72
    term
    Diarrhea
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      73
    3. group Id
      EG002
      num Affected
      18
      num At Risk
      72
    term
    Dry mouth
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      73
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      72
    term
    Dysphagia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      73
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      72
    term
    Chills
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      73
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      72
    term
    Fatigue
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      73
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      72
    term
    Localized edema [head and neck]
  10. assessment Type
    NON_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
      47
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      73
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      72
    term
    Neck pain
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      73
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      72
    term
    Dizziness
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      73
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      72
    term
    Headache
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      73
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      72
    term
    Gastrointestinal disorder
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      73
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      72
    term
    Appendicitis perforated

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

Preserved source evidence · Not medical advice