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NCT00503776 · ADVERSE EVENTS

Adverse events

Chemo/XRT +/- Amifostine to Assess Outcomes Related to Xerostomia, Mucositis, & Dysphagia · Source last updated 2017-06-20

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%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Arm IA

Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction.

0 / 87 / 8Not reported / Not reported
Arm IB

Patients undergo SNT and low weight resistance training (LWRT).

0 / 1212 / 12Not reported / Not reported
Arm IIA

Patients receive amifostine subcutaneously (SC) 30-60 minutes prior to each dose of intensity-modulated radiotherapy (IMRT). Patients also undergo SNT as in arm IA.

2 / 1210 / 12Not reported / Not reported
Arm IIB

Patients receive amifostine SC 30-60 minutes prior to each dose of IMRT. Patients also undergo SNT and LWRT as in arm IB.

4 / 98 / 9Not reported / Not reported

Group identifiers: EG000: Arm IA · EG001: Arm IB · EG002: Arm IIA · EG003: Arm IIB

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. organ System
    Ear and labyrinth disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      9
      num Events
      1
    term
    accute hearing loss
  2. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      12
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Diarrhea
  3. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      12
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Constipation
  4. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      12
      num Events
      1
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      9
      num Events
      3
    term
    mucositis/stomatitis-oral cavity
  5. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      12
      num Events
      1
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      9
      num Events
      2
    term
    Nausea
  6. organ System
    Skin and subcutaneous tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      9
      num Events
      1
    term
    Muscle weakness - lower extremity
  7. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      12
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Pain - abdomen NOS
  8. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      12
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    pain - larynx
  9. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      9
      num Events
      1
    term
    pain - oral cavity
  10. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      9
      num Events
      1
    term
    pain - NOS
  11. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      12
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    pain - rectal
  12. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      12
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Fever-in absence of neutropenia

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      8
      num Events
      22
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      12
      num Events
      23
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      12
      num Events
      24
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      9
      num Events
      14
    term
    constipation
  2. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      8
      num Events
      8
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      12
      num Events
      4
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      12
      num Events
      4
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      9
      num Events
      4
    term
    diarrhea
  3. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      8
      num Events
      17
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      12
      num Events
      30
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      12
      num Events
      29
    4. group Id
      EG003
      num Affected
      8
      num At Risk
      9
      num Events
      23
    term
    difficulty chewing
  4. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      8
      num Events
      32
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      12
      num Events
      46
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      12
      num Events
      42
    4. group Id
      EG003
      num Affected
      8
      num At Risk
      9
      num Events
      34
    term
    dysphagia
  5. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      8
      num Events
      29
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      12
      num Events
      40
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      12
      num Events
      33
    4. group Id
      EG003
      num Affected
      8
      num At Risk
      9
      num Events
      32
    term
    mucositis
  6. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      8
      num Events
      21
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      12
      num Events
      13
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      12
      num Events
      17
    4. group Id
      EG003
      num Affected
      8
      num At Risk
      9
      num Events
      15
    term
    nausea
  7. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      8
      num Events
      13
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      12
      num Events
      12
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      12
      num Events
      12
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      9
      num Events
      8
    term
    vomiting
  8. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      8
      num Events
      32
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      12
      num Events
      46
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      12
      num Events
      40
    4. group Id
      EG003
      num Affected
      8
      num At Risk
      9
      num Events
      31
    term
    dry mouth
Complete source fields
event Groups
  1. description
    Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction.
    id
    EG000
    other Num Affected
    7
    other Num At Risk
    8
    serious Num Affected
    0
    serious Num At Risk
    8
    title
    Arm IA
  2. description
    Patients undergo SNT and low weight resistance training (LWRT).
    id
    EG001
    other Num Affected
    12
    other Num At Risk
    12
    serious Num Affected
    0
    serious Num At Risk
    12
    title
    Arm IB
  3. description
    Patients receive amifostine subcutaneously (SC) 30-60 minutes prior to each dose of intensity-modulated radiotherapy (IMRT). Patients also undergo SNT as in arm IA.
    id
    EG002
    other Num Affected
    10
    other Num At Risk
    12
    serious Num Affected
    2
    serious Num At Risk
    12
    title
    Arm IIA
  4. description
    Patients receive amifostine SC 30-60 minutes prior to each dose of IMRT. Patients also undergo SNT and LWRT as in arm IB.
    id
    EG003
    other Num Affected
    8
    other Num At Risk
    9
    serious Num Affected
    4
    serious Num At Risk
    9
    title
    Arm IIB
frequency Threshold
5
other Events
  1. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      8
      num Events
      22
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      12
      num Events
      23
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      12
      num Events
      24
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      9
      num Events
      14
    term
    constipation
  2. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      8
      num Events
      8
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      12
      num Events
      4
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      12
      num Events
      4
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      9
      num Events
      4
    term
    diarrhea
  3. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      8
      num Events
      17
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      12
      num Events
      30
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      12
      num Events
      29
    4. group Id
      EG003
      num Affected
      8
      num At Risk
      9
      num Events
      23
    term
    difficulty chewing
  4. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      8
      num Events
      32
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      12
      num Events
      46
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      12
      num Events
      42
    4. group Id
      EG003
      num Affected
      8
      num At Risk
      9
      num Events
      34
    term
    dysphagia
  5. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      8
      num Events
      29
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      12
      num Events
      40
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      12
      num Events
      33
    4. group Id
      EG003
      num Affected
      8
      num At Risk
      9
      num Events
      32
    term
    mucositis
  6. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      8
      num Events
      21
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      12
      num Events
      13
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      12
      num Events
      17
    4. group Id
      EG003
      num Affected
      8
      num At Risk
      9
      num Events
      15
    term
    nausea
  7. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      8
      num Events
      13
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      12
      num Events
      12
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      12
      num Events
      12
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      9
      num Events
      8
    term
    vomiting
  8. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      8
      num Events
      32
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      12
      num Events
      46
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      12
      num Events
      40
    4. group Id
      EG003
      num Affected
      8
      num At Risk
      9
      num Events
      31
    term
    dry mouth
serious Events
  1. organ System
    Ear and labyrinth disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      9
      num Events
      1
    term
    accute hearing loss
  2. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      12
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Diarrhea
  3. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      12
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Constipation
  4. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      12
      num Events
      1
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      9
      num Events
      3
    term
    mucositis/stomatitis-oral cavity
  5. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      12
      num Events
      1
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      9
      num Events
      2
    term
    Nausea
  6. organ System
    Skin and subcutaneous tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      9
      num Events
      1
    term
    Muscle weakness - lower extremity
  7. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      12
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Pain - abdomen NOS
  8. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      12
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    pain - larynx
  9. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      9
      num Events
      1
    term
    pain - oral cavity
  10. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      9
      num Events
      1
    term
    pain - NOS
  11. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      12
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    pain - rectal
  12. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      12
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Fever-in absence of neutropenia

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Preserved source evidence · Not medical advice