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NCT04000880 · ADVERSE EVENTS

Adverse events

Adapting Multiple Behavior Interventions That Effectively Improve Cancer Survivor Health Cancer Survivor Health · Source last updated 2026-07-02

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
Adverse event data were collected from Baseline to 12-month period
Other-event reporting threshold
0%

The definitions of serious and non-serious adverse events were consistent with those used by ClinicalTrials.gov. but participants could report more than one adverse event, categories are not mutually exclusive.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Project 1: Diet-Exercise

Participants will receive and participate in web-based sessions that focus on diet for 6 months, followed by exercise for another 6 months. Participants will be encouraged to track their diet and weight for the first 6 months and to log their data in the intervention website, during the second 6 months they will be asked to log their physical activity data (minutes and step counts). Tailored feedback and goal recommendations will be provided through the website. Participants will also receive access to resources for relevant behavioral topics. All participants will be invited to participate in the secret Facebook group for the project (though participation is optional).

9 / 15147 / 1510 / 151
Project 2: Exercise-Diet

Participants will receive and participate in web-based sessions that focus on diet for 6 months, followed by exercise for another 6 months. Participants will be encouraged to track their diet and weight for the first 6 months and to log their data in the intervention website, during the second 6 months they will be asked to log their physical activity data (minutes and step counts). Tailored feedback and goal recommendations will be provided through the website. Participants will also receive access to resources for relevant behavioral topics. All participants will be invited to participate in the secret Facebook group for the project (though participation is optional).

6 / 15141 / 1511 / 151
Project 3: Combined Diet and Exercise

Participants will receive the diet and exercise content simultaneously in combined web-based sessions. Participants will receive and participate in web-based sessions that focus on diet and exercise for 12 months. Participants will be encouraged to track their diet, weight and physical activity data (minutes and step counts). Tailored feedback and goal recommendations will be provided through the website. Participants will also receive access to resources for relevant behavioral topics. All participants will be invited to participate in the secret Facebook group for the project (though participation is optional).

10 / 30146 / 3010 / 301

Group identifiers: EG000: Project 1: Diet-Exercise · EG001: Project 2: Exercise-Diet · EG002: Project 3: Combined Diet and Exercise

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
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      151
      num Events
      4
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      151
      num Events
      4
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      301
      num Events
      3
    term
    Second cancer or recurrence
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Kidney stones, hyponatremia
    organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      151
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      151
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      301
      num Events
      1
    term
    Kidney related problems
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      151
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      151
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      301
      num Events
      0
    term
    psychiatric reaction
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      151
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      151
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      301
      num Events
      0
    term
    Cellulitis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Aortic stenosis, high blood pressure, mini stroke, blood clots
    organ System
    Vascular disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      151
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      151
      num Events
      1
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      301
      num Events
      2
    term
    Vascular events
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    bowel obstruction, perforated colon
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      151
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      151
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      301
      num Events
      2
    term
    GI Events
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    car accident
    organ System
    Injury, poisoning and procedural complications
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      151
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      151
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      301
      num Events
      0
    term
    Accident
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      151
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      151
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      301
      num Events
      1
    term
    Anemia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Social circumstances
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      151
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      151
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      301
      num Events
      1
    term
    Hospice

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
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      151
      num Events
      6
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      151
      num Events
      10
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      301
      num Events
      11
    term
    Attributable
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      41
      num At Risk
      151
      num Events
      58
    2. group Id
      EG001
      num Affected
      32
      num At Risk
      151
      num Events
      42
    3. group Id
      EG002
      num Affected
      35
      num At Risk
      301
      num Events
      46
    term
    Non-Attributable
Complete source fields
description
The definitions of serious and non-serious adverse events were consistent with those used by ClinicalTrials.gov. but participants could report more than one adverse event, categories are not mutually exclusive.
event Groups
  1. deaths Num Affected
    0
    deaths Num At Risk
    151
    description
    Participants will receive and participate in web-based sessions that focus on diet for 6 months, followed by exercise for another 6 months. Participants will be encouraged to track their diet and weight for the first 6 months and to log their data in the intervention website, during the second 6 months they will be asked to log their physical activity data (minutes and step counts). Tailored feedback and goal recommendations will be provided through the website. Participants will also receive access to resources for relevant behavioral topics. All participants will be invited to participate in the secret Facebook group for the project (though participation is optional).
    id
    EG000
    other Num Affected
    47
    other Num At Risk
    151
    serious Num Affected
    9
    serious Num At Risk
    151
    title
    Project 1: Diet-Exercise
  2. deaths Num Affected
    1
    deaths Num At Risk
    151
    description
    Participants will receive and participate in web-based sessions that focus on diet for 6 months, followed by exercise for another 6 months. Participants will be encouraged to track their diet and weight for the first 6 months and to log their data in the intervention website, during the second 6 months they will be asked to log their physical activity data (minutes and step counts). Tailored feedback and goal recommendations will be provided through the website. Participants will also receive access to resources for relevant behavioral topics. All participants will be invited to participate in the secret Facebook group for the project (though participation is optional).
    id
    EG001
    other Num Affected
    41
    other Num At Risk
    151
    serious Num Affected
    6
    serious Num At Risk
    151
    title
    Project 2: Exercise-Diet
  3. deaths Num Affected
    0
    deaths Num At Risk
    301
    description
    Participants will receive the diet and exercise content simultaneously in combined web-based sessions. Participants will receive and participate in web-based sessions that focus on diet and exercise for 12 months. Participants will be encouraged to track their diet, weight and physical activity data (minutes and step counts). Tailored feedback and goal recommendations will be provided through the website. Participants will also receive access to resources for relevant behavioral topics. All participants will be invited to participate in the secret Facebook group for the project (though participation is optional).
    id
    EG002
    other Num Affected
    46
    other Num At Risk
    301
    serious Num Affected
    10
    serious Num At Risk
    301
    title
    Project 3: Combined Diet and Exercise
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      151
      num Events
      6
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      151
      num Events
      10
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      301
      num Events
      11
    term
    Attributable
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      41
      num At Risk
      151
      num Events
      58
    2. group Id
      EG001
      num Affected
      32
      num At Risk
      151
      num Events
      42
    3. group Id
      EG002
      num Affected
      35
      num At Risk
      301
      num Events
      46
    term
    Non-Attributable
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      151
      num Events
      4
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      151
      num Events
      4
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      301
      num Events
      3
    term
    Second cancer or recurrence
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Kidney stones, hyponatremia
    organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      151
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      151
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      301
      num Events
      1
    term
    Kidney related problems
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      151
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      151
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      301
      num Events
      0
    term
    psychiatric reaction
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      151
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      151
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      301
      num Events
      0
    term
    Cellulitis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Aortic stenosis, high blood pressure, mini stroke, blood clots
    organ System
    Vascular disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      151
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      151
      num Events
      1
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      301
      num Events
      2
    term
    Vascular events
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    bowel obstruction, perforated colon
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      151
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      151
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      301
      num Events
      2
    term
    GI Events
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    car accident
    organ System
    Injury, poisoning and procedural complications
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      151
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      151
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      301
      num Events
      0
    term
    Accident
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      151
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      151
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      301
      num Events
      1
    term
    Anemia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Social circumstances
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      151
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      151
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      301
      num Events
      1
    term
    Hospice
time Frame
Adverse event data were collected from Baseline to 12-month period

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Preserved source evidence · Not medical advice