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NCT03656133 · ADVERSE EVENTS

Adverse events

Use of a Proliferation Saturation Index to Determine Personalized Radiotherapy for HPV + Oropharyngeal Cancers · Source last updated 2026-02-20

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
Adverse events were collected from date participant signed informed consent to 7 days for non serious or 30 days for serious adverse events after last day of study participation, an average of 1 year.
Other-event reporting threshold
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Radiotherapy Fractionation

Radiotherapy fractionation: Standard fractionation at 2Gy once daily or Hyperfractionation at 1.2 Gy twice daily (≥ 6 hours apart)

1 / 557 / 552 / 55

Group identifiers: EG000: Radiotherapy Fractionation

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 5
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      55
      num Events
      1
    term
    Diarrhea
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE 5
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      55
      num Events
      1
    term
    Nausea

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
    Gastrointestinal disorders
    source Vocabulary
    CTCAE 5
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      55
      num Events
      6
    term
    Mucositis oral
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE 5
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      55
      num Events
      1
    term
    Diarrhea
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE 5
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      55
      num Events
      1
    term
    Dry mouth
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE 5
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      55
      num Events
      1
    term
    Nausea
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    CTCAE 5
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      55
      num Events
      4
    term
    Dermatitis radiation
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE 5
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      55
      num Events
      3
    term
    Pharyngeal mucositis
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE 5
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      55
      num Events
      1
    term
    Sore throat
Complete source fields
event Groups
  1. deaths Num Affected
    2
    deaths Num At Risk
    55
    description
    Radiotherapy fractionation: Standard fractionation at 2Gy once daily or Hyperfractionation at 1.2 Gy twice daily (≥ 6 hours apart)
    id
    EG000
    other Num Affected
    7
    other Num At Risk
    55
    serious Num Affected
    1
    serious Num At Risk
    55
    title
    Radiotherapy Fractionation
frequency Threshold
0
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE 5
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      55
      num Events
      6
    term
    Mucositis oral
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE 5
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      55
      num Events
      1
    term
    Diarrhea
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE 5
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      55
      num Events
      1
    term
    Dry mouth
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE 5
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      55
      num Events
      1
    term
    Nausea
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    CTCAE 5
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      55
      num Events
      4
    term
    Dermatitis radiation
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE 5
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      55
      num Events
      3
    term
    Pharyngeal mucositis
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE 5
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      55
      num Events
      1
    term
    Sore throat
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE 5
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      55
      num Events
      1
    term
    Diarrhea
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE 5
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      55
      num Events
      1
    term
    Nausea
time Frame
Adverse events were collected from date participant signed informed consent to 7 days for non serious or 30 days for serious adverse events after last day of study participation, an average of 1 year.

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

Preserved source evidence · Not medical advice