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NCT01772706 · ADVERSE EVENTS

Adverse events

Laser Mucite ORL : Effectiveness of Laser Therapy for Mucositis Induced by a Radio-chemotherapy in Head and Neck Cancer · Source last updated 2026-07-01

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
60 months
Other-event reporting threshold
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Laser Low-level Energy Functional

The material used will be a diode laser of 100 mW, with a wavelength of 658 nm. Application will be made after each radiotherapy session in an adapted room (low light intensity, possibility of ENT examination) on all grade superior or equal to 2 stomatitis injuries. The energetic dose delivered will be 4 J/cm2. The duration of the treatment for one will be determined by an abacus. low level laser therapy

11 / 4823 / 480 / 48
Laser Low-level Energy Nonfunctional

The procedure is identical to the one used in arm A but the laser will not be functional. The period of application will be around one minute. placebo (laser low level energy nonfunctional)

8 / 4918 / 490 / 49

Group identifiers: EG000: Laser Low-level Energy Functional · EG001: Laser Low-level Energy Nonfunctional

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
    Infections and infestations
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      48
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      49
      num Events
      2
    term
    Implant site infection
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      48
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      49
      num Events
      0
    term
    pneumopathy
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      48
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      49
      num Events
      0
    term
    Hypovolaemic shock
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      48
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      49
      num Events
      1
    term
    mucite
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      48
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      49
      num Events
      0
    term
    Hemorrhage symptom
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      48
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      49
      num Events
      1
    term
    aphagia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      48
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      49
      num Events
      0
    term
    Diabetic ketoacidosis
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      48
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      49
      num Events
      1
    term
    Renal failure
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      48
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      49
      num Events
      0
    term
    Arrest of urinary output
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      48
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      49
      num Events
      1
    term
    stroke
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      48
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      49
      num Events
      1
    term
    Acute respiratory distress syndrome
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      48
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      49
      num Events
      0
    term
    pneumopathy

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
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      48
      num Events
      23
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      49
      num Events
      18
    term
    mucositis
Complete source fields
event Groups
  1. deaths Num Affected
    0
    deaths Num At Risk
    48
    description
    The material used will be a diode laser of 100 mW, with a wavelength of 658 nm. Application will be made after each radiotherapy session in an adapted room (low light intensity, possibility of ENT examination) on all grade superior or equal to 2 stomatitis injuries. The energetic dose delivered will be 4 J/cm2. The duration of the treatment for one will be determined by an abacus. low level laser therapy
    id
    EG000
    other Num Affected
    23
    other Num At Risk
    48
    serious Num Affected
    11
    serious Num At Risk
    48
    title
    Laser Low-level Energy Functional
  2. deaths Num Affected
    0
    deaths Num At Risk
    49
    description
    The procedure is identical to the one used in arm A but the laser will not be functional. The period of application will be around one minute. placebo (laser low level energy nonfunctional)
    id
    EG001
    other Num Affected
    18
    other Num At Risk
    49
    serious Num Affected
    8
    serious Num At Risk
    49
    title
    Laser Low-level Energy Nonfunctional
frequency Threshold
0
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      48
      num Events
      23
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      49
      num Events
      18
    term
    mucositis
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      48
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      49
      num Events
      2
    term
    Implant site infection
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      48
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      49
      num Events
      0
    term
    pneumopathy
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      48
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      49
      num Events
      0
    term
    Hypovolaemic shock
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      48
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      49
      num Events
      1
    term
    mucite
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      48
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      49
      num Events
      0
    term
    Hemorrhage symptom
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      48
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      49
      num Events
      1
    term
    aphagia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      48
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      49
      num Events
      0
    term
    Diabetic ketoacidosis
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      48
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      49
      num Events
      1
    term
    Renal failure
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      48
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      49
      num Events
      0
    term
    Arrest of urinary output
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      48
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      49
      num Events
      1
    term
    stroke
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      48
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      49
      num Events
      1
    term
    Acute respiratory distress syndrome
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      48
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      49
      num Events
      0
    term
    pneumopathy
time Frame
60 months

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Preserved source evidence · Not medical advice