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NCT01898494 · ADVERSE EVENTS

Adverse events

Transoral Surgery Followed By Low-Dose or Standard-Dose Radiation Therapy With or Without Chemotherapy in Treating Patients With HPV Positive Stage III-IVA Oropharyngeal Cancer · Source last updated 2026-04-01

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
Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Other-event reporting threshold
5%

Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Arm S (Transoral Surgery)

Patients receive transoral surgery.

85 / 495110 / 49524 / 519
Arm A (Observation)

Patients receive observation after transoral surgery.

0 / 491 / 491 / 49
Arm B (Radiotherapy IMRT 50 Gy)

Patients with intermediate risk undergo low-dose (50Gy) intensity modulated radiation therapy (IMRT) once daily (QD) over 25 fractions.

17 / 12057 / 1204 / 126
Arm C (Radiotherapy IMRT 60 Gy)

Patients with intermediate risk undergo standard-dose (60Gy) IMRT QD over 30 fractions.

31 / 12771 / 1277 / 132
Arm D (Cisplatin + IMRT 66 Gy)

High risk patients receive IMRT at 66 Gy QD for 33 fractions. Patients also receive cisplatin intravenously (IV) over 60 minutes on days 1, 8, 15, 22, 29, 36, and 43 during radiation therapy.

81 / 13496 / 1349 / 138

Group identifiers: EG000: Arm S (Transoral Surgery) · EG001: Arm A (Observation) · EG002: Arm B (Radiotherapy IMRT 50 Gy) · EG003: Arm C (Radiotherapy IMRT 60 Gy) · EG004: Arm D (Cisplatin + IMRT 66 Gy)

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
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      495
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      49
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      120
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      127
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      134
    term
    Hearing impaired
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      495
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      49
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      120
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      127
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      134
    term
    Tinnitus
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      495
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      49
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      120
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      127
    5. group Id
      EG004
      num Affected
      5
      num At Risk
      134
    term
    Anemia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      495
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      49
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      120
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      127
    5. group Id
      EG004
      num Affected
      6
      num At Risk
      134
    term
    Febrile neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      495
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      49
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      120
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      127
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      134
    term
    Hemolysis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      495
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      49
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      120
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      127
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      134
    term
    Blood and lymphatic system disorders - Other, specify
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      495
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      49
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      120
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      127
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      134
    term
    Fatigue
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      495
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      49
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      120
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      127
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      134
    term
    Fever
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      495
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      49
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      120
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      127
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      134
    term
    Neck edema
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      495
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      49
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      120
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      127
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      134
    term
    Pain
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      495
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      49
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      120
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      127
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      134
    term
    General disorders and administration site conditions - Other
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      495
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      49
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      120
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      127
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      134
    term
    Hypothyroidism

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
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      495
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      49
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      120
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      127
    5. group Id
      EG004
      num Affected
      9
      num At Risk
      134
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      495
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      49
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      120
    4. group Id
      EG003
      num Affected
      17
      num At Risk
      127
    5. group Id
      EG004
      num Affected
      31
      num At Risk
      134
    term
    Fatigue
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      495
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      49
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      120
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      127
    5. group Id
      EG004
      num Affected
      8
      num At Risk
      134
    term
    Pain
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      495
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      49
    3. group Id
      EG002
      num Affected
      13
      num At Risk
      120
    4. group Id
      EG003
      num Affected
      27
      num At Risk
      127
    5. group Id
      EG004
      num Affected
      19
      num At Risk
      134
    term
    Dry mouth
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      72
      num At Risk
      495
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      49
    3. group Id
      EG002
      num Affected
      14
      num At Risk
      120
    4. group Id
      EG003
      num Affected
      21
      num At Risk
      127
    5. group Id
      EG004
      num Affected
      30
      num At Risk
      134
    term
    Dysphagia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      495
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      49
    3. group Id
      EG002
      num Affected
      26
      num At Risk
      120
    4. group Id
      EG003
      num Affected
      35
      num At Risk
      127
    5. group Id
      EG004
      num Affected
      43
      num At Risk
      134
    term
    Mucositis oral
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      495
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      49
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      120
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      127
    5. group Id
      EG004
      num Affected
      24
      num At Risk
      134
    term
    Nausea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      36
      num At Risk
      495
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      49
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      120
    4. group Id
      EG003
      num Affected
      13
      num At Risk
      127
    5. group Id
      EG004
      num Affected
      19
      num At Risk
      134
    term
    Oral pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      495
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      49
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      120
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      127
    5. group Id
      EG004
      num Affected
      7
      num At Risk
      134
    term
    Vomiting
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      495
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      49
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      120
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      127
    5. group Id
      EG004
      num Affected
      10
      num At Risk
      134
    term
    Mucosal infection
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      495
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      49
    3. group Id
      EG002
      num Affected
      13
      num At Risk
      120
    4. group Id
      EG003
      num Affected
      32
      num At Risk
      127
    5. group Id
      EG004
      num Affected
      42
      num At Risk
      134
    term
    Dermatitis radiation
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      495
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      49
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      120
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      127
    5. group Id
      EG004
      num Affected
      9
      num At Risk
      134
    term
    Neutrophil count decreased
Complete source fields
description
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
event Groups
  1. deaths Num Affected
    24
    deaths Num At Risk
    519
    description
    Patients receive transoral surgery.
    id
    EG000
    other Num Affected
    110
    other Num At Risk
    495
    serious Num Affected
    85
    serious Num At Risk
    495
    title
    Arm S (Transoral Surgery)
  2. deaths Num Affected
    1
    deaths Num At Risk
    49
    description
    Patients receive observation after transoral surgery.
    id
    EG001
    other Num Affected
    1
    other Num At Risk
    49
    serious Num Affected
    0
    serious Num At Risk
    49
    title
    Arm A (Observation)
  3. deaths Num Affected
    4
    deaths Num At Risk
    126
    description
    Patients with intermediate risk undergo low-dose (50Gy) intensity modulated radiation therapy (IMRT) once daily (QD) over 25 fractions.
    id
    EG002
    other Num Affected
    57
    other Num At Risk
    120
    serious Num Affected
    17
    serious Num At Risk
    120
    title
    Arm B (Radiotherapy IMRT 50 Gy)
  4. deaths Num Affected
    7
    deaths Num At Risk
    132
    description
    Patients with intermediate risk undergo standard-dose (60Gy) IMRT QD over 30 fractions.
    id
    EG003
    other Num Affected
    71
    other Num At Risk
    127
    serious Num Affected
    31
    serious Num At Risk
    127
    title
    Arm C (Radiotherapy IMRT 60 Gy)
  5. deaths Num Affected
    9
    deaths Num At Risk
    138
    description
    High risk patients receive IMRT at 66 Gy QD for 33 fractions. Patients also receive cisplatin intravenously (IV) over 60 minutes on days 1, 8, 15, 22, 29, 36, and 43 during radiation therapy.
    id
    EG004
    other Num Affected
    96
    other Num At Risk
    134
    serious Num Affected
    81
    serious Num At Risk
    134
    title
    Arm D (Cisplatin + IMRT 66 Gy)
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      495
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      49
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      120
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      127
    5. group Id
      EG004
      num Affected
      9
      num At Risk
      134
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      495
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      49
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      120
    4. group Id
      EG003
      num Affected
      17
      num At Risk
      127
    5. group Id
      EG004
      num Affected
      31
      num At Risk
      134
    term
    Fatigue
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      495
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      49
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      120
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      127
    5. group Id
      EG004
      num Affected
      8
      num At Risk
      134
    term
    Pain
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      495
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      49
    3. group Id
      EG002
      num Affected
      13
      num At Risk
      120
    4. group Id
      EG003
      num Affected
      27
      num At Risk
      127
    5. group Id
      EG004
      num Affected
      19
      num At Risk
      134
    term
    Dry mouth
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      72
      num At Risk
      495
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      49
    3. group Id
      EG002
      num Affected
      14
      num At Risk
      120
    4. group Id
      EG003
      num Affected
      21
      num At Risk
      127
    5. group Id
      EG004
      num Affected
      30
      num At Risk
      134
    term
    Dysphagia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      495
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      49
    3. group Id
      EG002
      num Affected
      26
      num At Risk
      120
    4. group Id
      EG003
      num Affected
      35
      num At Risk
      127
    5. group Id
      EG004
      num Affected
      43
      num At Risk
      134
    term
    Mucositis oral
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      495
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      49
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      120
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      127
    5. group Id
      EG004
      num Affected
      24
      num At Risk
      134
    term
    Nausea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      36
      num At Risk
      495
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      49
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      120
    4. group Id
      EG003
      num Affected
      13
      num At Risk
      127
    5. group Id
      EG004
      num Affected
      19
      num At Risk
      134
    term
    Oral pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      495
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      49
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      120
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      127
    5. group Id
      EG004
      num Affected
      7
      num At Risk
      134
    term
    Vomiting
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      495
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      49
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      120
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      127
    5. group Id
      EG004
      num Affected
      10
      num At Risk
      134
    term
    Mucosal infection
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      495
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      49
    3. group Id
      EG002
      num Affected
      13
      num At Risk
      120
    4. group Id
      EG003
      num Affected
      32
      num At Risk
      127
    5. group Id
      EG004
      num Affected
      42
      num At Risk
      134
    term
    Dermatitis radiation
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      495
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      49
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      120
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      127
    5. group Id
      EG004
      num Affected
      9
      num At Risk
      134
    term
    Neutrophil count decreased
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      495
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      49
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      120
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      127
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      134
    term
    Hearing impaired
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      495
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      49
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      120
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      127
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      134
    term
    Tinnitus
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      495
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      49
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      120
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      127
    5. group Id
      EG004
      num Affected
      5
      num At Risk
      134
    term
    Anemia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      495
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      49
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      120
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      127
    5. group Id
      EG004
      num Affected
      6
      num At Risk
      134
    term
    Febrile neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      495
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      49
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      120
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      127
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      134
    term
    Hemolysis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      495
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      49
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      120
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      127
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      134
    term
    Blood and lymphatic system disorders - Other, specify
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      495
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      49
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      120
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      127
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      134
    term
    Fatigue
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      495
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      49
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      120
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      127
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      134
    term
    Fever
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      495
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      49
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      120
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      127
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      134
    term
    Neck edema
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      495
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      49
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      120
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      127
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      134
    term
    Pain
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      495
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      49
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      120
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      127
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      134
    term
    General disorders and administration site conditions - Other
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      495
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      49
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      120
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      127
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      134
    term
    Hypothyroidism
time Frame
Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration

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Preserved source evidence · Not medical advice