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NCT00588770 · ADVERSE EVENTS

Adverse events

Chemotherapy With or Without Bevacizumab in Treating Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma · Source last updated 2026-08-28

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 at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events)
Other-event reporting threshold
5%

At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Chemotherapy (Arm A)

ARM A: Patients receive one of the four chemotherapy regimens ARM IA: Patients receive chemotherapy comprising docetaxel intravenously (IV) over 1 hour and cisplatin IV over 1-2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. ARM IIA: Patients receive docetaxel IV over 1 hour and carboplatin IV over 30 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. ARM IIIA: Patients receive cisplatin IV over 1-2 hours on day 1 and fluorouracil IV continuously on days 1-4. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. ARM IVA: Patients receive carboplatin IV over 30 minutes on day 1 and fluorouracil IV continuously on days 1-4. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

135 / 19950 / 199182 / 200
Chemotherapy + Bevacizumab (Arm B)

ARM B: Patients receive bevacizumab in addition to the chemotherapy regimen as in arm A ARM IB: Patients receive bevacizumab IV over 30-90 minutes on day 1 and docetaxel and cisplatin as in Arm IA. ARM IIB: Patients receive bevacizumab as in arm IB and docetaxel and carboplatin as in Arm IIA. ARM IIIB: Patients receive bevacizumab as in Arm IB and cisplatin and fluorouracil as in Arm IIIA. ARM IVB: Patients receive bevacizumab as in Arm IB and carboplatin and fluorouracil as in Arm IVA.

162 / 19350 / 193175 / 203

Group identifiers: EG000: Chemotherapy (Arm A) · EG001: Chemotherapy + Bevacizumab (Arm B)

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
      1
      num At Risk
      199
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      193
    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
      1
      num At Risk
      199
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      193
    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
      17
      num At Risk
      199
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      193
    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
      19
      num At Risk
      199
    2. group Id
      EG001
      num Affected
      35
      num At Risk
      193
    term
    Febrile neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      199
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      193
    term
    Asystole
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      199
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      193
    term
    Atrial fibrillation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      199
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      193
    term
    Cardiac arrest
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      199
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      193
    term
    Chest pain - cardiac
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      199
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      193
    term
    Left ventricular systolic dysfunction
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      199
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      193
    term
    Myocardial infarction
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      199
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      193
    term
    Supraventricular tachycardia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      199
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      193
    term
    Ventricular arrhythmia

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
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      199
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      193
    term
    Fatigue
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      199
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      193
    term
    Alopecia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      199
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      193
    term
    Platelet count decreased
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      199
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      193
    term
    Anorexia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      199
    2. group Id
      EG001
      num Affected
      24
      num At Risk
      193
    term
    Peripheral sensory neuropathy
Complete source fields
description
At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.
event Groups
  1. deaths Num Affected
    182
    deaths Num At Risk
    200
    description
    ARM A: Patients receive one of the four chemotherapy regimens ARM IA: Patients receive chemotherapy comprising docetaxel intravenously (IV) over 1 hour and cisplatin IV over 1-2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. ARM IIA: Patients receive docetaxel IV over 1 hour and carboplatin IV over 30 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. ARM IIIA: Patients receive cisplatin IV over 1-2 hours on day 1 and fluorouracil IV continuously on days 1-4. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. ARM IVA: Patients receive carboplatin IV over 30 minutes on day 1 and fluorouracil IV continuously on days 1-4. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
    id
    EG000
    other Num Affected
    50
    other Num At Risk
    199
    serious Num Affected
    135
    serious Num At Risk
    199
    title
    Chemotherapy (Arm A)
  2. deaths Num Affected
    175
    deaths Num At Risk
    203
    description
    ARM B: Patients receive bevacizumab in addition to the chemotherapy regimen as in arm A ARM IB: Patients receive bevacizumab IV over 30-90 minutes on day 1 and docetaxel and cisplatin as in Arm IA. ARM IIB: Patients receive bevacizumab as in arm IB and docetaxel and carboplatin as in Arm IIA. ARM IIIB: Patients receive bevacizumab as in Arm IB and cisplatin and fluorouracil as in Arm IIIA. ARM IVB: Patients receive bevacizumab as in Arm IB and carboplatin and fluorouracil as in Arm IVA.
    id
    EG001
    other Num Affected
    50
    other Num At Risk
    193
    serious Num Affected
    162
    serious Num At Risk
    193
    title
    Chemotherapy + Bevacizumab (Arm B)
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      199
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      193
    term
    Fatigue
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      199
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      193
    term
    Alopecia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      199
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      193
    term
    Platelet count decreased
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      199
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      193
    term
    Anorexia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      199
    2. group Id
      EG001
      num Affected
      24
      num At Risk
      193
    term
    Peripheral sensory neuropathy
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
      1
      num At Risk
      199
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      193
    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
      1
      num At Risk
      199
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      193
    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
      17
      num At Risk
      199
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      193
    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
      19
      num At Risk
      199
    2. group Id
      EG001
      num Affected
      35
      num At Risk
      193
    term
    Febrile neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      199
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      193
    term
    Asystole
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      199
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      193
    term
    Atrial fibrillation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      199
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      193
    term
    Cardiac arrest
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      199
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      193
    term
    Chest pain - cardiac
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      199
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      193
    term
    Left ventricular systolic dysfunction
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      199
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      193
    term
    Myocardial infarction
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      199
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      193
    term
    Supraventricular tachycardia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      199
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      193
    term
    Ventricular arrhythmia
time Frame
Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events)

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