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NCT00566540 · ADVERSE EVENTS

Adverse events

Ph 2 Intensification Regimen for Previously Untreated, Resectable, Advanced Squamous Cell Cancer · Source last updated 2021-11-26

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
Not reported
Other-event reporting threshold
5%

Adverse events were graded using the NCI Common Toxicity Criteria version 3.0.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Treatment (Neoadjuvant, Adjuvant Chemotherapy and Radiation)

PREOPERATIVE:Patients receive cisplatin IV over 2 hours 3 times weekly in week 1 once daily(QD),5 days a week, in weeks 1-2. SURGERY:Patients undergo triple endoscopy and biopsy with submandibular gland transfer in week 3. INTRAOPERATIVE: Patients also undergo Intensity-Modulated Radiation Therapy (IMRT) External Beam Radiation. POSTOPERATIVE: Patients receive paclitaxel IV over 3 hours in weeks 7-10 and cisplatin IV over 1-2 hours three times weekly in weeks 7 and 10. Patients also undergo Intensity-Modulated Radiation Therapy (IMRT) External Beam Radiation QD, 5 days a week, in weeks 7-10. Cisplatin: Patients will receive Cisplatin (30 mg/m2 i.v.) daily x 3 days in week 1. Paclitaxel: Patients will receive Paclitaxel (45 mg/m2i.v.) infusion over 3 hours during weeks 7,8,9,10 Intensity-Modulated Radiation Therapy (IMRT) External Beam Radiation: Patients will receive Intensity-Modulated Radiation Therapy (IMRT) External Beam Radiation to tumor and involved regional nod

11 / 1111 / 112 / 11

Group identifiers: EG000: Treatment (Neoadjuvant, Adjuvant Chemotherapy and Radiation)

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
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE version 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
      num Events
      1
    term
    Leukocytes (total WBC)
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE version 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
      num Events
      1
    term
    Rash: dermatitis associated with radiation - Chemoradiation
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE version 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
      num Events
      1
    term
    Colitis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE version 3.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      11
      num Events
      2
    term
    Dehydration
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE version 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
      num Events
      1
    term
    Diarrhea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE version 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
      num Events
      1
    term
    Vomiting
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE version 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
      num Events
      1
    term
    Hemorrhage, pulmonary/upper respiratory - Respiratory tract NOS
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE version 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
      num Events
      1
    term
    Infection with normal ANC or Grade 1 or 2 neutrophils - Lung (pneumonia)
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE version 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
      num Events
      1
    term
    Infection with normal ANC or Grade 1 or 2 neutrophils - Neck NOS
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE version 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
      num Events
      1
    term
    Infection with normal ANC or Grade 1 or 2 neutrophils - Oral cavity-gums (gingivitis)
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE version 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
      num Events
      1
    term
    Edema: limb

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
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE version 3.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      11
      num Events
      6
    term
    Extremity pain
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE version 3.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      11
      num Events
      4
    term
    Edema-limb
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE version 3.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      11
      num Events
      10
    term
    Oral cavity pain
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE version 3.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      11
      num Events
      4
    term
    Hyperglycemia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE version 3.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      11
      num Events
      4
    term
    Salivary gland changes
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    oral cavity
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE version 3.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      11
      num Events
      10
    term
    Mucositis/stomatitis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE version 3.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      11
      num Events
      4
    term
    Pulmonary/upper respiratory
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE version 3.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      11
      num Events
      6
    term
    Neck pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE version 3.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      11
      num Events
      3
    term
    Hypoalbuminemia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE version 3.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      11
      num Events
      10
    term
    Fatigue
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE version 3.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      11
      num Events
      10
    term
    Dry mouth/salivary gland (xerostomia)
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE version 3.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      11
      num Events
      5
    term
    Neutrophils/granulocytes/ANC
Complete source fields
description
Adverse events were graded using the NCI Common Toxicity Criteria version 3.0.
event Groups
  1. deaths Num Affected
    2
    deaths Num At Risk
    11
    description
    PREOPERATIVE:Patients receive cisplatin IV over 2 hours 3 times weekly in week 1 once daily(QD),5 days a week, in weeks 1-2. SURGERY:Patients undergo triple endoscopy and biopsy with submandibular gland transfer in week 3. INTRAOPERATIVE: Patients also undergo Intensity-Modulated Radiation Therapy (IMRT) External Beam Radiation. POSTOPERATIVE: Patients receive paclitaxel IV over 3 hours in weeks 7-10 and cisplatin IV over 1-2 hours three times weekly in weeks 7 and 10. Patients also undergo Intensity-Modulated Radiation Therapy (IMRT) External Beam Radiation QD, 5 days a week, in weeks 7-10. Cisplatin: Patients will receive Cisplatin (30 mg/m2 i.v.) daily x 3 days in week 1. Paclitaxel: Patients will receive Paclitaxel (45 mg/m2i.v.) infusion over 3 hours during weeks 7,8,9,10 Intensity-Modulated Radiation Therapy (IMRT) External Beam Radiation: Patients will receive Intensity-Modulated Radiation Therapy (IMRT) External Beam Radiation to tumor and involved regional nod
    id
    EG000
    other Num Affected
    11
    other Num At Risk
    11
    serious Num Affected
    11
    serious Num At Risk
    11
    title
    Treatment (Neoadjuvant, Adjuvant Chemotherapy and Radiation)
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE version 3.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      11
      num Events
      6
    term
    Extremity pain
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE version 3.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      11
      num Events
      4
    term
    Edema-limb
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE version 3.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      11
      num Events
      10
    term
    Oral cavity pain
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE version 3.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      11
      num Events
      4
    term
    Hyperglycemia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE version 3.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      11
      num Events
      4
    term
    Salivary gland changes
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    oral cavity
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE version 3.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      11
      num Events
      10
    term
    Mucositis/stomatitis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE version 3.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      11
      num Events
      4
    term
    Pulmonary/upper respiratory
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE version 3.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      11
      num Events
      6
    term
    Neck pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE version 3.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      11
      num Events
      3
    term
    Hypoalbuminemia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE version 3.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      11
      num Events
      10
    term
    Fatigue
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE version 3.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      11
      num Events
      10
    term
    Dry mouth/salivary gland (xerostomia)
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE version 3.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      11
      num Events
      5
    term
    Neutrophils/granulocytes/ANC
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE version 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
      num Events
      1
    term
    Leukocytes (total WBC)
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE version 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
      num Events
      1
    term
    Rash: dermatitis associated with radiation - Chemoradiation
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE version 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
      num Events
      1
    term
    Colitis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE version 3.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      11
      num Events
      2
    term
    Dehydration
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE version 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
      num Events
      1
    term
    Diarrhea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE version 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
      num Events
      1
    term
    Vomiting
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE version 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
      num Events
      1
    term
    Hemorrhage, pulmonary/upper respiratory - Respiratory tract NOS
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE version 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
      num Events
      1
    term
    Infection with normal ANC or Grade 1 or 2 neutrophils - Lung (pneumonia)
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE version 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
      num Events
      1
    term
    Infection with normal ANC or Grade 1 or 2 neutrophils - Neck NOS
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE version 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
      num Events
      1
    term
    Infection with normal ANC or Grade 1 or 2 neutrophils - Oral cavity-gums (gingivitis)
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE version 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
      num Events
      1
    term
    Edema: limb

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