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NCT01042522 · ADVERSE EVENTS

Adverse events

Paclitaxel and Carboplatin or Bleomycin Sulfate, Etoposide Phosphate, and Cisplatin in Treating Patients With Advanced or Recurrent Sex Cord-Ovarian Stromal Tumors · Source last updated 2022-01-25

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
The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
Other-event reporting threshold
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Arm I (Paclitaxel, Carboplatin)

Patients receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Carboplatin: Given IV Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV

6 / 3131 / 315 / 31
Arm II (Bleomycin Sulfate, Etoposide Phosphate, Cisplatin)

Patients receive bleomycin sulfate IV on day 1 and etoposide IV over 1 hour and cisplatin IV over 30 minutes on days 1-5. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Bleomycin Sulfate: Given IV Cisplatin: Given IV Etoposide Phosphate: Given IV Laboratory Biomarker Analysis: Correlative studies

11 / 3229 / 328 / 32

Group identifiers: EG000: Arm I (Paclitaxel, Carboplatin) · EG001: Arm II (Bleomycin Sulfate, Etoposide Phosphate, Cisplatin)

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
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      32
    term
    Anemia
  2. assessment Type
    NON_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
      31
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      32
    term
    Febrile Neutropenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      31
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      32
    term
    Sinus Bradycardia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      31
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      32
    term
    Ileus
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      32
    term
    Pain
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      32
    term
    Death Nos
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      31
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      32
    term
    Neutrophil Count Decreased
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      31
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      32
    term
    Hyperglycemia
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      31
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      32
    term
    Syncope
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      31
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      32
    term
    Thromboembolic Event

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
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      31
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      32
    term
    Leukocytosis
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      31
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      32
    term
    Blood And Lymphatic System Disorders - Other
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      31
    2. group Id
      EG001
      num Affected
      26
      num At Risk
      32
    term
    Anemia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      31
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      32
    term
    Atrial Fibrillation
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      31
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      32
    term
    Sinus Bradycardia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      32
    term
    Palpitations
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      32
    term
    Cardiac Disorders - Other
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      32
    term
    Sinus Tachycardia
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      31
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      32
    term
    Tinnitus
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      32
    term
    Ear Pain
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      32
    term
    Hypothyroidism
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      31
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      32
    term
    Hyperthyroidism
Complete source fields
event Groups
  1. deaths Num Affected
    5
    deaths Num At Risk
    31
    description
    Patients receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Carboplatin: Given IV Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV
    id
    EG000
    other Num Affected
    31
    other Num At Risk
    31
    serious Num Affected
    6
    serious Num At Risk
    31
    title
    Arm I (Paclitaxel, Carboplatin)
  2. deaths Num Affected
    8
    deaths Num At Risk
    32
    description
    Patients receive bleomycin sulfate IV on day 1 and etoposide IV over 1 hour and cisplatin IV over 30 minutes on days 1-5. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Bleomycin Sulfate: Given IV Cisplatin: Given IV Etoposide Phosphate: Given IV Laboratory Biomarker Analysis: Correlative studies
    id
    EG001
    other Num Affected
    29
    other Num At Risk
    32
    serious Num Affected
    11
    serious Num At Risk
    32
    title
    Arm II (Bleomycin Sulfate, Etoposide Phosphate, Cisplatin)
frequency Threshold
0
other Events
  1. assessment Type
    NON_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
      31
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      32
    term
    Leukocytosis
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      31
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      32
    term
    Blood And Lymphatic System Disorders - Other
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      31
    2. group Id
      EG001
      num Affected
      26
      num At Risk
      32
    term
    Anemia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      31
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      32
    term
    Atrial Fibrillation
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      31
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      32
    term
    Sinus Bradycardia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      32
    term
    Palpitations
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      32
    term
    Cardiac Disorders - Other
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      32
    term
    Sinus Tachycardia
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      31
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      32
    term
    Tinnitus
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      32
    term
    Ear Pain
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      32
    term
    Hypothyroidism
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      31
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      32
    term
    Hyperthyroidism
serious Events
  1. assessment Type
    NON_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
      31
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      32
    term
    Anemia
  2. assessment Type
    NON_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
      31
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      32
    term
    Febrile Neutropenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      31
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      32
    term
    Sinus Bradycardia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      31
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      32
    term
    Ileus
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      32
    term
    Pain
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      32
    term
    Death Nos
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      31
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      32
    term
    Neutrophil Count Decreased
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      31
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      32
    term
    Hyperglycemia
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      31
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      32
    term
    Syncope
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      31
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      32
    term
    Thromboembolic Event
time Frame
The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).

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