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NCT00954174 · ADVERSE EVENTS

Adverse events

Paclitaxel and Carboplatin or Ifosfamide in Treating Patients With Newly Diagnosed, Persistent or Recurrent Uterine, Ovarian, Fallopian Tube, or Peritoneal Cavity Cancer · Source last updated 2021-09-30

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
Measured within 6 months of enrollment; through all cycles of chemotherapy and up to 30 days after the last cycle of chemotherapy. Up to 10 cycles of chemotherapy were allowed. Cycles were to be repeated every 3 weeks.
Other-event reporting threshold
0%

Eligible and treated participants were affected if they experienced grade 1-5 adverse event. Adverse events were analyzed across cohorts since disease site was considered independent of AEs.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Regimen I - Uterine and Non-uterine Carcinosarcoma

Paclitaxel 175 mg/m2 IV over 3 hours Day 1 Carboplatin (AUC=6) IV Day 1 Repeat q 3 weeks x 6-10 cycles

80 / 268268 / 268160 / 272
Regimen II - Uterine and Non-uterine Carcinsarcoma Subjects

Ifosfamide 1.6 g/m2 IV days 1, 2, 3 Mesna Paclitaxel 135 mg/m2 by 3-hour infusion on Day 1 Repeat q 3 weeks x 6-10 cycles. G-CSF Support: Filgrastim or Pegfilgrastim beginning Day 4-6

68 / 247244 / 247160 / 267

Group identifiers: EG000: Regimen I - Uterine and Non-uterine Carcinosarcoma · EG001: Regimen II - Uterine and Non-uterine Carcinsarcoma Subjects

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 (3.0)
    stats
    1. group Id
      EG000
      num Affected
      32
      num At Risk
      268
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      247
    term
    Neutrophils
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      268
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      247
    term
    Platelets
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      268
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      247
    term
    Blood/Bone Marrow - Other
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      268
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      247
    term
    Cd4 Count
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      268
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      247
    term
    Leukocytes
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      268
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      247
    term
    Hemoglobin
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      268
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      247
    term
    S/N Arrhythmia: Atrial Fibrillation
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      268
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      247
    term
    Vasovagal Episode
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      268
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      247
    term
    Ventricular Arrhythmia - Fibrillation
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      268
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      247
    term
    Cardiac Ischemia/Infarction
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      268
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      247
    term
    Hypertension
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      268
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      247
    term
    Left Venticular Diastolic Dysfunction

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
    Immune system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      268
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      247
    term
    Allergic Reaction/Hypersensitivity
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      268
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      247
    term
    Rhinitis
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      268
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      247
    term
    Auditory/Ear - Other
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      268
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      247
    term
    Hearing (Without Monitoring Program)
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      268
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      247
    term
    Tinnitus
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      268
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      247
    term
    Hearing (Monitoring Program)
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      245
      num At Risk
      268
    2. group Id
      EG001
      num Affected
      116
      num At Risk
      247
    term
    Neutrophils
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      178
      num At Risk
      268
    2. group Id
      EG001
      num Affected
      137
      num At Risk
      247
    term
    Platelets
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      268
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      247
    term
    Blood/Bone Marrow - Other
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      268
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      247
    term
    Bone Marrow Cellularity
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      239
      num At Risk
      268
    2. group Id
      EG001
      num Affected
      164
      num At Risk
      247
    term
    Leukocytes
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      268
    2. group Id
      EG001
      num Affected
      26
      num At Risk
      247
    term
    Lymphopenia
Complete source fields
description
Eligible and treated participants were affected if they experienced grade 1-5 adverse event. Adverse events were analyzed across cohorts since disease site was considered independent of AEs.
event Groups
  1. deaths Num Affected
    160
    deaths Num At Risk
    272
    description
    Paclitaxel 175 mg/m2 IV over 3 hours Day 1 Carboplatin (AUC=6) IV Day 1 Repeat q 3 weeks x 6-10 cycles
    id
    EG000
    other Num Affected
    268
    other Num At Risk
    268
    serious Num Affected
    80
    serious Num At Risk
    268
    title
    Regimen I - Uterine and Non-uterine Carcinosarcoma
  2. deaths Num Affected
    160
    deaths Num At Risk
    267
    description
    Ifosfamide 1.6 g/m2 IV days 1, 2, 3 Mesna Paclitaxel 135 mg/m2 by 3-hour infusion on Day 1 Repeat q 3 weeks x 6-10 cycles. G-CSF Support: Filgrastim or Pegfilgrastim beginning Day 4-6
    id
    EG001
    other Num Affected
    244
    other Num At Risk
    247
    serious Num Affected
    68
    serious Num At Risk
    247
    title
    Regimen II - Uterine and Non-uterine Carcinsarcoma Subjects
frequency Threshold
0
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      268
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      247
    term
    Allergic Reaction/Hypersensitivity
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      268
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      247
    term
    Rhinitis
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      268
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      247
    term
    Auditory/Ear - Other
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      268
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      247
    term
    Hearing (Without Monitoring Program)
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      268
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      247
    term
    Tinnitus
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      268
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      247
    term
    Hearing (Monitoring Program)
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      245
      num At Risk
      268
    2. group Id
      EG001
      num Affected
      116
      num At Risk
      247
    term
    Neutrophils
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      178
      num At Risk
      268
    2. group Id
      EG001
      num Affected
      137
      num At Risk
      247
    term
    Platelets
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      268
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      247
    term
    Blood/Bone Marrow - Other
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      268
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      247
    term
    Bone Marrow Cellularity
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      239
      num At Risk
      268
    2. group Id
      EG001
      num Affected
      164
      num At Risk
      247
    term
    Leukocytes
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      268
    2. group Id
      EG001
      num Affected
      26
      num At Risk
      247
    term
    Lymphopenia
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      32
      num At Risk
      268
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      247
    term
    Neutrophils
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      268
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      247
    term
    Platelets
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      268
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      247
    term
    Blood/Bone Marrow - Other
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      268
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      247
    term
    Cd4 Count
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      268
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      247
    term
    Leukocytes
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      268
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      247
    term
    Hemoglobin
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      268
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      247
    term
    S/N Arrhythmia: Atrial Fibrillation
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      268
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      247
    term
    Vasovagal Episode
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      268
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      247
    term
    Ventricular Arrhythmia - Fibrillation
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      268
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      247
    term
    Cardiac Ischemia/Infarction
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      268
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      247
    term
    Hypertension
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      268
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      247
    term
    Left Venticular Diastolic Dysfunction
time Frame
Measured within 6 months of enrollment; through all cycles of chemotherapy and up to 30 days after the last cycle of chemotherapy. Up to 10 cycles of chemotherapy were allowed. Cycles were to be repeated every 3 weeks.

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