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NCT00063999 · ADVERSE EVENTS

Adverse events

Doxorubicin Hydrochloride, Cisplatin, and Paclitaxel or Carboplatin and Paclitaxel in Treating Patients With Stage III-IV or Recurrent Endometrial Cancer · Source last updated 2021-10-19

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
Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years.
Other-event reporting threshold
0%

CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Arm I (Doxorubicin, Cisplatin, Paclitaxel)

Patients receive doxorubicin IV over approximately 15-30 minutes on day 1, cisplatin IV over 60-90 minutes on day 1, paclitaxel IV over 3 hours on day 2, and filgrastim SC on days 3-12 or pegfilgrastim SC on day 3. Treatment repeats every 21 days for 7 courses in the absence of disease progression or unacceptable toxicity.

217 / 647631 / 647271 / 647
Arm II (Paclitaxel, Carboplatin)

Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 7 courses in the absence of disease progression or unacceptable toxicity.

156 / 665657 / 665280 / 665

Group identifiers: EG000: Arm I (Doxorubicin, Cisplatin, Paclitaxel) · EG001: Arm II (Paclitaxel, Carboplatin)

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
    Immune system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      647
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      665
    term
    Allergic Reaction/Hypersensitivity
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      647
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      665
    term
    Hemoglobin
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      647
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      665
    term
    Hematologic-Other
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      647
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      665
    term
    Transfusion: Platelets
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      647
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      665
    term
    Transfusion: Prbcs
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      647
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      665
    term
    Platelets
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      647
    2. group Id
      EG001
      num Affected
      26
      num At Risk
      665
    term
    Neutrophils/Granulocytes
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      647
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      665
    term
    Leukocytes
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      647
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      665
    term
    Hypertension
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      647
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      665
    term
    Circulatory Or Cardiac-Other
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      647
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      665
    term
    Cardiac Left Ventricular Function
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      647
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      665
    term
    Hypotension

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 (2.0)
    stats
    1. group Id
      EG000
      num Affected
      418
      num At Risk
      647
    2. group Id
      EG001
      num Affected
      556
      num At Risk
      665
    term
    Leukocytes
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      402
      num At Risk
      647
    2. group Id
      EG001
      num Affected
      590
      num At Risk
      665
    term
    Neutrophils/Granulocytes
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      244
      num At Risk
      647
    2. group Id
      EG001
      num Affected
      172
      num At Risk
      665
    term
    Platelets
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      445
      num At Risk
      647
    2. group Id
      EG001
      num Affected
      410
      num At Risk
      665
    term
    Hemoglobin
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      202
      num At Risk
      647
    2. group Id
      EG001
      num Affected
      156
      num At Risk
      665
    term
    Hematologic-Other
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      647
    2. group Id
      EG001
      num Affected
      29
      num At Risk
      665
    term
    Allergic Reaction/Hypersensitivity
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      647
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      665
    term
    Ear and labyrinth disorders
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      50
      num At Risk
      647
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      665
    term
    Cardiac Left Ventricular Function
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      55
      num At Risk
      647
    2. group Id
      EG001
      num Affected
      40
      num At Risk
      665
    term
    Cardiac disorders
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      647
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      665
    term
    Vascular disorders
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      37
      num At Risk
      647
    2. group Id
      EG001
      num Affected
      26
      num At Risk
      665
    term
    Constitutional
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      473
      num At Risk
      647
    2. group Id
      EG001
      num Affected
      486
      num At Risk
      665
    term
    Hair loss/alopecia (scalp or body)
Complete source fields
description
CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.
event Groups
  1. deaths Num Affected
    271
    deaths Num At Risk
    647
    description
    Patients receive doxorubicin IV over approximately 15-30 minutes on day 1, cisplatin IV over 60-90 minutes on day 1, paclitaxel IV over 3 hours on day 2, and filgrastim SC on days 3-12 or pegfilgrastim SC on day 3. Treatment repeats every 21 days for 7 courses in the absence of disease progression or unacceptable toxicity.
    id
    EG000
    other Num Affected
    631
    other Num At Risk
    647
    serious Num Affected
    217
    serious Num At Risk
    647
    title
    Arm I (Doxorubicin, Cisplatin, Paclitaxel)
  2. deaths Num Affected
    280
    deaths Num At Risk
    665
    description
    Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 7 courses in the absence of disease progression or unacceptable toxicity.
    id
    EG001
    other Num Affected
    657
    other Num At Risk
    665
    serious Num Affected
    156
    serious Num At Risk
    665
    title
    Arm II (Paclitaxel, Carboplatin)
frequency Threshold
0
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      418
      num At Risk
      647
    2. group Id
      EG001
      num Affected
      556
      num At Risk
      665
    term
    Leukocytes
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      402
      num At Risk
      647
    2. group Id
      EG001
      num Affected
      590
      num At Risk
      665
    term
    Neutrophils/Granulocytes
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      244
      num At Risk
      647
    2. group Id
      EG001
      num Affected
      172
      num At Risk
      665
    term
    Platelets
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      445
      num At Risk
      647
    2. group Id
      EG001
      num Affected
      410
      num At Risk
      665
    term
    Hemoglobin
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      202
      num At Risk
      647
    2. group Id
      EG001
      num Affected
      156
      num At Risk
      665
    term
    Hematologic-Other
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      647
    2. group Id
      EG001
      num Affected
      29
      num At Risk
      665
    term
    Allergic Reaction/Hypersensitivity
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      647
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      665
    term
    Ear and labyrinth disorders
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      50
      num At Risk
      647
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      665
    term
    Cardiac Left Ventricular Function
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      55
      num At Risk
      647
    2. group Id
      EG001
      num Affected
      40
      num At Risk
      665
    term
    Cardiac disorders
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      647
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      665
    term
    Vascular disorders
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      37
      num At Risk
      647
    2. group Id
      EG001
      num Affected
      26
      num At Risk
      665
    term
    Constitutional
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      473
      num At Risk
      647
    2. group Id
      EG001
      num Affected
      486
      num At Risk
      665
    term
    Hair loss/alopecia (scalp or body)
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      647
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      665
    term
    Allergic Reaction/Hypersensitivity
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      647
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      665
    term
    Hemoglobin
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      647
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      665
    term
    Hematologic-Other
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      647
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      665
    term
    Transfusion: Platelets
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      647
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      665
    term
    Transfusion: Prbcs
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      647
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      665
    term
    Platelets
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      647
    2. group Id
      EG001
      num Affected
      26
      num At Risk
      665
    term
    Neutrophils/Granulocytes
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      647
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      665
    term
    Leukocytes
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      647
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      665
    term
    Hypertension
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      647
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      665
    term
    Circulatory Or Cardiac-Other
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      647
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      665
    term
    Cardiac Left Ventricular Function
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      647
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      665
    term
    Hypotension
time Frame
Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years.

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