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NCT01533207 · ADVERSE EVENTS

Adverse events

Gemcitabine Hydrochloride and Docetaxel Followed by Doxorubicin Hydrochloride or Observation in Treating Patients With High-Risk Uterine Leiomyosarcoma Previously Removed by Surgery · Source last updated 2020-04-28

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
For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
Other-event reporting threshold
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Regimen 1

Gemcitabine 900 mg/m2 IV days 1 and 8 Docetaxel 75 mg/m2 IV day 8 GCSF 5 micrograms/kg days 9-15 or pegfilgrastim 6 mg day 9 or 10 Every 21 days for 4 cycles CT/MRI imaging to confirm disease-free Doxorubicin 60 mg/m2 IV every 21 days for 4 cycles

5 / 2016 / 205 / 20
Regimen II

Observation

0 / 1812 / 181 / 18

Group identifiers: EG000: Regimen 1 · EG001: Regimen II

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
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    term
    Mucositis Oral
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    term
    Wound Infection
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    term
    Skin Infection
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    term
    Catheter Related Infection
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    term
    Vascular Access Complication
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    term
    Neutrophil Count Decreased
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    term
    Skin And Subcutaneous Tissue Disorders - Other

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
      1
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    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
      20
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    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
      13
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      18
    term
    Anemia
  4. 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
      20
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    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
      4
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      18
    term
    Palpitations
  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
      20
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    term
    Chest Pain - Cardiac
  7. 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
      20
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    term
    Hearing Impaired
  8. 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
      20
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    term
    Ear Pain
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    term
    Watering Eyes
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      18
    term
    Blurred Vision
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    term
    Dysphagia
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      18
    term
    Dyspepsia
Complete source fields
event Groups
  1. deaths Num Affected
    5
    deaths Num At Risk
    20
    description
    Gemcitabine 900 mg/m2 IV days 1 and 8 Docetaxel 75 mg/m2 IV day 8 GCSF 5 micrograms/kg days 9-15 or pegfilgrastim 6 mg day 9 or 10 Every 21 days for 4 cycles CT/MRI imaging to confirm disease-free Doxorubicin 60 mg/m2 IV every 21 days for 4 cycles
    id
    EG000
    other Num Affected
    16
    other Num At Risk
    20
    serious Num Affected
    5
    serious Num At Risk
    20
    title
    Regimen 1
  2. deaths Num Affected
    1
    deaths Num At Risk
    18
    description
    Observation
    id
    EG001
    other Num Affected
    12
    other Num At Risk
    18
    serious Num Affected
    0
    serious Num At Risk
    18
    title
    Regimen II
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
      1
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    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
      20
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    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
      13
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      18
    term
    Anemia
  4. 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
      20
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    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
      4
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      18
    term
    Palpitations
  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
      20
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    term
    Chest Pain - Cardiac
  7. 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
      20
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    term
    Hearing Impaired
  8. 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
      20
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    term
    Ear Pain
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    term
    Watering Eyes
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      18
    term
    Blurred Vision
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    term
    Dysphagia
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      18
    term
    Dyspepsia
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    term
    Mucositis Oral
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    term
    Wound Infection
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    term
    Skin Infection
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    term
    Catheter Related Infection
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    term
    Vascular Access Complication
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    term
    Neutrophil Count Decreased
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    term
    Skin And Subcutaneous Tissue Disorders - Other
time Frame
For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.

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Preserved source evidence · Not medical advice