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NCT01012297 · ADVERSE EVENTS

Adverse events

Gemcitabine Hydrochloride and Docetaxel With or Without Bevacizumab in Treating Patients With Advanced or Recurrent Uterine Leiomyosarcoma · Source last updated 2026-06-24

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
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Arm I

Patients receive a placebo IV over 30-90 minutes on day 1, gemcitabine hydrochloride IV over 90 minutes on days 1 and 8, and docetaxel IV over 60 minutes on day 8. Patients also receive filgrastim subcutaneously (SC) on days 9-15 or pegfilgrastim SC on day 9 or 10. Docetaxel: Given IV Filgrastim: Given SC Gemcitabine Hydrochloride: Given IV Pegfilgrastim: Given SC Placebo: Given IV

17 / 5451 / 54Not reported / Not reported
Arm II

Patients receive bevacizumab IV over 30-90 minutes on day 1, gemcitabine hydrochloride IV over 90 minutes on days 1 and 8, and docetaxel IV over 60 minutes on day 8. Patients also receive filgrastim SC on days 9-15 or pegfilgrastim SC on day 9 or 10. Bevacizumab: Given IV Docetaxel: Given IV Filgrastim: Given SC Gemcitabine Hydrochloride: Given IV Pegfilgrastim: Given SC

21 / 5351 / 53Not reported / Not reported

Group identifiers: EG000: Arm I · EG001: Arm II

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      54
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      53
    term
    Pericardial Effusion
  2. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      54
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      53
    term
    Diarrhea
  3. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      54
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      53
    term
    Small Intestinal Obstruction
  4. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      54
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      53
    term
    Abdominal Pain
  5. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      54
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      53
    term
    Fatigue
  6. organ System
    Immune system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      54
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      53
    term
    Anaphylaxis
  7. organ System
    Immune system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      54
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      53
    term
    Allergic Reaction
  8. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      54
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      53
    term
    Infections And Infestations - Other
  9. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      54
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      53
    term
    Soft Tissue Infection
  10. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      54
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      53
    term
    Skin Infection
  11. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      54
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      53
    term
    Sepsis
  12. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      54
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      53
    term
    Lung Infection

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      54
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      53
    term
    Thrombotic Thrombocytopenic Purpura
  2. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      54
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      53
    term
    Blood And Lymphatic System Disorders - Other
  3. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      47
      num At Risk
      54
    2. group Id
      EG001
      num Affected
      48
      num At Risk
      53
    term
    Anemia
  4. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      54
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      53
    term
    Palpitations
  5. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      54
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      53
    term
    Pericardial Effusion
  6. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      54
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      53
    term
    Sinus Tachycardia
  7. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      54
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      53
    term
    Chest Pain - Cardiac
  8. organ System
    Ear and labyrinth disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      54
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      53
    term
    Vertigo
  9. organ System
    Ear and labyrinth disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      54
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      53
    term
    Tinnitus
  10. organ System
    Ear and labyrinth disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      54
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      53
    term
    Hearing Impaired
  11. organ System
    Ear and labyrinth disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      54
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      53
    term
    Ear Pain
  12. organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      54
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      53
    term
    Eye Disorders - Other
Complete source fields
event Groups
  1. description
    Patients receive a placebo IV over 30-90 minutes on day 1, gemcitabine hydrochloride IV over 90 minutes on days 1 and 8, and docetaxel IV over 60 minutes on day 8. Patients also receive filgrastim subcutaneously (SC) on days 9-15 or pegfilgrastim SC on day 9 or 10. Docetaxel: Given IV Filgrastim: Given SC Gemcitabine Hydrochloride: Given IV Pegfilgrastim: Given SC Placebo: Given IV
    id
    EG000
    other Num Affected
    51
    other Num At Risk
    54
    serious Num Affected
    17
    serious Num At Risk
    54
    title
    Arm I
  2. description
    Patients receive bevacizumab IV over 30-90 minutes on day 1, gemcitabine hydrochloride IV over 90 minutes on days 1 and 8, and docetaxel IV over 60 minutes on day 8. Patients also receive filgrastim SC on days 9-15 or pegfilgrastim SC on day 9 or 10. Bevacizumab: Given IV Docetaxel: Given IV Filgrastim: Given SC Gemcitabine Hydrochloride: Given IV Pegfilgrastim: Given SC
    id
    EG001
    other Num Affected
    51
    other Num At Risk
    53
    serious Num Affected
    21
    serious Num At Risk
    53
    title
    Arm II
frequency Threshold
0
other Events
  1. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      54
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      53
    term
    Thrombotic Thrombocytopenic Purpura
  2. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      54
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      53
    term
    Blood And Lymphatic System Disorders - Other
  3. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      47
      num At Risk
      54
    2. group Id
      EG001
      num Affected
      48
      num At Risk
      53
    term
    Anemia
  4. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      54
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      53
    term
    Palpitations
  5. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      54
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      53
    term
    Pericardial Effusion
  6. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      54
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      53
    term
    Sinus Tachycardia
  7. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      54
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      53
    term
    Chest Pain - Cardiac
  8. organ System
    Ear and labyrinth disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      54
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      53
    term
    Vertigo
  9. organ System
    Ear and labyrinth disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      54
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      53
    term
    Tinnitus
  10. organ System
    Ear and labyrinth disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      54
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      53
    term
    Hearing Impaired
  11. organ System
    Ear and labyrinth disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      54
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      53
    term
    Ear Pain
  12. organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      54
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      53
    term
    Eye Disorders - Other
serious Events
  1. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      54
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      53
    term
    Pericardial Effusion
  2. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      54
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      53
    term
    Diarrhea
  3. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      54
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      53
    term
    Small Intestinal Obstruction
  4. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      54
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      53
    term
    Abdominal Pain
  5. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      54
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      53
    term
    Fatigue
  6. organ System
    Immune system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      54
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      53
    term
    Anaphylaxis
  7. organ System
    Immune system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      54
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      53
    term
    Allergic Reaction
  8. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      54
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      53
    term
    Infections And Infestations - Other
  9. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      54
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      53
    term
    Soft Tissue Infection
  10. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      54
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      53
    term
    Skin Infection
  11. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      54
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      53
    term
    Sepsis
  12. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      54
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      53
    term
    Lung Infection

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Preserved source evidence · Not medical advice