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NCT00006227 · ADVERSE EVENTS

Adverse events

Paclitaxel in Treating Patients With Ovarian Stromal Cancer · Source last updated 2020-03-05

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 the duration of treatment and follow-up
Other-event reporting threshold
5%

Adverse events were defined according to CTC v2.0 for the period of protocol activation through March 31, 2010. Beginning on April 1, 2010 adverse events were defined according to CTCAE v4.0.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Treatment (Paclitaxel)

Patients receive paclitaxel IV over 3 hours on day 1. Treatment continues every 21 days in the absence of disease progression or unacceptable toxicity. Paclitaxel: Given IV

1 / 3131 / 3116 / 31

Group identifiers: EG000: Treatment (Paclitaxel)

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
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
      num Events
      1
    term
    Neutrophil count decreased
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
      num Events
      1
    term
    White blood cell decreased
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
      num Events
      1
    term
    Muscle weakness lower limb
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
      num Events
      1
    term
    Hyperglycemia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
      num Events
      1
    term
    Injection site reaction
  6. assessment Type
    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
      num Events
      1
    term
    Febrile neutropenia

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
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      31
    term
    Leukopenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      31
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      31
    term
    Anemia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      31
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      31
    term
    Allergic reaction
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      31
    term
    Cardiovascular
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      31
    term
    Constitutional
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      31
    term
    Dermatologic
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      31
    term
    Gastrointestinal
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      31
    term
    Genitourinary
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      31
    term
    Hepatic
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      31
    term
    Infection / fever
Complete source fields
description
Adverse events were defined according to CTC v2.0 for the period of protocol activation through March 31, 2010. Beginning on April 1, 2010 adverse events were defined according to CTCAE v4.0.
event Groups
  1. deaths Num Affected
    16
    deaths Num At Risk
    31
    description
    Patients receive paclitaxel IV over 3 hours on day 1. Treatment continues every 21 days in the absence of disease progression or unacceptable toxicity. Paclitaxel: Given IV
    id
    EG000
    other Num Affected
    31
    other Num At Risk
    31
    serious Num Affected
    1
    serious Num At Risk
    31
    title
    Treatment (Paclitaxel)
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      31
    term
    Leukopenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      31
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      31
    term
    Anemia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      31
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      31
    term
    Allergic reaction
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      31
    term
    Cardiovascular
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      31
    term
    Constitutional
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      31
    term
    Dermatologic
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      31
    term
    Gastrointestinal
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      31
    term
    Genitourinary
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      31
    term
    Hepatic
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      31
    term
    Infection / fever
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
      num Events
      1
    term
    Neutrophil count decreased
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
      num Events
      1
    term
    White blood cell decreased
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
      num Events
      1
    term
    Muscle weakness lower limb
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
      num Events
      1
    term
    Hyperglycemia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
      num Events
      1
    term
    Injection site reaction
  6. assessment Type
    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
      num Events
      1
    term
    Febrile neutropenia
time Frame
For the duration of treatment and follow-up

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice