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NCT00309985 · ADVERSE EVENTS

Adverse events

Androgen Ablation Therapy With or Without Chemotherapy in Treating Patients With Metastatic Prostate Cancer · Source last updated 2025-12-11

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
Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Other-event reporting threshold
5%

Submission of late adverse events is required at follow-up visits up to 10 years.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Arm A

Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone \[LHRH\] agonist therapy, LHRH antagonist therapy, or surgical castration). Patients also receive docetaxel IV over 1 hour on day 1. Treatment with docetaxel repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

116 / 39038 / 390Not reported / Not reported
Arm B

Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone \[LHRH\] agonist therapy, LHRH antagonist therapy, or surgical castration).

12 / 3921 / 392Not reported / Not reported

Group identifiers: EG000: Arm A · EG001: Arm B

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
    Immune system disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      390
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      392
    term
    Allergic reaction
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      390
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      392
    term
    Tinnitus
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      390
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      392
    term
    Anemia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      390
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      392
    term
    Leukocytes decreased
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      390
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      392
    term
    Lymphopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      47
      num At Risk
      390
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      392
    term
    Neutrophils decreased
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      390
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      392
    term
    Platelets decreased
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      390
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      392
    term
    Hypertension
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      390
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      392
    term
    Left ventricular diastolic dysfunction
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      390
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      392
    term
    Left ventricular systolic dysfunction
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      390
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      392
    term
    Fatigue
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      390
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      392
    term
    Weight gain

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
    General disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      35
      num At Risk
      390
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      392
    term
    Fatigue
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      390
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      392
    term
    Alopecia
Complete source fields
description
Submission of late adverse events is required at follow-up visits up to 10 years.
event Groups
  1. description
    Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone \[LHRH\] agonist therapy, LHRH antagonist therapy, or surgical castration). Patients also receive docetaxel IV over 1 hour on day 1. Treatment with docetaxel repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
    id
    EG000
    other Num Affected
    38
    other Num At Risk
    390
    serious Num Affected
    116
    serious Num At Risk
    390
    title
    Arm A
  2. description
    Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone \[LHRH\] agonist therapy, LHRH antagonist therapy, or surgical castration).
    id
    EG001
    other Num Affected
    1
    other Num At Risk
    392
    serious Num Affected
    12
    serious Num At Risk
    392
    title
    Arm B
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      35
      num At Risk
      390
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      392
    term
    Fatigue
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      390
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      392
    term
    Alopecia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      390
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      392
    term
    Allergic reaction
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      390
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      392
    term
    Tinnitus
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      390
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      392
    term
    Anemia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      390
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      392
    term
    Leukocytes decreased
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      390
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      392
    term
    Lymphopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      47
      num At Risk
      390
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      392
    term
    Neutrophils decreased
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      390
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      392
    term
    Platelets decreased
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      390
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      392
    term
    Hypertension
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      390
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      392
    term
    Left ventricular diastolic dysfunction
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      390
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      392
    term
    Left ventricular systolic dysfunction
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      390
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      392
    term
    Fatigue
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      390
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      392
    term
    Weight gain
time Frame
Assessed every 3 weeks while on treatment and for 30 days after the end of treatment

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Preserved source evidence · Not medical advice