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NCT00565851 · ADVERSE EVENTS

Adverse events

Carboplatin, Paclitaxel and Gemcitabine Hydrochloride With or Without Bevacizumab After Surgery in Treating Patients With Recurrent Ovarian, Epithelial, Primary Peritoneal, or Fallopian Tube Cancer · Source last updated 2025-12-30

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
During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Other-event reporting threshold
0%

Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Arm I (no Surgery; Carboplatin and Paclitaxel)

Patients receive paclitaxel IV over 3 hours or docetaxel IV over 1 hour and carboplatin over 30 minutes on day 1. Treatment repeats every 21 days. Patients are not in secondary cytoreductive surgery portion of study.

37 / 316304 / 316253 / 316
Arm II (no Surgery; Carboplatin, Paclitaxel and Bevacizumab)

Patients receive chemotherapy as in arm I and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days. Patients are not in secondary cytoreductive surgery portion of study.

104 / 456376 / 456299 / 456
Arm III (Surgery; Carboplatin and Paclitaxel)

Patients receive paclitaxel IV over 3 hours or docetaxel IV over 1 hour and carboplatin over 30 minutes on day 1. Treatment repeats every 21 days. Patients receive secondary cytoreductive surgery.

1 / 3329 / 3328 / 33
Arm IV (Surgery; Carboplatin, Paclitaxel and Bevacizumab)

Patients receive paclitaxel IV over 3 hours or docetaxel IV over 1 hour and carboplatin over 30 minutes on day 1. Treatment repeats every 21 days. Patients receive secondary cytoreductive surgery.

24 / 16577 / 16556 / 165
Arm V (no Surgery; Carboplatin and Gemcitabine)

Patients receive carboplatin as in arm I. Patients receive gemcitabine. Treatment repeats every 21 days. Patients do not receive secondary cytoreductive surgery.

0 / 63 / 64 / 6
Arm VI (no Surgery; Carboplatin, Gemcitabine and Bevacizumab)

Patients receive carboplatin as in arm I and bevacizumab IV over 30-90 minutes on day 1. Patients receive gemcitabine. Treatment repeats every 21 days. Patients do not receive secondary cytoreductive surgery.

1 / 349 / 3414 / 34
Arm VII (Surgery; Carboplatin and Gemcitabine)

Patients receive carboplatin as in arm I. Patients receive gemcitabine. Treatment repeats every 21 days. Patients receive secondary cytoreductive surgery.

2 / 53 / 54 / 5
Arm VIII (Surgery; Carboplatin, Gemcitabine and Bevacizumab)

Patients receive carboplatin as in arm I and bevacizumab IV over 30-90 minutes on day 1. Patients receive gemcitabine. Treatment repeats every 21 days. Patients receive secondary cytoreductive surgery.

2 / 379 / 3721 / 37

Group identifiers: EG000: Arm I (no Surgery; Carboplatin and Paclitaxel) · EG001: Arm II (no Surgery; Carboplatin, Paclitaxel and Bevacizumab) · EG002: Arm III (Surgery; Carboplatin and Paclitaxel) · EG003: Arm IV (Surgery; Carboplatin, Paclitaxel and Bevacizumab) · EG004: Arm V (no Surgery; Carboplatin and Gemcitabine) · EG005: Arm VI (no Surgery; Carboplatin, Gemcitabine and Bevacizumab) · EG006: Arm VII (Surgery; Carboplatin and Gemcitabine) · EG007: Arm VIII (Surgery; Carboplatin, Gemcitabine and Bevacizumab)

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 (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      316
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      456
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      33
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      165
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      34
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      5
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      37
    term
    Allergic Reaction/Hypersensitivity
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      316
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      456
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      33
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      165
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      34
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      37
    term
    Myelodysplasia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      316
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      456
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      33
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      165
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      34
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      37
    term
    Neutrophils
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      316
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      456
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      33
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      165
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      34
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      37
    term
    Platelets
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      316
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      456
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      33
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      165
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      34
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      37
    term
    Blood/Bone Marrow - Other
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      316
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      456
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      33
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      165
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      34
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      37
    term
    Leukocytes
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      316
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      456
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      33
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      165
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      34
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      37
    term
    S/N Arrhythmia: Atrial Fibrillation
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      316
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      456
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      33
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      165
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      34
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      37
    term
    Cardiac Ischemia/Infarction
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      316
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      456
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      33
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      165
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      34
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      37
    term
    Hypertension
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      316
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      456
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      33
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      165
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      34
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      37
    term
    Lt Ventricular Systolic Dysfunction
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      316
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      456
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      33
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      165
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      34
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      37
    term
    Hypotension
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      316
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      456
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      33
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      165
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      34
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      37
    term
    Cardipulmonary Arrest

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
    Immune system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      316
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      456
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      33
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      165
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      34
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      37
    term
    Allergy/Immunology - Other
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      76
      num At Risk
      316
    2. group Id
      EG001
      num Affected
      86
      num At Risk
      456
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      33
    4. group Id
      EG003
      num Affected
      16
      num At Risk
      165
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      34
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      5
    8. group Id
      EG007
      num Affected
      3
      num At Risk
      37
    term
    Allergic Reaction/Hypersensitivity
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      316
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      456
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      33
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      165
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      34
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      37
    term
    Vasculitis
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      316
    2. group Id
      EG001
      num Affected
      62
      num At Risk
      456
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      33
    4. group Id
      EG003
      num Affected
      8
      num At Risk
      165
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      34
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      37
    term
    Rhinitis
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      316
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      456
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      33
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      165
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      34
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      37
    term
    Autoimmune Reaction
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      316
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      456
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      33
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      165
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      34
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      37
    term
    Otitis Middle Ear
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      316
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      456
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      33
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      165
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      34
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      37
    term
    Auditory/Ear - Other
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      316
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      456
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      33
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      165
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      34
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      37
    term
    Hearing (Without Monitoring Program)
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      316
    2. group Id
      EG001
      num Affected
      23
      num At Risk
      456
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      33
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      165
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      34
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      5
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      37
    term
    Tinnitus
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      316
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      456
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      33
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      165
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      34
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      37
    term
    Hearing (Monitoring Program)
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      282
      num At Risk
      316
    2. group Id
      EG001
      num Affected
      363
      num At Risk
      456
    3. group Id
      EG002
      num Affected
      28
      num At Risk
      33
    4. group Id
      EG003
      num Affected
      72
      num At Risk
      165
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      7
      num At Risk
      34
    7. group Id
      EG006
      num Affected
      3
      num At Risk
      5
    8. group Id
      EG007
      num Affected
      8
      num At Risk
      37
    term
    Neutrophils
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      173
      num At Risk
      316
    2. group Id
      EG001
      num Affected
      264
      num At Risk
      456
    3. group Id
      EG002
      num Affected
      22
      num At Risk
      33
    4. group Id
      EG003
      num Affected
      52
      num At Risk
      165
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      7
      num At Risk
      34
    7. group Id
      EG006
      num Affected
      3
      num At Risk
      5
    8. group Id
      EG007
      num Affected
      8
      num At Risk
      37
    term
    Platelets
Complete source fields
description
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
event Groups
  1. deaths Num Affected
    253
    deaths Num At Risk
    316
    description
    Patients receive paclitaxel IV over 3 hours or docetaxel IV over 1 hour and carboplatin over 30 minutes on day 1. Treatment repeats every 21 days. Patients are not in secondary cytoreductive surgery portion of study.
    id
    EG000
    other Num Affected
    304
    other Num At Risk
    316
    serious Num Affected
    37
    serious Num At Risk
    316
    title
    Arm I (no Surgery; Carboplatin and Paclitaxel)
  2. deaths Num Affected
    299
    deaths Num At Risk
    456
    description
    Patients receive chemotherapy as in arm I and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days. Patients are not in secondary cytoreductive surgery portion of study.
    id
    EG001
    other Num Affected
    376
    other Num At Risk
    456
    serious Num Affected
    104
    serious Num At Risk
    456
    title
    Arm II (no Surgery; Carboplatin, Paclitaxel and Bevacizumab)
  3. deaths Num Affected
    28
    deaths Num At Risk
    33
    description
    Patients receive paclitaxel IV over 3 hours or docetaxel IV over 1 hour and carboplatin over 30 minutes on day 1. Treatment repeats every 21 days. Patients receive secondary cytoreductive surgery.
    id
    EG002
    other Num Affected
    29
    other Num At Risk
    33
    serious Num Affected
    1
    serious Num At Risk
    33
    title
    Arm III (Surgery; Carboplatin and Paclitaxel)
  4. deaths Num Affected
    56
    deaths Num At Risk
    165
    description
    Patients receive paclitaxel IV over 3 hours or docetaxel IV over 1 hour and carboplatin over 30 minutes on day 1. Treatment repeats every 21 days. Patients receive secondary cytoreductive surgery.
    id
    EG003
    other Num Affected
    77
    other Num At Risk
    165
    serious Num Affected
    24
    serious Num At Risk
    165
    title
    Arm IV (Surgery; Carboplatin, Paclitaxel and Bevacizumab)
  5. deaths Num Affected
    4
    deaths Num At Risk
    6
    description
    Patients receive carboplatin as in arm I. Patients receive gemcitabine. Treatment repeats every 21 days. Patients do not receive secondary cytoreductive surgery.
    id
    EG004
    other Num Affected
    3
    other Num At Risk
    6
    serious Num Affected
    0
    serious Num At Risk
    6
    title
    Arm V (no Surgery; Carboplatin and Gemcitabine)
  6. deaths Num Affected
    14
    deaths Num At Risk
    34
    description
    Patients receive carboplatin as in arm I and bevacizumab IV over 30-90 minutes on day 1. Patients receive gemcitabine. Treatment repeats every 21 days. Patients do not receive secondary cytoreductive surgery.
    id
    EG005
    other Num Affected
    9
    other Num At Risk
    34
    serious Num Affected
    1
    serious Num At Risk
    34
    title
    Arm VI (no Surgery; Carboplatin, Gemcitabine and Bevacizumab)
  7. deaths Num Affected
    4
    deaths Num At Risk
    5
    description
    Patients receive carboplatin as in arm I. Patients receive gemcitabine. Treatment repeats every 21 days. Patients receive secondary cytoreductive surgery.
    id
    EG006
    other Num Affected
    3
    other Num At Risk
    5
    serious Num Affected
    2
    serious Num At Risk
    5
    title
    Arm VII (Surgery; Carboplatin and Gemcitabine)
  8. deaths Num Affected
    21
    deaths Num At Risk
    37
    description
    Patients receive carboplatin as in arm I and bevacizumab IV over 30-90 minutes on day 1. Patients receive gemcitabine. Treatment repeats every 21 days. Patients receive secondary cytoreductive surgery.
    id
    EG007
    other Num Affected
    9
    other Num At Risk
    37
    serious Num Affected
    2
    serious Num At Risk
    37
    title
    Arm VIII (Surgery; Carboplatin, Gemcitabine and Bevacizumab)
frequency Threshold
0
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      316
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      456
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      33
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      165
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      34
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      37
    term
    Allergy/Immunology - Other
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      76
      num At Risk
      316
    2. group Id
      EG001
      num Affected
      86
      num At Risk
      456
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      33
    4. group Id
      EG003
      num Affected
      16
      num At Risk
      165
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      34
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      5
    8. group Id
      EG007
      num Affected
      3
      num At Risk
      37
    term
    Allergic Reaction/Hypersensitivity
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      316
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      456
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      33
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      165
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      34
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      37
    term
    Vasculitis
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      316
    2. group Id
      EG001
      num Affected
      62
      num At Risk
      456
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      33
    4. group Id
      EG003
      num Affected
      8
      num At Risk
      165
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      34
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      37
    term
    Rhinitis
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      316
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      456
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      33
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      165
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      34
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      37
    term
    Autoimmune Reaction
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      316
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      456
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      33
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      165
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      34
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      37
    term
    Otitis Middle Ear
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      316
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      456
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      33
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      165
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      34
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      37
    term
    Auditory/Ear - Other
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      316
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      456
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      33
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      165
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      34
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      37
    term
    Hearing (Without Monitoring Program)
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      316
    2. group Id
      EG001
      num Affected
      23
      num At Risk
      456
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      33
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      165
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      34
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      5
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      37
    term
    Tinnitus
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      316
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      456
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      33
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      165
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      34
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      37
    term
    Hearing (Monitoring Program)
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      282
      num At Risk
      316
    2. group Id
      EG001
      num Affected
      363
      num At Risk
      456
    3. group Id
      EG002
      num Affected
      28
      num At Risk
      33
    4. group Id
      EG003
      num Affected
      72
      num At Risk
      165
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      7
      num At Risk
      34
    7. group Id
      EG006
      num Affected
      3
      num At Risk
      5
    8. group Id
      EG007
      num Affected
      8
      num At Risk
      37
    term
    Neutrophils
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      173
      num At Risk
      316
    2. group Id
      EG001
      num Affected
      264
      num At Risk
      456
    3. group Id
      EG002
      num Affected
      22
      num At Risk
      33
    4. group Id
      EG003
      num Affected
      52
      num At Risk
      165
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      7
      num At Risk
      34
    7. group Id
      EG006
      num Affected
      3
      num At Risk
      5
    8. group Id
      EG007
      num Affected
      8
      num At Risk
      37
    term
    Platelets
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      316
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      456
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      33
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      165
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      34
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      5
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      37
    term
    Allergic Reaction/Hypersensitivity
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      316
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      456
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      33
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      165
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      34
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      37
    term
    Myelodysplasia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      316
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      456
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      33
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      165
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      34
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      37
    term
    Neutrophils
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      316
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      456
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      33
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      165
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      34
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      37
    term
    Platelets
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      316
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      456
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      33
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      165
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      34
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      37
    term
    Blood/Bone Marrow - Other
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      316
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      456
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      33
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      165
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      34
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      37
    term
    Leukocytes
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      316
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      456
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      33
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      165
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      34
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      37
    term
    S/N Arrhythmia: Atrial Fibrillation
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      316
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      456
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      33
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      165
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      34
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      37
    term
    Cardiac Ischemia/Infarction
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      316
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      456
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      33
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      165
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      34
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      37
    term
    Hypertension
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      316
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      456
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      33
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      165
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      34
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      37
    term
    Lt Ventricular Systolic Dysfunction
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      316
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      456
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      33
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      165
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      34
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      37
    term
    Hypotension
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      316
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      456
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      33
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      165
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      34
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      37
    term
    Cardipulmonary Arrest
time Frame
During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.

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Preserved source evidence · Not medical advice