Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00011986 · ADVERSE EVENTS

Adverse events

Combination Chemotherapy in Treating Patients With Stage III or Stage IV Ovarian Epithelial Cancer or Primary Peritoneal Cancer · Source last updated 2019-04-16

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
From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred.
Other-event reporting threshold
0%

Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Carbo/Taxol

Carboplatin AUC 6 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 8 cycles

86 / 777857 / 862Not reported / Not reported
Carbo/Taxol/Gemcitabine

Carboplatin AUC 5 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 8 cycles plus Gemcitabine 800 mg/m2/dIV on days 1 and 8 x 8 cycles

107 / 774856 / 860Not reported / Not reported
Carbo/Taxol/Doxil

Carboplatin AUC 5 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 8 cycles plus Doxil 30 mg/m2 IV every other cycle on day 1 x 8 cycles

115 / 767852 / 854Not reported / Not reported
Carbo/Topotecan - Carbo/Taxol

Topotecan 1.25 mg/m2/dIV days 1-3 plus Carboplatin AUC 5 IV on day 3 plus x 4 cycles followed by Carboplatin AUC 6 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 4 cycles

77 / 766843 / 846Not reported / Not reported
Carbo/Gemcitabine - Carbo/Taxol

Gemcitabine 1000 mg/m2/dIV on days 1 and 8 plus Carboplatin AUC 6 IV on day 8 plus x 4 cycles followed by Carboplatin AUC 6 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 4 cycles

100 / 767849 / 851Not reported / Not reported

Group identifiers: EG000: Carbo/Taxol · EG001: Carbo/Taxol/Gemcitabine · EG002: Carbo/Taxol/Doxil · EG003: Carbo/Topotecan - Carbo/Taxol · EG004: Carbo/Gemcitabine - Carbo/Taxol

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 (2.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      777
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      774
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      767
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      766
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      767
    term
    Allergy-Other
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      777
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      774
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      767
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      766
    5. group Id
      EG004
      num Affected
      6
      num At Risk
      767
    term
    Allergic Reaction/Hypersensitivity
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      777
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      774
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      767
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      766
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      767
    term
    Inner Ear/Hearing
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      777
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      774
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      767
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      766
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      767
    term
    Hearing-Other
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      777
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      774
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      767
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      766
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      767
    term
    Hemoglobin
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      777
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      774
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      767
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      766
    5. group Id
      EG004
      num Affected
      8
      num At Risk
      767
    term
    Platelets
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      777
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      774
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      767
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      766
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      767
    term
    Neutrophils/Granulocytes
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      777
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      774
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      767
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      766
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      767
    term
    Leukocytes
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      777
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      774
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      767
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      766
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      767
    term
    Hypertension
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      777
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      774
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      767
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      766
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      767
    term
    Circulatory Or Cardiac-Other
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      777
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      774
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      767
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      766
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      767
    term
    Cardiac Left Ventricular Function
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      777
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      774
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      767
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      766
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      767
    term
    Cardiac Troponin I

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 (2.0)
    stats
    1. group Id
      EG000
      num Affected
      746
      num At Risk
      862
    2. group Id
      EG001
      num Affected
      826
      num At Risk
      860
    3. group Id
      EG002
      num Affected
      806
      num At Risk
      854
    4. group Id
      EG003
      num Affected
      782
      num At Risk
      846
    5. group Id
      EG004
      num Affected
      800
      num At Risk
      851
    term
    Leukopenia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      821
      num At Risk
      862
    2. group Id
      EG001
      num Affected
      838
      num At Risk
      860
    3. group Id
      EG002
      num Affected
      818
      num At Risk
      854
    4. group Id
      EG003
      num Affected
      830
      num At Risk
      846
    5. group Id
      EG004
      num Affected
      825
      num At Risk
      851
    term
    Neutropenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      319
      num At Risk
      862
    2. group Id
      EG001
      num Affected
      675
      num At Risk
      860
    3. group Id
      EG002
      num Affected
      438
      num At Risk
      854
    4. group Id
      EG003
      num Affected
      460
      num At Risk
      846
    5. group Id
      EG004
      num Affected
      645
      num At Risk
      851
    term
    Thrombocytopenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      508
      num At Risk
      862
    2. group Id
      EG001
      num Affected
      700
      num At Risk
      860
    3. group Id
      EG002
      num Affected
      603
      num At Risk
      854
    4. group Id
      EG003
      num Affected
      647
      num At Risk
      846
    5. group Id
      EG004
      num Affected
      685
      num At Risk
      851
    term
    Anemia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      164
      num At Risk
      862
    2. group Id
      EG001
      num Affected
      351
      num At Risk
      860
    3. group Id
      EG002
      num Affected
      261
      num At Risk
      854
    4. group Id
      EG003
      num Affected
      260
      num At Risk
      846
    5. group Id
      EG004
      num Affected
      327
      num At Risk
      851
    term
    Other Hemotologic
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      65
      num At Risk
      862
    2. group Id
      EG001
      num Affected
      42
      num At Risk
      860
    3. group Id
      EG002
      num Affected
      54
      num At Risk
      854
    4. group Id
      EG003
      num Affected
      39
      num At Risk
      846
    5. group Id
      EG004
      num Affected
      47
      num At Risk
      851
    term
    Allergy
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      862
    2. group Id
      EG001
      num Affected
      20
      num At Risk
      860
    3. group Id
      EG002
      num Affected
      23
      num At Risk
      854
    4. group Id
      EG003
      num Affected
      17
      num At Risk
      846
    5. group Id
      EG004
      num Affected
      15
      num At Risk
      851
    term
    Auditory
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      43
      num At Risk
      862
    2. group Id
      EG001
      num Affected
      72
      num At Risk
      860
    3. group Id
      EG002
      num Affected
      62
      num At Risk
      854
    4. group Id
      EG003
      num Affected
      36
      num At Risk
      846
    5. group Id
      EG004
      num Affected
      61
      num At Risk
      851
    term
    Cardiovascular
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      862
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      860
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      854
    4. group Id
      EG003
      num Affected
      14
      num At Risk
      846
    5. group Id
      EG004
      num Affected
      10
      num At Risk
      851
    term
    Coagulation
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      365
      num At Risk
      862
    2. group Id
      EG001
      num Affected
      434
      num At Risk
      860
    3. group Id
      EG002
      num Affected
      403
      num At Risk
      854
    4. group Id
      EG003
      num Affected
      367
      num At Risk
      846
    5. group Id
      EG004
      num Affected
      363
      num At Risk
      851
    term
    Constitutional
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      63
      num At Risk
      862
    2. group Id
      EG001
      num Affected
      61
      num At Risk
      860
    3. group Id
      EG002
      num Affected
      109
      num At Risk
      854
    4. group Id
      EG003
      num Affected
      47
      num At Risk
      846
    5. group Id
      EG004
      num Affected
      64
      num At Risk
      851
    term
    Dermatologic
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      36
      num At Risk
      862
    2. group Id
      EG001
      num Affected
      38
      num At Risk
      860
    3. group Id
      EG002
      num Affected
      41
      num At Risk
      854
    4. group Id
      EG003
      num Affected
      40
      num At Risk
      846
    5. group Id
      EG004
      num Affected
      27
      num At Risk
      851
    term
    Endocrine
Complete source fields
description
Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.
event Groups
  1. description
    Carboplatin AUC 6 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 8 cycles
    id
    EG000
    other Num Affected
    857
    other Num At Risk
    862
    serious Num Affected
    86
    serious Num At Risk
    777
    title
    Carbo/Taxol
  2. description
    Carboplatin AUC 5 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 8 cycles plus Gemcitabine 800 mg/m2/dIV on days 1 and 8 x 8 cycles
    id
    EG001
    other Num Affected
    856
    other Num At Risk
    860
    serious Num Affected
    107
    serious Num At Risk
    774
    title
    Carbo/Taxol/Gemcitabine
  3. description
    Carboplatin AUC 5 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 8 cycles plus Doxil 30 mg/m2 IV every other cycle on day 1 x 8 cycles
    id
    EG002
    other Num Affected
    852
    other Num At Risk
    854
    serious Num Affected
    115
    serious Num At Risk
    767
    title
    Carbo/Taxol/Doxil
  4. description
    Topotecan 1.25 mg/m2/dIV days 1-3 plus Carboplatin AUC 5 IV on day 3 plus x 4 cycles followed by Carboplatin AUC 6 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 4 cycles
    id
    EG003
    other Num Affected
    843
    other Num At Risk
    846
    serious Num Affected
    77
    serious Num At Risk
    766
    title
    Carbo/Topotecan - Carbo/Taxol
  5. description
    Gemcitabine 1000 mg/m2/dIV on days 1 and 8 plus Carboplatin AUC 6 IV on day 8 plus x 4 cycles followed by Carboplatin AUC 6 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 4 cycles
    id
    EG004
    other Num Affected
    849
    other Num At Risk
    851
    serious Num Affected
    100
    serious Num At Risk
    767
    title
    Carbo/Gemcitabine - Carbo/Taxol
frequency Threshold
0
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      746
      num At Risk
      862
    2. group Id
      EG001
      num Affected
      826
      num At Risk
      860
    3. group Id
      EG002
      num Affected
      806
      num At Risk
      854
    4. group Id
      EG003
      num Affected
      782
      num At Risk
      846
    5. group Id
      EG004
      num Affected
      800
      num At Risk
      851
    term
    Leukopenia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      821
      num At Risk
      862
    2. group Id
      EG001
      num Affected
      838
      num At Risk
      860
    3. group Id
      EG002
      num Affected
      818
      num At Risk
      854
    4. group Id
      EG003
      num Affected
      830
      num At Risk
      846
    5. group Id
      EG004
      num Affected
      825
      num At Risk
      851
    term
    Neutropenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      319
      num At Risk
      862
    2. group Id
      EG001
      num Affected
      675
      num At Risk
      860
    3. group Id
      EG002
      num Affected
      438
      num At Risk
      854
    4. group Id
      EG003
      num Affected
      460
      num At Risk
      846
    5. group Id
      EG004
      num Affected
      645
      num At Risk
      851
    term
    Thrombocytopenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      508
      num At Risk
      862
    2. group Id
      EG001
      num Affected
      700
      num At Risk
      860
    3. group Id
      EG002
      num Affected
      603
      num At Risk
      854
    4. group Id
      EG003
      num Affected
      647
      num At Risk
      846
    5. group Id
      EG004
      num Affected
      685
      num At Risk
      851
    term
    Anemia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      164
      num At Risk
      862
    2. group Id
      EG001
      num Affected
      351
      num At Risk
      860
    3. group Id
      EG002
      num Affected
      261
      num At Risk
      854
    4. group Id
      EG003
      num Affected
      260
      num At Risk
      846
    5. group Id
      EG004
      num Affected
      327
      num At Risk
      851
    term
    Other Hemotologic
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      65
      num At Risk
      862
    2. group Id
      EG001
      num Affected
      42
      num At Risk
      860
    3. group Id
      EG002
      num Affected
      54
      num At Risk
      854
    4. group Id
      EG003
      num Affected
      39
      num At Risk
      846
    5. group Id
      EG004
      num Affected
      47
      num At Risk
      851
    term
    Allergy
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      862
    2. group Id
      EG001
      num Affected
      20
      num At Risk
      860
    3. group Id
      EG002
      num Affected
      23
      num At Risk
      854
    4. group Id
      EG003
      num Affected
      17
      num At Risk
      846
    5. group Id
      EG004
      num Affected
      15
      num At Risk
      851
    term
    Auditory
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      43
      num At Risk
      862
    2. group Id
      EG001
      num Affected
      72
      num At Risk
      860
    3. group Id
      EG002
      num Affected
      62
      num At Risk
      854
    4. group Id
      EG003
      num Affected
      36
      num At Risk
      846
    5. group Id
      EG004
      num Affected
      61
      num At Risk
      851
    term
    Cardiovascular
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      862
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      860
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      854
    4. group Id
      EG003
      num Affected
      14
      num At Risk
      846
    5. group Id
      EG004
      num Affected
      10
      num At Risk
      851
    term
    Coagulation
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      365
      num At Risk
      862
    2. group Id
      EG001
      num Affected
      434
      num At Risk
      860
    3. group Id
      EG002
      num Affected
      403
      num At Risk
      854
    4. group Id
      EG003
      num Affected
      367
      num At Risk
      846
    5. group Id
      EG004
      num Affected
      363
      num At Risk
      851
    term
    Constitutional
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      63
      num At Risk
      862
    2. group Id
      EG001
      num Affected
      61
      num At Risk
      860
    3. group Id
      EG002
      num Affected
      109
      num At Risk
      854
    4. group Id
      EG003
      num Affected
      47
      num At Risk
      846
    5. group Id
      EG004
      num Affected
      64
      num At Risk
      851
    term
    Dermatologic
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      36
      num At Risk
      862
    2. group Id
      EG001
      num Affected
      38
      num At Risk
      860
    3. group Id
      EG002
      num Affected
      41
      num At Risk
      854
    4. group Id
      EG003
      num Affected
      40
      num At Risk
      846
    5. group Id
      EG004
      num Affected
      27
      num At Risk
      851
    term
    Endocrine
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      777
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      774
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      767
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      766
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      767
    term
    Allergy-Other
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      777
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      774
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      767
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      766
    5. group Id
      EG004
      num Affected
      6
      num At Risk
      767
    term
    Allergic Reaction/Hypersensitivity
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      777
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      774
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      767
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      766
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      767
    term
    Inner Ear/Hearing
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      777
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      774
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      767
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      766
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      767
    term
    Hearing-Other
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      777
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      774
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      767
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      766
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      767
    term
    Hemoglobin
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      777
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      774
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      767
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      766
    5. group Id
      EG004
      num Affected
      8
      num At Risk
      767
    term
    Platelets
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      777
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      774
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      767
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      766
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      767
    term
    Neutrophils/Granulocytes
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      777
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      774
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      767
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      766
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      767
    term
    Leukocytes
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      777
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      774
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      767
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      766
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      767
    term
    Hypertension
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      777
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      774
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      767
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      766
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      767
    term
    Circulatory Or Cardiac-Other
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      777
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      774
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      767
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      766
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      767
    term
    Cardiac Left Ventricular Function
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      777
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      774
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      767
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      766
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      767
    term
    Cardiac Troponin I
time Frame
From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred.

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice