Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00064077 · ADVERSE EVENTS

Adverse events

Comparison of Four Combination Chemotherapy Regimens Using Cisplatin in Treating Patients With Stage IVB, Recurrent, or Persistent Cancer of the Cervix · Source last updated 2018-10-17

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 cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.
Other-event reporting threshold
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Arm I (Paclitaxel, Cisplatin)

Patients receive paclitaxel IV over 24 hours on day 1 and cisplatin IV over 1-4 hours on day 2. Cisplatin: Given IV Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies

42 / 103101 / 103Not reported / Not reported
Arm II (Vinorelbine, Cisplatin)

Patients receive vinorelbine IV over 6-10 minutes on days 1 and 8 and cisplatin IV over 1-4 hours on day 1. Cisplatin: Given IV Quality-of-Life Assessment: Ancillary studies Vinorelbine Tartrate: Given IV

39 / 108105 / 108Not reported / Not reported
Arm III (Gemcitabine, Cisplatin)

Patients receive gemcitabine IV over 30-60 minutes on days 1 and 8 and cisplatin as in arm II. Cisplatin: Given IV Gemcitabine Hydrochloride Quality-of-Life Assessment: Ancillary studies

38 / 112109 / 112Not reported / Not reported
Arm IV (Topotecan, Cisplatin)

Patients receive topotecan IV over 30 minutes on days 1-3 and cisplatin as in arm II. Cisplatin: Given IV Quality-of-Life Assessment: Ancillary studies Topotecan Hydrochloride: Given IV

38 / 111108 / 111Not reported / Not reported

Group identifiers: EG000: Arm I (Paclitaxel, Cisplatin) · EG001: Arm II (Vinorelbine, Cisplatin) · EG002: Arm III (Gemcitabine, Cisplatin) · EG003: Arm IV (Topotecan, Cisplatin)

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
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      103
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      108
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      112
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      111
    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
      3
      num At Risk
      103
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      108
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      112
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      111
    term
    Anemia
  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
      1
      num At Risk
      103
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      108
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      112
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      111
    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
      3
      num At Risk
      103
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      108
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      112
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      111
    term
    Neutropenia
  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
      0
      num At Risk
      103
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      108
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      112
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      111
    term
    Transfusion Prbc's
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      103
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      108
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      112
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      111
    term
    Thrombosis Embolism
  7. 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
      103
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      108
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      112
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      111
    term
    Ischemia/Cardiac Infarction
  8. 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
      103
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      108
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      112
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      111
    term
    Sinus Tachycardia
  9. 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
      103
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      108
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      112
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      111
    term
    Cardiac Left Ventricular Function
  10. 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
      103
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      108
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      112
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      111
    term
    Hypotension
  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
      103
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      108
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      112
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      111
    term
    Other Cardiovascular
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      103
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      108
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      112
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      111
    term
    Nausea

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
      92
      num At Risk
      103
    2. group Id
      EG001
      num Affected
      98
      num At Risk
      108
    3. group Id
      EG002
      num Affected
      90
      num At Risk
      112
    4. group Id
      EG003
      num Affected
      102
      num At Risk
      111
    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
      94
      num At Risk
      103
    2. group Id
      EG001
      num Affected
      100
      num At Risk
      108
    3. group Id
      EG002
      num Affected
      104
      num At Risk
      112
    4. group Id
      EG003
      num Affected
      106
      num At Risk
      111
    term
    Anemia
  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
      36
      num At Risk
      103
    2. group Id
      EG001
      num Affected
      32
      num At Risk
      108
    3. group Id
      EG002
      num Affected
      88
      num At Risk
      112
    4. group Id
      EG003
      num Affected
      87
      num At Risk
      111
    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
      92
      num At Risk
      103
    2. group Id
      EG001
      num Affected
      94
      num At Risk
      108
    3. group Id
      EG002
      num Affected
      76
      num At Risk
      112
    4. group Id
      EG003
      num Affected
      102
      num At Risk
      111
    term
    Neutropenia
  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
      38
      num At Risk
      103
    2. group Id
      EG001
      num Affected
      53
      num At Risk
      108
    3. group Id
      EG002
      num Affected
      57
      num At Risk
      112
    4. group Id
      EG003
      num Affected
      57
      num At Risk
      111
    term
    Otherhematologic
  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
      103
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      108
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      112
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      111
    term
    Lymphatics
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      103
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      108
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      112
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      111
    term
    Thrombosis Embolism
  8. 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
      103
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      108
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      112
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      111
    term
    Sinus Bradycardia
  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
      103
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      108
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      112
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      111
    term
    Cardiac Left Ventricular Function
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      103
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      108
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      112
    4. group Id
      EG003
      num Affected
      13
      num At Risk
      111
    term
    Other Cardiovascular
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      103
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      108
    3. group Id
      EG002
      num Affected
      17
      num At Risk
      112
    4. group Id
      EG003
      num Affected
      11
      num At Risk
      111
    term
    Inner Ear/Hearing
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      103
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      108
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      112
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      111
    term
    Other Hearing
Complete source fields
event Groups
  1. description
    Patients receive paclitaxel IV over 24 hours on day 1 and cisplatin IV over 1-4 hours on day 2. Cisplatin: Given IV Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies
    id
    EG000
    other Num Affected
    101
    other Num At Risk
    103
    serious Num Affected
    42
    serious Num At Risk
    103
    title
    Arm I (Paclitaxel, Cisplatin)
  2. description
    Patients receive vinorelbine IV over 6-10 minutes on days 1 and 8 and cisplatin IV over 1-4 hours on day 1. Cisplatin: Given IV Quality-of-Life Assessment: Ancillary studies Vinorelbine Tartrate: Given IV
    id
    EG001
    other Num Affected
    105
    other Num At Risk
    108
    serious Num Affected
    39
    serious Num At Risk
    108
    title
    Arm II (Vinorelbine, Cisplatin)
  3. description
    Patients receive gemcitabine IV over 30-60 minutes on days 1 and 8 and cisplatin as in arm II. Cisplatin: Given IV Gemcitabine Hydrochloride Quality-of-Life Assessment: Ancillary studies
    id
    EG002
    other Num Affected
    109
    other Num At Risk
    112
    serious Num Affected
    38
    serious Num At Risk
    112
    title
    Arm III (Gemcitabine, Cisplatin)
  4. description
    Patients receive topotecan IV over 30 minutes on days 1-3 and cisplatin as in arm II. Cisplatin: Given IV Quality-of-Life Assessment: Ancillary studies Topotecan Hydrochloride: Given IV
    id
    EG003
    other Num Affected
    108
    other Num At Risk
    111
    serious Num Affected
    38
    serious Num At Risk
    111
    title
    Arm IV (Topotecan, Cisplatin)
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
      92
      num At Risk
      103
    2. group Id
      EG001
      num Affected
      98
      num At Risk
      108
    3. group Id
      EG002
      num Affected
      90
      num At Risk
      112
    4. group Id
      EG003
      num Affected
      102
      num At Risk
      111
    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
      94
      num At Risk
      103
    2. group Id
      EG001
      num Affected
      100
      num At Risk
      108
    3. group Id
      EG002
      num Affected
      104
      num At Risk
      112
    4. group Id
      EG003
      num Affected
      106
      num At Risk
      111
    term
    Anemia
  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
      36
      num At Risk
      103
    2. group Id
      EG001
      num Affected
      32
      num At Risk
      108
    3. group Id
      EG002
      num Affected
      88
      num At Risk
      112
    4. group Id
      EG003
      num Affected
      87
      num At Risk
      111
    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
      92
      num At Risk
      103
    2. group Id
      EG001
      num Affected
      94
      num At Risk
      108
    3. group Id
      EG002
      num Affected
      76
      num At Risk
      112
    4. group Id
      EG003
      num Affected
      102
      num At Risk
      111
    term
    Neutropenia
  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
      38
      num At Risk
      103
    2. group Id
      EG001
      num Affected
      53
      num At Risk
      108
    3. group Id
      EG002
      num Affected
      57
      num At Risk
      112
    4. group Id
      EG003
      num Affected
      57
      num At Risk
      111
    term
    Otherhematologic
  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
      103
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      108
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      112
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      111
    term
    Lymphatics
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      103
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      108
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      112
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      111
    term
    Thrombosis Embolism
  8. 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
      103
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      108
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      112
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      111
    term
    Sinus Bradycardia
  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
      103
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      108
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      112
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      111
    term
    Cardiac Left Ventricular Function
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      103
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      108
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      112
    4. group Id
      EG003
      num Affected
      13
      num At Risk
      111
    term
    Other Cardiovascular
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      103
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      108
    3. group Id
      EG002
      num Affected
      17
      num At Risk
      112
    4. group Id
      EG003
      num Affected
      11
      num At Risk
      111
    term
    Inner Ear/Hearing
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      103
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      108
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      112
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      111
    term
    Other Hearing
serious 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
      0
      num At Risk
      103
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      108
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      112
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      111
    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
      3
      num At Risk
      103
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      108
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      112
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      111
    term
    Anemia
  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
      1
      num At Risk
      103
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      108
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      112
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      111
    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
      3
      num At Risk
      103
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      108
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      112
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      111
    term
    Neutropenia
  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
      0
      num At Risk
      103
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      108
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      112
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      111
    term
    Transfusion Prbc's
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      103
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      108
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      112
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      111
    term
    Thrombosis Embolism
  7. 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
      103
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      108
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      112
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      111
    term
    Ischemia/Cardiac Infarction
  8. 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
      103
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      108
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      112
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      111
    term
    Sinus Tachycardia
  9. 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
      103
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      108
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      112
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      111
    term
    Cardiac Left Ventricular Function
  10. 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
      103
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      108
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      112
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      111
    term
    Hypotension
  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
      103
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      108
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      112
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      111
    term
    Other Cardiovascular
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      103
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      108
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      112
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      111
    term
    Nausea
time Frame
Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.

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

Preserved source evidence · Not medical advice