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NCT00803062 · ADVERSE EVENTS

Adverse events

Paclitaxel and Cisplatin or Topotecan With or Without Bevacizumab in Treating Patients With Stage IVB, Recurrent, or Persistent Cervical Cancer · Source last updated 2019-07-23

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
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Other-event reporting threshold
0%

Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Arm I (Paclitaxel and Cisplatin)

Paclitaxel 135 mg/m2 IV over 24 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 1 Cycles repeated q21 days to progression/toxicity

42 / 112112 / 112Not reported / Not reported
Arm II (Paclitaxel, Cisplatin, Bevacizumab)

Paclitaxel 135 mg/m2 IV over 24 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 Bevacizumab 15 mg/kg IV day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 Bevacizumab 15 mg/kg IV day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 1 Bevacizumab 15 mg/kg IV day 1 Cycles repeated q21 days to progression/toxicity

53 / 111111 / 111Not reported / Not reported
Arm III (Topotecan Hydrochloride and Paclitaxel)

Paclitaxel 175 mg/m2 over 3 hrs on day 1 Topotecan 0.75 mg/m2 over 30 mins days 1-3 Cycles repeated q21 days to progression/toxicity

37 / 107107 / 107Not reported / Not reported
Arm IV (Topotecan Hydrochloride, Paclitaxel, Bevacizumab)

Paclitaxel 175 mg/m2 over 3 hrs on day 1 Topotecan 0.75 mg/m2 over 30 mins days 1-3 Bevacizumab 15 mg/kg IV day 1 Cycles repeated q21 days to progression/toxicity

61 / 109107 / 109Not reported / Not reported

Group identifiers: EG000: Arm I (Paclitaxel and Cisplatin) · EG001: Arm II (Paclitaxel, Cisplatin, Bevacizumab) · EG002: Arm III (Topotecan Hydrochloride and Paclitaxel) · EG003: Arm IV (Topotecan Hydrochloride, Paclitaxel, 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
      0
      num At Risk
      112
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      111
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      107
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      109
    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
      2
      num At Risk
      112
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      111
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      107
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      109
    term
    Neutrophils
  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
      0
      num At Risk
      112
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      111
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      107
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      109
    term
    Platelets
  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
      112
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      111
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      107
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      109
    term
    Blood/Bone Marrow - Other
  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
      112
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      111
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      107
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      109
    term
    Leukocytes
  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
      1
      num At Risk
      112
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      111
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      107
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      109
    term
    Hemoglobin
  7. 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
      112
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      111
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      107
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      109
    term
    Vasovagal Episode
  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
      112
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      111
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      107
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      109
    term
    Supraventricular Tachycardia
  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
      112
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      111
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      107
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      109
    term
    Cardiac Ischemia/Infarction
  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
      112
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      111
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      107
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      109
    term
    Hypertension
  11. 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
      112
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      111
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      107
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      109
    term
    Hypotension
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      112
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      111
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      107
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      109
    term
    Inr

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
      19
      num At Risk
      112
    2. group Id
      EG001
      num Affected
      20
      num At Risk
      111
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      107
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      109
    term
    Allergic Reaction/Hypersensitivity
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      112
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      111
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      107
    4. group Id
      EG003
      num Affected
      10
      num At Risk
      109
    term
    Rhinitis
  3. 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
      112
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      111
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      107
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      109
    term
    Auditory/Ear - Other
  4. 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
      112
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      111
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      107
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      109
    term
    Hearing (Without Monitoring Program)
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      112
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      111
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      107
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      109
    term
    Tinnitus
  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
      112
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      111
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      107
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      109
    term
    Hearing (Monitoring Program)
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      79
      num At Risk
      112
    2. group Id
      EG001
      num Affected
      90
      num At Risk
      111
    3. group Id
      EG002
      num Affected
      75
      num At Risk
      107
    4. group Id
      EG003
      num Affected
      93
      num At Risk
      109
    term
    Neutrophils
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      39
      num At Risk
      112
    2. group Id
      EG001
      num Affected
      55
      num At Risk
      111
    3. group Id
      EG002
      num Affected
      45
      num At Risk
      107
    4. group Id
      EG003
      num Affected
      61
      num At Risk
      109
    term
    Platelets
  9. 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
      112
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      111
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      107
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      109
    term
    Blood/Bone Marrow - Other
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      88
      num At Risk
      112
    2. group Id
      EG001
      num Affected
      95
      num At Risk
      111
    3. group Id
      EG002
      num Affected
      89
      num At Risk
      107
    4. group Id
      EG003
      num Affected
      99
      num At Risk
      109
    term
    Leukocytes
  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
      4
      num At Risk
      112
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      111
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      107
    4. group Id
      EG003
      num Affected
      13
      num At Risk
      109
    term
    Lymphopenia
  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
      107
      num At Risk
      112
    2. group Id
      EG001
      num Affected
      101
      num At Risk
      111
    3. group Id
      EG002
      num Affected
      104
      num At Risk
      107
    4. group Id
      EG003
      num Affected
      101
      num At Risk
      109
    term
    Hemoglobin
Complete source fields
description
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
event Groups
  1. description
    Paclitaxel 135 mg/m2 IV over 24 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 1 Cycles repeated q21 days to progression/toxicity
    id
    EG000
    other Num Affected
    112
    other Num At Risk
    112
    serious Num Affected
    42
    serious Num At Risk
    112
    title
    Arm I (Paclitaxel and Cisplatin)
  2. description
    Paclitaxel 135 mg/m2 IV over 24 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 Bevacizumab 15 mg/kg IV day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 Bevacizumab 15 mg/kg IV day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 1 Bevacizumab 15 mg/kg IV day 1 Cycles repeated q21 days to progression/toxicity
    id
    EG001
    other Num Affected
    111
    other Num At Risk
    111
    serious Num Affected
    53
    serious Num At Risk
    111
    title
    Arm II (Paclitaxel, Cisplatin, Bevacizumab)
  3. description
    Paclitaxel 175 mg/m2 over 3 hrs on day 1 Topotecan 0.75 mg/m2 over 30 mins days 1-3 Cycles repeated q21 days to progression/toxicity
    id
    EG002
    other Num Affected
    107
    other Num At Risk
    107
    serious Num Affected
    37
    serious Num At Risk
    107
    title
    Arm III (Topotecan Hydrochloride and Paclitaxel)
  4. description
    Paclitaxel 175 mg/m2 over 3 hrs on day 1 Topotecan 0.75 mg/m2 over 30 mins days 1-3 Bevacizumab 15 mg/kg IV day 1 Cycles repeated q21 days to progression/toxicity
    id
    EG003
    other Num Affected
    107
    other Num At Risk
    109
    serious Num Affected
    61
    serious Num At Risk
    109
    title
    Arm IV (Topotecan Hydrochloride, Paclitaxel, 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
      19
      num At Risk
      112
    2. group Id
      EG001
      num Affected
      20
      num At Risk
      111
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      107
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      109
    term
    Allergic Reaction/Hypersensitivity
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      112
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      111
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      107
    4. group Id
      EG003
      num Affected
      10
      num At Risk
      109
    term
    Rhinitis
  3. 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
      112
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      111
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      107
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      109
    term
    Auditory/Ear - Other
  4. 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
      112
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      111
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      107
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      109
    term
    Hearing (Without Monitoring Program)
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      112
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      111
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      107
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      109
    term
    Tinnitus
  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
      112
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      111
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      107
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      109
    term
    Hearing (Monitoring Program)
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      79
      num At Risk
      112
    2. group Id
      EG001
      num Affected
      90
      num At Risk
      111
    3. group Id
      EG002
      num Affected
      75
      num At Risk
      107
    4. group Id
      EG003
      num Affected
      93
      num At Risk
      109
    term
    Neutrophils
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      39
      num At Risk
      112
    2. group Id
      EG001
      num Affected
      55
      num At Risk
      111
    3. group Id
      EG002
      num Affected
      45
      num At Risk
      107
    4. group Id
      EG003
      num Affected
      61
      num At Risk
      109
    term
    Platelets
  9. 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
      112
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      111
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      107
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      109
    term
    Blood/Bone Marrow - Other
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      88
      num At Risk
      112
    2. group Id
      EG001
      num Affected
      95
      num At Risk
      111
    3. group Id
      EG002
      num Affected
      89
      num At Risk
      107
    4. group Id
      EG003
      num Affected
      99
      num At Risk
      109
    term
    Leukocytes
  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
      4
      num At Risk
      112
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      111
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      107
    4. group Id
      EG003
      num Affected
      13
      num At Risk
      109
    term
    Lymphopenia
  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
      107
      num At Risk
      112
    2. group Id
      EG001
      num Affected
      101
      num At Risk
      111
    3. group Id
      EG002
      num Affected
      104
      num At Risk
      107
    4. group Id
      EG003
      num Affected
      101
      num At Risk
      109
    term
    Hemoglobin
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
      0
      num At Risk
      112
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      111
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      107
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      109
    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
      2
      num At Risk
      112
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      111
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      107
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      109
    term
    Neutrophils
  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
      0
      num At Risk
      112
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      111
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      107
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      109
    term
    Platelets
  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
      112
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      111
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      107
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      109
    term
    Blood/Bone Marrow - Other
  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
      112
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      111
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      107
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      109
    term
    Leukocytes
  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
      1
      num At Risk
      112
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      111
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      107
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      109
    term
    Hemoglobin
  7. 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
      112
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      111
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      107
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      109
    term
    Vasovagal Episode
  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
      112
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      111
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      107
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      109
    term
    Supraventricular Tachycardia
  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
      112
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      111
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      107
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      109
    term
    Cardiac Ischemia/Infarction
  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
      112
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      111
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      107
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      109
    term
    Hypertension
  11. 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
      112
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      111
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      107
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      109
    term
    Hypotension
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      112
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      111
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      107
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      109
    term
    Inr
time Frame
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment

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Preserved source evidence · Not medical advice