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NCT01064648 · ADVERSE EVENTS

Adverse events

Pemetrexed Disodium and Cisplatin With or Without Cediranib Maleate in Treating Patients With Malignant Pleural Mesothelioma · Source last updated 2026-09-09

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
For phase I patients, adverse assessment is repeated weekly during first cycle (1 cycle = 21 days), then every cycle until patient is off protocol treatment. For phase II patients, adverse assessment is repeated every cycle until patient is off protocol treatment, up to 3 years.
Other-event reporting threshold
5%

For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Phase I Cisplatin-pemetrexed Cediranib 30mg

Phase I Cisplatin-pemetrexed Cediranib 30mg

4 / 77 / 77 / 7
Phase I Cisplatin-pemetrexed Cediranib 20mg

Phase I Cisplatin-pemetrexed Cediranib 20mg

6 / 1313 / 139 / 13
Phase II Cisplatin-pemetrexed Cediranib 20mg

Phase II Cisplatin-pemetrexed Cediranib 20mg

32 / 4442 / 4439 / 45
Phase II Cisplatin-pemetrexed Placebo

Phase II Cisplatin-pemetrexed Placebo

25 / 4643 / 4641 / 47

Group identifiers: EG000: Phase I Cisplatin-pemetrexed Cediranib 30mg · EG001: Phase I Cisplatin-pemetrexed Cediranib 20mg · EG002: Phase II Cisplatin-pemetrexed Cediranib 20mg · EG003: Phase II Cisplatin-pemetrexed Placebo

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      44
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      46
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      44
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      46
    term
    Acute coronary syndrome
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      44
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      46
    term
    Atrial fibrillation
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      44
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      46
    term
    Atrial flutter
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      44
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      46
    term
    Heart failure
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      44
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      46
    term
    Mobitz (type) II atrioventricular block
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      44
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      46
    term
    Pericardial effusion
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      44
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      46
    term
    Pericarditis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      44
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      46
    term
    Sinus bradycardia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      44
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      46
    term
    Sinus tachycardia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      44
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      46
    term
    Supraventricular tachycardia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      44
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      46
    term
    Abdominal pain

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      30
      num At Risk
      44
    4. group Id
      EG003
      num Affected
      31
      num At Risk
      46
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      44
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      46
    term
    Blood and lymphatic system disorders - Other
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      44
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      46
    term
    Atrial fibrillation
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      44
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      46
    term
    Atrial flutter
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      44
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      46
    term
    Cardiac disorders-Other
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      44
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      46
    term
    Chest pain - cardiac
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      44
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      46
    term
    Mitral valve disease
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      44
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      46
    term
    Palpitations
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      44
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      46
    term
    Pericardial effusion
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      44
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      46
    term
    Pericarditis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      44
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      46
    term
    Restrictive cardiomyopathy
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      44
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      46
    term
    Sinus tachycardia
Complete source fields
description
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
event Groups
  1. deaths Num Affected
    7
    deaths Num At Risk
    7
    description
    Phase I Cisplatin-pemetrexed Cediranib 30mg
    id
    EG000
    other Num Affected
    7
    other Num At Risk
    7
    serious Num Affected
    4
    serious Num At Risk
    7
    title
    Phase I Cisplatin-pemetrexed Cediranib 30mg
  2. deaths Num Affected
    9
    deaths Num At Risk
    13
    description
    Phase I Cisplatin-pemetrexed Cediranib 20mg
    id
    EG001
    other Num Affected
    13
    other Num At Risk
    13
    serious Num Affected
    6
    serious Num At Risk
    13
    title
    Phase I Cisplatin-pemetrexed Cediranib 20mg
  3. deaths Num Affected
    39
    deaths Num At Risk
    45
    description
    Phase II Cisplatin-pemetrexed Cediranib 20mg
    id
    EG002
    other Num Affected
    42
    other Num At Risk
    44
    serious Num Affected
    32
    serious Num At Risk
    44
    title
    Phase II Cisplatin-pemetrexed Cediranib 20mg
  4. deaths Num Affected
    41
    deaths Num At Risk
    47
    description
    Phase II Cisplatin-pemetrexed Placebo
    id
    EG003
    other Num Affected
    43
    other Num At Risk
    46
    serious Num Affected
    25
    serious Num At Risk
    46
    title
    Phase II Cisplatin-pemetrexed Placebo
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      30
      num At Risk
      44
    4. group Id
      EG003
      num Affected
      31
      num At Risk
      46
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      44
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      46
    term
    Blood and lymphatic system disorders - Other
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      44
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      46
    term
    Atrial fibrillation
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      44
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      46
    term
    Atrial flutter
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      44
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      46
    term
    Cardiac disorders-Other
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      44
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      46
    term
    Chest pain - cardiac
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      44
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      46
    term
    Mitral valve disease
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      44
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      46
    term
    Palpitations
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      44
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      46
    term
    Pericardial effusion
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      44
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      46
    term
    Pericarditis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      44
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      46
    term
    Restrictive cardiomyopathy
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      44
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      46
    term
    Sinus tachycardia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      44
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      46
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      44
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      46
    term
    Acute coronary syndrome
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      44
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      46
    term
    Atrial fibrillation
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      44
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      46
    term
    Atrial flutter
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      44
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      46
    term
    Heart failure
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      44
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      46
    term
    Mobitz (type) II atrioventricular block
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      44
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      46
    term
    Pericardial effusion
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      44
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      46
    term
    Pericarditis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      44
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      46
    term
    Sinus bradycardia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      44
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      46
    term
    Sinus tachycardia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      44
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      46
    term
    Supraventricular tachycardia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      44
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      46
    term
    Abdominal pain
time Frame
For phase I patients, adverse assessment is repeated weekly during first cycle (1 cycle = 21 days), then every cycle until patient is off protocol treatment. For phase II patients, adverse assessment is repeated every cycle until patient is off protocol treatment, up to 3 years.

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