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NCT00217737 · ADVERSE EVENTS

Adverse events

Oxaliplatin, Leucovorin, and Fluorouracil With or Without Bevacizumab in Treating Patients Who Have Undergone Surgery for Stage II Colon Cancer · Source last updated 2026-08-25

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 2 weeks while on treatment and for 30 days after the end of treatment, up to 10 years
Other-event reporting threshold
5%

All patients received treatment at Step 2 and had adverse event data were included in the analysis of adverse events. Patients who underwent observation in Arm C did not receive any treatment, so no adverse event data were collected for these patients. All patients registered/randomized at Step 2 were included in the analysis of all-cause mortality.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Arm A (5-FU, Leucovorin, Oxaliplatin)

Patients receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1. Patients also receive fluorouracil IV continuously over 46 hours beginning on day 1. Treatment repeats every 2 weeks for 12 courses in the absence of disease progression or unacceptable toxicity.

308 / 428399 / 42873 / 460
Arm B (5-FU, Leucovorin, Oxaliplatin, Bevacizumab)

Patients receive oxaliplatin, leucovorin calcium, and fluorouracil as in Arm A and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 2 weeks for 12 courses in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab alone for 12 additional courses in the absence of disease progression or unacceptable toxicity.

292 / 410388 / 41069 / 458
Arm C (Observation)

Patients undergo observation

0 / 00 / 0145 / 1013
No Randomization/Registration at Step 2

Patients whose risk assessment information was unavailable or who did not registered to Step 2 are included in this group.

0 / 00 / 061 / 500

Group identifiers: EG000: Arm A (5-FU, Leucovorin, Oxaliplatin) · EG001: Arm B (5-FU, Leucovorin, Oxaliplatin, Bevacizumab) · EG002: Arm C (Observation) · EG003: No Randomization/Registration at Step 2

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
    Immune system disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      428
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      410
    3. group Id
      EG002
      num At Risk
      0
    4. group Id
      EG003
      num At Risk
      0
    term
    Allergic reaction
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      428
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      410
    3. group Id
      EG002
      num At Risk
      0
    4. group Id
      EG003
      num At Risk
      0
    term
    Hearing w/o audiogr not in monitor prg
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      428
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      410
    3. group Id
      EG002
      num At Risk
      0
    4. group Id
      EG003
      num At Risk
      0
    term
    Otitis, middle ear (non-infectious)
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      428
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      410
    3. group Id
      EG002
      num At Risk
      0
    4. group Id
      EG003
      num At Risk
      0
    term
    Anemia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      42
      num At Risk
      428
    2. group Id
      EG001
      num Affected
      29
      num At Risk
      410
    3. group Id
      EG002
      num At Risk
      0
    4. group Id
      EG003
      num At Risk
      0
    term
    Leukocytes decreased
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      428
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      410
    3. group Id
      EG002
      num At Risk
      0
    4. group Id
      EG003
      num At Risk
      0
    term
    Lymphopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      178
      num At Risk
      428
    2. group Id
      EG001
      num Affected
      138
      num At Risk
      410
    3. group Id
      EG002
      num At Risk
      0
    4. group Id
      EG003
      num At Risk
      0
    term
    Neutrophils decreased
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      428
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      410
    3. group Id
      EG002
      num At Risk
      0
    4. group Id
      EG003
      num At Risk
      0
    term
    Platelets decreased
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      428
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      410
    3. group Id
      EG002
      num At Risk
      0
    4. group Id
      EG003
      num At Risk
      0
    term
    Arrhythmia-other
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      428
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      410
    3. group Id
      EG002
      num At Risk
      0
    4. group Id
      EG003
      num At Risk
      0
    term
    Cardiac-ischemia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      428
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      410
    3. group Id
      EG002
      num At Risk
      0
    4. group Id
      EG003
      num At Risk
      0
    term
    Cardiac troponin I (cTnI) increased
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      428
    2. group Id
      EG001
      num Affected
      36
      num At Risk
      410
    3. group Id
      EG002
      num At Risk
      0
    4. group Id
      EG003
      num At Risk
      0
    term
    Hypertension

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
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      235
      num At Risk
      428
    2. group Id
      EG001
      num Affected
      205
      num At Risk
      410
    3. group Id
      EG002
      num At Risk
      0
    4. group Id
      EG003
      num At Risk
      0
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      222
      num At Risk
      428
    2. group Id
      EG001
      num Affected
      174
      num At Risk
      410
    3. group Id
      EG002
      num At Risk
      0
    4. group Id
      EG003
      num At Risk
      0
    term
    Leukocytes decreased
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      184
      num At Risk
      428
    2. group Id
      EG001
      num Affected
      156
      num At Risk
      410
    3. group Id
      EG002
      num At Risk
      0
    4. group Id
      EG003
      num At Risk
      0
    term
    Neutrophils decreased
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      227
      num At Risk
      428
    2. group Id
      EG001
      num Affected
      152
      num At Risk
      410
    3. group Id
      EG002
      num At Risk
      0
    4. group Id
      EG003
      num At Risk
      0
    term
    Platelets decreased
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      428
    2. group Id
      EG001
      num Affected
      111
      num At Risk
      410
    3. group Id
      EG002
      num At Risk
      0
    4. group Id
      EG003
      num At Risk
      0
    term
    Hypertension
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      294
      num At Risk
      428
    2. group Id
      EG001
      num Affected
      278
      num At Risk
      410
    3. group Id
      EG002
      num At Risk
      0
    4. group Id
      EG003
      num At Risk
      0
    term
    Fatigue
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      36
      num At Risk
      428
    2. group Id
      EG001
      num Affected
      30
      num At Risk
      410
    3. group Id
      EG002
      num At Risk
      0
    4. group Id
      EG003
      num At Risk
      0
    term
    Insomnia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      428
    2. group Id
      EG001
      num Affected
      33
      num At Risk
      410
    3. group Id
      EG002
      num At Risk
      0
    4. group Id
      EG003
      num At Risk
      0
    term
    Weight loss
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      102
      num At Risk
      428
    2. group Id
      EG001
      num Affected
      85
      num At Risk
      410
    3. group Id
      EG002
      num At Risk
      0
    4. group Id
      EG003
      num At Risk
      0
    term
    Alopecia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      428
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      410
    3. group Id
      EG002
      num At Risk
      0
    4. group Id
      EG003
      num At Risk
      0
    term
    Hyperpigmentation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      428
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      410
    3. group Id
      EG002
      num At Risk
      0
    4. group Id
      EG003
      num At Risk
      0
    term
    Nail changes
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      45
      num At Risk
      428
    2. group Id
      EG001
      num Affected
      50
      num At Risk
      410
    3. group Id
      EG002
      num At Risk
      0
    4. group Id
      EG003
      num At Risk
      0
    term
    Rash/desquamation
Complete source fields
description
All patients received treatment at Step 2 and had adverse event data were included in the analysis of adverse events. Patients who underwent observation in Arm C did not receive any treatment, so no adverse event data were collected for these patients. All patients registered/randomized at Step 2 were included in the analysis of all-cause mortality.
event Groups
  1. deaths Num Affected
    73
    deaths Num At Risk
    460
    description
    Patients receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1. Patients also receive fluorouracil IV continuously over 46 hours beginning on day 1. Treatment repeats every 2 weeks for 12 courses in the absence of disease progression or unacceptable toxicity.
    id
    EG000
    other Num Affected
    399
    other Num At Risk
    428
    serious Num Affected
    308
    serious Num At Risk
    428
    title
    Arm A (5-FU, Leucovorin, Oxaliplatin)
  2. deaths Num Affected
    69
    deaths Num At Risk
    458
    description
    Patients receive oxaliplatin, leucovorin calcium, and fluorouracil as in Arm A and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 2 weeks for 12 courses in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab alone for 12 additional courses in the absence of disease progression or unacceptable toxicity.
    id
    EG001
    other Num Affected
    388
    other Num At Risk
    410
    serious Num Affected
    292
    serious Num At Risk
    410
    title
    Arm B (5-FU, Leucovorin, Oxaliplatin, Bevacizumab)
  3. deaths Num Affected
    145
    deaths Num At Risk
    1013
    description
    Patients undergo observation
    id
    EG002
    other Num Affected
    0
    other Num At Risk
    0
    serious Num Affected
    0
    serious Num At Risk
    0
    title
    Arm C (Observation)
  4. deaths Num Affected
    61
    deaths Num At Risk
    500
    description
    Patients whose risk assessment information was unavailable or who did not registered to Step 2 are included in this group.
    id
    EG003
    other Num Affected
    0
    other Num At Risk
    0
    serious Num Affected
    0
    serious Num At Risk
    0
    title
    No Randomization/Registration at Step 2
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      235
      num At Risk
      428
    2. group Id
      EG001
      num Affected
      205
      num At Risk
      410
    3. group Id
      EG002
      num At Risk
      0
    4. group Id
      EG003
      num At Risk
      0
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      222
      num At Risk
      428
    2. group Id
      EG001
      num Affected
      174
      num At Risk
      410
    3. group Id
      EG002
      num At Risk
      0
    4. group Id
      EG003
      num At Risk
      0
    term
    Leukocytes decreased
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      184
      num At Risk
      428
    2. group Id
      EG001
      num Affected
      156
      num At Risk
      410
    3. group Id
      EG002
      num At Risk
      0
    4. group Id
      EG003
      num At Risk
      0
    term
    Neutrophils decreased
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      227
      num At Risk
      428
    2. group Id
      EG001
      num Affected
      152
      num At Risk
      410
    3. group Id
      EG002
      num At Risk
      0
    4. group Id
      EG003
      num At Risk
      0
    term
    Platelets decreased
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      428
    2. group Id
      EG001
      num Affected
      111
      num At Risk
      410
    3. group Id
      EG002
      num At Risk
      0
    4. group Id
      EG003
      num At Risk
      0
    term
    Hypertension
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      294
      num At Risk
      428
    2. group Id
      EG001
      num Affected
      278
      num At Risk
      410
    3. group Id
      EG002
      num At Risk
      0
    4. group Id
      EG003
      num At Risk
      0
    term
    Fatigue
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      36
      num At Risk
      428
    2. group Id
      EG001
      num Affected
      30
      num At Risk
      410
    3. group Id
      EG002
      num At Risk
      0
    4. group Id
      EG003
      num At Risk
      0
    term
    Insomnia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      428
    2. group Id
      EG001
      num Affected
      33
      num At Risk
      410
    3. group Id
      EG002
      num At Risk
      0
    4. group Id
      EG003
      num At Risk
      0
    term
    Weight loss
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      102
      num At Risk
      428
    2. group Id
      EG001
      num Affected
      85
      num At Risk
      410
    3. group Id
      EG002
      num At Risk
      0
    4. group Id
      EG003
      num At Risk
      0
    term
    Alopecia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      428
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      410
    3. group Id
      EG002
      num At Risk
      0
    4. group Id
      EG003
      num At Risk
      0
    term
    Hyperpigmentation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      428
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      410
    3. group Id
      EG002
      num At Risk
      0
    4. group Id
      EG003
      num At Risk
      0
    term
    Nail changes
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      45
      num At Risk
      428
    2. group Id
      EG001
      num Affected
      50
      num At Risk
      410
    3. group Id
      EG002
      num At Risk
      0
    4. group Id
      EG003
      num At Risk
      0
    term
    Rash/desquamation
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      428
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      410
    3. group Id
      EG002
      num At Risk
      0
    4. group Id
      EG003
      num At Risk
      0
    term
    Allergic reaction
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      428
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      410
    3. group Id
      EG002
      num At Risk
      0
    4. group Id
      EG003
      num At Risk
      0
    term
    Hearing w/o audiogr not in monitor prg
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      428
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      410
    3. group Id
      EG002
      num At Risk
      0
    4. group Id
      EG003
      num At Risk
      0
    term
    Otitis, middle ear (non-infectious)
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      428
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      410
    3. group Id
      EG002
      num At Risk
      0
    4. group Id
      EG003
      num At Risk
      0
    term
    Anemia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      42
      num At Risk
      428
    2. group Id
      EG001
      num Affected
      29
      num At Risk
      410
    3. group Id
      EG002
      num At Risk
      0
    4. group Id
      EG003
      num At Risk
      0
    term
    Leukocytes decreased
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      428
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      410
    3. group Id
      EG002
      num At Risk
      0
    4. group Id
      EG003
      num At Risk
      0
    term
    Lymphopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      178
      num At Risk
      428
    2. group Id
      EG001
      num Affected
      138
      num At Risk
      410
    3. group Id
      EG002
      num At Risk
      0
    4. group Id
      EG003
      num At Risk
      0
    term
    Neutrophils decreased
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      428
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      410
    3. group Id
      EG002
      num At Risk
      0
    4. group Id
      EG003
      num At Risk
      0
    term
    Platelets decreased
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      428
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      410
    3. group Id
      EG002
      num At Risk
      0
    4. group Id
      EG003
      num At Risk
      0
    term
    Arrhythmia-other
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      428
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      410
    3. group Id
      EG002
      num At Risk
      0
    4. group Id
      EG003
      num At Risk
      0
    term
    Cardiac-ischemia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      428
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      410
    3. group Id
      EG002
      num At Risk
      0
    4. group Id
      EG003
      num At Risk
      0
    term
    Cardiac troponin I (cTnI) increased
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      428
    2. group Id
      EG001
      num Affected
      36
      num At Risk
      410
    3. group Id
      EG002
      num At Risk
      0
    4. group Id
      EG003
      num At Risk
      0
    term
    Hypertension
time Frame
Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, up to 10 years

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

Preserved source evidence · Independent clinical review pending · Not medical advice