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NCT02888743 · ADVERSE EVENTS

Adverse events

Durvalumab and Tremelimumab With or Without High or Low-Dose Radiation Therapy in Treating Patients With Metastatic Colorectal or Non-small Cell Lung Cancer · Source last updated 2026-07-31

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
Two years
Other-event reporting threshold
5%

SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
NSCLC Arm A (Tremelimumab, Durvalumab, HD-RT)

Patients receive tremelimumab and durvalumab as in Arm C. Beginning at week 2, patients receive high dose radiation therapy QD over 10 days for up to 3 fractions. Durvalumab: Given IV Radiation Therapy: Undergo radiation therapy Tremelimumab: Given IV

9 / 2625 / 2615 / 26
NSCLC Arm B (Tremelimumab, Durvalumab, LD-RT)

Patients receive tremelimumab and durvalumab as in Arm C. Beginning at week 2, patients receive low dose radiation therapy every 6 hours BID on weeks 2, 6, 10 and 14. Durvalumab: Given IV Radiation Therapy: Undergo radiation therapy Tremelimumab: Given IV

11 / 2624 / 2615 / 26
NSCLC Arm C (Tremelimumab, Durvalumab)

Patients receive tremelimumab IV and durvalumab IV over 60 minutes every 4 weeks for up to 16 weeks in the absence of disease progression or unacceptable toxicity. Patients then receive durvalumab IV over 60 minutes 4 weeks after last combination dose for up to 9 additional doses. Durvalumab: Given IV Tremelimumab: Given IV

8 / 2624 / 269 / 26
CRC Arm A (Tremelimumab, Durvalumab, HD-RT)

Patients receive tremelimumab IV and durvalumab IV over 60 minutes every 4 weeks for up to 16 weeks in the absence of disease progression or unacceptable toxicity. Patients then receive durvalumab IV over 60 minutes 4 weeks after last combination dose for up to 9 additional doses. Beginning at week 2, patients receive high dose radiation therapy QD over 10 days for up to 3 fractions. Durvalumab: Given IV Radiation Therapy: Undergo radiation therapy Tremelimumab: Given IV

5 / 109 / 106 / 10
CRC Arm B (Tremelimumab, Durvalumab, LD-RT)

Patients receive tremelimumab IV and durvalumab IV over 60 minutes every 4 weeks for up to 16 weeks in the absence of disease progression or unacceptable toxicity. Patients then receive durvalumab IV over 60 minutes 4 weeks after last combination dose for up to 9 additional doses. Beginning at week 2, patients receive low dose radiation therapy every 6 hours BID on weeks 2, 6, 10 and 14. Durvalumab: Given IV Radiation Therapy: Undergo radiation therapy Tremelimumab: Given IV

6 / 99 / 96 / 9

Group identifiers: EG000: NSCLC Arm A (Tremelimumab, Durvalumab, HD-RT) · EG001: NSCLC Arm B (Tremelimumab, Durvalumab, LD-RT) · EG002: NSCLC Arm C (Tremelimumab, Durvalumab) · EG003: CRC Arm A (Tremelimumab, Durvalumab, HD-RT) · EG004: CRC Arm B (Tremelimumab, Durvalumab, LD-RT)

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
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      26
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      26
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      26
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      26
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      26
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      26
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Cardiac arrest
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      26
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      26
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      26
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Cyanosis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      26
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      26
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      26
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Sinus Tachycardia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      26
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      26
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      26
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      9
      num Events
      1
    term
    Hypothyroidism
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      26
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      26
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      26
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Adrenal insufficiency
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      26
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      26
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      26
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      9
      num Events
      1
    term
    Blurred vision
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      26
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      26
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      26
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      9
      num Events
      1
    term
    Abdominal pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      26
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      26
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      26
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      10
      num Events
      3
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      9
      num Events
      4
    term
    Ascites
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      26
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      26
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      26
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Colitis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      26
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      26
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      26
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Constipation
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      26
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      26
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      26
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      10
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Diarrhea

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
      0
      num At Risk
      26
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      26
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      26
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      9
      num Events
      1
    term
    Absolute Neutrophil Count
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      26
      num Events
      6
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      26
      num Events
      13
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      26
      num Events
      7
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      10
      num Events
      5
    5. group Id
      EG004
      num Affected
      6
      num At Risk
      9
      num Events
      15
    term
    Anemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      26
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      26
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      26
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      10
      num Events
      1
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      9
      num Events
      6
    term
    Decreased Hematocrit
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      26
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      26
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      26
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      10
      num Events
      3
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      9
      num Events
      3
    term
    Decreased MCHC
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      26
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      26
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      26
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      10
      num Events
      1
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      9
      num Events
      2
    term
    Decreased RBC
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      26
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      26
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      26
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      10
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Elevated Absolute Monocyte
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      26
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      26
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      26
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      10
      num Events
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Elevated Bands
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      26
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      26
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      26
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      10
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Elevated BUN
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      26
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      26
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      26
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      9
      num Events
      1
    term
    Eosinophil Count Elevated
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      26
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      26
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      26
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      9
      num Events
      1
    term
    Increased Monocyte Count
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      26
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      26
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      26
      num Events
      0
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      10
      num Events
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Increased Neutrophils
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      26
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      26
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      26
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      9
      num Events
      1
    term
    Increased Platelets
Complete source fields
description
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
event Groups
  1. deaths Num Affected
    15
    deaths Num At Risk
    26
    description
    Patients receive tremelimumab and durvalumab as in Arm C. Beginning at week 2, patients receive high dose radiation therapy QD over 10 days for up to 3 fractions. Durvalumab: Given IV Radiation Therapy: Undergo radiation therapy Tremelimumab: Given IV
    id
    EG000
    other Num Affected
    25
    other Num At Risk
    26
    serious Num Affected
    9
    serious Num At Risk
    26
    title
    NSCLC Arm A (Tremelimumab, Durvalumab, HD-RT)
  2. deaths Num Affected
    15
    deaths Num At Risk
    26
    description
    Patients receive tremelimumab and durvalumab as in Arm C. Beginning at week 2, patients receive low dose radiation therapy every 6 hours BID on weeks 2, 6, 10 and 14. Durvalumab: Given IV Radiation Therapy: Undergo radiation therapy Tremelimumab: Given IV
    id
    EG001
    other Num Affected
    24
    other Num At Risk
    26
    serious Num Affected
    11
    serious Num At Risk
    26
    title
    NSCLC Arm B (Tremelimumab, Durvalumab, LD-RT)
  3. deaths Num Affected
    9
    deaths Num At Risk
    26
    description
    Patients receive tremelimumab IV and durvalumab IV over 60 minutes every 4 weeks for up to 16 weeks in the absence of disease progression or unacceptable toxicity. Patients then receive durvalumab IV over 60 minutes 4 weeks after last combination dose for up to 9 additional doses. Durvalumab: Given IV Tremelimumab: Given IV
    id
    EG002
    other Num Affected
    24
    other Num At Risk
    26
    serious Num Affected
    8
    serious Num At Risk
    26
    title
    NSCLC Arm C (Tremelimumab, Durvalumab)
  4. deaths Num Affected
    6
    deaths Num At Risk
    10
    description
    Patients receive tremelimumab IV and durvalumab IV over 60 minutes every 4 weeks for up to 16 weeks in the absence of disease progression or unacceptable toxicity. Patients then receive durvalumab IV over 60 minutes 4 weeks after last combination dose for up to 9 additional doses. Beginning at week 2, patients receive high dose radiation therapy QD over 10 days for up to 3 fractions. Durvalumab: Given IV Radiation Therapy: Undergo radiation therapy Tremelimumab: Given IV
    id
    EG003
    other Num Affected
    9
    other Num At Risk
    10
    serious Num Affected
    5
    serious Num At Risk
    10
    title
    CRC Arm A (Tremelimumab, Durvalumab, HD-RT)
  5. deaths Num Affected
    6
    deaths Num At Risk
    9
    description
    Patients receive tremelimumab IV and durvalumab IV over 60 minutes every 4 weeks for up to 16 weeks in the absence of disease progression or unacceptable toxicity. Patients then receive durvalumab IV over 60 minutes 4 weeks after last combination dose for up to 9 additional doses. Beginning at week 2, patients receive low dose radiation therapy every 6 hours BID on weeks 2, 6, 10 and 14. Durvalumab: Given IV Radiation Therapy: Undergo radiation therapy Tremelimumab: Given IV
    id
    EG004
    other Num Affected
    9
    other Num At Risk
    9
    serious Num Affected
    6
    serious Num At Risk
    9
    title
    CRC Arm B (Tremelimumab, Durvalumab, LD-RT)
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
      0
      num At Risk
      26
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      26
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      26
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      9
      num Events
      1
    term
    Absolute Neutrophil Count
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      26
      num Events
      6
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      26
      num Events
      13
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      26
      num Events
      7
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      10
      num Events
      5
    5. group Id
      EG004
      num Affected
      6
      num At Risk
      9
      num Events
      15
    term
    Anemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      26
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      26
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      26
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      10
      num Events
      1
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      9
      num Events
      6
    term
    Decreased Hematocrit
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      26
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      26
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      26
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      10
      num Events
      3
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      9
      num Events
      3
    term
    Decreased MCHC
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      26
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      26
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      26
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      10
      num Events
      1
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      9
      num Events
      2
    term
    Decreased RBC
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      26
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      26
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      26
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      10
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Elevated Absolute Monocyte
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      26
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      26
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      26
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      10
      num Events
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Elevated Bands
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      26
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      26
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      26
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      10
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Elevated BUN
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      26
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      26
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      26
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      9
      num Events
      1
    term
    Eosinophil Count Elevated
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      26
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      26
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      26
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      9
      num Events
      1
    term
    Increased Monocyte Count
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      26
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      26
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      26
      num Events
      0
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      10
      num Events
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Increased Neutrophils
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      26
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      26
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      26
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      9
      num Events
      1
    term
    Increased Platelets
serious 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
      1
      num At Risk
      26
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      26
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      26
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      26
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      26
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      26
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Cardiac arrest
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      26
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      26
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      26
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Cyanosis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      26
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      26
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      26
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Sinus Tachycardia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      26
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      26
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      26
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      9
      num Events
      1
    term
    Hypothyroidism
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      26
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      26
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      26
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Adrenal insufficiency
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      26
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      26
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      26
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      9
      num Events
      1
    term
    Blurred vision
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      26
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      26
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      26
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      9
      num Events
      1
    term
    Abdominal pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      26
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      26
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      26
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      10
      num Events
      3
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      9
      num Events
      4
    term
    Ascites
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      26
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      26
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      26
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Colitis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      26
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      26
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      26
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Constipation
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      26
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      26
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      26
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      10
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Diarrhea
time Frame
Two years

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Preserved source evidence · Not medical advice