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NCT01623167 · ADVERSE EVENTS

Adverse events

Eltrombopag With Standard Immunosuppression for Severe Aplastic Anemia · Source last updated 2026-04-13

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
6 months
Other-event reporting threshold
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
hATG, CsA, EPAG Day 14 to Month 6

Receive horse ATG days 1- 4, receive CsA day 1 to month 6, and receive eltrombopag day 14 to month 6 hATG/CsA /eltrombopag -Cohort 1: hATG (standard of care) administered for 4 days, CsA (standard of care) administered starting day 1 for 6 months, eltrombopag (experimental) administered Day 14 to month 6

17 / 3030 / 301 / 30
hATG, CsA, EPAG Day 14 to Month 3

Receive horse ATG days 1- 4, receive CsA day 1 to month 6, and receive eltrombopag day 14 to month 3 hATG/CsA /eltrombopag Cohort 2: hATG (standard of care) administered for 4 days, CsA (standard of care) administered starting day 1 for 6 months, eltrombopag (experimental) administered Day 14 to month 3

15 / 3131 / 310 / 31
hATG, CsA (Dose Reduced), EPAG Day 1 to Month 6

Receive horse ATG days 1- 4, receive CsA day 1 to month 6 at higher dose, then reduced dose for 18months, and receive eltrombopag day 1 to month 6 hATG/CsA /eltrombopag Cohort 3: hATG (standard of care) administered for 4 days, CsA (standard of care) administered starting day 1 for 6 months at higher dose, then reduced dose for 18 months, eltrombopag (experimental) administered Day 1 to month 6

14 / 3131 / 310 / 31

Group identifiers: EG000: hATG, CsA, EPAG Day 14 to Month 6 · EG001: hATG, CsA, EPAG Day 14 to Month 3 · EG002: hATG, CsA (Dose Reduced), EPAG Day 1 to Month 6

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
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      30
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      31
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      31
      num Events
      1
    term
    Abdominal pain
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      30
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      31
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      31
      num Events
      2
    term
    Acute kidney injury
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      30
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      31
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      31
      num Events
      0
    term
    Alanine aminotransferase increased
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      30
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      31
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      31
      num Events
      0
    term
    Amnesia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      30
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      31
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      31
      num Events
      1
    term
    Anaphylaxis (Red blood cells transfusion reaction)
  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
      30
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      31
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      31
      num Events
      0
    term
    Anemia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      30
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      31
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      31
      num Events
      0
    term
    Anorectal infection
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      30
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      31
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      31
      num Events
      0
    term
    Appendicitis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      30
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      31
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      31
      num Events
      0
    term
    Aspartate aminotransferase increased
  10. 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
      30
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      31
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      31
      num Events
      0
    term
    Idiopathic Thrombocytopenic Purpura
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      30
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      31
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      31
      num Events
      0
    term
    Catheter related infection
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      30
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      31
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      31
      num Events
      0
    term
    Depression

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
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      30
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      31
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      31
      num Events
      1
    term
    Abdominal pain
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      30
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      31
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      31
      num Events
      0
    term
    Acute kidney injury
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      30
      num Events
      3
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      31
      num Events
      17
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      31
      num Events
      17
    term
    Alanine aminotransferase increased
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      30
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      31
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      31
      num Events
      0
    term
    Alanine aminotransferase increased (intermittent)
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      30
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      31
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      31
      num Events
      0
    term
    Allergic reaction
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      30
      num Events
      2
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      31
      num Events
      4
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      31
      num Events
      8
    term
    Aspartate aminotransferase increased
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      30
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      31
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      31
      num Events
      0
    term
    Atrial fibrillation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      30
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      31
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      31
      num Events
      0
    term
    Back pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      30
      num Events
      10
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      31
      num Events
      10
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      31
      num Events
      8
    term
    Blood bilirubin increased
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      30
      num Events
      3
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      31
      num Events
      4
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      31
      num Events
      1
    term
    Blood bilirubin increased (intermittent)
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      30
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      31
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      31
      num Events
      0
    term
    Blurred vision
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      30
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      31
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      31
      num Events
      0
    term
    CPK increased
Complete source fields
event Groups
  1. deaths Num Affected
    1
    deaths Num At Risk
    30
    description
    Receive horse ATG days 1- 4, receive CsA day 1 to month 6, and receive eltrombopag day 14 to month 6 hATG/CsA /eltrombopag -Cohort 1: hATG (standard of care) administered for 4 days, CsA (standard of care) administered starting day 1 for 6 months, eltrombopag (experimental) administered Day 14 to month 6
    id
    EG000
    other Num Affected
    30
    other Num At Risk
    30
    serious Num Affected
    17
    serious Num At Risk
    30
    title
    hATG, CsA, EPAG Day 14 to Month 6
  2. deaths Num Affected
    0
    deaths Num At Risk
    31
    description
    Receive horse ATG days 1- 4, receive CsA day 1 to month 6, and receive eltrombopag day 14 to month 3 hATG/CsA /eltrombopag Cohort 2: hATG (standard of care) administered for 4 days, CsA (standard of care) administered starting day 1 for 6 months, eltrombopag (experimental) administered Day 14 to month 3
    id
    EG001
    other Num Affected
    31
    other Num At Risk
    31
    serious Num Affected
    15
    serious Num At Risk
    31
    title
    hATG, CsA, EPAG Day 14 to Month 3
  3. deaths Num Affected
    0
    deaths Num At Risk
    31
    description
    Receive horse ATG days 1- 4, receive CsA day 1 to month 6 at higher dose, then reduced dose for 18months, and receive eltrombopag day 1 to month 6 hATG/CsA /eltrombopag Cohort 3: hATG (standard of care) administered for 4 days, CsA (standard of care) administered starting day 1 for 6 months at higher dose, then reduced dose for 18 months, eltrombopag (experimental) administered Day 1 to month 6
    id
    EG002
    other Num Affected
    31
    other Num At Risk
    31
    serious Num Affected
    14
    serious Num At Risk
    31
    title
    hATG, CsA (Dose Reduced), EPAG Day 1 to Month 6
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      30
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      31
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      31
      num Events
      1
    term
    Abdominal pain
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      30
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      31
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      31
      num Events
      0
    term
    Acute kidney injury
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      30
      num Events
      3
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      31
      num Events
      17
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      31
      num Events
      17
    term
    Alanine aminotransferase increased
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      30
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      31
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      31
      num Events
      0
    term
    Alanine aminotransferase increased (intermittent)
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      30
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      31
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      31
      num Events
      0
    term
    Allergic reaction
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      30
      num Events
      2
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      31
      num Events
      4
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      31
      num Events
      8
    term
    Aspartate aminotransferase increased
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      30
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      31
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      31
      num Events
      0
    term
    Atrial fibrillation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      30
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      31
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      31
      num Events
      0
    term
    Back pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      30
      num Events
      10
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      31
      num Events
      10
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      31
      num Events
      8
    term
    Blood bilirubin increased
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      30
      num Events
      3
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      31
      num Events
      4
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      31
      num Events
      1
    term
    Blood bilirubin increased (intermittent)
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      30
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      31
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      31
      num Events
      0
    term
    Blurred vision
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      30
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      31
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      31
      num Events
      0
    term
    CPK increased
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      30
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      31
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      31
      num Events
      1
    term
    Abdominal pain
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      30
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      31
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      31
      num Events
      2
    term
    Acute kidney injury
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      30
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      31
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      31
      num Events
      0
    term
    Alanine aminotransferase increased
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      30
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      31
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      31
      num Events
      0
    term
    Amnesia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      30
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      31
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      31
      num Events
      1
    term
    Anaphylaxis (Red blood cells transfusion reaction)
  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
      30
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      31
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      31
      num Events
      0
    term
    Anemia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      30
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      31
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      31
      num Events
      0
    term
    Anorectal infection
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      30
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      31
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      31
      num Events
      0
    term
    Appendicitis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      30
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      31
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      31
      num Events
      0
    term
    Aspartate aminotransferase increased
  10. 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
      30
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      31
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      31
      num Events
      0
    term
    Idiopathic Thrombocytopenic Purpura
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      30
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      31
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      31
      num Events
      0
    term
    Catheter related infection
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      30
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      31
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      31
      num Events
      0
    term
    Depression
time Frame
6 months

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Preserved source evidence · Not medical advice