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NCT01338987 · ADVERSE EVENTS

Adverse events

Pilot Study of Leuprolide to Improve Immune Function After Allogeneic Bone Marrow Transplantation · Source last updated 2021-03-18

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
Date treatment consent signed to date off study, approximately 79 months and 11 days.
Other-event reporting threshold
0%

40/45 participants were evaluable for adverse events.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Males That Did Not Receive Leuprolide for 1st Transplant

Males undergoing first transplant who did not receive leuprolide.

5 / 1010 / 104 / 10
Males Randomized to Receive Leuprolide for 1st Transplant

Males undergoing first transplant who were randomized to receive leuprolide.

6 / 88 / 83 / 8
Females That Received Leuprolide for 1st Transplant

Females undergoing first transplant who all received leuprolide.

15 / 2020 / 208 / 20
Matched Related Donors for Transplant

Individuals related to patients and who gave hematopoietic stem cells for patients receiving allogeneic bone marrow transplant on this study.

2 / 314 / 310 / 31
Recipients of 2nd Transplant

Patients receiving second allogeneic bone marrow transplant on this study.

2 / 22 / 22 / 2

Group identifiers: EG000: Males That Did Not Receive Leuprolide for 1st Transplant · EG001: Males Randomized to Receive Leuprolide for 1st Transplant · EG002: Females That Received Leuprolide for 1st Transplant · EG003: Matched Related Donors for Transplant · EG004: Recipients of 2nd Transplant

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
      10
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      20
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Abdominal pain
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      20
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      2
      num Events
      1
    term
    Acidosis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      20
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Adult respiratory distress syndrome
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      20
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Alanine aminotransferase increased
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      20
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Aspiration
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
      num Events
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      20
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Blood bilirubin increased
  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
      10
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      20
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Cataract
  8. 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
      10
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      20
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Catheter related infection
  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
      10
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      20
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Colitis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      20
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Colonic perforation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      20
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Corneal ulcer
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      20
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Cystitis noninfective

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
      1
      num At Risk
      10
      num Events
      2
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      8
      num Events
      3
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      20
      num Events
      8
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      2
      num Events
      2
    term
    Abdominal pain
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      20
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Acidosis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      10
      num Events
      2
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      8
      num Events
      4
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      20
      num Events
      10
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      2
      num Events
      3
    term
    Activated partial thromboplastin time prolonged
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      20
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Acute kidney injury
  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
      10
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      20
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Adrenal insufficiency
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      20
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Agitation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      10
      num Events
      24
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      8
      num Events
      8
    3. group Id
      EG002
      num Affected
      14
      num At Risk
      20
      num Events
      45
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      2
      num Events
      3
    term
    Alanine aminotransferase increased
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      10
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
      num Events
      6
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      20
      num Events
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      2
      num Events
      1
    term
    Alkaline phosphatase increased
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      20
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      2
      num Events
      1
    term
    Alkalosis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      20
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Allergic rhinitis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      10
      num Events
      28
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      8
      num Events
      28
    3. group Id
      EG002
      num Affected
      12
      num At Risk
      20
      num Events
      39
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      31
      num Events
      3
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      2
      num Events
      4
    term
    Anemia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      20
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Anorexia
Complete source fields
description
40/45 participants were evaluable for adverse events.
event Groups
  1. deaths Num Affected
    4
    deaths Num At Risk
    10
    description
    Males undergoing first transplant who did not receive leuprolide.
    id
    EG000
    other Num Affected
    10
    other Num At Risk
    10
    serious Num Affected
    5
    serious Num At Risk
    10
    title
    Males That Did Not Receive Leuprolide for 1st Transplant
  2. deaths Num Affected
    3
    deaths Num At Risk
    8
    description
    Males undergoing first transplant who were randomized to receive leuprolide.
    id
    EG001
    other Num Affected
    8
    other Num At Risk
    8
    serious Num Affected
    6
    serious Num At Risk
    8
    title
    Males Randomized to Receive Leuprolide for 1st Transplant
  3. deaths Num Affected
    8
    deaths Num At Risk
    20
    description
    Females undergoing first transplant who all received leuprolide.
    id
    EG002
    other Num Affected
    20
    other Num At Risk
    20
    serious Num Affected
    15
    serious Num At Risk
    20
    title
    Females That Received Leuprolide for 1st Transplant
  4. deaths Num Affected
    0
    deaths Num At Risk
    31
    description
    Individuals related to patients and who gave hematopoietic stem cells for patients receiving allogeneic bone marrow transplant on this study.
    id
    EG003
    other Num Affected
    4
    other Num At Risk
    31
    serious Num Affected
    2
    serious Num At Risk
    31
    title
    Matched Related Donors for Transplant
  5. deaths Num Affected
    2
    deaths Num At Risk
    2
    description
    Patients receiving second allogeneic bone marrow transplant on this study.
    id
    EG004
    other Num Affected
    2
    other Num At Risk
    2
    serious Num Affected
    2
    serious Num At Risk
    2
    title
    Recipients of 2nd Transplant
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
      1
      num At Risk
      10
      num Events
      2
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      8
      num Events
      3
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      20
      num Events
      8
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      2
      num Events
      2
    term
    Abdominal pain
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      20
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Acidosis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      10
      num Events
      2
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      8
      num Events
      4
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      20
      num Events
      10
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      2
      num Events
      3
    term
    Activated partial thromboplastin time prolonged
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      20
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Acute kidney injury
  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
      10
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      20
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Adrenal insufficiency
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      20
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Agitation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      10
      num Events
      24
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      8
      num Events
      8
    3. group Id
      EG002
      num Affected
      14
      num At Risk
      20
      num Events
      45
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      2
      num Events
      3
    term
    Alanine aminotransferase increased
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      10
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
      num Events
      6
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      20
      num Events
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      2
      num Events
      1
    term
    Alkaline phosphatase increased
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      20
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      2
      num Events
      1
    term
    Alkalosis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      20
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Allergic rhinitis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      10
      num Events
      28
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      8
      num Events
      28
    3. group Id
      EG002
      num Affected
      12
      num At Risk
      20
      num Events
      39
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      31
      num Events
      3
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      2
      num Events
      4
    term
    Anemia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      20
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Anorexia
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
      10
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      20
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Abdominal pain
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      20
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      2
      num Events
      1
    term
    Acidosis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      20
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Adult respiratory distress syndrome
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      20
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Alanine aminotransferase increased
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      20
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Aspiration
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
      num Events
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      20
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Blood bilirubin increased
  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
      10
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      20
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Cataract
  8. 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
      10
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      20
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Catheter related infection
  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
      10
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      20
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Colitis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      20
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Colonic perforation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      20
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Corneal ulcer
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      20
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Cystitis noninfective
time Frame
Date treatment consent signed to date off study, approximately 79 months and 11 days.

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Preserved source evidence · Not medical advice