Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00790842 · ADVERSE EVENTS

Adverse events

Lenalidomide and Low-Dose Dexamethasone in Patients With Previously Treated Multiple Myeloma and Kidney Dysfunction · Source last updated 2018-10-24

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
Adverse events were collected at every visit during treatment and for 30 days after the end of treatment (up to 56 months for at least 1 patient). The following events were captured: Grade 1 and 2 adverse events deemed possibly, probably or definitely related to study treatment; Grade 3 and 4 adverse events regardless of attribution, and any death within 30 days of the patient's last study treatment or procedure regardless of attribution.
Other-event reporting threshold
5%

Serious adverse events include any adverse event occurring at least once at grade 3 or higher. The remaining adverse events occurring in at least 5% of patients (3 or more patients) are reported as other adverse events. Events were captured during each clinic visit while on treatment and for 30 days following the end of treatment.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Group A Lenalidomide 10 mg/Day

CrCl 30-60 mL/min. Lenalidomide 10 mg/day for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days.

5 / 65 / 61 / 6
Group A Lenalidomide 15 mg/Day

CrCl 30-60 mL/min. Lenalidomide 15 mg/day for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days.

2 / 32 / 31 / 3
Group A Lenalidomide 25 mg/Day

CrCl 30-60 mL/min. Lenalidomide 25 mg/day for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days.

5 / 66 / 60 / 6
Group A Expansion Cohort

CrCl 30-60 mL/min. Lenalidomide 25 mg/day for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days. Enrolled after determination of recommended phase 2 dose.

10 / 1414 / 144 / 14
Group B Lenalidomide 15 mg/2 Days

CrCl \<30 mL/min, not on dialysis. Lenalidomide 15 mg every 2 days for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days.

3 / 31 / 30 / 3
Group B Lenalidomide 25 mg/2 Days

CrCl \<30 mL/min, not on dialysis. Lenalidomide 25 mg every 2 days for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days.

3 / 33 / 30 / 3
Group B Lenalidomide 15 mg/Day

CrCl \<30 mL/min, not on dialysis. Lenalidomide 15 mg/day for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days.

1 / 33 / 30 / 3
Group B Lenalidomide 25 mg/Day

CrCl \<30 mL/min, not on dialysis. Lenalidomide 25 mg/day for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days.

5 / 88 / 80 / 8
Group B Expansion Cohort

CrCl \<30 mL/min, not on dialysis. Lenalidomide 25 mg/day for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days. Enrolled after determination of recommended phase 2 dose.

1 / 22 / 20 / 2
Group C Lenalidomide 15 mg 3x/wk

CrCl \< 30 mL/min, on dialysis. Lenalidomide 15 mg three times weekly for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days.

2 / 31 / 30 / 3
Group C Lenalidomide 10 mg/Day

CrCl \< 30 mL/min, on dialysis. Lenalidomide 10 mg/day for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days.

3 / 32 / 31 / 3
Group C Lenalidomide 15 mg/Day

CrCl \< 30 mL/min, on dialysis. Lenalidomide 15 mg/day for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days.

3 / 33 / 31 / 3
Group C Lenalidomide 25 mg/Day

CrCl \< 30 mL/min, on dialysis. Lenalidomide 25 mg/day for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days.

4 / 54 / 50 / 5

Group identifiers: EG000: Group A Lenalidomide 10 mg/Day · EG001: Group A Lenalidomide 15 mg/Day · EG002: Group A Lenalidomide 25 mg/Day · EG003: Group A Expansion Cohort · EG004: Group B Lenalidomide 15 mg/2 Days · EG005: Group B Lenalidomide 25 mg/2 Days · EG006: Group B Lenalidomide 15 mg/Day · EG007: Group B Lenalidomide 25 mg/Day · EG008: Group B Expansion Cohort · EG009: Group C Lenalidomide 15 mg 3x/wk · EG010: Group C Lenalidomide 10 mg/Day · EG011: Group C Lenalidomide 15 mg/Day · EG012: Group C Lenalidomide 25 mg/Day

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
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      14
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      3
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      8
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      3
    term
    Anemia
  2. 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
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      14
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      8
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      3
    term
    Other (Eosinophilia)
  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
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      14
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      8
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      3
    term
    Other (Pancytopenia)
  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
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      14
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      3
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      8
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      3
    term
    Other (Thrombocytopenia)
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      14
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      8
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      3
    term
    Atrioventricular Block Complete
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      14
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      8
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      3
    term
    Heart Failure
  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
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      14
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      8
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      3
    term
    Myocardial infarction
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      14
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      8
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      3
    term
    Middle ear inflammation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      14
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      8
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      3
    term
    Cataract
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      14
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      8
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      3
    term
    Vitreous hemorrhage
  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
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      14
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      8
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      3
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      3
    term
    Abdominal Distension
  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
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      14
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      8
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      3
    term
    Ascites

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
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      14
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      8
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      2
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      3
    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
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      14
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      8
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      3
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      3
    term
    Atrial fibrillation
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      14
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      8
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      3
    term
    Blurred vision
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      14
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      8
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      3
    term
    Watering eyes
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      14
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      3
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      8
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      3
    term
    Constipation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      14
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      8
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      2
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      3
    term
    Diarrhea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      14
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      8
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      3
    term
    Fecal incontinence
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      14
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      8
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      3
    term
    Mucositis oral
  9. 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
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      14
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      3
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      8
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      3
    term
    Upper respiratory infection
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      14
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      3
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      8
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      3
    term
    Bruising
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      14
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      8
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      3
    term
    Fall
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      14
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      8
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      3
    term
    Other (Laceration)
Complete source fields
description
Serious adverse events include any adverse event occurring at least once at grade 3 or higher. The remaining adverse events occurring in at least 5% of patients (3 or more patients) are reported as other adverse events. Events were captured during each clinic visit while on treatment and for 30 days following the end of treatment.
event Groups
  1. deaths Num Affected
    1
    deaths Num At Risk
    6
    description
    CrCl 30-60 mL/min. Lenalidomide 10 mg/day for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days.
    id
    EG000
    other Num Affected
    5
    other Num At Risk
    6
    serious Num Affected
    5
    serious Num At Risk
    6
    title
    Group A Lenalidomide 10 mg/Day
  2. deaths Num Affected
    1
    deaths Num At Risk
    3
    description
    CrCl 30-60 mL/min. Lenalidomide 15 mg/day for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days.
    id
    EG001
    other Num Affected
    2
    other Num At Risk
    3
    serious Num Affected
    2
    serious Num At Risk
    3
    title
    Group A Lenalidomide 15 mg/Day
  3. deaths Num Affected
    0
    deaths Num At Risk
    6
    description
    CrCl 30-60 mL/min. Lenalidomide 25 mg/day for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days.
    id
    EG002
    other Num Affected
    6
    other Num At Risk
    6
    serious Num Affected
    5
    serious Num At Risk
    6
    title
    Group A Lenalidomide 25 mg/Day
  4. deaths Num Affected
    4
    deaths Num At Risk
    14
    description
    CrCl 30-60 mL/min. Lenalidomide 25 mg/day for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days. Enrolled after determination of recommended phase 2 dose.
    id
    EG003
    other Num Affected
    14
    other Num At Risk
    14
    serious Num Affected
    10
    serious Num At Risk
    14
    title
    Group A Expansion Cohort
  5. deaths Num Affected
    0
    deaths Num At Risk
    3
    description
    CrCl \<30 mL/min, not on dialysis. Lenalidomide 15 mg every 2 days for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days.
    id
    EG004
    other Num Affected
    1
    other Num At Risk
    3
    serious Num Affected
    3
    serious Num At Risk
    3
    title
    Group B Lenalidomide 15 mg/2 Days
  6. deaths Num Affected
    0
    deaths Num At Risk
    3
    description
    CrCl \<30 mL/min, not on dialysis. Lenalidomide 25 mg every 2 days for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days.
    id
    EG005
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    3
    serious Num At Risk
    3
    title
    Group B Lenalidomide 25 mg/2 Days
  7. deaths Num Affected
    0
    deaths Num At Risk
    3
    description
    CrCl \<30 mL/min, not on dialysis. Lenalidomide 15 mg/day for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days.
    id
    EG006
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    1
    serious Num At Risk
    3
    title
    Group B Lenalidomide 15 mg/Day
  8. deaths Num Affected
    0
    deaths Num At Risk
    8
    description
    CrCl \<30 mL/min, not on dialysis. Lenalidomide 25 mg/day for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days.
    id
    EG007
    other Num Affected
    8
    other Num At Risk
    8
    serious Num Affected
    5
    serious Num At Risk
    8
    title
    Group B Lenalidomide 25 mg/Day
  9. deaths Num Affected
    0
    deaths Num At Risk
    2
    description
    CrCl \<30 mL/min, not on dialysis. Lenalidomide 25 mg/day for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days. Enrolled after determination of recommended phase 2 dose.
    id
    EG008
    other Num Affected
    2
    other Num At Risk
    2
    serious Num Affected
    1
    serious Num At Risk
    2
    title
    Group B Expansion Cohort
  10. deaths Num Affected
    0
    deaths Num At Risk
    3
    description
    CrCl \< 30 mL/min, on dialysis. Lenalidomide 15 mg three times weekly for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days.
    id
    EG009
    other Num Affected
    1
    other Num At Risk
    3
    serious Num Affected
    2
    serious Num At Risk
    3
    title
    Group C Lenalidomide 15 mg 3x/wk
  11. deaths Num Affected
    1
    deaths Num At Risk
    3
    description
    CrCl \< 30 mL/min, on dialysis. Lenalidomide 10 mg/day for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days.
    id
    EG010
    other Num Affected
    2
    other Num At Risk
    3
    serious Num Affected
    3
    serious Num At Risk
    3
    title
    Group C Lenalidomide 10 mg/Day
  12. deaths Num Affected
    1
    deaths Num At Risk
    3
    description
    CrCl \< 30 mL/min, on dialysis. Lenalidomide 15 mg/day for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days.
    id
    EG011
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    3
    serious Num At Risk
    3
    title
    Group C Lenalidomide 15 mg/Day
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
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      14
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      8
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      2
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      3
    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
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      14
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      8
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      3
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      3
    term
    Atrial fibrillation
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      14
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      8
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      3
    term
    Blurred vision
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      14
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      8
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      3
    term
    Watering eyes
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      14
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      3
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      8
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      3
    term
    Constipation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      14
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      8
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      2
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      3
    term
    Diarrhea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      14
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      8
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      3
    term
    Fecal incontinence
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      14
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      8
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      3
    term
    Mucositis oral
  9. 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
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      14
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      3
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      8
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      3
    term
    Upper respiratory infection
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      14
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      3
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      8
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      3
    term
    Bruising
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      14
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      8
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      3
    term
    Fall
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      14
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      8
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      3
    term
    Other (Laceration)
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
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      14
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      3
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      8
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      3
    term
    Anemia
  2. 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
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      14
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      8
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      3
    term
    Other (Eosinophilia)
  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
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      14
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      8
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      3
    term
    Other (Pancytopenia)
  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
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      14
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      3
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      8
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      3
    term
    Other (Thrombocytopenia)
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      14
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      8
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      3
    term
    Atrioventricular Block Complete
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      14
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      8
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      3
    term
    Heart Failure
  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
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      14
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      8
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      3
    term
    Myocardial infarction
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      14
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      8
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      3
    term
    Middle ear inflammation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      14
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      8
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      3
    term
    Cataract
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      14
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      8
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      3
    term
    Vitreous hemorrhage
  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
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      14
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      8
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      3
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      3
    term
    Abdominal Distension
  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
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      14
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      8
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      3
    term
    Ascites
time Frame
Adverse events were collected at every visit during treatment and for 30 days after the end of treatment (up to 56 months for at least 1 patient). The following events were captured: Grade 1 and 2 adverse events deemed possibly, probably or definitely related to study treatment; Grade 3 and 4 adverse events regardless of attribution, and any death within 30 days of the patient's last study treatment or procedure regardless of attribution.

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice