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NCT04447027 · ADVERSE EVENTS

Adverse events

Romidepsin, CC-486 (5-azacitidine), Dexamethasone, and Lenalidomide (RAdR) for Relapsed/Refractory T-cell Malignancies · Source last updated 2026-08-13

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame
All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
Other-event reporting threshold
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide

T-cell Malignancies, Dose Escalation, Arm 1, Dose Level -1 Arm 1, Dose Level-1: Lenalidomide 2.5 mg Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 200 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies for determination of maximum tolerated dose (MTD).

0 / 22 / 22 / 2
Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide

T-cell Malignancies, Dose Escalation, Arm 1, Dose Level 1 Arm 1, Dose Level 1: Lenalidomide 5 mg Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 300 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies for determination of maximum tolerated dose (MTD).

2 / 66 / 63 / 6
Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide

T-cell Malignancies, Dose Escalation, Arm 1, Dose Level 2 Arm 1, Dose Level 2: Lenalidomide 10 mg Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 300 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies for determination of maximum tolerated dose (MTD).

1 / 66 / 63 / 6
Arm 1, Cohort 1, Dose Level 3 Dose Escalation

T-cell Malignancies, Dose Escalation, Arm 1, Dose Level 3 Arm 1, Dose Level 3: Lenalidomide 15 mg Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 300 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies for determination of maximum tolerated dose (MTD).

2 / 33 / 31 / 3
Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide

T-cell Malignancies, Dose Escalation, Arm 1, Dose Level 4 Arm 1, Dose Level 4: Lenalidomide 20 mg Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 300 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies for determination of maximum tolerated dose (MTD).

0 / 33 / 30 / 3
Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide

T-cell Malignancies, Dose Expansion, Arm 2, Dose Level 2 Arm 2, Dose Level 2: Lenalidomide by oral intake at maximum tolerated dose (MTD) on days -7 to 10 of each 21-day cycle (max 6 cycles) with CC-486 (5-azacitidine) at 300mg/day by oral intake on days 1-10, Romidepsin at 12 mg/m\^2 by intravenous (IV) infusion on Day 1 and day 10; and Dexamethasone at 40 mg by oral intake on days 1 and 10 of each cycle. Relapsed/refractory mature T cell malignancies enrolled after maximum tolerated dose (MTD) is determined.

0 / 22 / 21 / 2
Arm 2, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide

T-cell Malignancies, Dose Expansion, Arm 2, Dose Level 4 Arm 2, Dose Level 4: Lenalidomide by oral intake at maximum tolerated dose (MTD) Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 300 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies enrolled after maximum tolerated dose (MTD) is determined.

0 / 11 / 11 / 1
Arm 3, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide

T-cell Malignancies, Dose Expansion, Arm 3, Dose Level 4 Arm 3, Dose Level 4: Lenalidomide 20 mg maximum tolerated dose (MTD) by oral intake at on days -7 to 10 of each 21-day cycle (max 6 cycles) with CC-486 (5-azacitidine) at 300mg/day by oral intake on days 1-10, Romidepsin at 12 mg/m\^2 by intravenous (IV) infusion on Day 1 and day 10; and Dexamethasone at 40 mg by oral intake on days 1 and 10 of each cycle. Relapsed/refractory mature T cell malignancies enrolled after maximum tolerated dose (MTD) is determined.

0 / 33 / 30 / 3

Group identifiers: EG000: Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide · EG001: Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide · EG002: Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide · EG003: Arm 1, Cohort 1, Dose Level 3 Dose Escalation · EG004: Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide · EG005: Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide · EG006: Arm 2, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide · EG007: Arm 3, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide

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
    Endocrine disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      3
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      2
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Adrenal insufficiency
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      2
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Anemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      2
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Anorexia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      2
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Atrial fibrillation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      3
      num Events
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      2
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Blood bilirubin increased
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      2
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Fatigue
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      2
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Heart failure
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      3
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      2
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Hepatobiliary disorders - Other, specify: Drug-Induced Liver Injury
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      2
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Hypotension
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      2
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Nausea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    (incl cysts and polyps) - Other, specify: Tumor flare reaction
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      3
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      2
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Neoplasms benign, malignant and unspecified
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      3
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      2
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Pain in extremity

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 (5.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      2
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      3
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      2
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Abdominal pain
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      3
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      2
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      1
      num Events
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Acute kidney injury
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      3
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      2
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Adrenal insufficiency
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      2
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      3
      num Events
      7
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      3
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      2
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Alanine aminotransferase increased
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      3
      num Events
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      2
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Alkaline phosphatase increased
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      6
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      2
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Allergic reaction
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      2
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Anal hemorrhage
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      3
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      2
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Anal pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
      num Events
      10
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      6
      num Events
      16
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      6
      num Events
      10
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      3
      num Events
      14
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      3
      num Events
      3
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      2
      num Events
      5
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      1
      num Events
      18
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      3
      num Events
      5
    term
    Anemia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      2
      num Events
      2
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      6
      num Events
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      3
      num Events
      4
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      3
      num Events
      2
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      2
      num Events
      1
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      1
      num Events
      1
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      3
      num Events
      1
    term
    Anorexia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      3
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      2
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Anxiety
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      2
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Arthralgia
Complete source fields
event Groups
  1. deaths Num Affected
    2
    deaths Num At Risk
    2
    description
    T-cell Malignancies, Dose Escalation, Arm 1, Dose Level -1 Arm 1, Dose Level-1: Lenalidomide 2.5 mg Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 200 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies for determination of maximum tolerated dose (MTD).
    id
    EG000
    other Num Affected
    2
    other Num At Risk
    2
    serious Num Affected
    0
    serious Num At Risk
    2
    title
    Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide
  2. deaths Num Affected
    3
    deaths Num At Risk
    6
    description
    T-cell Malignancies, Dose Escalation, Arm 1, Dose Level 1 Arm 1, Dose Level 1: Lenalidomide 5 mg Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 300 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies for determination of maximum tolerated dose (MTD).
    id
    EG001
    other Num Affected
    6
    other Num At Risk
    6
    serious Num Affected
    2
    serious Num At Risk
    6
    title
    Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide
  3. deaths Num Affected
    3
    deaths Num At Risk
    6
    description
    T-cell Malignancies, Dose Escalation, Arm 1, Dose Level 2 Arm 1, Dose Level 2: Lenalidomide 10 mg Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 300 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies for determination of maximum tolerated dose (MTD).
    id
    EG002
    other Num Affected
    6
    other Num At Risk
    6
    serious Num Affected
    1
    serious Num At Risk
    6
    title
    Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide
  4. deaths Num Affected
    1
    deaths Num At Risk
    3
    description
    T-cell Malignancies, Dose Escalation, Arm 1, Dose Level 3 Arm 1, Dose Level 3: Lenalidomide 15 mg Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 300 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies for determination of maximum tolerated dose (MTD).
    id
    EG003
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    2
    serious Num At Risk
    3
    title
    Arm 1, Cohort 1, Dose Level 3 Dose Escalation
  5. deaths Num Affected
    0
    deaths Num At Risk
    3
    description
    T-cell Malignancies, Dose Escalation, Arm 1, Dose Level 4 Arm 1, Dose Level 4: Lenalidomide 20 mg Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 300 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies for determination of maximum tolerated dose (MTD).
    id
    EG004
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    0
    serious Num At Risk
    3
    title
    Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide
  6. deaths Num Affected
    1
    deaths Num At Risk
    2
    description
    T-cell Malignancies, Dose Expansion, Arm 2, Dose Level 2 Arm 2, Dose Level 2: Lenalidomide by oral intake at maximum tolerated dose (MTD) on days -7 to 10 of each 21-day cycle (max 6 cycles) with CC-486 (5-azacitidine) at 300mg/day by oral intake on days 1-10, Romidepsin at 12 mg/m\^2 by intravenous (IV) infusion on Day 1 and day 10; and Dexamethasone at 40 mg by oral intake on days 1 and 10 of each cycle. Relapsed/refractory mature T cell malignancies enrolled after maximum tolerated dose (MTD) is determined.
    id
    EG005
    other Num Affected
    2
    other Num At Risk
    2
    serious Num Affected
    0
    serious Num At Risk
    2
    title
    Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide
  7. deaths Num Affected
    1
    deaths Num At Risk
    1
    description
    T-cell Malignancies, Dose Expansion, Arm 2, Dose Level 4 Arm 2, Dose Level 4: Lenalidomide by oral intake at maximum tolerated dose (MTD) Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 300 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies enrolled after maximum tolerated dose (MTD) is determined.
    id
    EG006
    other Num Affected
    1
    other Num At Risk
    1
    serious Num Affected
    0
    serious Num At Risk
    1
    title
    Arm 2, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide
  8. deaths Num Affected
    0
    deaths Num At Risk
    3
    description
    T-cell Malignancies, Dose Expansion, Arm 3, Dose Level 4 Arm 3, Dose Level 4: Lenalidomide 20 mg maximum tolerated dose (MTD) by oral intake at on days -7 to 10 of each 21-day cycle (max 6 cycles) with CC-486 (5-azacitidine) at 300mg/day by oral intake on days 1-10, Romidepsin at 12 mg/m\^2 by intravenous (IV) infusion on Day 1 and day 10; and Dexamethasone at 40 mg by oral intake on days 1 and 10 of each cycle. Relapsed/refractory mature T cell malignancies enrolled after maximum tolerated dose (MTD) is determined.
    id
    EG007
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    0
    serious Num At Risk
    3
    title
    Arm 3, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      2
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      3
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      2
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Abdominal pain
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      3
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      2
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      1
      num Events
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Acute kidney injury
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      3
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      2
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Adrenal insufficiency
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      2
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      3
      num Events
      7
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      3
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      2
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Alanine aminotransferase increased
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      3
      num Events
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      2
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Alkaline phosphatase increased
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      6
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      2
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Allergic reaction
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      2
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Anal hemorrhage
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      3
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      2
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Anal pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
      num Events
      10
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      6
      num Events
      16
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      6
      num Events
      10
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      3
      num Events
      14
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      3
      num Events
      3
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      2
      num Events
      5
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      1
      num Events
      18
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      3
      num Events
      5
    term
    Anemia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      2
      num Events
      2
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      6
      num Events
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      3
      num Events
      4
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      3
      num Events
      2
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      2
      num Events
      1
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      1
      num Events
      1
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      3
      num Events
      1
    term
    Anorexia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      3
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      2
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Anxiety
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      2
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Arthralgia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      3
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      2
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Adrenal insufficiency
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      2
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Anemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      2
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Anorexia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      2
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Atrial fibrillation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      3
      num Events
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      2
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Blood bilirubin increased
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      2
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Fatigue
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      2
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Heart failure
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      3
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      2
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Hepatobiliary disorders - Other, specify: Drug-Induced Liver Injury
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      2
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Hypotension
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      2
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Nausea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    (incl cysts and polyps) - Other, specify: Tumor flare reaction
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      3
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      2
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Neoplasms benign, malignant and unspecified
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      3
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      2
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Pain in extremity
time Frame
All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.

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