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NCT01998035 · ADVERSE EVENTS

Adverse events

Romidepsin Plus Oral 5-Azacitidine in Relapsed/Refractory Lymphoid Malignancies · Source last updated 2024-08-22

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
1.5 years
Other-event reporting threshold
5%

Adverse events were only recorded/collected as the combined total from participants per study phase. Adverse events were not collected per dose level and thus cannot be reported per dose level. For Phase 1, adverse events were collected from the 26 participants who received the study interventions and completed the study.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Phase 1

Phase 1 is to determine the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of the combinations of oral 5-azacitidine and romidepsin in patients with lymphoma. Patients will be administered the study drugs in a 3 + 3 dose-escalation study. Romidepsin is an anti-cancer ("antineoplastic" or "cytotoxic") chemotherapy drug. Romidepsin is classified as a "Histone Deacetylase Inhibitor". Dose escalation: 10, 14 mg/m2 Oral 5-Azacitidine is a pyrimidine nucleoside analogue of cytidine with antineoplastic activity. Dose escalation: 100, 200, 300 mg

11 / 2626 / 2611 / 26
Phase 2

Patients will be treated with oral 5-azacytidine and romidepsin at the MTD. The treatment will be administered as follows: oral 5-azacytidine 300 mg (flat dose) on Days 1-14 and romidepsin 14 mg/m2 (flat dose) on Days 8, 15, and 22 on a 35-day cycle.

12 / 2525 / 250 / 25

Group identifiers: EG000: Phase 1 · EG001: Phase 2

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
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      26
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
    term
    Alkaline phosphatase elevation
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      26
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      25
    term
    Anemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      26
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      25
    term
    Febrile neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      26
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      25
    term
    Hyperglycemia (Grade 3 and 4)
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      26
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
    term
    Hypermagnesemia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      26
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
    term
    Hypokalemia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      26
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
    term
    Hyponatremia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      26
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
    term
    Hypotension
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      26
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      25
    term
    Lymphocyte count decrease
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      26
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      25
    term
    Neutrophil count decrease
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      26
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      25
    term
    Platelet count decrease

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
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      26
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      25
    term
    Fatigue
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      26
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      25
    term
    Nausea
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      26
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      25
    term
    Vomiting
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      26
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      25
    term
    Creatinine elevation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      26
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      25
    term
    Diarrhea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      26
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      25
    term
    Fever
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      26
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      25
    term
    Hypercalcemia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      26
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      25
    term
    Hypoalbuminemia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      26
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      25
    term
    Hypocalcemia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      26
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      25
    term
    Hypoglycemia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      26
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      25
    term
    Hyperglycemia (Grade 1 and 2)
Complete source fields
description
Adverse events were only recorded/collected as the combined total from participants per study phase. Adverse events were not collected per dose level and thus cannot be reported per dose level. For Phase 1, adverse events were collected from the 26 participants who received the study interventions and completed the study.
event Groups
  1. deaths Num Affected
    11
    deaths Num At Risk
    26
    description
    Phase 1 is to determine the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of the combinations of oral 5-azacitidine and romidepsin in patients with lymphoma. Patients will be administered the study drugs in a 3 + 3 dose-escalation study. Romidepsin is an anti-cancer ("antineoplastic" or "cytotoxic") chemotherapy drug. Romidepsin is classified as a "Histone Deacetylase Inhibitor". Dose escalation: 10, 14 mg/m2 Oral 5-Azacitidine is a pyrimidine nucleoside analogue of cytidine with antineoplastic activity. Dose escalation: 100, 200, 300 mg
    id
    EG000
    other Num Affected
    26
    other Num At Risk
    26
    serious Num Affected
    11
    serious Num At Risk
    26
    title
    Phase 1
  2. deaths Num Affected
    0
    deaths Num At Risk
    25
    description
    Patients will be treated with oral 5-azacytidine and romidepsin at the MTD. The treatment will be administered as follows: oral 5-azacytidine 300 mg (flat dose) on Days 1-14 and romidepsin 14 mg/m2 (flat dose) on Days 8, 15, and 22 on a 35-day cycle.
    id
    EG001
    other Num Affected
    25
    other Num At Risk
    25
    serious Num Affected
    12
    serious Num At Risk
    25
    title
    Phase 2
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      26
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      25
    term
    Fatigue
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      26
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      25
    term
    Nausea
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      26
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      25
    term
    Vomiting
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      26
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      25
    term
    Creatinine elevation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      26
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      25
    term
    Diarrhea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      26
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      25
    term
    Fever
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      26
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      25
    term
    Hypercalcemia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      26
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      25
    term
    Hypoalbuminemia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      26
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      25
    term
    Hypocalcemia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      26
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      25
    term
    Hypoglycemia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      26
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      25
    term
    Hyperglycemia (Grade 1 and 2)
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      26
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
    term
    Alkaline phosphatase elevation
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      26
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      25
    term
    Anemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      26
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      25
    term
    Febrile neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      26
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      25
    term
    Hyperglycemia (Grade 3 and 4)
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      26
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
    term
    Hypermagnesemia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      26
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
    term
    Hypokalemia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      26
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
    term
    Hyponatremia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      26
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
    term
    Hypotension
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      26
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      25
    term
    Lymphocyte count decrease
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      26
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      25
    term
    Neutrophil count decrease
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      26
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      25
    term
    Platelet count decrease
time Frame
1.5 years

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Preserved source evidence · Not medical advice