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NCT00007345 · ADVERSE EVENTS

Adverse events

Depsipeptide to Treat Patients With Cutaneous T-Cell Lymphoma and Peripheral T-Cell Lymphoma · Source last updated 2017-05-16

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
147 months and 5 days
Other-event reporting threshold
0%

Although 7 cohorts were written in the protocol, the cohorts were consolidated for submission to the Food and Drug Administration (FDA) into the peripheral T-cell lymphoma (PTCL) and cutaneous T-cell lymphoma (CTCL) groups, thus they are presented in this format.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Peripheral T-cell Lymphoma (PTCL)

Participants received at least one protocol prescribed dose or higher of Romidepsin intravenously at 14mg/m\^2 and at 17.5 mg/m\^2 on days 1, 8, and 15 of a 28 day cycle.

20 / 4747 / 476 / 47
Cutaneous T-cell Lymphoma (CTCL)

Participants received at least one protocol prescribed dose or higher of Romidepsin intravenously at 14mg/m\^2 and at 17.5 mg/m\^2 on days 1, 8, and 15 of a 28 day cycle.

38 / 8483 / 845 / 84

Group identifiers: EG000: Peripheral T-cell Lymphoma (PTCL) · EG001: Cutaneous T-cell Lymphoma (CTCL)

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
    CTC2.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      47
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      84
      num Events
      2
    term
    ANC (absolute neutrophil count)
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTC2.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      47
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      84
      num Events
      1
    term
    Death/ARDS (acute respiratory distress syndrome)
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTC2.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      47
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      84
      num Events
      2
    term
    Anorexia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTC2.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      47
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      84
      num Events
      1
    term
    Death/Cardiac arrest
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTC2.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      47
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      84
      num Events
      1
    term
    Cardiac troponin T
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTC2.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      47
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      84
      num Events
      2
    term
    Catheter-related infection
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTC2.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      47
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      84
      num Events
      1
    term
    Confusion
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTC2.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      47
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      84
      num Events
      1
    term
    DOE (dyspnea on exertion)
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTC2.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      47
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      84
      num Events
      1
    term
    Fatigue
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTC2.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      47
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      84
      num Events
      1
    term
    Hypotension
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTC2.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      47
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      84
      num Events
      1
    term
    Infection: EBV (Epstein Barr virus) reactivation
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTC2.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      47
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      84
      num Events
      1
    term
    Death/Infection with unknown ANC (absolute neutrophil count)

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
    CTC2.0
    stats
    1. group Id
      EG000
      num Affected
      38
      num At Risk
      47
      num Events
      151
    2. group Id
      EG001
      num Affected
      53
      num At Risk
      84
      num Events
      166
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTC2.0
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      47
      num Events
      124
    2. group Id
      EG001
      num Affected
      37
      num At Risk
      84
      num Events
      79
    term
    Anorexia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTC2.0
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      47
      num Events
      29
    2. group Id
      EG001
      num Affected
      33
      num At Risk
      84
      num Events
      61
    term
    Constipation
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTC2.0
    stats
    1. group Id
      EG000
      num Affected
      34
      num At Risk
      47
      num Events
      129
    2. group Id
      EG001
      num Affected
      68
      num At Risk
      84
      num Events
      194
    term
    Fatigue
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTC2.0
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      47
      num Events
      32
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      84
      num Events
      33
    term
    Headache
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTC2.0
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      47
      num Events
      127
    2. group Id
      EG001
      num Affected
      33
      num At Risk
      84
      num Events
      109
    term
    Hyperglycemia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTC2.0
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      47
      num Events
      19
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      84
      num Events
      35
    term
    Hypokalemia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTC2.0
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      47
      num Events
      67
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      84
      num Events
      71
    term
    Hypermagnesemia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTC2.0
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      47
      num Events
      86
    2. group Id
      EG001
      num Affected
      25
      num At Risk
      84
      num Events
      71
    term
    Hyperuricemia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTC2.0
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      47
      num Events
      27
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      84
      num Events
      26
    term
    Hyponatremia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTC2.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      47
      num Events
      39
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      84
      num Events
      42
    term
    Hypotension
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTC2.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      47
      num Events
      0
    2. group Id
      EG001
      num Affected
      42
      num At Risk
      84
      num Events
      149
    term
    Lymphocyte count
Complete source fields
description
Although 7 cohorts were written in the protocol, the cohorts were consolidated for submission to the Food and Drug Administration (FDA) into the peripheral T-cell lymphoma (PTCL) and cutaneous T-cell lymphoma (CTCL) groups, thus they are presented in this format.
event Groups
  1. deaths Num Affected
    6
    deaths Num At Risk
    47
    description
    Participants received at least one protocol prescribed dose or higher of Romidepsin intravenously at 14mg/m\^2 and at 17.5 mg/m\^2 on days 1, 8, and 15 of a 28 day cycle.
    id
    EG000
    other Num Affected
    47
    other Num At Risk
    47
    serious Num Affected
    20
    serious Num At Risk
    47
    title
    Peripheral T-cell Lymphoma (PTCL)
  2. deaths Num Affected
    5
    deaths Num At Risk
    84
    description
    Participants received at least one protocol prescribed dose or higher of Romidepsin intravenously at 14mg/m\^2 and at 17.5 mg/m\^2 on days 1, 8, and 15 of a 28 day cycle.
    id
    EG001
    other Num Affected
    83
    other Num At Risk
    84
    serious Num Affected
    38
    serious Num At Risk
    84
    title
    Cutaneous T-cell Lymphoma (CTCL)
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTC2.0
    stats
    1. group Id
      EG000
      num Affected
      38
      num At Risk
      47
      num Events
      151
    2. group Id
      EG001
      num Affected
      53
      num At Risk
      84
      num Events
      166
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTC2.0
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      47
      num Events
      124
    2. group Id
      EG001
      num Affected
      37
      num At Risk
      84
      num Events
      79
    term
    Anorexia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTC2.0
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      47
      num Events
      29
    2. group Id
      EG001
      num Affected
      33
      num At Risk
      84
      num Events
      61
    term
    Constipation
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTC2.0
    stats
    1. group Id
      EG000
      num Affected
      34
      num At Risk
      47
      num Events
      129
    2. group Id
      EG001
      num Affected
      68
      num At Risk
      84
      num Events
      194
    term
    Fatigue
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTC2.0
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      47
      num Events
      32
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      84
      num Events
      33
    term
    Headache
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTC2.0
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      47
      num Events
      127
    2. group Id
      EG001
      num Affected
      33
      num At Risk
      84
      num Events
      109
    term
    Hyperglycemia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTC2.0
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      47
      num Events
      19
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      84
      num Events
      35
    term
    Hypokalemia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTC2.0
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      47
      num Events
      67
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      84
      num Events
      71
    term
    Hypermagnesemia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTC2.0
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      47
      num Events
      86
    2. group Id
      EG001
      num Affected
      25
      num At Risk
      84
      num Events
      71
    term
    Hyperuricemia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTC2.0
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      47
      num Events
      27
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      84
      num Events
      26
    term
    Hyponatremia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTC2.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      47
      num Events
      39
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      84
      num Events
      42
    term
    Hypotension
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTC2.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      47
      num Events
      0
    2. group Id
      EG001
      num Affected
      42
      num At Risk
      84
      num Events
      149
    term
    Lymphocyte count
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTC2.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      47
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      84
      num Events
      2
    term
    ANC (absolute neutrophil count)
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTC2.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      47
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      84
      num Events
      1
    term
    Death/ARDS (acute respiratory distress syndrome)
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTC2.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      47
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      84
      num Events
      2
    term
    Anorexia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTC2.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      47
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      84
      num Events
      1
    term
    Death/Cardiac arrest
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTC2.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      47
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      84
      num Events
      1
    term
    Cardiac troponin T
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTC2.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      47
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      84
      num Events
      2
    term
    Catheter-related infection
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTC2.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      47
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      84
      num Events
      1
    term
    Confusion
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTC2.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      47
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      84
      num Events
      1
    term
    DOE (dyspnea on exertion)
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTC2.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      47
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      84
      num Events
      1
    term
    Fatigue
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTC2.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      47
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      84
      num Events
      1
    term
    Hypotension
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTC2.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      47
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      84
      num Events
      1
    term
    Infection: EBV (Epstein Barr virus) reactivation
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTC2.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      47
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      84
      num Events
      1
    term
    Death/Infection with unknown ANC (absolute neutrophil count)
time Frame
147 months and 5 days

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