Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00290433 · ADVERSE EVENTS

Adverse events

Efficacy of the HCVIDDOXIL Regimen in Patients With Newly Diagnosed Peripheral T-Cell Lymphoma · Source last updated 2020-09-23

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

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

Collection time frame
Adverse events were assessed from the initiation of the regimen through the end of the chemotherapy cycle, up to 3 years.
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
HCVIDDOXIL Regimen

Cycle 1: Cyclophosphamide 300 mg/m\^2 intravenous (IV) twice a day on Days 1-3. Mesna 600 mg/m\^2 continuous IV Days 1-3. Doxil 25 mg/m\^2 IV over 1 hour on Day 2. Vincristine 1.4 mg/m\^2 IV on Days 4 and 11. Dexamethasone 40 mg Iv or oral on Days 1 - 4 and 11 - 14. Cycle 2: Methotrexate 200 mg/m\^2 over 2 hours on Day 1 and 800 mg/m\^2 over 22 hours on day 1. Cytarabine 3 Gm/m\^2 IV twice a day on Days 2 and 3.

1 / 5346 / 53Not reported / Not reported

Group identifiers: EG000: HCVIDDOXIL Regimen

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
    Infections and infestations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      53
      num Events
      1
    term
    massive cytomegalovirus infection

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      42
      num At Risk
      53
      num Events
      42
    term
    Neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      46
      num At Risk
      53
      num Events
      46
    term
    Anemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      46
      num At Risk
      53
      num Events
      46
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      53
      num Events
      21
    term
    Febrile Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      35
      num At Risk
      53
      num Events
      35
    term
    Fever
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      53
      num Events
      19
    term
    Infectious Disease
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      40
      num At Risk
      53
      num Events
      40
    term
    Fatigue
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      53
      num Events
      21
    term
    Liver Toxicities
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      53
      num Events
      19
    term
    Constipation
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      53
      num Events
      19
    term
    Dizziness
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      53
      num Events
      19
    term
    Dyspnea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      53
      num Events
      11
    term
    Hyperglycemia
Complete source fields
event Groups
  1. description
    Cycle 1: Cyclophosphamide 300 mg/m\^2 intravenous (IV) twice a day on Days 1-3. Mesna 600 mg/m\^2 continuous IV Days 1-3. Doxil 25 mg/m\^2 IV over 1 hour on Day 2. Vincristine 1.4 mg/m\^2 IV on Days 4 and 11. Dexamethasone 40 mg Iv or oral on Days 1 - 4 and 11 - 14. Cycle 2: Methotrexate 200 mg/m\^2 over 2 hours on Day 1 and 800 mg/m\^2 over 22 hours on day 1. Cytarabine 3 Gm/m\^2 IV twice a day on Days 2 and 3.
    id
    EG000
    other Num Affected
    46
    other Num At Risk
    53
    serious Num Affected
    1
    serious Num At Risk
    53
    title
    HCVIDDOXIL Regimen
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      42
      num At Risk
      53
      num Events
      42
    term
    Neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      46
      num At Risk
      53
      num Events
      46
    term
    Anemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      46
      num At Risk
      53
      num Events
      46
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      53
      num Events
      21
    term
    Febrile Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      35
      num At Risk
      53
      num Events
      35
    term
    Fever
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      53
      num Events
      19
    term
    Infectious Disease
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      40
      num At Risk
      53
      num Events
      40
    term
    Fatigue
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      53
      num Events
      21
    term
    Liver Toxicities
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      53
      num Events
      19
    term
    Constipation
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      53
      num Events
      19
    term
    Dizziness
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      53
      num Events
      19
    term
    Dyspnea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      53
      num Events
      11
    term
    Hyperglycemia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      53
      num Events
      1
    term
    massive cytomegalovirus infection
time Frame
Adverse events were assessed from the initiation of the regimen through the end of the chemotherapy cycle, up to 3 years.

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

Preserved source evidence · Not medical advice