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NCT00708721 · ADVERSE EVENTS

Adverse events

Low-dose Oral Clofarabine for the Treatment of IPSS INT-1, INT-2 or HIGH Myelodysplastic Syndromes and Chronic Myelomonocytic Leukemia · Source last updated 2017-06-01

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

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

Collection time frame
Adverse events were collected after the administration of the study drug and followed until resolution.
Other-event reporting threshold
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
All Groups

All patients who received study treatment.

8 / 1111 / 11Not reported / Not reported

Group identifiers: EG000: All Groups

Serious adverse events

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

  1. organ System
    Vascular disorders
    source Vocabulary
    NCI CTCAE version 3.
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
    term
    Subdural hematoma
  2. organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    NCI CTCAE version 3.
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      11
    term
    pneumonia
  3. organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    NCI CTCAE version 3.
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
    term
    femur fracture
  4. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    NCI CTCAE version 3.
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      11
    term
    thrombocytopenia
  5. organ System
    Infections and infestations
    source Vocabulary
    NCI CTCAE version 3.
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
    term
    cellulitis right forearm
  6. organ System
    Infections and infestations
    source Vocabulary
    NCI CTCAE version 3.
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
    term
    urinary tract infection
  7. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    NCI CTCAE version 3.
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
    term
    cytopenia
  8. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    NCI CTCAE version 3.
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
    term
    febrile neutropenia
  9. organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    NCI CTCAE version 3.
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
    term
    joint swelling
  10. organ System
    Infections and infestations
    source Vocabulary
    NCI CTCAE version 3.
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
    term
    e. coli positive
  11. organ System
    Reproductive system and breast disorders
    source Vocabulary
    NCI CTCAE version 3.
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
    term
    Ovarian abscess
  12. organ System
    Nervous system disorders
    source Vocabulary
    NCI CTCAE version 3.
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
    term
    mental status change

Other reported adverse events

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

  1. organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    NCI CTCAE version 3.
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
    term
    allergic rhinits
  2. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    NCI CTCAE version 3.
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      11
    term
    anemia
  3. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    NCI CTCAE version 3.
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      11
    term
    leukopenia
  4. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    NCI CTCAE version 3.
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      11
    term
    lymphopenia
  5. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    NCI CTCAE version 3.
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      11
    term
    neutropenia
  6. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    NCI CTCAE version 3.
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
    term
    splenomegaly
  7. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    NCI CTCAE version 3.
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      11
    term
    thrombocytopenia
  8. organ System
    Cardiac disorders
    source Vocabulary
    NCI CTCAE version 3.
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
    term
    Afibrilation with RVR
  9. organ System
    Cardiac disorders
    source Vocabulary
    NCI CTCAE version 3.
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
    term
    Atrial Flutter with AV Block
  10. organ System
    Cardiac disorders
    source Vocabulary
    NCI CTCAE version 3.
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
    term
    Ventricular Tachycardia
  11. organ System
    Cardiac disorders
    source Vocabulary
    NCI CTCAE version 3.
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      11
    term
    Cardiomegaly
  12. organ System
    Cardiac disorders
    source Vocabulary
    NCI CTCAE version 3.
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
    term
    Hypertension
Complete source fields
event Groups
  1. description
    All patients who received study treatment.
    id
    EG000
    other Num Affected
    11
    other Num At Risk
    11
    serious Num Affected
    8
    serious Num At Risk
    11
    title
    All Groups
frequency Threshold
0
other Events
  1. organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    NCI CTCAE version 3.
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
    term
    allergic rhinits
  2. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    NCI CTCAE version 3.
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      11
    term
    anemia
  3. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    NCI CTCAE version 3.
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      11
    term
    leukopenia
  4. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    NCI CTCAE version 3.
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      11
    term
    lymphopenia
  5. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    NCI CTCAE version 3.
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      11
    term
    neutropenia
  6. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    NCI CTCAE version 3.
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
    term
    splenomegaly
  7. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    NCI CTCAE version 3.
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      11
    term
    thrombocytopenia
  8. organ System
    Cardiac disorders
    source Vocabulary
    NCI CTCAE version 3.
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
    term
    Afibrilation with RVR
  9. organ System
    Cardiac disorders
    source Vocabulary
    NCI CTCAE version 3.
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
    term
    Atrial Flutter with AV Block
  10. organ System
    Cardiac disorders
    source Vocabulary
    NCI CTCAE version 3.
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
    term
    Ventricular Tachycardia
  11. organ System
    Cardiac disorders
    source Vocabulary
    NCI CTCAE version 3.
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      11
    term
    Cardiomegaly
  12. organ System
    Cardiac disorders
    source Vocabulary
    NCI CTCAE version 3.
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
    term
    Hypertension
serious Events
  1. organ System
    Vascular disorders
    source Vocabulary
    NCI CTCAE version 3.
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
    term
    Subdural hematoma
  2. organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    NCI CTCAE version 3.
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      11
    term
    pneumonia
  3. organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    NCI CTCAE version 3.
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
    term
    femur fracture
  4. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    NCI CTCAE version 3.
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      11
    term
    thrombocytopenia
  5. organ System
    Infections and infestations
    source Vocabulary
    NCI CTCAE version 3.
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
    term
    cellulitis right forearm
  6. organ System
    Infections and infestations
    source Vocabulary
    NCI CTCAE version 3.
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
    term
    urinary tract infection
  7. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    NCI CTCAE version 3.
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
    term
    cytopenia
  8. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    NCI CTCAE version 3.
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
    term
    febrile neutropenia
  9. organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    NCI CTCAE version 3.
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
    term
    joint swelling
  10. organ System
    Infections and infestations
    source Vocabulary
    NCI CTCAE version 3.
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
    term
    e. coli positive
  11. organ System
    Reproductive system and breast disorders
    source Vocabulary
    NCI CTCAE version 3.
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
    term
    Ovarian abscess
  12. organ System
    Nervous system disorders
    source Vocabulary
    NCI CTCAE version 3.
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
    term
    mental status change
time Frame
Adverse events were collected after the administration of the study drug and followed until resolution.

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