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NCT00123487 · ADVERSE EVENTS

Adverse events

Advanced Chronic Myelogenous Leukemia (CML) - Follow On: Study of BMS-354825 in Subjects With CML · Source last updated 2014-11-03

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
Day 1 up to 7 years
Other-event reporting threshold
5%

Participants who received at least one dose of study drug were analyzed. Participants were analyzed based on the treatment they actually received, not what they were randomized to receive.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Dasatinib 140 mg QD

Dasatinib was administered orally at a dose of 140 mg once a day (QD) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant.

228 / 304289 / 304Not reported / Not reported
Dasatinib 70 mg BID

Dasatinib was administered orally at a dose of 70 mg twice a day (BID) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant.

236 / 305290 / 305Not reported / Not reported

Group identifiers: EG000: Dasatinib 140 mg QD · EG001: Dasatinib 70 mg BID

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
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      304
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      305
    term
    Adenocarcinoma of colon
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      304
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      305
    term
    Alanine aminotransferase
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      304
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      305
    term
    Arachnoiditis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      304
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      305
    term
    Arterial haemorrhage
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      304
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      305
    term
    Atypical pneumonia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      304
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      305
    term
    Bacterial sepsis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      304
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      305
    term
    Biopsy lymph gland
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      304
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      305
    term
    Blast cell proliferation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      304
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      305
    term
    Bone pain
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      304
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      305
    term
    Brain neoplasm
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      304
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      305
    term
    Central nervous system lesion
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      304
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      305
    term
    Chills

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
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      304
    2. group Id
      EG001
      num Affected
      25
      num At Risk
      305
    term
    Bone pain
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      304
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      305
    term
    Chills
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      44
      num At Risk
      304
    2. group Id
      EG001
      num Affected
      37
      num At Risk
      305
    term
    Constipation
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      304
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      305
    term
    Febrile neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      304
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      305
    term
    Oral herpes
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      48
      num At Risk
      304
    2. group Id
      EG001
      num Affected
      37
      num At Risk
      305
    term
    Pain in extremity
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      304
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      305
    term
    Pneumonia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      304
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      305
    term
    Abdominal pain upper
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      35
      num At Risk
      304
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      305
    term
    Chest pain
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      304
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      305
    term
    Nasopharyngitis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      29
      num At Risk
      304
    2. group Id
      EG001
      num Affected
      25
      num At Risk
      305
    term
    Pruritus
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      304
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      305
    term
    Alopecia
Complete source fields
description
Participants who received at least one dose of study drug were analyzed. Participants were analyzed based on the treatment they actually received, not what they were randomized to receive.
event Groups
  1. description
    Dasatinib was administered orally at a dose of 140 mg once a day (QD) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant.
    id
    EG000
    other Num Affected
    289
    other Num At Risk
    304
    serious Num Affected
    228
    serious Num At Risk
    304
    title
    Dasatinib 140 mg QD
  2. description
    Dasatinib was administered orally at a dose of 70 mg twice a day (BID) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant.
    id
    EG001
    other Num Affected
    290
    other Num At Risk
    305
    serious Num Affected
    236
    serious Num At Risk
    305
    title
    Dasatinib 70 mg BID
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      304
    2. group Id
      EG001
      num Affected
      25
      num At Risk
      305
    term
    Bone pain
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      304
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      305
    term
    Chills
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      44
      num At Risk
      304
    2. group Id
      EG001
      num Affected
      37
      num At Risk
      305
    term
    Constipation
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      304
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      305
    term
    Febrile neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      304
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      305
    term
    Oral herpes
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      48
      num At Risk
      304
    2. group Id
      EG001
      num Affected
      37
      num At Risk
      305
    term
    Pain in extremity
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      304
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      305
    term
    Pneumonia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      304
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      305
    term
    Abdominal pain upper
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      35
      num At Risk
      304
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      305
    term
    Chest pain
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      304
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      305
    term
    Nasopharyngitis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      29
      num At Risk
      304
    2. group Id
      EG001
      num Affected
      25
      num At Risk
      305
    term
    Pruritus
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      304
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      305
    term
    Alopecia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      304
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      305
    term
    Adenocarcinoma of colon
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      304
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      305
    term
    Alanine aminotransferase
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      304
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      305
    term
    Arachnoiditis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      304
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      305
    term
    Arterial haemorrhage
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      304
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      305
    term
    Atypical pneumonia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      304
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      305
    term
    Bacterial sepsis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      304
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      305
    term
    Biopsy lymph gland
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      304
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      305
    term
    Blast cell proliferation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      304
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      305
    term
    Bone pain
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      304
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      305
    term
    Brain neoplasm
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      304
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      305
    term
    Central nervous system lesion
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      304
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      305
    term
    Chills
time Frame
Day 1 up to 7 years

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