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NCT01844765 · ADVERSE EVENTS

Adverse events

Open Label, Phase II Study to Evaluate Efficacy and Safety of Oral Nilotinib in Philadelphia Positive (Ph+) Chronic Myelogenous Leukemia (CML) Pediatric Patients. · Source last updated 2021-04-22

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
On treatment deaths were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 64.5 months (treatment duration ranged from 0.7 to 63.5 months). Deaths post treatment survival follow up were collected after the on- treatment period, up to approx. 7 years.
Other-event reporting threshold
5%

Adverse Event: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Resistant/Intolerant Ph+ CML in CP

Patients resistant or intolerant to either imatinib or dasatinib

11 / 3333 / 330 / 33
Newly Diagnosed and Untreated Ph+ CML in First CP

Patients newly diagnosed in Chronic phase. Diagnosis within 6 months of date of first cytogenetic analysis confirming Philadelphia chromosome with (9;22) translocation by standard conventional cytogenetic analysis

4 / 2525 / 250 / 25
All Patients

All of the patients enrolled in the study.

15 / 5858 / 580 / 58

Group identifiers: EG000: Resistant/Intolerant Ph+ CML in CP · EG001: Newly Diagnosed and Untreated Ph+ CML in First CP · EG002: All Patients

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
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      58
    term
    Leukocytosis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      58
    term
    Lymphadenitis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      58
    term
    Growth hormone deficiency
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      25
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      58
    term
    Abdominal pain
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      25
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      58
    term
    Diarrhoea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      58
    term
    Haemorrhoids thrombosed
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      58
    term
    Toothache
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      58
    term
    Pyrexia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      58
    term
    Hepatomegaly
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      25
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      58
    term
    Hyperbilirubinaemia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      58
    term
    Appendicitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      58
    term
    Bronchitis

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
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      25
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      58
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      25
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      58
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      25
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      58
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      25
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      58
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      25
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      58
    term
    Palpitations
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Congenital, familial and genetic disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      25
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      58
    term
    Gilbert's syndrome
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      25
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      58
    term
    Ear pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      25
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      58
    term
    Conjunctival haemorrhage
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      25
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      58
    term
    Ocular hyperaemia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      25
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      58
    term
    Abdominal pain
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      25
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      58
    term
    Abdominal pain upper
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      25
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      58
    term
    Constipation
Complete source fields
description
Adverse Event: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
event Groups
  1. deaths Num Affected
    0
    deaths Num At Risk
    33
    description
    Patients resistant or intolerant to either imatinib or dasatinib
    id
    EG000
    other Num Affected
    33
    other Num At Risk
    33
    serious Num Affected
    11
    serious Num At Risk
    33
    title
    Resistant/Intolerant Ph+ CML in CP
  2. deaths Num Affected
    0
    deaths Num At Risk
    25
    description
    Patients newly diagnosed in Chronic phase. Diagnosis within 6 months of date of first cytogenetic analysis confirming Philadelphia chromosome with (9;22) translocation by standard conventional cytogenetic analysis
    id
    EG001
    other Num Affected
    25
    other Num At Risk
    25
    serious Num Affected
    4
    serious Num At Risk
    25
    title
    Newly Diagnosed and Untreated Ph+ CML in First CP
  3. deaths Num Affected
    0
    deaths Num At Risk
    58
    description
    All of the patients enrolled in the study.
    id
    EG002
    other Num Affected
    58
    other Num At Risk
    58
    serious Num Affected
    15
    serious Num At Risk
    58
    title
    All Patients
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      25
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      58
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      25
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      58
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      25
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      58
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      25
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      58
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      25
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      58
    term
    Palpitations
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Congenital, familial and genetic disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      25
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      58
    term
    Gilbert's syndrome
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      25
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      58
    term
    Ear pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      25
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      58
    term
    Conjunctival haemorrhage
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      25
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      58
    term
    Ocular hyperaemia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      25
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      58
    term
    Abdominal pain
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      25
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      58
    term
    Abdominal pain upper
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      25
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      58
    term
    Constipation
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      58
    term
    Leukocytosis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      58
    term
    Lymphadenitis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      58
    term
    Growth hormone deficiency
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      25
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      58
    term
    Abdominal pain
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      25
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      58
    term
    Diarrhoea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      58
    term
    Haemorrhoids thrombosed
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      58
    term
    Toothache
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      58
    term
    Pyrexia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      58
    term
    Hepatomegaly
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      25
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      58
    term
    Hyperbilirubinaemia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      58
    term
    Appendicitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      58
    term
    Bronchitis
time Frame
On treatment deaths were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 64.5 months (treatment duration ranged from 0.7 to 63.5 months). Deaths post treatment survival follow up were collected after the on- treatment period, up to approx. 7 years.

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Preserved source evidence · Not medical advice