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NCT02807272 · ADVERSE EVENTS

Adverse events

Tipifarnib in Subjects With Chronic Myelomonocytic Leukemia, Other MDS/MPN, and Acute Myeloid Leukemia · Source last updated 2024-07-17

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
Up to approximately 3 years
Other-event reporting threshold
5%

FAS: All enrolled participants who received at least one dose of tipifarnib. Data was pooled into CMML and MDS/MPN arms as pre-specified in SAP.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
CMML

Participants with CMML were grouped by KRAS/NRAS mutational status (wild type \[WT\], mutation \[Mut\], missing) and given tipifarnib 1200mg twice daily (BID) for 7 days in alternating weeks (Days 1-7, 15-21) in 28-day cycles.

23 / 3737 / 3717 / 37
MDS/MPS

Participants with MDS/MPN were stratified by ratio of expression (high or low) between CXCR4 and CXCR2 (CXCR4/2 ratio) receptors to receive tipifarnib at a dose of 400 mg, orally, BID on Day 1 through 21 of each 28-day treatment cycle.

1 / 77 / 71 / 7

Group identifiers: EG000: CMML · EG001: MDS/MPS

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 19.0.
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
    term
    Febrile neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 19.0.
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    term
    Anaemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 19.0.
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    term
    Atrial fibrillation
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 19.0.
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    term
    Cardiac arrest
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 19.0.
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    term
    Cardiac failure
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 19.0.
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    term
    Cardiac failure congestive
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 19.0.
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    term
    Myocardial infarction
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.0.
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    term
    Gastric haemorrhage
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.0.
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    term
    Dental caries
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.0.
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    term
    Duodenal ulcer
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.0.
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    term
    Gastritis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.0.
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    term
    Nausea

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 19.0.
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      7
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 19.0.
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
    term
    Leukocytosis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 19.0.
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    term
    Sinus tachycardia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.0.
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      7
    term
    Nausea
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.0.
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      7
    term
    Diarrhoea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.0.
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      7
    term
    Constipation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.0.
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    term
    Vomiting
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.0.
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      7
    term
    Abdominal pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.0.
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    term
    Dyspepsia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.0.
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      7
    term
    Gastrooesophageal reflux disease
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.0.
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
    term
    Abdominal pain upper
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.0.
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    term
    Dry mouth
Complete source fields
description
FAS: All enrolled participants who received at least one dose of tipifarnib. Data was pooled into CMML and MDS/MPN arms as pre-specified in SAP.
event Groups
  1. deaths Num Affected
    17
    deaths Num At Risk
    37
    description
    Participants with CMML were grouped by KRAS/NRAS mutational status (wild type \[WT\], mutation \[Mut\], missing) and given tipifarnib 1200mg twice daily (BID) for 7 days in alternating weeks (Days 1-7, 15-21) in 28-day cycles.
    id
    EG000
    other Num Affected
    37
    other Num At Risk
    37
    serious Num Affected
    23
    serious Num At Risk
    37
    title
    CMML
  2. deaths Num Affected
    1
    deaths Num At Risk
    7
    description
    Participants with MDS/MPN were stratified by ratio of expression (high or low) between CXCR4 and CXCR2 (CXCR4/2 ratio) receptors to receive tipifarnib at a dose of 400 mg, orally, BID on Day 1 through 21 of each 28-day treatment cycle.
    id
    EG001
    other Num Affected
    7
    other Num At Risk
    7
    serious Num Affected
    1
    serious Num At Risk
    7
    title
    MDS/MPS
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 19.0.
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      7
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 19.0.
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
    term
    Leukocytosis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 19.0.
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    term
    Sinus tachycardia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.0.
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      7
    term
    Nausea
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.0.
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      7
    term
    Diarrhoea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.0.
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      7
    term
    Constipation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.0.
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    term
    Vomiting
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.0.
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      7
    term
    Abdominal pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.0.
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    term
    Dyspepsia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.0.
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      7
    term
    Gastrooesophageal reflux disease
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.0.
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
    term
    Abdominal pain upper
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.0.
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    term
    Dry mouth
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 19.0.
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
    term
    Febrile neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 19.0.
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    term
    Anaemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 19.0.
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    term
    Atrial fibrillation
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 19.0.
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    term
    Cardiac arrest
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 19.0.
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    term
    Cardiac failure
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 19.0.
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    term
    Cardiac failure congestive
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 19.0.
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    term
    Myocardial infarction
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.0.
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    term
    Gastric haemorrhage
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.0.
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    term
    Dental caries
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.0.
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    term
    Duodenal ulcer
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.0.
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    term
    Gastritis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.0.
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    term
    Nausea
time Frame
Up to approximately 3 years

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