Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01651039 · ADVERSE EVENTS

Adverse events

Phase II, Single-Center, Oral Panobinostat in Combination With Lenalidomide and Dexamethasone in Multiple Myeloma (MM) · Source last updated 2018-04-09

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
Not reported
Other-event reporting threshold
0%

Adverse events collected for all subjects who signed consent

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

Adverse events collected for all subjects who signed consent.

14 / 4138 / 411 / 41

Group identifiers: EG000: All Subjects

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
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      41
      num Events
      1
    term
    Cardiac Catherization
  2. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      41
      num Events
      1
    term
    Chest Pain
  3. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      41
      num Events
      1
    term
    Ehrlichiosis Babesiosis
  4. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      41
      num Events
      1
    term
    Failure to thrive
  5. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      41
      num Events
      2
    term
    Hypercalcemia
  6. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      41
      num Events
      1
    term
    Hypotension
  7. organ System
    Surgical and medical procedures
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      41
      num Events
      1
    term
    Lap low Anterior Surgery
  8. organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      41
      num Events
      2
    term
    Neck Pain
  9. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      41
      num Events
      1
    term
    Neutropenia
  10. organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      41
      num Events
      3
    term
    Pneumonia
  11. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      41
      num Events
      1
    term
    Pulmonary Embolism
  12. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      41
      num Events
      1
    term
    Sepsis

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
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      41
      num Events
      4
    term
    Abdominal Pain
  2. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      41
      num Events
      1
    term
    Abdominal discomfort
  3. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      41
      num Events
      1
    term
    Acute GI upset
  4. organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      41
      num Events
      1
    term
    Acute kidney injury
  5. organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      41
      num Events
      2
    term
    acute renal insufficiency
  6. organ System
    Endocrine disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      41
      num Events
      1
    term
    Adrenal insufficiency
  7. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      41
      num Events
      2
    term
    Alanine Aminotransferase
  8. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      41
      num Events
      1
    term
    Allergic rhinitis
  9. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      41
      num Events
      1
    term
    Alk phos elevation
  10. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      41
      num Events
      2
    term
    ALT elevation
  11. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      41
      num Events
      2
    term
    ALT increased
  12. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      41
      num Events
      1
    term
    Altered smell
Complete source fields
description
Adverse events collected for all subjects who signed consent
event Groups
  1. deaths Num Affected
    1
    deaths Num At Risk
    41
    description
    Adverse events collected for all subjects who signed consent.
    id
    EG000
    other Num Affected
    38
    other Num At Risk
    41
    serious Num Affected
    14
    serious Num At Risk
    41
    title
    All Subjects
frequency Threshold
0
other Events
  1. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      41
      num Events
      4
    term
    Abdominal Pain
  2. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      41
      num Events
      1
    term
    Abdominal discomfort
  3. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      41
      num Events
      1
    term
    Acute GI upset
  4. organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      41
      num Events
      1
    term
    Acute kidney injury
  5. organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      41
      num Events
      2
    term
    acute renal insufficiency
  6. organ System
    Endocrine disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      41
      num Events
      1
    term
    Adrenal insufficiency
  7. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      41
      num Events
      2
    term
    Alanine Aminotransferase
  8. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      41
      num Events
      1
    term
    Allergic rhinitis
  9. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      41
      num Events
      1
    term
    Alk phos elevation
  10. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      41
      num Events
      2
    term
    ALT elevation
  11. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      41
      num Events
      2
    term
    ALT increased
  12. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      41
      num Events
      1
    term
    Altered smell
serious Events
  1. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      41
      num Events
      1
    term
    Cardiac Catherization
  2. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      41
      num Events
      1
    term
    Chest Pain
  3. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      41
      num Events
      1
    term
    Ehrlichiosis Babesiosis
  4. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      41
      num Events
      1
    term
    Failure to thrive
  5. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      41
      num Events
      2
    term
    Hypercalcemia
  6. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      41
      num Events
      1
    term
    Hypotension
  7. organ System
    Surgical and medical procedures
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      41
      num Events
      1
    term
    Lap low Anterior Surgery
  8. organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      41
      num Events
      2
    term
    Neck Pain
  9. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      41
      num Events
      1
    term
    Neutropenia
  10. organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      41
      num Events
      3
    term
    Pneumonia
  11. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      41
      num Events
      1
    term
    Pulmonary Embolism
  12. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      41
      num Events
      1
    term
    Sepsis

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

Preserved source evidence · Not medical advice