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NCT01029054 · ADVERSE EVENTS

Adverse events

Carfilzomib and Lenalidomide With Dexamethasone Combination in Newly Diagnosed, Previously Untreated Multiple Myeloma · Source last updated 2017-01-30

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
All Adverse Events (AEs) that occurred after the subject signed consent were documented.
Other-event reporting threshold
5%

A Serious Adverse Event (SAE) is defined as: death, a life-threatening experience, hospitalization, results in persistent or significant disability/incapacity, congenital anomaly/birth defect in the offspring of an exposed subject, important medical events based upon appropriate medical judgment, pregnancy.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Carfilzomib, Lenalidomide w/Dexamethasone

Carfilzomib will be administered as an IV infusion on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for Cycles 1 - 8 (induction) and on Days 1, 2, 15, and 16 of a 28-day cycle for Cycles 9+ (maintenance). Lenalidomide will be administered PO daily at 25 mg on Days 1- 21 of the 28-day cycle for Cycles 1 - 8+. Dexamethasone will be administered PO or IV between 30 minutes and 4 hours preceding the carfilzomib push.

23 / 5353 / 53Not reported / Not reported

Group identifiers: EG000: Carfilzomib, Lenalidomide w/Dexamethasone

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
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      53
    term
    Acute Renal Failure
  2. organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      53
    term
    Acute Mental Status Change
  3. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      53
    term
    Appendicitis
  4. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      53
    term
    Atrial Fibrillation
  5. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      53
    term
    Clostridium Difficile
  6. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      53
    term
    Colitis
  7. organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      53
    term
    Compression Fracture
  8. organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      53
    term
    Confusion
  9. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      53
    term
    Constipation
  10. organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      53
    term
    Dyspnea
  11. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      53
    term
    Febrile Neutropenia
  12. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      53
    term
    Fever

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
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      38
      num At Risk
      53
    term
    Hyperglycemia
  2. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      53
    term
    Edema
  3. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      53
    term
    Hypophosphatemia
  4. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      53
    term
    Fatigue
  5. organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      53
    term
    Muscle Cramping
  6. organ System
    Skin and subcutaneous tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      53
    term
    Rash
  7. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      53
    term
    Elevated Liver Function Test
  8. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      53
    term
    Diarrhea
  9. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      53
    term
    Infection
  10. organ System
    Vascular disorders
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      53
    term
    Phlebitis
  11. organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      53
    term
    Peripheral Neuropathy
  12. organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      53
    term
    Dyspnea
Complete source fields
description
A Serious Adverse Event (SAE) is defined as: death, a life-threatening experience, hospitalization, results in persistent or significant disability/incapacity, congenital anomaly/birth defect in the offspring of an exposed subject, important medical events based upon appropriate medical judgment, pregnancy.
event Groups
  1. description
    Carfilzomib will be administered as an IV infusion on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for Cycles 1 - 8 (induction) and on Days 1, 2, 15, and 16 of a 28-day cycle for Cycles 9+ (maintenance). Lenalidomide will be administered PO daily at 25 mg on Days 1- 21 of the 28-day cycle for Cycles 1 - 8+. Dexamethasone will be administered PO or IV between 30 minutes and 4 hours preceding the carfilzomib push.
    id
    EG000
    other Num Affected
    53
    other Num At Risk
    53
    serious Num Affected
    23
    serious Num At Risk
    53
    title
    Carfilzomib, Lenalidomide w/Dexamethasone
frequency Threshold
5
other Events
  1. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      38
      num At Risk
      53
    term
    Hyperglycemia
  2. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      53
    term
    Edema
  3. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      53
    term
    Hypophosphatemia
  4. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      53
    term
    Fatigue
  5. organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      53
    term
    Muscle Cramping
  6. organ System
    Skin and subcutaneous tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      53
    term
    Rash
  7. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      53
    term
    Elevated Liver Function Test
  8. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      53
    term
    Diarrhea
  9. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      53
    term
    Infection
  10. organ System
    Vascular disorders
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      53
    term
    Phlebitis
  11. organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      53
    term
    Peripheral Neuropathy
  12. organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      53
    term
    Dyspnea
serious Events
  1. organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      53
    term
    Acute Renal Failure
  2. organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      53
    term
    Acute Mental Status Change
  3. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      53
    term
    Appendicitis
  4. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      53
    term
    Atrial Fibrillation
  5. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      53
    term
    Clostridium Difficile
  6. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      53
    term
    Colitis
  7. organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      53
    term
    Compression Fracture
  8. organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      53
    term
    Confusion
  9. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      53
    term
    Constipation
  10. organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      53
    term
    Dyspnea
  11. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      53
    term
    Febrile Neutropenia
  12. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      53
    term
    Fever
time Frame
All Adverse Events (AEs) that occurred after the subject signed consent were documented.

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

Preserved source evidence · Not medical advice