Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00540644 · ADVERSE EVENTS

Adverse events

Phase II Study of Revlimid®, Oral Cyclophosphamide and Prednisone for Patients With Newly Diagnosed Multiple Myeloma · Source last updated 2016-06-21

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 5 years
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Original Study - Revlimid, Cyclophosphamide, Prednisone

Original portion of the study where patients received Revlimid® 25 mg p.o. daily on days 1-21 of each 28-day cycle. Cyclophosphamide 50 mg p.o. BID daily on days 1-21 of each 28-day cycle. Prednisone 50 mg p.o. Q.O.D.

12 / 4848 / 48Not reported / Not reported
Extension - Revlimid, Cyclophosphamide, Prednisone

Extension portion of the study where patients received Revlimid® 25 mg p.o. daily on days 1-21 of each 28-day cycle. Cyclophosphamide 50 mg p.o. BID daily on days 1-21 of each 28-day cycle. Prednisone 50 mg p.o. Q.O.D.

5 / 2222 / 22Not reported / Not reported

Group identifiers: EG000: Original Study - Revlimid, Cyclophosphamide, Prednisone · EG001: Extension - Revlimid, Cyclophosphamide, Prednisone

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
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      48
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      22
    term
    FEBRILE NEUTROPENIA (FEVER OF UNKNOWN ORIGIN WITHOUT CLINICALLY OR MICROBIOLOGICALLY DOCUMENTED INFE
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      48
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
    term
    CARDIAC GENERAL - OTHER
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      48
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
    term
    FEVER (IN THE ABSENCE OF NEUTROPENIA, WHERE NEUTROPENIA IS DEFINED AS ANC <1.0 X 10E9/L)
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      48
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      22
    term
    INFECTION (DOCUMENTED CLINICALLY OR MICROBIOLOGICALLY) WITH GRADE 3 OR 4 NEUTROPHILS (ANC <1.0 X 10E
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      48
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
    term
    INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - LUNG (PNEUMONIA)
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      48
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      22
    term
    HEMOGLOBIN
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      48
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      22
    term
    NEUTROPHILS/GRANULOCYTES (ANC/AGC)
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      48
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      22
    term
    PAIN - BACK
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      48
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
    term
    PAIN - EXTREMITY-LIMB
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      48
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
    term
    SEIZURE
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      48
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      22
    term
    CONFUSION
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      48
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      22
    term
    RENAL FAILURE

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
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      48
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      22
    term
    PALPITATIONS
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      48
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      22
    term
    SUPRAVENTRICULAR AND NODAL ARRHYTHMIA - SINUS BRADYCARDIA
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      48
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      22
    term
    AUDITORY/EAR - OTHER
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      48
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      22
    term
    OTITIS, MIDDLE EAR (NON-INFECTIOUS)
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      48
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      22
    term
    OCULAR/VISUAL - OTHER
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      48
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      22
    term
    CONSTIPATION
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      48
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      22
    term
    DIARRHEA
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      48
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      22
    term
    DRY MOUTH/SALIVARY GLAND (XEROSTOMIA)
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      48
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      22
    term
    DYSPHAGIA (DIFFICULTY SWALLOWING)
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      48
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      22
    term
    GASTROINTESTINAL - OTHER
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      48
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      22
    term
    HEARTBURN/DYSPEPSIA
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      48
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      22
    term
    HEMORRHOIDS
Complete source fields
event Groups
  1. description
    Original portion of the study where patients received Revlimid® 25 mg p.o. daily on days 1-21 of each 28-day cycle. Cyclophosphamide 50 mg p.o. BID daily on days 1-21 of each 28-day cycle. Prednisone 50 mg p.o. Q.O.D.
    id
    EG000
    other Num Affected
    48
    other Num At Risk
    48
    serious Num Affected
    12
    serious Num At Risk
    48
    title
    Original Study - Revlimid, Cyclophosphamide, Prednisone
  2. description
    Extension portion of the study where patients received Revlimid® 25 mg p.o. daily on days 1-21 of each 28-day cycle. Cyclophosphamide 50 mg p.o. BID daily on days 1-21 of each 28-day cycle. Prednisone 50 mg p.o. Q.O.D.
    id
    EG001
    other Num Affected
    22
    other Num At Risk
    22
    serious Num Affected
    5
    serious Num At Risk
    22
    title
    Extension - Revlimid, Cyclophosphamide, Prednisone
frequency Threshold
5
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      48
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      22
    term
    PALPITATIONS
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      48
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      22
    term
    SUPRAVENTRICULAR AND NODAL ARRHYTHMIA - SINUS BRADYCARDIA
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      48
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      22
    term
    AUDITORY/EAR - OTHER
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      48
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      22
    term
    OTITIS, MIDDLE EAR (NON-INFECTIOUS)
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      48
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      22
    term
    OCULAR/VISUAL - OTHER
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      48
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      22
    term
    CONSTIPATION
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      48
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      22
    term
    DIARRHEA
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      48
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      22
    term
    DRY MOUTH/SALIVARY GLAND (XEROSTOMIA)
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      48
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      22
    term
    DYSPHAGIA (DIFFICULTY SWALLOWING)
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      48
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      22
    term
    GASTROINTESTINAL - OTHER
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      48
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      22
    term
    HEARTBURN/DYSPEPSIA
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      48
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      22
    term
    HEMORRHOIDS
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      48
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      22
    term
    FEBRILE NEUTROPENIA (FEVER OF UNKNOWN ORIGIN WITHOUT CLINICALLY OR MICROBIOLOGICALLY DOCUMENTED INFE
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      48
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
    term
    CARDIAC GENERAL - OTHER
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      48
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
    term
    FEVER (IN THE ABSENCE OF NEUTROPENIA, WHERE NEUTROPENIA IS DEFINED AS ANC <1.0 X 10E9/L)
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      48
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      22
    term
    INFECTION (DOCUMENTED CLINICALLY OR MICROBIOLOGICALLY) WITH GRADE 3 OR 4 NEUTROPHILS (ANC <1.0 X 10E
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      48
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
    term
    INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - LUNG (PNEUMONIA)
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      48
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      22
    term
    HEMOGLOBIN
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      48
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      22
    term
    NEUTROPHILS/GRANULOCYTES (ANC/AGC)
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      48
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      22
    term
    PAIN - BACK
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      48
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
    term
    PAIN - EXTREMITY-LIMB
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      48
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
    term
    SEIZURE
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      48
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      22
    term
    CONFUSION
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      48
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      22
    term
    RENAL FAILURE
time Frame
up to 5 years

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

Preserved source evidence · Not medical advice