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NCT00445692 · ADVERSE EVENTS

Adverse events

Lenalidomide, Dexamethasone, and Clarithromycin in Treating Patients Who Have Undergone Stem Cell Transplant for Multiple Myeloma · Source last updated 2019-11-13

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
10.25 years
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Treatment (Clarithromycin, Dexamethasone, Lenalidomide)

Patients receive clarithromycin orally (PO) twice daily and dexamethasone PO once a week. Treatment with clarithromycin and dexamethasone continues for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients also receive lenalidomide PO once daily on days 1-14. Courses with lenalidomide repeat every 21 days in the absence of disease progression or unacceptable toxicity. Lenalidomide is taken 4 hours or more after last dose of daily clarithromycin. NOTE: \*After one year of treatment, dexamethasone is tapered for an additional 4 weeks. Clarithromycin: Given Orally (PO) Dexamethasone: Given PO Lenalidomide: Given PO

11 / 3119 / 3113 / 31

Group identifiers: EG000: Treatment (Clarithromycin, Dexamethasone, Lenalidomide)

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
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
    term
    Upper Respiratory Syncytial Virus infection
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
    term
    Varicella-zoster virus pneumonia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
    term
    Cellulitis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      31
    term
    Pneumonia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
    term
    Peripheral edema
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
    term
    Pneumocystis Carinii Pneumonia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
    term
    H1N1 influenza / Streptococcus pneumonia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
    term
    Ileus
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
    term
    Secondary cancer, Acute Myeloid Leukemia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
    term
    Upper respiratory syncytial viurs infection/Leukocytoclastic vasculitis

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
    notes
    grades 2 and 3 only occurred
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      31
    term
    Peripheral Neuropathy
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    grades 2-4 reported, grade 2 ( n=3) , grade 3 (n=4), grade 4 (n=2).
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      31
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      31
    term
    upper respiratory infection
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      31
    term
    sinus/acute otitis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      31
    term
    cellulitis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      31
    term
    vaginitis
Complete source fields
event Groups
  1. deaths Num Affected
    13
    deaths Num At Risk
    31
    description
    Patients receive clarithromycin orally (PO) twice daily and dexamethasone PO once a week. Treatment with clarithromycin and dexamethasone continues for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients also receive lenalidomide PO once daily on days 1-14. Courses with lenalidomide repeat every 21 days in the absence of disease progression or unacceptable toxicity. Lenalidomide is taken 4 hours or more after last dose of daily clarithromycin. NOTE: \*After one year of treatment, dexamethasone is tapered for an additional 4 weeks. Clarithromycin: Given Orally (PO) Dexamethasone: Given PO Lenalidomide: Given PO
    id
    EG000
    other Num Affected
    19
    other Num At Risk
    31
    serious Num Affected
    11
    serious Num At Risk
    31
    title
    Treatment (Clarithromycin, Dexamethasone, Lenalidomide)
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    grades 2 and 3 only occurred
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      31
    term
    Peripheral Neuropathy
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    grades 2-4 reported, grade 2 ( n=3) , grade 3 (n=4), grade 4 (n=2).
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      31
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      31
    term
    upper respiratory infection
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      31
    term
    sinus/acute otitis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      31
    term
    cellulitis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      31
    term
    vaginitis
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
    term
    Upper Respiratory Syncytial Virus infection
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
    term
    Varicella-zoster virus pneumonia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
    term
    Cellulitis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      31
    term
    Pneumonia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
    term
    Peripheral edema
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
    term
    Pneumocystis Carinii Pneumonia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
    term
    H1N1 influenza / Streptococcus pneumonia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
    term
    Ileus
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
    term
    Secondary cancer, Acute Myeloid Leukemia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
    term
    Upper respiratory syncytial viurs infection/Leukocytoclastic vasculitis
time Frame
10.25 years

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Preserved source evidence · Not medical advice