Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01283997 · ADVERSE EVENTS

Adverse events

Prevention of Treatment Induced Neuropathy in Multiple Myeloma · Source last updated 2024-06-13

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
From the first dose through 330 days after the last dose of study medication
Other-event reporting threshold
1%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Placebo Group

Participants received one pill by mouth on Day 1. Staring on Day 2, 2 times a day (every 12 hours) by mouth for 10 weeks.

15 / 3939 / 390 / 39
Minocycline Group

Participants received minocycline 200 mg orally for 1 dose, then 100 mg orally every 12 hours for 10 weeks beginning at initiation of induction therapy for multiple myeloma

12 / 4040 / 400 / 40

Group identifiers: EG000: Placebo Group · EG001: Minocycline Group

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
    Investigations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      39
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      40
    term
    Elevated SGPT
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      39
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      40
    term
    Elevated serum myeloma protein
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      39
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      40
    term
    Elevated urinary protein
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      39
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      40
    term
    Elevated serum and urine protein
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      39
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      40
    term
    Pain - back
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      39
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      40
    term
    Rash
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      39
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      40
    term
    Abnormal serum and urine
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      39
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      40
    term
    Hypertension
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      39
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      40
    term
    Atrial fibrillation
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      39
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      40
    term
    Depression
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      39
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      40
    term
    Elevated LDH
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      39
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      40
    term
    Elevated serum total protein

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
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      39
    2. group Id
      EG001
      num Affected
      24
      num At Risk
      40
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Abnormal CBC, cell-shape and size
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      39
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      40
    term
    Blood and lymphatic system disorders - Other, specify
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      39
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      40
    term
    Hematuria
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      39
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      40
    term
    Atrial fibrillation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Back spasm
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      39
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      40
    term
    Muscle cramp
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Calf swelling
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      39
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      40
    term
    Edema Limbs
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      39
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      40
    term
    Constipation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      39
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      40
    term
    Cough
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Decreased Monocyte
    organ System
    Investigations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      39
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      40
    term
    Blood and lymphatic system disorders - Other, specify
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Decreased S-Chloride
    organ System
    Investigations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      39
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      40
    term
    Investigations - Other, specify
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Decreased eosinophil
    organ System
    Investigations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      39
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      40
    term
    Blood and lymphatic system disorders - Other, specify
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      39
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      40
    term
    Anemia
Complete source fields
event Groups
  1. deaths Num Affected
    0
    deaths Num At Risk
    39
    description
    Participants received one pill by mouth on Day 1. Staring on Day 2, 2 times a day (every 12 hours) by mouth for 10 weeks.
    id
    EG000
    other Num Affected
    39
    other Num At Risk
    39
    serious Num Affected
    15
    serious Num At Risk
    39
    title
    Placebo Group
  2. deaths Num Affected
    0
    deaths Num At Risk
    40
    description
    Participants received minocycline 200 mg orally for 1 dose, then 100 mg orally every 12 hours for 10 weeks beginning at initiation of induction therapy for multiple myeloma
    id
    EG001
    other Num Affected
    40
    other Num At Risk
    40
    serious Num Affected
    12
    serious Num At Risk
    40
    title
    Minocycline Group
frequency Threshold
1
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      39
    2. group Id
      EG001
      num Affected
      24
      num At Risk
      40
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Abnormal CBC, cell-shape and size
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      39
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      40
    term
    Blood and lymphatic system disorders - Other, specify
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      39
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      40
    term
    Hematuria
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      39
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      40
    term
    Atrial fibrillation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Back spasm
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      39
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      40
    term
    Muscle cramp
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Calf swelling
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      39
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      40
    term
    Edema Limbs
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      39
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      40
    term
    Constipation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      39
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      40
    term
    Cough
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Decreased Monocyte
    organ System
    Investigations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      39
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      40
    term
    Blood and lymphatic system disorders - Other, specify
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Decreased S-Chloride
    organ System
    Investigations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      39
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      40
    term
    Investigations - Other, specify
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Decreased eosinophil
    organ System
    Investigations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      39
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      40
    term
    Blood and lymphatic system disorders - Other, specify
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      39
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      40
    term
    Anemia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      39
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      40
    term
    Elevated SGPT
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      39
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      40
    term
    Elevated serum myeloma protein
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      39
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      40
    term
    Elevated urinary protein
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      39
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      40
    term
    Elevated serum and urine protein
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      39
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      40
    term
    Pain - back
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      39
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      40
    term
    Rash
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      39
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      40
    term
    Abnormal serum and urine
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      39
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      40
    term
    Hypertension
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      39
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      40
    term
    Atrial fibrillation
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      39
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      40
    term
    Depression
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      39
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      40
    term
    Elevated LDH
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      39
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      40
    term
    Elevated serum total protein
time Frame
From the first dose through 330 days after the last dose of study medication

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

Preserved source evidence · Not medical advice