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NCT00505895 · ADVERSE EVENTS

Adverse events

FM 140 vs FM100 Study in Patients With Multiple Myeloma · Source last updated 2014-10-17

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
The end of active treatment was the day of the drug administration of Rituximab on Day+16. Study participation was from baseline to 100 days after transplantation. Overall study period was March 2002 to May 2013.
Other-event reporting threshold
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Fludarabine + Melphalan + Stem Cell Infusion

Fludarabine 30 mg/m\^2 intravenous (IV) daily over 30 minutes for 4 Days (Beginning Day -4). Melphalan 140 mg/m\^2 IV over 20 minutes on Day -1. Stem Cell Infusion on Day 0. Rituximab 375 mg/m\^2 IV infused starting on day -5.

23 / 278 / 27Not reported / Not reported
Fludarabine + Lower-Dose Melphalan + Stem Cell Infusion

Fludarabine 30 mg/m\^2 IV daily over 30 minutes for 4 Days (Beginning Day -4). Lower-Dose Melphalan 100 mg/m\^2 IV over 20 minutes on Day -1. Stem Cell Infusion on Day 0. Rituximab 375 mg/m\^2 IV infused starting on day -5.

16 / 2310 / 23Not reported / Not reported

Group identifiers: EG000: Fludarabine + Melphalan + Stem Cell Infusion · EG001: Fludarabine + Lower-Dose Melphalan + Stem Cell Infusion

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
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      27
      num Events
      23
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      23
      num Events
      16
    term
    Death
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      27
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Diarrhea
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      27
      num Events
      5
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      23
      num Events
      14
    term
    Infection
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      27
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      23
      num Events
      1
    term
    Pneumonitis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      27
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Seizures
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      27
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Total Bilirubin Level Change
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      27
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      23
      num Events
      1
    term
    Secondary graft failure
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      27
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      23
      num Events
      1
    term
    Rash
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      27
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      23
      num Events
      1
    term
    Altered mental status
  10. 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
      27
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      23
      num Events
      1
    term
    Elevated creatinine
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      27
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Pulmonary hemorrhage
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      27
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Elevated ALT

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
    Infections and infestations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      27
      num Events
      3
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      23
      num Events
      3
    term
    Fever
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      27
      num Events
      1
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      23
      num Events
      3
    term
    Volume overload
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      27
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      23
      num Events
      1
    term
    Hypertension
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      27
      num Events
      5
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      23
      num Events
      6
    term
    Diarrhea
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      27
      num Events
      3
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      23
      num Events
      5
    term
    Dysphagia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      27
      num Events
      8
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      23
      num Events
      11
    term
    Nausea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      27
      num Events
      3
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      23
      num Events
      3
    term
    Rash
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      27
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      23
      num Events
      1
    term
    Dizziness
  9. 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
      27
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      23
      num Events
      1
    term
    Hematuria
  10. 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
      27
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      23
      num Events
      1
    term
    Elevated Creatinine
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      27
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      23
      num Events
      2
    term
    Conjunctivitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      27
      num Events
      2
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      23
      num Events
      3
    term
    Infection
Complete source fields
event Groups
  1. description
    Fludarabine 30 mg/m\^2 intravenous (IV) daily over 30 minutes for 4 Days (Beginning Day -4). Melphalan 140 mg/m\^2 IV over 20 minutes on Day -1. Stem Cell Infusion on Day 0. Rituximab 375 mg/m\^2 IV infused starting on day -5.
    id
    EG000
    other Num Affected
    8
    other Num At Risk
    27
    serious Num Affected
    23
    serious Num At Risk
    27
    title
    Fludarabine + Melphalan + Stem Cell Infusion
  2. description
    Fludarabine 30 mg/m\^2 IV daily over 30 minutes for 4 Days (Beginning Day -4). Lower-Dose Melphalan 100 mg/m\^2 IV over 20 minutes on Day -1. Stem Cell Infusion on Day 0. Rituximab 375 mg/m\^2 IV infused starting on day -5.
    id
    EG001
    other Num Affected
    10
    other Num At Risk
    23
    serious Num Affected
    16
    serious Num At Risk
    23
    title
    Fludarabine + Lower-Dose Melphalan + Stem Cell Infusion
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      27
      num Events
      3
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      23
      num Events
      3
    term
    Fever
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      27
      num Events
      1
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      23
      num Events
      3
    term
    Volume overload
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      27
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      23
      num Events
      1
    term
    Hypertension
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      27
      num Events
      5
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      23
      num Events
      6
    term
    Diarrhea
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      27
      num Events
      3
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      23
      num Events
      5
    term
    Dysphagia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      27
      num Events
      8
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      23
      num Events
      11
    term
    Nausea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      27
      num Events
      3
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      23
      num Events
      3
    term
    Rash
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      27
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      23
      num Events
      1
    term
    Dizziness
  9. 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
      27
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      23
      num Events
      1
    term
    Hematuria
  10. 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
      27
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      23
      num Events
      1
    term
    Elevated Creatinine
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      27
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      23
      num Events
      2
    term
    Conjunctivitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      27
      num Events
      2
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      23
      num Events
      3
    term
    Infection
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      27
      num Events
      23
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      23
      num Events
      16
    term
    Death
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      27
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Diarrhea
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      27
      num Events
      5
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      23
      num Events
      14
    term
    Infection
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      27
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      23
      num Events
      1
    term
    Pneumonitis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      27
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Seizures
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      27
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Total Bilirubin Level Change
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      27
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      23
      num Events
      1
    term
    Secondary graft failure
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      27
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      23
      num Events
      1
    term
    Rash
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      27
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      23
      num Events
      1
    term
    Altered mental status
  10. 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
      27
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      23
      num Events
      1
    term
    Elevated creatinine
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      27
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Pulmonary hemorrhage
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      27
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Elevated ALT
time Frame
The end of active treatment was the day of the drug administration of Rituximab on Day+16. Study participation was from baseline to 100 days after transplantation. Overall study period was March 2002 to May 2013.

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