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NCT00925782 · ADVERSE EVENTS

Adverse events

PK Study of Melphalan HCL & Alkeran for Injection of MA Conditioning in MM Patients of Autologous Transplantation · Source last updated 2019-12-17

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
Day -30 to 7 days post day of engraftment.
Other-event reporting threshold
5%

The time between randomized sequence of treatment (24 hours) is not sufficiently long to evaluate adverse events by intervention and Adverse Events were not collected per sequence

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
All Study Participants

Open-label, randomized, cross-over design study where Propylene Glycol Free Melphalan and Alkeran were assessed in the same multiple myeloma patients undergoing transplantation. The time between randomized sequence of treatment is not sufficiently long to evaluate adverse events by intervention of or by sequence.

7 / 2424 / 24Not reported / Not reported

Group identifiers: EG000: All Study Participants

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
    Mucosal inflamation
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      24
      num Events
      2
    term
    Mucosal inflammation (grade 3)
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    Fatigue
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      24
      num Events
      1
    term
    Fatigue (grade 3)
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    Febrile neutropenia
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      24
      num Events
      2
    term
    Febrile neutropenia (grade 3)
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    Bundle branch block
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      24
      num Events
      1
    term
    Bundle branch block (grade 3)
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    Sepsis
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      24
      num Events
      1
    term
    Sepsis (grade 4)

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
    Gastrointestinal disorders
    source Vocabulary
    Nausea
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      24
      num Events
      24
    term
    Nausea
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    Diarrhoea
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      24
      num Events
      23
    term
    Diarrhoea
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    Vomiting
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      24
      num Events
      21
    term
    Vomiting
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    Dry mouth
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      24
      num Events
      11
    term
    Dry mouth
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    Stomatitis
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      24
      num Events
      9
    term
    Stomatitis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    Constipation
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      24
      num Events
      8
    term
    Constipation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    Abdominal pain
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      24
      num Events
      7
    term
    Abdominal pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    Dysphagia
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      24
      num Events
      6
    term
    Dysphagia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    Dyspepsia
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      24
      num Events
      3
    term
    Dyspepsia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    Gastroesophageal ref
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      24
      num Events
      3
    term
    Gastroesophageal reflux
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    Abdominal tenderness
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      24
      num Events
      2
    term
    Abdominal tenderness
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    Anorectal discomfort
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      24
      num Events
      2
    term
    Anorectal discomfort
Complete source fields
description
The time between randomized sequence of treatment (24 hours) is not sufficiently long to evaluate adverse events by intervention and Adverse Events were not collected per sequence
event Groups
  1. description
    Open-label, randomized, cross-over design study where Propylene Glycol Free Melphalan and Alkeran were assessed in the same multiple myeloma patients undergoing transplantation. The time between randomized sequence of treatment is not sufficiently long to evaluate adverse events by intervention of or by sequence.
    id
    EG000
    other Num Affected
    24
    other Num At Risk
    24
    serious Num Affected
    7
    serious Num At Risk
    24
    title
    All Study Participants
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    Nausea
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      24
      num Events
      24
    term
    Nausea
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    Diarrhoea
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      24
      num Events
      23
    term
    Diarrhoea
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    Vomiting
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      24
      num Events
      21
    term
    Vomiting
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    Dry mouth
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      24
      num Events
      11
    term
    Dry mouth
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    Stomatitis
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      24
      num Events
      9
    term
    Stomatitis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    Constipation
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      24
      num Events
      8
    term
    Constipation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    Abdominal pain
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      24
      num Events
      7
    term
    Abdominal pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    Dysphagia
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      24
      num Events
      6
    term
    Dysphagia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    Dyspepsia
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      24
      num Events
      3
    term
    Dyspepsia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    Gastroesophageal ref
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      24
      num Events
      3
    term
    Gastroesophageal reflux
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    Abdominal tenderness
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      24
      num Events
      2
    term
    Abdominal tenderness
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    Anorectal discomfort
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      24
      num Events
      2
    term
    Anorectal discomfort
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    Mucosal inflamation
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      24
      num Events
      2
    term
    Mucosal inflammation (grade 3)
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    Fatigue
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      24
      num Events
      1
    term
    Fatigue (grade 3)
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    Febrile neutropenia
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      24
      num Events
      2
    term
    Febrile neutropenia (grade 3)
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    Bundle branch block
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      24
      num Events
      1
    term
    Bundle branch block (grade 3)
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    Sepsis
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      24
      num Events
      1
    term
    Sepsis (grade 4)
time Frame
Day -30 to 7 days post day of engraftment.

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Preserved source evidence · Not medical advice