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NCT00434161 · ADVERSE EVENTS

Adverse events

A Study of Palifermin for the Reduction of Oral Mucositis in Subjects With Multiple Myeloma · Source last updated 2015-03-30

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
Adverse Events were collected for a period of up to 222 days.
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Palifermin Before Only

Subjects to receive palifermin before-high dose chemotherapy (total 3 doses) and matched placebo after-high dose chemotherapy (total 3 doses). A total of 109 subjects were randomized to treatment and 107 received at least one dose of study treatment. Due to protocol deviations 4 patients randomized to Palifermin Before and After group were included Palifermin Before Only group and therefore a total of 111 subjects were included in this safety analysis set.

13 / 111110 / 111Not reported / Not reported
Placebo

Subjects to receive matched placebo before- and after-high dose chemotherapy

3 / 5756 / 57Not reported / Not reported
Palifermin Before and After

Subjects to receive palifermin before- and after-high dose chemotherapy (total of 6 doses). A total of 115 subjects were randomized to treatment and 113 received at least one dose of study treatment. Due to protocol deviations additional 4 patients randomized to Palifermin Before and After group were included Palifermin Before Only group and therefore a total of 109 subjects were included in this safety analysis set.

18 / 109109 / 109Not reported / Not reported

Group identifiers: EG000: Palifermin Before Only · EG001: Placebo · EG002: Palifermin Before and After

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
    Cardiac disorders
    source Vocabulary
    MedDRA (11.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      57
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      109
    term
    Atrial fibrillation
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (11.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      57
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      109
    term
    Bacteraemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (11.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      57
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      109
    term
    Bronchopneumonia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (11.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      57
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      109
    term
    Cardiac arrest
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (11.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      57
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      109
    term
    Cardiac failure
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (11.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      57
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      109
    term
    Catheter related infection
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (11.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      57
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      109
    term
    Clostridium difficile colitis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA (11.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      57
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      109
    term
    Colon cancer
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    MedDRA (11.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      57
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      109
    term
    Confusional state
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA (11.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      57
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      109
    term
    Dehydration
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (11.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      57
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      109
    term
    Diarrhoea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (11.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      57
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      109
    term
    Diarrhoea haemorrhagic

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
    MedDRA (11.1)
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      57
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      109
    term
    Abdominal pain
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (11.1)
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      57
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      109
    term
    Abdominal pain upper
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (11.1)
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      57
    3. group Id
      EG002
      num Affected
      17
      num At Risk
      109
    term
    Anemia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA (11.1)
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      57
    3. group Id
      EG002
      num Affected
      12
      num At Risk
      109
    term
    Anorexia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    MedDRA (11.1)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      57
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      109
    term
    Anxiety
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (11.1)
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      57
    3. group Id
      EG002
      num Affected
      14
      num At Risk
      109
    term
    Asthenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA (11.1)
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      57
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      109
    term
    Back pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (11.1)
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      57
    3. group Id
      EG002
      num Affected
      15
      num At Risk
      109
    term
    Constipation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA (11.1)
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      57
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      109
    term
    Cough
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (11.1)
    stats
    1. group Id
      EG000
      num Affected
      80
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      42
      num At Risk
      57
    3. group Id
      EG002
      num Affected
      81
      num At Risk
      109
    term
    Diarrhoea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA (11.1)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      57
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      109
    term
    Dysgeusia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (11.1)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      57
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      109
    term
    Dyspepsia
Complete source fields
event Groups
  1. description
    Subjects to receive palifermin before-high dose chemotherapy (total 3 doses) and matched placebo after-high dose chemotherapy (total 3 doses). A total of 109 subjects were randomized to treatment and 107 received at least one dose of study treatment. Due to protocol deviations 4 patients randomized to Palifermin Before and After group were included Palifermin Before Only group and therefore a total of 111 subjects were included in this safety analysis set.
    id
    EG000
    other Num Affected
    110
    other Num At Risk
    111
    serious Num Affected
    13
    serious Num At Risk
    111
    title
    Palifermin Before Only
  2. description
    Subjects to receive matched placebo before- and after-high dose chemotherapy
    id
    EG001
    other Num Affected
    56
    other Num At Risk
    57
    serious Num Affected
    3
    serious Num At Risk
    57
    title
    Placebo
  3. description
    Subjects to receive palifermin before- and after-high dose chemotherapy (total of 6 doses). A total of 115 subjects were randomized to treatment and 113 received at least one dose of study treatment. Due to protocol deviations additional 4 patients randomized to Palifermin Before and After group were included Palifermin Before Only group and therefore a total of 109 subjects were included in this safety analysis set.
    id
    EG002
    other Num Affected
    109
    other Num At Risk
    109
    serious Num Affected
    18
    serious Num At Risk
    109
    title
    Palifermin Before and After
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (11.1)
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      57
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      109
    term
    Abdominal pain
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (11.1)
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      57
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      109
    term
    Abdominal pain upper
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (11.1)
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      57
    3. group Id
      EG002
      num Affected
      17
      num At Risk
      109
    term
    Anemia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA (11.1)
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      57
    3. group Id
      EG002
      num Affected
      12
      num At Risk
      109
    term
    Anorexia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    MedDRA (11.1)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      57
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      109
    term
    Anxiety
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (11.1)
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      57
    3. group Id
      EG002
      num Affected
      14
      num At Risk
      109
    term
    Asthenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA (11.1)
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      57
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      109
    term
    Back pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (11.1)
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      57
    3. group Id
      EG002
      num Affected
      15
      num At Risk
      109
    term
    Constipation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA (11.1)
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      57
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      109
    term
    Cough
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (11.1)
    stats
    1. group Id
      EG000
      num Affected
      80
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      42
      num At Risk
      57
    3. group Id
      EG002
      num Affected
      81
      num At Risk
      109
    term
    Diarrhoea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA (11.1)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      57
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      109
    term
    Dysgeusia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (11.1)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      57
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      109
    term
    Dyspepsia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (11.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      57
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      109
    term
    Atrial fibrillation
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (11.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      57
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      109
    term
    Bacteraemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (11.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      57
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      109
    term
    Bronchopneumonia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (11.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      57
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      109
    term
    Cardiac arrest
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (11.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      57
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      109
    term
    Cardiac failure
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (11.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      57
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      109
    term
    Catheter related infection
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (11.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      57
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      109
    term
    Clostridium difficile colitis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA (11.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      57
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      109
    term
    Colon cancer
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    MedDRA (11.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      57
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      109
    term
    Confusional state
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA (11.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      57
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      109
    term
    Dehydration
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (11.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      57
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      109
    term
    Diarrhoea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (11.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      57
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      109
    term
    Diarrhoea haemorrhagic
time Frame
Adverse Events were collected for a period of up to 222 days.

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

Preserved source evidence · Not medical advice