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NCT00398411 · ADVERSE EVENTS

Adverse events

Moxifloxacin in the Prevention of Bacteremia After High-dose Chemotherapy and Transplantation of Peripheral Stem Cells · Source last updated 2015-06-29

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 (AE) have been documented throughout study duration, serious adverse events (SAE) until 4 weeks after end of study.
Other-event reporting threshold
5%

The following AE have been documented in the trial but are not reported in this section unless as SAE: Infections, already reported as outcome measures. Expected AE as defined in the protocol: leukopenia, anemia, thrombocytopenia, including their manifestations; hepatosplenomegaly, bone pain, increase of lactate dehydrogenase, hyperuricemia.

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

moxifloxacin 400 mg tablets once daily

2 / 3434 / 34Not reported / Not reported
Placebo

identical appearing placebo

3 / 3232 / 32Not reported / Not reported

Group identifiers: EG000: Moxifloxacin · EG001: Placebo

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
      34
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      32
      num Events
      0
    term
    atypical pneumonia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      34
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      32
      num Events
      1
    term
    cardiac arrest
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      32
      num Events
      0
    term
    cholecystitis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      34
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      32
      num Events
      1
    term
    clostridium difficile infection
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      34
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      32
      num Events
      1
    term
    staphyloccocus epidermidis sepsis

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
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      34
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      32
      num Events
      1
    term
    abdominal cramps
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      34
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      32
      num Events
      1
    term
    back pain
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      34
      num Events
      8
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      32
      num Events
      7
    term
    constipation
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      34
      num Events
      5
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      32
      num Events
      6
    term
    cough
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      32
      num Events
      2
    term
    cramps in the calf
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      34
      num Events
      36
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      32
      num Events
      23
    term
    diarrhea
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      34
      num Events
      2
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      32
      num Events
      3
    term
    dysuria
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      34
      num Events
      37
    2. group Id
      EG001
      num Affected
      26
      num At Risk
      32
      num Events
      42
    term
    edema
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      34
      num Events
      7
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      32
      num Events
      6
    term
    exanthema
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      34
      num Events
      35
    2. group Id
      EG001
      num Affected
      31
      num At Risk
      32
      num Events
      45
    term
    fever
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      34
      num Events
      13
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      32
      num Events
      11
    term
    headache
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      34
      num Events
      6
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      32
      num Events
      2
    term
    heartburn / reflux
Complete source fields
description
The following AE have been documented in the trial but are not reported in this section unless as SAE: Infections, already reported as outcome measures. Expected AE as defined in the protocol: leukopenia, anemia, thrombocytopenia, including their manifestations; hepatosplenomegaly, bone pain, increase of lactate dehydrogenase, hyperuricemia.
event Groups
  1. description
    moxifloxacin 400 mg tablets once daily
    id
    EG000
    other Num Affected
    34
    other Num At Risk
    34
    serious Num Affected
    2
    serious Num At Risk
    34
    title
    Moxifloxacin
  2. description
    identical appearing placebo
    id
    EG001
    other Num Affected
    32
    other Num At Risk
    32
    serious Num Affected
    3
    serious Num At Risk
    32
    title
    Placebo
frequency Threshold
5
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      34
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      32
      num Events
      1
    term
    abdominal cramps
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      34
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      32
      num Events
      1
    term
    back pain
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      34
      num Events
      8
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      32
      num Events
      7
    term
    constipation
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      34
      num Events
      5
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      32
      num Events
      6
    term
    cough
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      32
      num Events
      2
    term
    cramps in the calf
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      34
      num Events
      36
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      32
      num Events
      23
    term
    diarrhea
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      34
      num Events
      2
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      32
      num Events
      3
    term
    dysuria
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      34
      num Events
      37
    2. group Id
      EG001
      num Affected
      26
      num At Risk
      32
      num Events
      42
    term
    edema
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      34
      num Events
      7
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      32
      num Events
      6
    term
    exanthema
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      34
      num Events
      35
    2. group Id
      EG001
      num Affected
      31
      num At Risk
      32
      num Events
      45
    term
    fever
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      34
      num Events
      13
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      32
      num Events
      11
    term
    headache
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      34
      num Events
      6
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      32
      num Events
      2
    term
    heartburn / reflux
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      32
      num Events
      0
    term
    atypical pneumonia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      34
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      32
      num Events
      1
    term
    cardiac arrest
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      32
      num Events
      0
    term
    cholecystitis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      34
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      32
      num Events
      1
    term
    clostridium difficile infection
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      34
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      32
      num Events
      1
    term
    staphyloccocus epidermidis sepsis
time Frame
Adverse events (AE) have been documented throughout study duration, serious adverse events (SAE) until 4 weeks after end of study.

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