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NCT01371656 · ADVERSE EVENTS

Adverse events

Levofloxacin in Preventing Infection in Young Patients With Acute Leukemia Receiving Chemotherapy or Undergoing Stem Cell Transplantation · Source last updated 2020-12-07

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
Up to 60 days after enrollment or receiving of levofloxacin
Other-event reporting threshold
0%

Routine reporting includes all toxicities reported via AdEERs and all grade 4 \& higher non-hematologic Adverse Events

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Arm I (Levofloxacin)

Patients receive levofloxacin PO or IV over 60-90 minutes once or twice daily beginning on day 3 during 2 consecutive courses of chemotherapy or beginning on day -2 during HSCT and continuing until blood counts recover. levofloxacin: Given PO or IV

4 / 30636 / 30669 / 306
Arm II (Standard of Care)

Patients receive established standard of care and receive chemotherapy or HSCT as patients in Arm I.

3 / 30737 / 30767 / 307

Group identifiers: EG000: Arm I (Levofloxacin) · EG001: Arm II (Standard of Care)

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
    Renal and urinary disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      306
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      307
    term
    Acute kidney injury
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      306
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      307
    term
    Capillary leak syndrome
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      306
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      307
    term
    Death NOS
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      306
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      307
    term
    Heart failure
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      306
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      307
    term
    Infections and infestations - Other, specify
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      306
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      307
    term
    Lung infection
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      306
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      307
    term
    Multi-organ failure
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      306
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      307
    term
    Pulmonary edema
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      306
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      307
    term
    Respiratory failure
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      306
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      307
    term
    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
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      306
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      307
    term
    Acidosis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      306
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      307
    term
    Acute kidney injury
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      306
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      307
    term
    Adult respiratory distress syndrome
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      306
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      307
    term
    Alanine aminotransferase increased
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      306
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      307
    term
    Alkalosis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      306
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      307
    term
    Anaphylaxis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      306
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      307
    term
    Aspartate aminotransferase increased
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      306
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      307
    term
    Asystole
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      306
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      307
    term
    Atelectasis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      306
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      307
    term
    Blood bilirubin increased
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      306
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      307
    term
    Bronchopulmonary hemorrhage
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      306
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      307
    term
    Capillary leak syndrome
Complete source fields
description
Routine reporting includes all toxicities reported via AdEERs and all grade 4 \& higher non-hematologic Adverse Events
event Groups
  1. deaths Num Affected
    69
    deaths Num At Risk
    306
    description
    Patients receive levofloxacin PO or IV over 60-90 minutes once or twice daily beginning on day 3 during 2 consecutive courses of chemotherapy or beginning on day -2 during HSCT and continuing until blood counts recover. levofloxacin: Given PO or IV
    id
    EG000
    other Num Affected
    36
    other Num At Risk
    306
    serious Num Affected
    4
    serious Num At Risk
    306
    title
    Arm I (Levofloxacin)
  2. deaths Num Affected
    67
    deaths Num At Risk
    307
    description
    Patients receive established standard of care and receive chemotherapy or HSCT as patients in Arm I.
    id
    EG001
    other Num Affected
    37
    other Num At Risk
    307
    serious Num Affected
    3
    serious Num At Risk
    307
    title
    Arm II (Standard of Care)
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      306
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      307
    term
    Acidosis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      306
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      307
    term
    Acute kidney injury
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      306
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      307
    term
    Adult respiratory distress syndrome
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      306
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      307
    term
    Alanine aminotransferase increased
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      306
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      307
    term
    Alkalosis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      306
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      307
    term
    Anaphylaxis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      306
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      307
    term
    Aspartate aminotransferase increased
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      306
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      307
    term
    Asystole
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      306
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      307
    term
    Atelectasis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      306
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      307
    term
    Blood bilirubin increased
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      306
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      307
    term
    Bronchopulmonary hemorrhage
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      306
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      307
    term
    Capillary leak syndrome
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      306
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      307
    term
    Acute kidney injury
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      306
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      307
    term
    Capillary leak syndrome
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      306
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      307
    term
    Death NOS
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      306
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      307
    term
    Heart failure
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      306
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      307
    term
    Infections and infestations - Other, specify
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      306
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      307
    term
    Lung infection
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      306
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      307
    term
    Multi-organ failure
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      306
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      307
    term
    Pulmonary edema
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      306
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      307
    term
    Respiratory failure
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      306
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      307
    term
    Sepsis
time Frame
Up to 60 days after enrollment or receiving of levofloxacin

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Preserved source evidence · Not medical advice