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NCT01307579 · ADVERSE EVENTS

Adverse events

Caspofungin Versus Fluconazole in Preventing Invasive Fungal Infections (IFI) in Patients Undergoing Chemotherapy for Acute Myeloid Leukemia · Source last updated 2021-03-30

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
Up to 12 months of receiving protocol treatment
Other-event reporting threshold
0%

Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.

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

Patients receive caspofungin acetate IV over one hour QD beginning within 24-72 hours following the last dose of chemotherapy for each course. and continuing until ANC \> 100-500/uL following the nadir or the next chemotherapy course begins. Caspofungin Acetate: Given IV Laboratory Biomarker Analysis: Correlative studies

11 / 25362 / 25376 / 253
Arm II (Fluconazole)

Patients receive fluconazole IV over 1-2 hours or PO QD beginning within 24-72 hours following the last dose of chemotherapy for each course. Fluconazole: Given IV or PO Laboratory Biomarker Analysis: Correlative studies

9 / 25572 / 25582 / 255

Group identifiers: EG000: Arm I (Caspofungin Acetate) · EG001: Arm II (Fluconazole)

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
      253
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      255
    term
    Acute kidney injury
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      253
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      255
    term
    Alanine aminotransferase increased
  3. 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
      253
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      255
    term
    Apnea
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      253
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      255
    term
    Death NOS
  5. 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
      253
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      255
    term
    Dyspnea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      253
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      255
    term
    Edema cerebral
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      253
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      255
    term
    Electrocardiogram QT corrected interval prolonged
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      253
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      255
    term
    Febrile neutropenia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      253
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      255
    term
    Heart failure
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      253
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      255
    term
    Hepatic failure
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      253
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      255
    term
    Hepatic necrosis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      253
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      255
    term
    Hydrocephalus

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
    Renal and urinary disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      253
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      255
    term
    Acute kidney injury
  2. 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
      253
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      255
    term
    Adult respiratory distress syndrome
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      253
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      255
    term
    Alanine aminotransferase increased
  4. 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
      253
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      255
    term
    Allergic reaction
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      253
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      255
    term
    Anemia
  6. 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
      253
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      255
    term
    Appendicitis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      253
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      255
    term
    Ascites
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      253
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      255
    term
    Aspartate aminotransferase increased
  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
      253
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      255
    term
    Atelectasis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      253
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      255
    term
    Blood bilirubin increased
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      253
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      255
    term
    Cardiac arrest
  12. 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
      253
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      255
    term
    Catheter related infection
Complete source fields
description
Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.
event Groups
  1. deaths Num Affected
    76
    deaths Num At Risk
    253
    description
    Patients receive caspofungin acetate IV over one hour QD beginning within 24-72 hours following the last dose of chemotherapy for each course. and continuing until ANC \> 100-500/uL following the nadir or the next chemotherapy course begins. Caspofungin Acetate: Given IV Laboratory Biomarker Analysis: Correlative studies
    id
    EG000
    other Num Affected
    62
    other Num At Risk
    253
    serious Num Affected
    11
    serious Num At Risk
    253
    title
    Arm I (Caspofungin Acetate)
  2. deaths Num Affected
    82
    deaths Num At Risk
    255
    description
    Patients receive fluconazole IV over 1-2 hours or PO QD beginning within 24-72 hours following the last dose of chemotherapy for each course. Fluconazole: Given IV or PO Laboratory Biomarker Analysis: Correlative studies
    id
    EG001
    other Num Affected
    72
    other Num At Risk
    255
    serious Num Affected
    9
    serious Num At Risk
    255
    title
    Arm II (Fluconazole)
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      253
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      255
    term
    Acute kidney injury
  2. 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
      253
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      255
    term
    Adult respiratory distress syndrome
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      253
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      255
    term
    Alanine aminotransferase increased
  4. 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
      253
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      255
    term
    Allergic reaction
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      253
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      255
    term
    Anemia
  6. 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
      253
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      255
    term
    Appendicitis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      253
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      255
    term
    Ascites
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      253
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      255
    term
    Aspartate aminotransferase increased
  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
      253
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      255
    term
    Atelectasis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      253
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      255
    term
    Blood bilirubin increased
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      253
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      255
    term
    Cardiac arrest
  12. 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
      253
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      255
    term
    Catheter related infection
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
      253
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      255
    term
    Acute kidney injury
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      253
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      255
    term
    Alanine aminotransferase increased
  3. 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
      253
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      255
    term
    Apnea
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      253
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      255
    term
    Death NOS
  5. 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
      253
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      255
    term
    Dyspnea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      253
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      255
    term
    Edema cerebral
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      253
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      255
    term
    Electrocardiogram QT corrected interval prolonged
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      253
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      255
    term
    Febrile neutropenia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      253
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      255
    term
    Heart failure
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      253
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      255
    term
    Hepatic failure
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      253
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      255
    term
    Hepatic necrosis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      253
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      255
    term
    Hydrocephalus
time Frame
Up to 12 months of receiving protocol treatment

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