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NCT00627393 · ADVERSE EVENTS

Adverse events

Safety and Effectiveness of Granulocyte Transfusions in Resolving Infection in People With Neutropenia (The RING Study) · Source last updated 2015-04-17

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
Serious adverse events were reported up to 42 days after randomization.
Other-event reporting threshold
0%

Serious adverse events and other adverse events (i.e. granulocyte transfusion related events) data were collected. The number of participants at risk for other adverse events corresponds to the number of participants who received granulocyte transfusions (6 control arm subjects and 51 granulocyte arm subjects).

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

Received antimicrobial therapy alone.

25 / 581 / 6Not reported / Not reported
Granulocyte Arm

Received G-CSF/dexamethasone-mobilized granulocyte transfusions in addition to antimicrobial therapy.

26 / 5632 / 51Not reported / Not reported

Group identifiers: EG000: Control Arm · EG001: Granulocyte Arm

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
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      58
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      56
    term
    Abdominal infection
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      58
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      56
    term
    Abdominal sepsis
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Nausea, vomiting and abdominal pain.
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      58
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      56
    term
    Abdominal symptom
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    PTT (Grade 2)
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      58
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      56
    term
    Activated partial thromboplastin time shortened
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      58
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      56
    term
    Acute lung injury
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      58
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      56
    term
    Acute respiratory distress syndrome
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      58
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      56
    term
    Anaemia
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      58
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      56
    term
    Ataxia
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      58
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      56
    term
    Atrial fibrillation
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      58
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      56
    term
    Increased blast cell count
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      58
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      56
    term
    Increased blood creatinine
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      58
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      56
    term
    Bronchopneumonia

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
    Immune system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      51
      num Events
      5
    term
    Allergic reaction/ hypersensitivity
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      51
      num Events
      0
    term
    Sinus bradycardia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
      num Events
      3
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      51
      num Events
      36
    term
    Sinus tachycardia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
      num Events
      1
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      51
      num Events
      15
    term
    Hypertension
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      51
      num Events
      14
    term
    Hypotension
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      51
      num Events
      3
    term
    Dyspnea
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      51
      num Events
      16
    term
    Hypoxia
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      51
      num Events
      1
    term
    Headache
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      51
      num Events
      1
    term
    Wheezing
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      51
      num Events
      0
    term
    Cough
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      51
      num Events
      0
    term
    Hemolysis
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      51
      num Events
      42
    term
    Rigors and Chills
Complete source fields
description
Serious adverse events and other adverse events (i.e. granulocyte transfusion related events) data were collected. The number of participants at risk for other adverse events corresponds to the number of participants who received granulocyte transfusions (6 control arm subjects and 51 granulocyte arm subjects).
event Groups
  1. description
    Received antimicrobial therapy alone.
    id
    EG000
    other Num Affected
    1
    other Num At Risk
    6
    serious Num Affected
    25
    serious Num At Risk
    58
    title
    Control Arm
  2. description
    Received G-CSF/dexamethasone-mobilized granulocyte transfusions in addition to antimicrobial therapy.
    id
    EG001
    other Num Affected
    32
    other Num At Risk
    51
    serious Num Affected
    26
    serious Num At Risk
    56
    title
    Granulocyte Arm
frequency Threshold
0
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      51
      num Events
      5
    term
    Allergic reaction/ hypersensitivity
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      51
      num Events
      0
    term
    Sinus bradycardia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
      num Events
      3
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      51
      num Events
      36
    term
    Sinus tachycardia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
      num Events
      1
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      51
      num Events
      15
    term
    Hypertension
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      51
      num Events
      14
    term
    Hypotension
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      51
      num Events
      3
    term
    Dyspnea
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      51
      num Events
      16
    term
    Hypoxia
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      51
      num Events
      1
    term
    Headache
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      51
      num Events
      1
    term
    Wheezing
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      51
      num Events
      0
    term
    Cough
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      51
      num Events
      0
    term
    Hemolysis
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      51
      num Events
      42
    term
    Rigors and Chills
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      58
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      56
    term
    Abdominal infection
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      58
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      56
    term
    Abdominal sepsis
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Nausea, vomiting and abdominal pain.
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      58
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      56
    term
    Abdominal symptom
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    PTT (Grade 2)
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      58
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      56
    term
    Activated partial thromboplastin time shortened
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      58
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      56
    term
    Acute lung injury
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      58
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      56
    term
    Acute respiratory distress syndrome
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      58
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      56
    term
    Anaemia
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      58
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      56
    term
    Ataxia
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      58
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      56
    term
    Atrial fibrillation
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      58
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      56
    term
    Increased blast cell count
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      58
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      56
    term
    Increased blood creatinine
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      58
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      56
    term
    Bronchopneumonia
time Frame
Serious adverse events were reported up to 42 days after randomization.

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