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NCT00617929 · ADVERSE EVENTS

Adverse events

Antithymocyte Globulin, Clofarabine, and Rituximab in Treating Patients After an Unsuccessful Stem Cell Transplant · Source last updated 2017-12-28

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
Not reported
Other-event reporting threshold
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Conditioning for Graft Failure After Transplant

Day -7: Rituximab 375 mg/m2 Day -6: Antithymocyte globulin (Thymoglobulin) 3 mg/kg IV over 4 hours Day -5: Antithymocyte globulin (Thymoglobulin) 3 mg/kg IV over 4 hours Day -4: Clofarabine 30 mg/m2 IV over 1 hour and Antithymocyte globulin (Thymoglobulin) 3 mg/kg IV over 4 hours Day -3: Clofarabine 30 mg/m2 IV over 1 hour Day -2: Clofarabine 30 mg/m2 IV over 1 hour Day -1: Rest Day 0: Stem Cell Infusion

7 / 1111 / 11Not reported / Not reported

Group identifiers: EG000: Conditioning for Graft Failure After Transplant

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. organ System
    Injury, poisoning and procedural complications
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      11
    term
    Graft failure
  2. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
    term
    Febrile neutropenia
  3. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      11
    term
    Multi-system organ failure
  4. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
    term
    Infection
  5. notes
    Disease relapse
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
    term
    Neoplasm, malignant

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
    term
    Peripheral neuropathy
  2. organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      11
    term
    Renal failure
  3. organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      11
    term
    Respiratory distress
  4. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
    term
    Tachycardia
  5. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
    term
    Esophageal necrosis
  6. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      11
    term
    Gastrointestinal bleed
  7. organ System
    Hepatobiliary disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
    term
    Cholangitis
  8. organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
    term
    Aseptic/avascular necrosis
  9. organ System
    Psychiatric disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
    term
    Anxiety attacks
  10. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
    term
    Pain NOS
  11. organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      11
    term
    Pneumonia
  12. organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
    term
    Encephalopathy
Complete source fields
event Groups
  1. description
    Day -7: Rituximab 375 mg/m2 Day -6: Antithymocyte globulin (Thymoglobulin) 3 mg/kg IV over 4 hours Day -5: Antithymocyte globulin (Thymoglobulin) 3 mg/kg IV over 4 hours Day -4: Clofarabine 30 mg/m2 IV over 1 hour and Antithymocyte globulin (Thymoglobulin) 3 mg/kg IV over 4 hours Day -3: Clofarabine 30 mg/m2 IV over 1 hour Day -2: Clofarabine 30 mg/m2 IV over 1 hour Day -1: Rest Day 0: Stem Cell Infusion
    id
    EG000
    other Num Affected
    11
    other Num At Risk
    11
    serious Num Affected
    7
    serious Num At Risk
    11
    title
    Conditioning for Graft Failure After Transplant
frequency Threshold
0
other Events
  1. organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
    term
    Peripheral neuropathy
  2. organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      11
    term
    Renal failure
  3. organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      11
    term
    Respiratory distress
  4. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
    term
    Tachycardia
  5. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
    term
    Esophageal necrosis
  6. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      11
    term
    Gastrointestinal bleed
  7. organ System
    Hepatobiliary disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
    term
    Cholangitis
  8. organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
    term
    Aseptic/avascular necrosis
  9. organ System
    Psychiatric disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
    term
    Anxiety attacks
  10. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
    term
    Pain NOS
  11. organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      11
    term
    Pneumonia
  12. organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
    term
    Encephalopathy
serious Events
  1. organ System
    Injury, poisoning and procedural complications
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      11
    term
    Graft failure
  2. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
    term
    Febrile neutropenia
  3. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      11
    term
    Multi-system organ failure
  4. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
    term
    Infection
  5. notes
    Disease relapse
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
    term
    Neoplasm, malignant

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Preserved source evidence · Not medical advice