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NCT00290472 · ADVERSE EVENTS

Adverse events

CCI-779 in Treating Patients With Recurrent or Refractory B-Cell Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia · Source last updated 2014-05-23

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
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Temsirolimus

All patients

21 / 8989 / 89Not reported / Not reported

Group identifiers: EG000: Temsirolimus

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
    source Vocabulary
    CTCAE 2.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      89
    term
    Anorectal infection
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      89
    term
    Anorexia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      89
    term
    Arthralgia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE 2.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      89
    term
    Atrial fibrillation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE 2.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      89
    term
    Cardiac disorder
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 2.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      89
    term
    Chest pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 2.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      89
    term
    Death
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE 2.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      89
    term
    Dehydration
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE 2.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      89
    term
    Dysphagia, esophagitis, odynophagia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE 2.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      89
    term
    Dyspnea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE 2.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      89
    term
    Esophagitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 2.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      89
    term
    Fatigue

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
    Gastrointestinal disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      89
    term
    Abdominal pain
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 2.0
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      89
    term
    Alanine aminotransferase increased
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE 2.0
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      89
    term
    Allergic rhinitis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE 2.0
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      89
    term
    Anorexia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE 2.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      89
    term
    Arthralgia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 2.0
    stats
    1. group Id
      EG000
      num Affected
      34
      num At Risk
      89
    term
    Aspartate aminotransferase increased
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE 2.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      89
    term
    Back pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 2.0
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      89
    term
    Blood alkaline phosphatase intreased
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 2.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      89
    term
    Blood creatinine increased
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE 2.0
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      89
    term
    Bone pain
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 2.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      89
    term
    CD4 lymphocytes decreased
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 2.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      89
    term
    Chills
Complete source fields
event Groups
  1. description
    All patients
    id
    EG000
    other Num Affected
    89
    other Num At Risk
    89
    serious Num Affected
    21
    serious Num At Risk
    89
    title
    Temsirolimus
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      89
    term
    Abdominal pain
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 2.0
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      89
    term
    Alanine aminotransferase increased
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE 2.0
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      89
    term
    Allergic rhinitis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE 2.0
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      89
    term
    Anorexia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE 2.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      89
    term
    Arthralgia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 2.0
    stats
    1. group Id
      EG000
      num Affected
      34
      num At Risk
      89
    term
    Aspartate aminotransferase increased
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE 2.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      89
    term
    Back pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 2.0
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      89
    term
    Blood alkaline phosphatase intreased
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 2.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      89
    term
    Blood creatinine increased
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE 2.0
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      89
    term
    Bone pain
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 2.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      89
    term
    CD4 lymphocytes decreased
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 2.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      89
    term
    Chills
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE 2.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      89
    term
    Anorectal infection
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      89
    term
    Anorexia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      89
    term
    Arthralgia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE 2.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      89
    term
    Atrial fibrillation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE 2.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      89
    term
    Cardiac disorder
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 2.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      89
    term
    Chest pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 2.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      89
    term
    Death
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE 2.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      89
    term
    Dehydration
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE 2.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      89
    term
    Dysphagia, esophagitis, odynophagia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE 2.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      89
    term
    Dyspnea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE 2.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      89
    term
    Esophagitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 2.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      89
    term
    Fatigue

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