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NCT00438802 · ADVERSE EVENTS

Adverse events

Alefacept in Treating Patients With Relapsed or Refractory Cutaneous T-Cell Lymphoma or Peripheral T-Cell Non-Hodgkin's Lymphoma · Source last updated 2019-08-13

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
Dose Level 1

Alefacept by IV 1 x every 4 weeks

3 / 65 / 6Not reported / Not reported
Dose Level 2

Alefacept by IV 1 x every 4 weeks

2 / 87 / 8Not reported / Not reported
Dose Level 3

Alefacept by IV 1 x every 4 weeks

2 / 98 / 9Not reported / Not reported

Group identifiers: EG000: Dose Level 1 · EG001: Dose Level 2 · EG002: Dose Level 3

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
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Hemoglobin decreased
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 6
    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
      8
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Atrial fibrillation
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 6
    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
      8
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Death NOS
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 6
    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
      8
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Disease progression
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 6
    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
      8
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Pneumonia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Skin infection
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    CD4 lymphocytes decreased
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Leukocyte count decreased
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Neutrophil count decreased
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 6
    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
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      9
      num Events
      1
    term
    Peripheral motor neuropathy
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA 6
    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
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      9
      num Events
      1
    term
    Rash desquamating

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
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      6
      num Events
      21
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      8
      num Events
      30
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      9
      num Events
      13
    term
    Hemoglobin decreased
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 6
    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
      8
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Oral pain
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Chills
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 6
    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
      8
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Fatigue
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    MedDRA 6
    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
      8
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Cytokine release syndrome
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    MedDRA 6
    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
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      9
      num Events
      1
    term
    Hypersensitivity
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 6
    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
      8
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Pneumonia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
      num Events
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Sinusitis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 6
    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
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      9
      num Events
      4
    term
    Skin infection
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Upper respiratory infection
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 6
    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
      8
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Urinary tract infection
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 6
    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
      8
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Alanine aminotransferase increased
Complete source fields
event Groups
  1. description
    Alefacept by IV 1 x every 4 weeks
    id
    EG000
    other Num Affected
    5
    other Num At Risk
    6
    serious Num Affected
    3
    serious Num At Risk
    6
    title
    Dose Level 1
  2. description
    Alefacept by IV 1 x every 4 weeks
    id
    EG001
    other Num Affected
    7
    other Num At Risk
    8
    serious Num Affected
    2
    serious Num At Risk
    8
    title
    Dose Level 2
  3. description
    Alefacept by IV 1 x every 4 weeks
    id
    EG002
    other Num Affected
    8
    other Num At Risk
    9
    serious Num Affected
    2
    serious Num At Risk
    9
    title
    Dose Level 3
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      6
      num Events
      21
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      8
      num Events
      30
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      9
      num Events
      13
    term
    Hemoglobin decreased
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 6
    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
      8
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Oral pain
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Chills
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 6
    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
      8
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Fatigue
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    MedDRA 6
    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
      8
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Cytokine release syndrome
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    MedDRA 6
    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
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      9
      num Events
      1
    term
    Hypersensitivity
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 6
    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
      8
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Pneumonia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
      num Events
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Sinusitis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 6
    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
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      9
      num Events
      4
    term
    Skin infection
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Upper respiratory infection
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 6
    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
      8
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Urinary tract infection
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 6
    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
      8
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Alanine aminotransferase increased
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Hemoglobin decreased
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 6
    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
      8
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Atrial fibrillation
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 6
    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
      8
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Death NOS
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 6
    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
      8
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Disease progression
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 6
    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
      8
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Pneumonia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Skin infection
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    CD4 lymphocytes decreased
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Leukocyte count decreased
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Neutrophil count decreased
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 6
    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
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      9
      num Events
      1
    term
    Peripheral motor neuropathy
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA 6
    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
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      9
      num Events
      1
    term
    Rash desquamating

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Preserved source evidence · Not medical advice