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NCT01426828 · ADVERSE EVENTS

Adverse events

Id-KLH Vaccine + T Cells in Subjects With Myeloma Undergoing Transplant · Source last updated 2020-12-04

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
1 year
Other-event reporting threshold
5%

The adverse event data included below reflects all data that can currently be verified by the sponsor. There is additional data that has yet to be verified by the investigator that will be included when available.

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

Arm A will receive the CD3/CD28 activated autologous lymphocytes intravenously and subcutaneous injections of "KLH only" vaccine. CD3/CD28: CD3/CD28 activated autologous lymphocytes intravenously

6 / 2220 / 220 / 22
Arm B

Arm B will receive the CD3/CD28 activated autologous lymphocytes intravenously and subcutaneous injections of ID-KLH Vaccine Myeloma Immunoglobulin Idiotype Vaccine (id-KLH vaccine) CD3/CD28: CD3/CD28 activated autologous lymphocytes intravenously

4 / 1816 / 180 / 18

Group identifiers: EG000: Arm A · EG001: Arm B

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
    Metabolism and nutrition disorders
    source Vocabulary
    NIH CTC, version 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      22
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      18
    term
    Dehydration
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NIH CTC, version 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      22
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    term
    Diarrhea
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    NIH CTC, version 4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      22
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      18
    term
    Febrile neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    NIH CTC, version 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      22
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      18
    term
    Fever
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    NIH CTC, version 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      22
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    term
    Fracture
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    NIH CTC, version 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      22
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    term
    Infections and infestations - Other (Influenza A)
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    NIH CTC, version 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      22
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    term
    Lung infection
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NIH CTC, version 4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      22
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      18
    term
    Nausea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    NIH CTC, version 4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      22
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      18
    term
    Neutrophil count decreased
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    NIH CTC, version 4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      22
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      18
    term
    Platelet count decreased
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    NIH CTC, version 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      22
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    term
    Skin and subcutaneous tissue disorders - Other (Sweet's syndrome)
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    NIH CTC, version 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      22
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      18
    term
    Upper respiratory infection

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
    NIH CTC, version 4.0
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      22
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      18
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    NIH CTC, version 4.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      22
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      18
    term
    Anorexia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    NIH CTC, version 4.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      22
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    term
    Atelectasis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    NIH CTC, version 4.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      22
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    term
    Bone pain
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    NIH CTC, version 4.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      22
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      18
    term
    Chills
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NIH CTC, version 4.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      22
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      18
    term
    Constipation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    NIH CTC, version 4.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      22
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    term
    Cough
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NIH CTC, version 4.0
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      22
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      18
    term
    Diarrhea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    NIH CTC, version 4.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      22
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    term
    Dyspnea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NIH CTC, version 4.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      22
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    term
    Edema limbs
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NIH CTC, version 4.0
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      22
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      18
    term
    Fatigue
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    NIH CTC, version 4.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      22
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      18
    term
    Febrile neutropenia
Complete source fields
description
The adverse event data included below reflects all data that can currently be verified by the sponsor. There is additional data that has yet to be verified by the investigator that will be included when available.
event Groups
  1. deaths Num Affected
    0
    deaths Num At Risk
    22
    description
    Arm A will receive the CD3/CD28 activated autologous lymphocytes intravenously and subcutaneous injections of "KLH only" vaccine. CD3/CD28: CD3/CD28 activated autologous lymphocytes intravenously
    id
    EG000
    other Num Affected
    20
    other Num At Risk
    22
    serious Num Affected
    6
    serious Num At Risk
    22
    title
    Arm A
  2. deaths Num Affected
    0
    deaths Num At Risk
    18
    description
    Arm B will receive the CD3/CD28 activated autologous lymphocytes intravenously and subcutaneous injections of ID-KLH Vaccine Myeloma Immunoglobulin Idiotype Vaccine (id-KLH vaccine) CD3/CD28: CD3/CD28 activated autologous lymphocytes intravenously
    id
    EG001
    other Num Affected
    16
    other Num At Risk
    18
    serious Num Affected
    4
    serious Num At Risk
    18
    title
    Arm B
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    NIH CTC, version 4.0
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      22
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      18
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    NIH CTC, version 4.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      22
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      18
    term
    Anorexia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    NIH CTC, version 4.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      22
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    term
    Atelectasis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    NIH CTC, version 4.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      22
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    term
    Bone pain
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    NIH CTC, version 4.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      22
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      18
    term
    Chills
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NIH CTC, version 4.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      22
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      18
    term
    Constipation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    NIH CTC, version 4.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      22
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    term
    Cough
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NIH CTC, version 4.0
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      22
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      18
    term
    Diarrhea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    NIH CTC, version 4.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      22
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    term
    Dyspnea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NIH CTC, version 4.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      22
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    term
    Edema limbs
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NIH CTC, version 4.0
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      22
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      18
    term
    Fatigue
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    NIH CTC, version 4.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      22
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      18
    term
    Febrile neutropenia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    NIH CTC, version 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      22
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      18
    term
    Dehydration
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NIH CTC, version 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      22
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    term
    Diarrhea
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    NIH CTC, version 4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      22
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      18
    term
    Febrile neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    NIH CTC, version 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      22
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      18
    term
    Fever
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    NIH CTC, version 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      22
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    term
    Fracture
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    NIH CTC, version 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      22
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    term
    Infections and infestations - Other (Influenza A)
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    NIH CTC, version 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      22
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    term
    Lung infection
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NIH CTC, version 4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      22
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      18
    term
    Nausea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    NIH CTC, version 4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      22
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      18
    term
    Neutrophil count decreased
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    NIH CTC, version 4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      22
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      18
    term
    Platelet count decreased
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    NIH CTC, version 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      22
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    term
    Skin and subcutaneous tissue disorders - Other (Sweet's syndrome)
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    NIH CTC, version 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      22
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      18
    term
    Upper respiratory infection
time Frame
1 year

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