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NCT01018979 · ADVERSE EVENTS

Adverse events

Safety and PK/PD of TG-0054 in Multiple Myeloma, Non-Hodgkin Lymphoma and Hodgkin Disease Patients · Source last updated 2021-05-11

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
The whole study period, from Visit 1 (screening, day -14) to Visit 9 (7 days after the last dose)
Other-event reporting threshold
0%

There were 8 serious AEs (SAE) reported that were all unrelated to study drug. No AEs led to discontinuation of study drug treatment and there were no deaths reported in this study.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
TG-0054 (2.24 mg/kg)

TG-0054: 2.24 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)

2 / 76 / 7Not reported / Not reported
TG-0054 (3.14 mg/kg)

TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)

6 / 128 / 12Not reported / Not reported

Group identifiers: EG000: TG-0054 (2.24 mg/kg) · EG001: TG-0054 (3.14 mg/kg)

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
    notes
    Post-treatment SAE. Definitely not related to study drug
    organ System
    Surgical and medical procedures
    source Vocabulary
    MedDRA 11.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      12
    term
    ADMISSION FOR PREPARATION OF PERIPHERAL BLOOD STEM CELL HARVEST
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Post-treatment SAE. Definitely not related to study drug
    organ System
    Surgical and medical procedures
    source Vocabulary
    MedDRA 11.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      12
    term
    AUTOLOGOUS STEM CELL TRANSPLANT
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Post-treatment SAE. Definitely not related to study drug
    organ System
    Surgical and medical procedures
    source Vocabulary
    MedDRA 11.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
    term
    HOSPITALIZATION FOR BONE MARROW TRANSPLANTATION
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Post-treatment SAE. Definitely not related to study drug
    organ System
    Surgical and medical procedures
    source Vocabulary
    MedDRA 11.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
    term
    AUTOLOGOUS HEMATOPOIETIC STEM CELL TRANSPLANTATION
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Post-treatment SAE. Definitely not related to study drug
    organ System
    Surgical and medical procedures
    source Vocabulary
    MedDRA 11.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      12
    term
    TREATMENT OF NON-HODGKIN LYMPHOMA
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Post-treatment SAE. Definitely not related to study drug
    organ System
    Surgical and medical procedures
    source Vocabulary
    MedDRA 11.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      12
    term
    PEIPHERAL BLOOD STEM CELL HARVEST

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
    notes
    Post-treatment AE. Probably related to study drug.
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 11.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    ABDOMINAL PAIN
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Post-treatment AE. Probably not related to study drug.
    organ System
    Investigations
    source Vocabulary
    MedDRA 11.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    ABNORMAL DATA OF INCREASE BILIRUBIN
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Post-treatment AE. Possible related to study drug.
    organ System
    Investigations
    source Vocabulary
    MedDRA 11.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      12
      num Events
      1
    term
    CARDIAC DISORDERS-OTHER:QT PROLONG AT 24HR-36HR AFTER INFUSION
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Post-treatment AE. Probably not related to study drug.
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 11.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    CHEST TIGHTNESS
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Post-treatment AE. Definitely not related to study drug.
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 11.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    CLONIC OF RIGHT KNEE
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Post-treatment AE. 1 probably related and 1 definitely related.
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 11.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      12
      num Events
      1
    term
    DIARRHEA
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Post-treatment AE. 2 definitely not related and 1 possible related.
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 11.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      7
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      12
      num Events
      1
    term
    DIZZINESS
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Post-treatment AE. Definitely not related.
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 11.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      12
      num Events
      1
    term
    DRY COUGH
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Post-treatment AE. Definitely not related to study drug.
    organ System
    General disorders
    source Vocabulary
    MedDRA 11.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      12
      num Events
      1
    term
    ECCHYMOSIS OVER FEMORAL PUNCTURE SITE
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Post-treatment AE. Definitely not related to study drug.
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 11.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      12
      num Events
      1
    term
    EMESIS
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Post-treatment AE. Possible related to study drug.
    organ System
    General disorders
    source Vocabulary
    MedDRA 11.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      12
      num Events
      1
    term
    FEVER
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Post-treatment AE. All possible related to study drug.
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 11.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    HYPERCALCEMIA
Complete source fields
description
There were 8 serious AEs (SAE) reported that were all unrelated to study drug. No AEs led to discontinuation of study drug treatment and there were no deaths reported in this study.
event Groups
  1. description
    TG-0054: 2.24 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
    id
    EG000
    other Num Affected
    6
    other Num At Risk
    7
    serious Num Affected
    2
    serious Num At Risk
    7
    title
    TG-0054 (2.24 mg/kg)
  2. description
    TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
    id
    EG001
    other Num Affected
    8
    other Num At Risk
    12
    serious Num Affected
    6
    serious Num At Risk
    12
    title
    TG-0054 (3.14 mg/kg)
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Post-treatment AE. Probably related to study drug.
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 11.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    ABDOMINAL PAIN
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Post-treatment AE. Probably not related to study drug.
    organ System
    Investigations
    source Vocabulary
    MedDRA 11.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    ABNORMAL DATA OF INCREASE BILIRUBIN
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Post-treatment AE. Possible related to study drug.
    organ System
    Investigations
    source Vocabulary
    MedDRA 11.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      12
      num Events
      1
    term
    CARDIAC DISORDERS-OTHER:QT PROLONG AT 24HR-36HR AFTER INFUSION
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Post-treatment AE. Probably not related to study drug.
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 11.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    CHEST TIGHTNESS
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Post-treatment AE. Definitely not related to study drug.
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 11.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    CLONIC OF RIGHT KNEE
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Post-treatment AE. 1 probably related and 1 definitely related.
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 11.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      12
      num Events
      1
    term
    DIARRHEA
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Post-treatment AE. 2 definitely not related and 1 possible related.
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 11.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      7
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      12
      num Events
      1
    term
    DIZZINESS
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Post-treatment AE. Definitely not related.
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 11.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      12
      num Events
      1
    term
    DRY COUGH
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Post-treatment AE. Definitely not related to study drug.
    organ System
    General disorders
    source Vocabulary
    MedDRA 11.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      12
      num Events
      1
    term
    ECCHYMOSIS OVER FEMORAL PUNCTURE SITE
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Post-treatment AE. Definitely not related to study drug.
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 11.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      12
      num Events
      1
    term
    EMESIS
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Post-treatment AE. Possible related to study drug.
    organ System
    General disorders
    source Vocabulary
    MedDRA 11.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      12
      num Events
      1
    term
    FEVER
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Post-treatment AE. All possible related to study drug.
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 11.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    HYPERCALCEMIA
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Post-treatment SAE. Definitely not related to study drug
    organ System
    Surgical and medical procedures
    source Vocabulary
    MedDRA 11.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      12
    term
    ADMISSION FOR PREPARATION OF PERIPHERAL BLOOD STEM CELL HARVEST
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Post-treatment SAE. Definitely not related to study drug
    organ System
    Surgical and medical procedures
    source Vocabulary
    MedDRA 11.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      12
    term
    AUTOLOGOUS STEM CELL TRANSPLANT
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Post-treatment SAE. Definitely not related to study drug
    organ System
    Surgical and medical procedures
    source Vocabulary
    MedDRA 11.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
    term
    HOSPITALIZATION FOR BONE MARROW TRANSPLANTATION
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Post-treatment SAE. Definitely not related to study drug
    organ System
    Surgical and medical procedures
    source Vocabulary
    MedDRA 11.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
    term
    AUTOLOGOUS HEMATOPOIETIC STEM CELL TRANSPLANTATION
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Post-treatment SAE. Definitely not related to study drug
    organ System
    Surgical and medical procedures
    source Vocabulary
    MedDRA 11.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      12
    term
    TREATMENT OF NON-HODGKIN LYMPHOMA
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Post-treatment SAE. Definitely not related to study drug
    organ System
    Surgical and medical procedures
    source Vocabulary
    MedDRA 11.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      12
    term
    PEIPHERAL BLOOD STEM CELL HARVEST
time Frame
The whole study period, from Visit 1 (screening, day -14) to Visit 9 (7 days after the last dose)

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