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NCT01112293 · ADVERSE EVENTS

Adverse events

Anti-TGF Monoclonal Antibody (GC1008) in Relapsed Malignant Pleural Mesothelioma · Source last updated 2020-04-10

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
Adverse event data was collected from time of first administration of study product until 30 days of the last administration of study product, approximately 1 year and 5 months.
Other-event reporting threshold
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Investigational Drug infusion-for Safety and Effectiveness

Phase II, Single-Arm, Multi-Site study. All subjects will receive the investigational agent, GC1008 in 3 week cycles of treatment. GC1008: GC1008 is a human IgG4 kappa monoclonal antibody capable of neutralizing all mammalian isoforms of TGFbeta (i.e., beta1, beta 2 and beta 3). GC1008 is a high affinity antibody with dissociation constants (Kds) of 1.8 nM, 2.8 nM and 1.4 nM for TGF1,2,and 3, respectively.

6 / 1412 / 1412 / 14

Group identifiers: EG000: Investigational Drug infusion-for Safety and Effectiveness

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
    Gastrointestinal disorders
    source Vocabulary
    NCI CTCAE v.4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      14
      num Events
      2
    term
    Nausea
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    NCI CTCAE v.4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      14
      num Events
      1
    term
    Hyponatremia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    NCI CTCAE v.4.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      14
      num Events
      2
    term
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    NCI CTCAE v.4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      14
      num Events
      1
    term
    Fatigue
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    NCI CTCAE v.4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      14
      num Events
      1
    term
    Thrombosis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    NCI CTCAE v.4.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      14
      num Events
      2
    term
    Disease Progression
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    NCI CTCAE v.4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      14
      num Events
      1
    term
    Fever
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    NCI CTCAE v.4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      14
      num Events
      1
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI CTCAE v.4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      14
      num Events
      1
    term
    Ileus

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
    Metabolism and nutrition disorders
    source Vocabulary
    NCI CTCAE v.4.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      14
      num Events
      6
    term
    Anorexia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    NCI CTCAE v.4.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      14
      num Events
      11
    term
    Fatigue
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI CTCAE v.4.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      14
      num Events
      2
    term
    Dysphagia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    NCI CTCAE v.4.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      14
      num Events
      3
    term
    Non-Cardiac Chest Pain
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    NCI CTCAE v.4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      14
      num Events
      1
    term
    Hoarseness
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    NCI CTCAE v.4.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      14
      num Events
      3
    term
    Epistaxis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    NCI CTCAE v.4.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      14
      num Events
      5
    term
    Cough
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI CTCAE v.4.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      14
      num Events
      2
    term
    Constipation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI CTCAE v.4.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      14
      num Events
      2
    term
    Dyspepsia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    NCI CTCAE v.4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      14
      num Events
      1
    term
    Nasal Congestion
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    NCI CTCAE v.4.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      14
      num Events
      2
    term
    Back Pain
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    NCI CTCAE v.4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      14
      num Events
      1
    term
    Lung Infection
Complete source fields
event Groups
  1. deaths Num Affected
    12
    deaths Num At Risk
    14
    description
    Phase II, Single-Arm, Multi-Site study. All subjects will receive the investigational agent, GC1008 in 3 week cycles of treatment. GC1008: GC1008 is a human IgG4 kappa monoclonal antibody capable of neutralizing all mammalian isoforms of TGFbeta (i.e., beta1, beta 2 and beta 3). GC1008 is a high affinity antibody with dissociation constants (Kds) of 1.8 nM, 2.8 nM and 1.4 nM for TGF1,2,and 3, respectively.
    id
    EG000
    other Num Affected
    12
    other Num At Risk
    14
    serious Num Affected
    6
    serious Num At Risk
    14
    title
    Investigational Drug infusion-for Safety and Effectiveness
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    NCI CTCAE v.4.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      14
      num Events
      6
    term
    Anorexia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    NCI CTCAE v.4.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      14
      num Events
      11
    term
    Fatigue
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI CTCAE v.4.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      14
      num Events
      2
    term
    Dysphagia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    NCI CTCAE v.4.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      14
      num Events
      3
    term
    Non-Cardiac Chest Pain
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    NCI CTCAE v.4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      14
      num Events
      1
    term
    Hoarseness
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    NCI CTCAE v.4.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      14
      num Events
      3
    term
    Epistaxis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    NCI CTCAE v.4.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      14
      num Events
      5
    term
    Cough
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI CTCAE v.4.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      14
      num Events
      2
    term
    Constipation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI CTCAE v.4.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      14
      num Events
      2
    term
    Dyspepsia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    NCI CTCAE v.4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      14
      num Events
      1
    term
    Nasal Congestion
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    NCI CTCAE v.4.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      14
      num Events
      2
    term
    Back Pain
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    NCI CTCAE v.4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      14
      num Events
      1
    term
    Lung Infection
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI CTCAE v.4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      14
      num Events
      2
    term
    Nausea
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    NCI CTCAE v.4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      14
      num Events
      1
    term
    Hyponatremia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    NCI CTCAE v.4.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      14
      num Events
      2
    term
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    NCI CTCAE v.4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      14
      num Events
      1
    term
    Fatigue
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    NCI CTCAE v.4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      14
      num Events
      1
    term
    Thrombosis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    NCI CTCAE v.4.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      14
      num Events
      2
    term
    Disease Progression
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    NCI CTCAE v.4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      14
      num Events
      1
    term
    Fever
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    NCI CTCAE v.4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      14
      num Events
      1
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI CTCAE v.4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      14
      num Events
      1
    term
    Ileus
time Frame
Adverse event data was collected from time of first administration of study product until 30 days of the last administration of study product, approximately 1 year and 5 months.

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