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NCT00496860 · ADVERSE EVENTS

Adverse events

Safety and Efficacy Study of ALT-801 to Treat Progressive Metastatic Malignancies · Source last updated 2013-07-22

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
ALT-801 0.015 mg/kg/Dose

0.015 mg/kg/dose of ALT-801

0 / 44 / 4Not reported / Not reported
ALT-801 0.040 mg/kg/Dose

0.040 mg/kg/dose of ALT-801

2 / 1616 / 16Not reported / Not reported
ALT-801 0.080 mg/kg/Dose

0.080 mg/kg/dose of ALT-801

4 / 66 / 6Not reported / Not reported

Group identifiers: EG000: ALT-801 0.015 mg/kg/Dose · EG001: ALT-801 0.040 mg/kg/Dose · EG002: ALT-801 0.080 mg/kg/Dose

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Pleural Effusion
  2. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Death-NOS
  3. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    Thrombocytopenia
  4. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    Cardiac Ischemia/Infarction
  5. organ System
    Vascular disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    THROMBOSIS
  6. organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    Pulmonary Infiltrates

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. organ System
    Immune system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Rhinitis
  2. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      4
      num Events
      2
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      16
      num Events
      12
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      6
      num Events
      3
    term
    Hemoglobin
  3. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      16
      num Events
      7
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      6
      num Events
      2
    term
    Lymphopenia
  4. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      4
      num Events
      3
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      16
      num Events
      10
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      6
      num Events
      4
    term
    Platelets
  5. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      16
      num Events
      8
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      6
      num Events
      3
    term
    Supraventricular arrhythmia - Sinus tachycardia
  6. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      16
      num Events
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    Ventricular arrhythmia - Ventricular tachycardia
  7. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Hypertension
  8. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      4
      num Events
      2
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      16
      num Events
      9
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      6
      num Events
      5
    term
    Hypotension
  9. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    INR
  10. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      4
      num Events
      2
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      16
      num Events
      9
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Fatigue
  11. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      4
      num Events
      4
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      16
      num Events
      16
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      6
      num Events
      6
    term
    Fever
  12. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      16
      num Events
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Insomnia
Complete source fields
event Groups
  1. description
    0.015 mg/kg/dose of ALT-801
    id
    EG000
    other Num Affected
    4
    other Num At Risk
    4
    serious Num Affected
    0
    serious Num At Risk
    4
    title
    ALT-801 0.015 mg/kg/Dose
  2. description
    0.040 mg/kg/dose of ALT-801
    id
    EG001
    other Num Affected
    16
    other Num At Risk
    16
    serious Num Affected
    2
    serious Num At Risk
    16
    title
    ALT-801 0.040 mg/kg/Dose
  3. description
    0.080 mg/kg/dose of ALT-801
    id
    EG002
    other Num Affected
    6
    other Num At Risk
    6
    serious Num Affected
    4
    serious Num At Risk
    6
    title
    ALT-801 0.080 mg/kg/Dose
frequency Threshold
5
other Events
  1. organ System
    Immune system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Rhinitis
  2. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      4
      num Events
      2
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      16
      num Events
      12
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      6
      num Events
      3
    term
    Hemoglobin
  3. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      16
      num Events
      7
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      6
      num Events
      2
    term
    Lymphopenia
  4. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      4
      num Events
      3
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      16
      num Events
      10
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      6
      num Events
      4
    term
    Platelets
  5. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      16
      num Events
      8
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      6
      num Events
      3
    term
    Supraventricular arrhythmia - Sinus tachycardia
  6. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      16
      num Events
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    Ventricular arrhythmia - Ventricular tachycardia
  7. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Hypertension
  8. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      4
      num Events
      2
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      16
      num Events
      9
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      6
      num Events
      5
    term
    Hypotension
  9. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    INR
  10. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      4
      num Events
      2
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      16
      num Events
      9
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Fatigue
  11. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      4
      num Events
      4
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      16
      num Events
      16
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      6
      num Events
      6
    term
    Fever
  12. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      16
      num Events
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Insomnia
serious Events
  1. organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Pleural Effusion
  2. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Death-NOS
  3. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    Thrombocytopenia
  4. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    Cardiac Ischemia/Infarction
  5. organ System
    Vascular disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    THROMBOSIS
  6. organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    Pulmonary Infiltrates

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Preserved source evidence · Not medical advice