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NCT00003457 · ADVERSE EVENTS

Adverse events

Antineoplaston Therapy in Treating Patients With Brain Tumors · Source last updated 2017-08-22

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
15 years, 7 months
Other-event reporting threshold
5%

Adverse event data was collected through regular patient assessment and regular laboratory testing

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Antineoplaston Therapy

Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached. Antineoplaston therapy (Atengenal + Astugenal): Adults with a persistent or recurrent brain tumor will receive Antineoplaston therapy (Atengenal + Astugenal).

27 / 4040 / 40Not reported / Not reported

Group identifiers: EG000: Antineoplaston Therapy

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
    The Hemoglobin was not related to Antineoplaston therapy.
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
    term
    Hemoglobin
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    The Cardiac ischemia/infarction was not related to Antineoplaston therapy.
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
    term
    Cardiac ischemia/infarction
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    The Pericardial effusion (non-malignant) was not related to Antineoplaston therapy.
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
    term
    Pericardial effusion (non-malignant)
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    The Central venous catheter infections were not related to Antineoplaston therapy.
    organ System
    General disorders
    source Vocabulary
    Institutional
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      40
    term
    Central venous catheter infection
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    The INR (International Normalized Ratio of prothrombin time) was not related to Antineoplaston therapy.
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
    term
    INR (International Normalized Ratio of prothrombin time)
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    One of the Fatigues (asthenia, lethargy, malaise) was probably related to Antineoplaston therapy.
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      40
    term
    Fatigue (asthenia, lethargy, malaise) Fatigue (asthenia, lethargy, malaise)
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    The Bruising (in absence of Grade 3 or 4 thrombocytopenia) was not related to Antineoplaston therapy.
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
    term
    Bruising (in absence of Grade 3 or 4 thrombocytopenia)
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    The Pancreatic endocrine: glucose intolerance was not related to Antineoplaston therapy.
    organ System
    Endocrine disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
    term
    Pancreatic endocrine: glucose intolerance
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    The Obstruction, GI: Small bowel NOS was not related to Antineoplaston therapy.
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
    term
    Obstruction, GI: Small bowel NOS
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    The Perforation, GI: Duodenum was not related to Antineoplaston therapy.
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
    term
    Perforation, GI: Duodenum
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    The Hemorrhages, CNS were not related to Antineoplaston therapy.
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      40
    term
    Hemorrhage, CNS
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    The Hemorrhage, GI: Abdomen NOS was not related to Antineoplaston therapy.
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
    term
    Hemorrhage, GI: Abdomen NOS

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
    Immune system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      40
    term
    Allergic reaction/hypersensitivity (including drug fever)
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      40
    term
    Tinnitus
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      40
    term
    Hemoglobin
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      40
    term
    Leukocytes (total WBC)
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      40
    term
    Lymphopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      40
    term
    Neutrophils/granulocytes (ANC/AGC)
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      40
    term
    Platelets
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      40
    term
    Hypertension
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    Institutional
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      40
    term
    Central venous catheter infection
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    Institutional
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      40
    term
    Non-functional central venous catheter
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      40
    term
    Central venous catheter - Other
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      40
    term
    Fatigue (asthenia, lethargy, malaise)
Complete source fields
description
Adverse event data was collected through regular patient assessment and regular laboratory testing
event Groups
  1. description
    Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached. Antineoplaston therapy (Atengenal + Astugenal): Adults with a persistent or recurrent brain tumor will receive Antineoplaston therapy (Atengenal + Astugenal).
    id
    EG000
    other Num Affected
    40
    other Num At Risk
    40
    serious Num Affected
    27
    serious Num At Risk
    40
    title
    Antineoplaston Therapy
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      40
    term
    Allergic reaction/hypersensitivity (including drug fever)
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      40
    term
    Tinnitus
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      40
    term
    Hemoglobin
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      40
    term
    Leukocytes (total WBC)
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      40
    term
    Lymphopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      40
    term
    Neutrophils/granulocytes (ANC/AGC)
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      40
    term
    Platelets
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      40
    term
    Hypertension
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    Institutional
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      40
    term
    Central venous catheter infection
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    Institutional
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      40
    term
    Non-functional central venous catheter
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      40
    term
    Central venous catheter - Other
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      40
    term
    Fatigue (asthenia, lethargy, malaise)
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    The Hemoglobin was not related to Antineoplaston therapy.
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
    term
    Hemoglobin
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    The Cardiac ischemia/infarction was not related to Antineoplaston therapy.
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
    term
    Cardiac ischemia/infarction
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    The Pericardial effusion (non-malignant) was not related to Antineoplaston therapy.
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
    term
    Pericardial effusion (non-malignant)
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    The Central venous catheter infections were not related to Antineoplaston therapy.
    organ System
    General disorders
    source Vocabulary
    Institutional
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      40
    term
    Central venous catheter infection
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    The INR (International Normalized Ratio of prothrombin time) was not related to Antineoplaston therapy.
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
    term
    INR (International Normalized Ratio of prothrombin time)
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    One of the Fatigues (asthenia, lethargy, malaise) was probably related to Antineoplaston therapy.
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      40
    term
    Fatigue (asthenia, lethargy, malaise) Fatigue (asthenia, lethargy, malaise)
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    The Bruising (in absence of Grade 3 or 4 thrombocytopenia) was not related to Antineoplaston therapy.
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
    term
    Bruising (in absence of Grade 3 or 4 thrombocytopenia)
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    The Pancreatic endocrine: glucose intolerance was not related to Antineoplaston therapy.
    organ System
    Endocrine disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
    term
    Pancreatic endocrine: glucose intolerance
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    The Obstruction, GI: Small bowel NOS was not related to Antineoplaston therapy.
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
    term
    Obstruction, GI: Small bowel NOS
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    The Perforation, GI: Duodenum was not related to Antineoplaston therapy.
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
    term
    Perforation, GI: Duodenum
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    The Hemorrhages, CNS were not related to Antineoplaston therapy.
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      40
    term
    Hemorrhage, CNS
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    The Hemorrhage, GI: Abdomen NOS was not related to Antineoplaston therapy.
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
    term
    Hemorrhage, GI: Abdomen NOS
time Frame
15 years, 7 months

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Preserved source evidence · Not medical advice