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NCT00003458 · ADVERSE EVENTS

Adverse events

Antineoplaston Therapy in Treating Children With Brain Tumors · Source last updated 2022-03-07

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
18 years, 5 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. Children with a brain tumor will receive Antineoplaston therapy (Atengenal + Astugenal).

21 / 3434 / 34Not 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
      34
    term
    Hemoglobin
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    The central venous catheter infection was not related to Antineoplaston therapy.
    organ System
    Infections and infestations
    source Vocabulary
    Institutional
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      34
    term
    Central Venous Catheter Infection
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    The fever was not related to Antineoplaston therapy.
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
    term
    Fever
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    The vomiting 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
      34
    term
    Vomiting
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    The hemotoma 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
      34
    term
    Hematoma
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Neither of the hemorrhage, CNS were 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
      34
    term
    Hemorrhage, CNS
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    The infection (documented clinically): lung (pneumonia) was not related to Antineoplaston therapy.
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
    term
    Infection (documented clinically): Lung (pneumonia)
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    The infection (documented clinically): skin (cellulitis) was not related to Antineoplaston therapy.
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
    term
    Infection (documented clinically): Skin (cellulitis)
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    The hypernatremia was possibly related to Antineoplaston therapy.
    organ System
    Investigations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
    term
    Hyperntremia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    The hydrocephalus was not related to Antineoplason therapy
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
    term
    Hydrocephalus
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    The neuropathy: motor was not related to Antineoplason therapy
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
    term
    Neuropathy: motor
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    The seizures were not related to Antineoplason therapy
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      34
    term
    Seizure

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
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      34
    term
    Hemoglobin
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      34
    term
    Leukocytes (total WBC)
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      34
    term
    Lymphopenia
  4. 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
      34
    term
    Neutrophils/granulocytes (ANC/AGC)
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      34
    term
    Platelets
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      34
    term
    Central venous catheter infection
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    Institutional
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      34
    term
    Non-functional central venous catheter
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    Institutional
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      34
    term
    Thrombosis/embolism - Central venous catheter
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      34
    term
    Fatigue (asthenia, lethargy, malaise)
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      34
    term
    Fever
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      34
    term
    Rigors/chills
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      34
    term
    Weight gain
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. Children with a brain tumor will receive Antineoplaston therapy (Atengenal + Astugenal).
    id
    EG000
    other Num Affected
    34
    other Num At Risk
    34
    serious Num Affected
    21
    serious Num At Risk
    34
    title
    Antineoplaston Therapy
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      34
    term
    Hemoglobin
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      34
    term
    Leukocytes (total WBC)
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      34
    term
    Lymphopenia
  4. 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
      34
    term
    Neutrophils/granulocytes (ANC/AGC)
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      34
    term
    Platelets
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      34
    term
    Central venous catheter infection
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    Institutional
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      34
    term
    Non-functional central venous catheter
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    Institutional
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      34
    term
    Thrombosis/embolism - Central venous catheter
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      34
    term
    Fatigue (asthenia, lethargy, malaise)
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      34
    term
    Fever
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      34
    term
    Rigors/chills
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      34
    term
    Weight gain
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
      34
    term
    Hemoglobin
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    The central venous catheter infection was not related to Antineoplaston therapy.
    organ System
    Infections and infestations
    source Vocabulary
    Institutional
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      34
    term
    Central Venous Catheter Infection
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    The fever was not related to Antineoplaston therapy.
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
    term
    Fever
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    The vomiting 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
      34
    term
    Vomiting
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    The hemotoma 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
      34
    term
    Hematoma
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Neither of the hemorrhage, CNS were 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
      34
    term
    Hemorrhage, CNS
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    The infection (documented clinically): lung (pneumonia) was not related to Antineoplaston therapy.
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
    term
    Infection (documented clinically): Lung (pneumonia)
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    The infection (documented clinically): skin (cellulitis) was not related to Antineoplaston therapy.
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
    term
    Infection (documented clinically): Skin (cellulitis)
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    The hypernatremia was possibly related to Antineoplaston therapy.
    organ System
    Investigations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
    term
    Hyperntremia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    The hydrocephalus was not related to Antineoplason therapy
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
    term
    Hydrocephalus
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    The neuropathy: motor was not related to Antineoplason therapy
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
    term
    Neuropathy: motor
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    The seizures were not related to Antineoplason therapy
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      34
    term
    Seizure
time Frame
18 years, 5 months

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Preserved source evidence · Not medical advice