NCT00003469 · ADVERSE EVENTS

Adverse events

Antineoplaston Therapy in Treating Children With Rhabdoid Tumor of the Central Nervous System · Source last updated 2017-08-24

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: 7 years, 2 months
Other-event reporting threshold: 5%

Four patients were recruited between February 1996 and October 2010. All study subjects were seen at the Burzynski Clinic in Houston TX

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
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): Children with a Rhabdoid tumor will receive Antineoplaston therapy (Atengenal + Astugenal).	3 / 4	4 / 4	Not 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.

assessment Type
SYSTEMATIC_ASSESSMENT
notes
The Central Venous Catheter Infection was not related to Antineoplaston therapy
organ System
General disorders
source Vocabulary
Institutional
stats
group Id
EG000
num Affected
1
num At Risk
4
term
Central Venous Catheter Infection
assessment Type
SYSTEMATIC_ASSESSMENT
notes
The Vomiting was not related to Antineoplaston therapy
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
4
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
notes
The Hypernatremia was not related to Antineoplaston Therapy.
organ System
Investigations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
4
term
Hypernatremia
assessment Type
SYSTEMATIC_ASSESSMENT
notes
The Hypokalemia was not related to Antineoplaston therapy.
organ System
Investigations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
4
term
Hypokalemia
assessment Type
SYSTEMATIC_ASSESSMENT
notes
The Pain: Head/headache was not related to Antineoplaston therapy.
organ System
Nervous system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
4
term
Pain: Head/headache

Other reported adverse events

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

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
4
term
Allergic reaction/hypersensitivity (including drug fever)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
3
num At Risk
4
term
Hemoglobin
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
4
term
Leukocytes (total WBC)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
4
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
4
term
Neutrophils/granulocytes (ANC/AGC)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
4
term
Hypotension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
Institutional
stats
group Id
EG000
num Affected
1
num At Risk
4
term
Central venous catheter infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
Institutional
stats
group Id
EG000
num Affected
2
num At Risk
4
term
Non-functional central venous catheter
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
2
num At Risk
4
term
Fatigue (asthenia, lethargy, malaise
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
4
term
Fever
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
4
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
4
term
Diarrhea

Complete source fields

description

Four patients were recruited between February 1996 and October 2010. All study subjects were seen at the Burzynski Clinic in Houston TX

event Groups

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): Children with a Rhabdoid tumor will receive Antineoplaston therapy (Atengenal + Astugenal).
id
EG000
other Num Affected
4
other Num At Risk
4
serious Num Affected
3
serious Num At Risk
4
title
Antineoplaston Therapy

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
4
term
Allergic reaction/hypersensitivity (including drug fever)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
3
num At Risk
4
term
Hemoglobin
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
4
term
Leukocytes (total WBC)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
4
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
4
term
Neutrophils/granulocytes (ANC/AGC)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
4
term
Hypotension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
Institutional
stats
group Id
EG000
num Affected
1
num At Risk
4
term
Central venous catheter infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
Institutional
stats
group Id
EG000
num Affected
2
num At Risk
4
term
Non-functional central venous catheter
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
2
num At Risk
4
term
Fatigue (asthenia, lethargy, malaise
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
4
term
Fever
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
4
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
4
term
Diarrhea

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
notes
The Central Venous Catheter Infection was not related to Antineoplaston therapy
organ System
General disorders
source Vocabulary
Institutional
stats
group Id
EG000
num Affected
1
num At Risk
4
term
Central Venous Catheter Infection
assessment Type
SYSTEMATIC_ASSESSMENT
notes
The Vomiting was not related to Antineoplaston therapy
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
4
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
notes
The Hypernatremia was not related to Antineoplaston Therapy.
organ System
Investigations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
4
term
Hypernatremia
assessment Type
SYSTEMATIC_ASSESSMENT
notes
The Hypokalemia was not related to Antineoplaston therapy.
organ System
Investigations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
4
term
Hypokalemia
assessment Type
SYSTEMATIC_ASSESSMENT
notes
The Pain: Head/headache was not related to Antineoplaston therapy.
organ System
Nervous system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
4
term
Pain: Head/headache

time Frame

7 years, 2 months

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Preserved source evidence · Not medical advice