Study: NCT00003470

Adverse event: Central venous catheter infection
Serious: yes
Organ System: Infections and infestations
Notes: The Central venous catheter infections were not related to Antineoplaston therapy.
Frequency: 3 affected / 27 at risk

Adverse event: Fatigue (asthenia, lethargy, malaise)
Serious: yes
Organ System: General disorders
Notes: The Fatigues (asthenia, lethargy, malaise) were not related to Antineoplaston therapy.
Frequency: 2 affected / 27 at risk

Adverse event: Edema/Fluid retention
Serious: yes
Organ System: General disorders
Notes: The Edema/Fluid retention was not related to Antineoplaston therapy.
Frequency: 1 affected / 27 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Notes: The Vomiting was not related to Antineoplaston therapy.
Frequency: 1 affected / 27 at risk

Adverse event: Infection (documented clinically): Bladder (urinary)
Serious: yes
Organ System: Infections and infestations
Notes: The Infection (documented clinically): Bladder (urinary) was not related to Antineoplaston therapy.
Frequency: 1 affected / 27 at risk

Adverse event: Infection (documented clinically): Lung (pneumonia)
Serious: yes
Organ System: Infections and infestations
Notes: The Infections (documented clinically): Lung (pneumonias) were not related to Antineoplaston therapy.
Frequency: 2 affected / 27 at risk

Adverse event: Infection (documented clinically): Skin (cellulitis)
Serious: yes
Organ System: Infections and infestations
Notes: The Infection (documented clinically): Skin (cellulitis) was not related to Antineoplaston therapy.
Frequency: 1 affected / 27 at risk

Adverse event: Infection with normal ANC: Brain + Spinal cord (encephalomyelitis)
Serious: yes
Organ System: Infections and infestations
Notes: The Infection with normal ANC: Brain + Spinal cord (encephalomyelitis) was not related to Antineoplaston therapy.
Frequency: 1 affected / 27 at risk

Adverse event: Lung (pneumonia)
Serious: yes
Organ System: Infections and infestations
Notes: The Lung (pneumonia) was not related to Antineoplaston therapy.
Frequency: 1 affected / 27 at risk

Adverse event: Hypernatraemia
Serious: yes
Organ System: Investigations
Notes: The Hypernatremia was possibly related to Antineoplaston therapy.
Frequency: 1 affected / 27 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Investigations
Notes: The Hypokalemia was possibly related to Antineoplaston therapy.
Frequency: 1 affected / 27 at risk

Adverse event: Alanine aminotransferase
Serious: yes
Organ System: Investigations
Notes: The SGPT was not related to Antineoplaston therapy.
Frequency: 1 affected / 27 at risk

Adverse event: Ataxia (incoordination)
Serious: yes
Organ System: Nervous system disorders
Notes: The Ataxia (incoordination) was not related to Antineoplaston therapy.
Frequency: 1 affected / 27 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Nervous system disorders
Notes: The Confusions were not related to Antineoplaston therapy.
Frequency: 2 affected / 27 at risk

Adverse event: Mood alteration: Agitation
Serious: yes
Organ System: Nervous system disorders
Notes: The Mood alteration: Agitation was not related to Antineoplaston therapy.
Frequency: 1 affected / 27 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Notes: The Seizures were not related to Antineoplaston therapy.
Frequency: 3 affected / 27 at risk

Adverse event: Somnolence/depressed level of consciousness
Serious: yes
Organ System: Nervous system disorders
Notes: The Somnolences/depressed levels of consciousness were not related to Antineoplaston therapy.
Frequency: 3 affected / 27 at risk

Adverse event: Tremor
Serious: yes
Organ System: Nervous system disorders
Notes: The Tremor was not related to Antineoplaston therapy.
Frequency: 1 affected / 27 at risk

Adverse event: Pulmonary/Upper Respiratory - Other (Pneumonia)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: The Pulmonary/Upper Respiratory - Other (Pneumonia) was not related to Antineoplaston therapy.
Frequency: 1 affected / 27 at risk

Adverse event: Thrombosis/thrombus/embolism
Serious: yes
Organ System: Vascular disorders
Notes: The Thrombosis/thrombus/embolism was not related to Antineoplaston therapy.
Frequency: 1 affected / 27 at risk

Adverse event: Allergic reaction/hypersensitivity (including drug fever)
Serious: no
Organ System: Immune system disorders
Frequency: 4 affected / 27 at risk

Adverse event: Allergic rhinitis (including sneezing, nasal stuffiness,
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 27 at risk

Adverse event: Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 27 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 27 at risk

Adverse event: Leukocytes (total WBC)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 27 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 27 at risk

Adverse event: Platelets
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 27 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 27 at risk

Adverse event: Central venous catheter infection
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 27 at risk

Adverse event: Non-functional central venous catheter
Serious: no
Organ System: General disorders
Frequency: 9 affected / 27 at risk

Adverse event: Central venous catheter - Other
Serious: no
Organ System: General disorders
Frequency: 2 affected / 27 at risk

Adverse event: Pain: Central venous catheter
Serious: no
Organ System: General disorders
Frequency: 4 affected / 27 at risk

Adverse event: Central venous catheter thrombosis/embolism
Serious: no
Organ System: General disorders
Frequency: 2 affected / 27 at risk

Adverse event: Fatigue (asthenia, lethargy, malaise)
Serious: no
Organ System: General disorders
Frequency: 20 affected / 27 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 4 affected / 27 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 27 at risk

Adverse event: Rigors/chills
Serious: no
Organ System: General disorders
Frequency: 3 affected / 27 at risk

Adverse event: Weight increased
Serious: no
Organ System: General disorders
Frequency: 3 affected / 27 at risk

Adverse event: Dermatology/Skin - Other
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 27 at risk

Adverse event: Edema/Fluid retention
Serious: no
Organ System: General disorders
Frequency: 14 affected / 27 at risk

Adverse event: Hot flashes/flushes
Serious: no
Organ System: Endocrine disorders
Frequency: 2 affected / 27 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 27 at risk

Adverse event: Dry mouth/salivary gland (xerostomia)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 27 at risk

Adverse event: Heartburn/dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 27 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 27 at risk

Adverse event: Taste alteration (dysgeusia)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 27 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 27 at risk

Adverse event: Hemorrhage, GU: Urinary NOS
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 27 at risk

Adverse event: Infection (documented clinically): Bladder (urinary)
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 27 at risk

Adverse event: Infection (documented clinically): Lung (pneumonia)
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 27 at risk

Adverse event: Infection (documented clinically): Skin (cellulitis)
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 27 at risk

Adverse event: Infection (documented clinically): Upper airway NOS
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 27 at risk

Adverse event: Opportunistic infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 27 at risk

Adverse event: Albumin, serum-low (hypoalbuminemia)
Serious: no
Organ System: Investigations
Frequency: 2 affected / 27 at risk

Adverse event: Blood alkaline phosphatase
Serious: no
Organ System: Investigations
Frequency: 3 affected / 27 at risk

Adverse event: Hypercholesterolaemia
Serious: no
Organ System: Investigations
Frequency: 2 affected / 27 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Investigations
Frequency: 10 affected / 27 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Investigations
Frequency: 2 affected / 27 at risk

Adverse event: Hypernatraemia
Serious: no
Organ System: Investigations
Frequency: 21 affected / 27 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Investigations
Frequency: 7 affected / 27 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Investigations
Frequency: 6 affected / 27 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Investigations
Frequency: 22 affected / 27 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Investigations
Frequency: 5 affected / 27 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Investigations
Frequency: 3 affected / 27 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Investigations
Frequency: 4 affected / 27 at risk

Adverse event: Metabolic/Laboratory - Other
Serious: no
Organ System: Investigations
Frequency: 2 affected / 27 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Investigations
Frequency: 7 affected / 27 at risk

Adverse event: Aspartate aminotransferase
Serious: no
Organ System: Investigations
Frequency: 6 affected / 27 at risk

Adverse event: Alanine aminotransferase
Serious: no
Organ System: Investigations
Frequency: 3 affected / 27 at risk

Adverse event: Ataxia (incoordination)
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 27 at risk

Adverse event: Confusional state
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 27 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 27 at risk

Adverse event: Mood alteration: Agitation
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 27 at risk

Adverse event: Neuropathy: motor
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 27 at risk

Adverse event: Psychosis (hallucinations/delusions)
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 27 at risk

Adverse event: Seizure
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 27 at risk

Adverse event: Somnolence/depressed level of consciousness
Serious: no
Organ System: Nervous system disorders
Frequency: 17 affected / 27 at risk

Adverse event: Speech impairment
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 27 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 27 at risk

Adverse event: Vision-blurred vision
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 27 at risk

Adverse event: Pain: Back
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 27 at risk

Adverse event: Pain: Extremity-limb
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 27 at risk

Adverse event: Pain: Head/headache
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 27 at risk

Adverse event: Pain: Joint
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 27 at risk

Adverse event: Dyspnea (shortness of breath)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 27 at risk

Adverse event: Urinary frequency/urgency
Serious: no
Organ System: Renal and urinary disorders
Frequency: 5 affected / 27 at risk