Study: NCT00003472

Adverse event: Central Venous Catheter: Infection
Serious: yes
Organ System: General disorders
Notes: The Central Venous Catheter: Infection were not related to Antineoplaston Therapy.
Frequency: 2 affected / 13 at risk

Adverse event: Fatigue (asthenia, lethargy, malaise)
Serious: yes
Organ System: General disorders
Notes: The Fatigue (asthenia, lethargy, malaise) was not related to Antineoplaston Therapy.
Frequency: 1 affected / 13 at risk

Adverse event: Hemorrhage, CNS
Serious: yes
Organ System: Nervous system disorders
Notes: The Hemorrhage, CNS was not related to Antineoplaston Therapy.
Frequency: 1 affected / 13 at risk

Adverse event: Infection (documented clinically): Blood
Serious: yes
Organ System: Infections and infestations
Notes: The Infection (documented clinically): Blood was not related to Antineoplaston Therapy
Frequency: 1 affected / 13 at risk

Adverse event: Infection (documented clinically): Lung (pneumonia)
Serious: yes
Organ System: Infections and infestations
Notes: The Infection (documented clinically): Lung (pneumonia) was not related to Antineoplaston Therapy
Frequency: 1 affected / 13 at risk

Adverse event: Infection (documented clinically): Scrotum
Serious: yes
Organ System: Infections and infestations
Notes: The Infection (documented clinically): Scrotum was not related to Antineoplaston Therapy.
Frequency: 1 affected / 13 at risk

Adverse event: Infection (documented clinically): Soft tissue NOS
Serious: yes
Organ System: Infections and infestations
Notes: The Infection (documented clinically): Soft tissue NOS was not related to Antineoplaston Therapy.
Frequency: 1 affected / 13 at risk

Adverse event: Hypernatraemia
Serious: yes
Organ System: Investigations
Notes: The Hypernatremia was related to Antineoplaston Therapy.
Frequency: 1 affected / 13 at risk

Adverse event: Fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: The Fracture was not related to Antineoplaston Therapy.
Frequency: 1 affected / 13 at risk

Adverse event: Cognitive disorder
Serious: yes
Organ System: Nervous system disorders
Notes: The Cognitive disturbance was not related to Antineoplaston Therapy
Frequency: 1 affected / 13 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Nervous system disorders
Notes: The confusion was related to Antineoplaston Therapy.
Frequency: 1 affected / 13 at risk

Adverse event: Neuropathy: motor
Serious: yes
Organ System: Nervous system disorders
Notes: The Neuropathy: motor was not related to Antineoplaston Therapy
Frequency: 1 affected / 13 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Notes: The Seizures were not related to Antineoplaston Therapy.
Frequency: 2 affected / 13 at risk

Adverse event: Somnolence/depressed level of consciousness
Serious: yes
Organ System: Nervous system disorders
Notes: The Somnolence/depressed level of consciousness was not related to Antineoplaston Therapy.
Frequency: 1 affected / 13 at risk

Adverse event: Allergic reaction/hypersensitivity (including drug fever)
Serious: no
Organ System: Immune system disorders
Frequency: 3 affected / 13 at risk

Adverse event: Otitis, external ear (non-infectious)
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 13 at risk

Adverse event: Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 13 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 13 at risk

Adverse event: Leukocytes (total WBC)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 13 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 13 at risk

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 13 at risk

Adverse event: Platelets
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 13 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 13 at risk

Adverse event: Central Venous Catheter: Infection
Serious: no
Organ System: General disorders
Frequency: 4 affected / 13 at risk

Adverse event: Central Venous Catheter: Non-functional
Serious: no
Organ System: General disorders
Frequency: 3 affected / 13 at risk

Adverse event: Central Venous Catheter: Pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 13 at risk

Adverse event: Central Venous Catheter: Thrombosis/embolism
Serious: no
Organ System: General disorders
Frequency: 2 affected / 13 at risk

Adverse event: Fatigue (asthenia, lethargy, malaise)
Serious: no
Organ System: General disorders
Frequency: 10 affected / 13 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 13 at risk

Adverse event: Weight increased
Serious: no
Organ System: General disorders
Frequency: 1 affected / 13 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 13 at risk

Adverse event: Rash: acne/acneiform
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 13 at risk

Adverse event: Edema/Fluid retention
Serious: no
Organ System: General disorders
Frequency: 6 affected / 13 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 13 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 13 at risk

Adverse event: Heartburn/dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 13 at risk

Adverse event: Mucositis/stomatitis (clinical exam): Oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 13 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 13 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 13 at risk

Adverse event: Hemorrhage, CNS
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 13 at risk

Adverse event: Hemorrhage, GU: Bladder
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 13 at risk

Adverse event: Infection - Other
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 13 at risk

Adverse event: Infection (documented clinically): Bladder (urinary)
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 13 at risk

Adverse event: Infection (documented clinically): Blood
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 13 at risk

Adverse event: Infection (documented clinically): Lung (pneumonia)
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 13 at risk

Adverse event: Infection (documented clinically): Middle ear (otitis)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 13 at risk

Adverse event: Infection (documented clinically): Mucosa
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 13 at risk

Adverse event: Infection (documented clinically): Scrotum
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 13 at risk

Adverse event: Infection (documented clinically): Soft tissue NOS
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 13 at risk

Adverse event: Infection (documented clinically): Upper airway NOS
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 13 at risk

Adverse event: Infection (documented clinically): Urinary tract NOS
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 13 at risk

Adverse event: Opportunistic infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 13 at risk

Adverse event: Albumin, serum-low (hypoalbuminemia)
Serious: no
Organ System: Investigations
Frequency: 1 affected / 13 at risk

Adverse event: Blood alkaline phosphatase
Serious: no
Organ System: Investigations
Frequency: 2 affected / 13 at risk

Adverse event: GGT (gamma-Glutamyl transpeptidase)
Serious: no
Organ System: Investigations
Frequency: 2 affected / 13 at risk

Adverse event: Hypercholesterolaemia
Serious: no
Organ System: Investigations
Frequency: 3 affected / 13 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Investigations
Frequency: 3 affected / 13 at risk

Adverse event: Hypernatraemia
Serious: no
Organ System: Investigations
Frequency: 6 affected / 13 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Investigations
Frequency: 4 affected / 13 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Investigations
Frequency: 3 affected / 13 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Investigations
Frequency: 11 affected / 13 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Investigations
Frequency: 3 affected / 13 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Investigations
Frequency: 2 affected / 13 at risk

Adverse event: Aspartate aminotransferase
Serious: no
Organ System: Investigations
Frequency: 1 affected / 13 at risk

Adverse event: Alanine aminotransferase
Serious: no
Organ System: Investigations
Frequency: 1 affected / 13 at risk

Adverse event: Uric acid, serum-high (hyperuricemia)
Serious: no
Organ System: Investigations
Frequency: 1 affected / 13 at risk

Adverse event: Fracture
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 13 at risk

Adverse event: Ataxia (incoordination)
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 13 at risk

Adverse event: Cognitive disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 13 at risk

Adverse event: Confusional state
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 13 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 13 at risk

Adverse event: Mood alteration: Agitation
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 13 at risk

Adverse event: Neurology - Other
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 13 at risk

Adverse event: Pyramidal tract dysfunction
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 13 at risk

Adverse event: Seizure
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 13 at risk

Adverse event: Somnolence/depressed level of consciousness
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 13 at risk

Adverse event: Speech impairment
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 13 at risk

Adverse event: Neuropathy: motor
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 13 at risk

Adverse event: Ocular/Visual - Other
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 13 at risk

Adverse event: Pain: Abdomen NOS
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 13 at risk

Adverse event: Pain: Bladder
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 13 at risk

Adverse event: Pain: Breast
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 13 at risk

Adverse event: Pain: Chest wall
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 13 at risk

Adverse event: Pain: Head/headache
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 13 at risk

Adverse event: Pain: Joint
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 13 at risk

Adverse event: Pain: Muscle
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 13 at risk

Adverse event: Pain: Neck
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 13 at risk

Adverse event: Pain: Throat/pharynx/larynx
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 13 at risk

Adverse event: Dyspnea (shortness of breath)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 13 at risk

Adverse event: Urinary frequency/urgency
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 13 at risk