Study: NCT00003537

Adverse event: Supraventricular and nodal arrhythmia: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Notes: The Supraventricular and nodal arrhythmia: Atrial fibrillation was not related to Antineoplaston therapy.
Frequency: 1 affected / 19 at risk

Adverse event: Ventricular arrhythmia: Ventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Notes: The Ventricular arrhythmia: Ventricular tachycardia was not related to Antineoplaston therapy.
Frequency: 1 affected / 19 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Cardiac disorders
Notes: Th hypotension was not related to Antineoplaston therapy.
Frequency: 1 affected / 19 at risk

Adverse event: Pericardial effusion (non-malignant)
Serious: yes
Organ System: Cardiac disorders
Notes: The Pericardial effusion (non-malignant) was not related to Antineoplaston therapy.
Frequency: 1 affected / 19 at risk

Adverse event: Central venous catheter infection
Serious: yes
Organ System: General disorders
Notes: The Central venous catheter infections were not related to Antineoplaston therapy
Frequency: 4 affected / 19 at risk

Adverse event: Thrombosis/embolism
Serious: yes
Organ System: General disorders
Notes: The Thrombosis/embolism was not related to Antineoplaton therapy.
Frequency: 1 affected / 19 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Notes: The Fevers were not related to Antineoplaston therapy.
Frequency: 2 affected / 19 at risk

Adverse event: Rigors/chills
Serious: yes
Organ System: General disorders
Notes: The Rigors/chills were not related to Antineoplaston therapy.
Frequency: 2 affected / 19 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 / 19 at risk

Adverse event: Infection (documented clinically): Lung (pneumonia)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: The Infections (documented clinically): Lung (pneumonia) were not related to Antineoplaston therapy.
Frequency: 3 affected / 19 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 / 19 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Investigations
Notes: The Hypokalemia was not related to Antineoplaston therapy.
Frequency: 1 affected / 19 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 / 19 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Notes: The Seizures were not related to Antineoplaston therapy.
Frequency: 2 affected / 19 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 / 19 at risk

Adverse event: Diplopia
Serious: yes
Organ System: Eye disorders
Notes: The diplopia was not related to Antineoplaston therapy.
Frequency: 1 affected / 19 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: The Pneumothorax was not related to Antineoplaston therapy.
Frequency: 1 affected / 19 at risk

Adverse event: Thrombosis/embolism (vascular access-related)
Serious: yes
Organ System: Vascular disorders
Notes: The Thrombosis/embolism (vascular access-related) was not related to Antineoplaston therapy.
Frequency: 1 affected / 19 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 / 19 at risk

Adverse event: Allergic reaction/hypersensitivity (including drug fever)
Serious: no
Organ System: Immune system disorders
Frequency: 6 affected / 19 at risk

Adverse event: Auditory/Ear - Other
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 19 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 19 at risk

Adverse event: Leukocytes (total WBC)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 19 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 19 at risk

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 19 at risk

Adverse event: Platelets
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 19 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 19 at risk

Adverse event: Supraventricular and nodal arrhythmia: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 19 at risk

Adverse event: Supraventricular and nodal arrhythmia: Sinus tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 19 at risk

Adverse event: Ventricular arrhythmia: Ventricular tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 19 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 19 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 19 at risk

Adverse event: Left ventricular dysfunction
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 19 at risk

Adverse event: Pericardial effusion (non-malignant)
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 19 at risk

Adverse event: Central venous catheter infection
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 19 at risk

Adverse event: Non-functional central venous catheter
Serious: no
Organ System: General disorders
Frequency: 6 affected / 19 at risk

Adverse event: Central venous catheter - Other
Serious: no
Organ System: General disorders
Frequency: 6 affected / 19 at risk

Adverse event: Pain: Central venous catheter
Serious: no
Organ System: General disorders
Frequency: 2 affected / 19 at risk

Adverse event: Central venous catheter thrombosis/embolism
Serious: no
Organ System: General disorders
Frequency: 5 affected / 19 at risk

Adverse event: Fatigue (asthenia, lethargy, malaise)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 19 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 5 affected / 19 at risk

Adverse event: Rigors/chills
Serious: no
Organ System: General disorders
Frequency: 4 affected / 19 at risk

Adverse event: Sweating (diaphoresis)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 19 at risk

Adverse event: Weight increased
Serious: no
Organ System: General disorders
Frequency: 1 affected / 19 at risk

Adverse event: Dermatology/Skin - Other
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 19 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 19 at risk

Adverse event: Hair loss/alopecia (scalp or body)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 19 at risk

Adverse event: Nail disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 19 at risk

Adverse event: Pruritus/itching
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 19 at risk

Adverse event: Edema/Fluid retention
Serious: no
Organ System: General disorders
Frequency: 8 affected / 19 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 19 at risk

Adverse event: Dry mouth/salivary gland (xerostomia)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 19 at risk

Adverse event: Gastrointestinal - Other
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 19 at risk

Adverse event: Heartburn/dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 19 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 19 at risk

Adverse event: Taste alteration (dysgeusia)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 19 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 19 at risk

Adverse event: Hemorrhage, CNS
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 19 at risk

Adverse event: Hemorrhage, GU: Bladder
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 19 at risk

Adverse event: Hemorrhage, GU: Urinary NOS
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 19 at risk

Adverse event: Petechiae
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 19 at risk

Adverse event: Infection - Other
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 19 at risk

Adverse event: Infection (documented clinically): Bladder (urinary)
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 19 at risk

Adverse event: Infection (documented clinically): Middle ear (otitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 19 at risk

Adverse event: Infection (documented clinically): Blood
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 19 at risk

Adverse event: Infection (documented clinically): Bronchus
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 19 at risk

Adverse event: Infection (documented clinically): Lung (pneumonia)
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 19 at risk

Adverse event: Infection (documented clinically): Mucosa
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 19 at risk

Adverse event: Infection (documented clinically): Neck NOS
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 19 at risk

Adverse event: Infection (documented clinically): Oral cavity-gums (gingivitis)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 19 at risk

Adverse event: Infection (documented clinically): Sinus
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 19 at risk

Adverse event: Infection (documented clinically): Upper airway NOS
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 19 at risk

Adverse event: Opportunistic infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 19 at risk

Adverse event: Edema:head and neck
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 19 at risk

Adverse event: Albumin, serum-low (hypoalbuminemia)
Serious: no
Organ System: Investigations
Frequency: 2 affected / 19 at risk

Adverse event: Blood alkaline phosphatase
Serious: no
Organ System: Investigations
Frequency: 3 affected / 19 at risk

Adverse event: GGT (gamma-Glutamyl transpeptidase)
Serious: no
Organ System: Investigations
Frequency: 3 affected / 19 at risk

Adverse event: Hyperbilirubinaemia
Serious: no
Organ System: Investigations
Frequency: 1 affected / 19 at risk

Adverse event: Hypercalcaemia
Serious: no
Organ System: Investigations
Frequency: 2 affected / 19 at risk

Adverse event: Hypercholesterolaemia
Serious: no
Organ System: Investigations
Frequency: 2 affected / 19 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Investigations
Frequency: 7 affected / 19 at risk

Adverse event: Hypernatraemia
Serious: no
Organ System: Investigations
Frequency: 12 affected / 19 at risk

Adverse event: Hypertriglyceridaemia
Serious: no
Organ System: Investigations
Frequency: 3 affected / 19 at risk

Adverse event: Hyperuricaemia
Serious: no
Organ System: Investigations
Frequency: 1 affected / 19 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Investigations
Frequency: 4 affected / 19 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Investigations
Frequency: 18 affected / 19 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Investigations
Frequency: 5 affected / 19 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Investigations
Frequency: 1 affected / 19 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Investigations
Frequency: 1 affected / 19 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Investigations
Frequency: 4 affected / 19 at risk

Adverse event: Metabolic/Laboratory - Other
Serious: no
Organ System: Investigations
Frequency: 1 affected / 19 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 5 affected / 19 at risk

Adverse event: Aspartate aminotransferase
Serious: no
Organ System: Investigations
Frequency: 7 affected / 19 at risk

Adverse event: Alanine aminotransferase
Serious: no
Organ System: Investigations
Frequency: 8 affected / 19 at risk

Adverse event: Uric acid, serum-high (hyperuricemia)
Serious: no
Organ System: Investigations
Frequency: 1 affected / 19 at risk

Adverse event: Musculoskeletal/Soft Tissue - Other
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 19 at risk

Adverse event: Ataxia (incoordination)
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 19 at risk

Adverse event: Confusional state
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 19 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 19 at risk

Adverse event: Mood alteration
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 19 at risk

Adverse event: Mood alteration: Agitation
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 19 at risk

Adverse event: Neurology - Other
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 19 at risk

Adverse event: Mood alteration: Anxiety
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 19 at risk

Adverse event: Neuropathy: motor
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 19 at risk

Adverse event: Neuropathy: sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 19 at risk

Adverse event: Psychosis (hallucinations/delusions)
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 19 at risk

Adverse event: Pyramidal tract dysfunction
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 19 at risk

Adverse event: Seizure
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 19 at risk

Adverse event: Somnolence/depressed level of consciousness
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 19 at risk

Adverse event: Speech impairment
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 19 at risk

Adverse event: Diplopia
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 19 at risk

Adverse event: Nystagmus
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 19 at risk

Adverse event: Vision-blurred vision
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 19 at risk

Adverse event: Vision-photophobia
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 19 at risk

Adverse event: Pain: Abdomen NOS
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 19 at risk

Adverse event: Pain: Back
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 19 at risk

Adverse event: Pain: Chest/thorax NOS
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 19 at risk

Adverse event: Pain: External ear
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 19 at risk

Adverse event: Pain: Extremity-limb
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 19 at risk

Adverse event: Pain: Head/headache
Serious: no
Organ System: Nervous system disorders
Frequency: 13 affected / 19 at risk

Adverse event: Pain: Joint
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 19 at risk

Adverse event: Pain: Middle ear
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 19 at risk

Adverse event: Pain: Muscle
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 19 at risk

Adverse event: Pain: Neck
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 19 at risk

Adverse event: Dyspnea (shortness of breath)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 19 at risk

Adverse event: Pleural effusion (non-malignant)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 19 at risk

Adverse event: Pneumothorax
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 19 at risk

Adverse event: Urinary frequency/urgency
Serious: no
Organ System: Renal and urinary disorders
Frequency: 5 affected / 19 at risk

Adverse event: Flu-like syndrome
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 19 at risk

Adverse event: Thrombosis/embolism (vascular access-related)
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 19 at risk

Adverse event: Thrombosis/thrombus/embolism
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 19 at risk