Study: NCT00003457

Adverse event: Haemoglobin
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: The Hemoglobin was not related to Antineoplaston therapy.
Frequency: 1 affected / 40 at risk

Adverse event: Cardiac ischemia/infarction
Serious: yes
Organ System: Cardiac disorders
Notes: The Cardiac ischemia/infarction was not related to Antineoplaston therapy.
Frequency: 1 affected / 40 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 / 40 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: 5 affected / 40 at risk

Adverse event: INR (International Normalized Ratio of prothrombin time)
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: The INR (International Normalized Ratio of prothrombin time) was not related to Antineoplaston therapy.
Frequency: 1 affected / 40 at risk

Adverse event: Fatigue (asthenia, lethargy, malaise) Fatigue (asthenia, lethargy, malaise)
Serious: yes
Organ System: General disorders
Notes: One of the Fatigues (asthenia, lethargy, malaise) was probably related to Antineoplaston therapy.
Frequency: 2 affected / 40 at risk

Adverse event: Bruising (in absence of Grade 3 or 4 thrombocytopenia)
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: The Bruising (in absence of Grade 3 or 4 thrombocytopenia) was not related to Antineoplaston therapy.
Frequency: 1 affected / 40 at risk

Adverse event: Pancreatic endocrine: glucose intolerance
Serious: yes
Organ System: Endocrine disorders
Notes: The Pancreatic endocrine: glucose intolerance was not related to Antineoplaston therapy.
Frequency: 1 affected / 40 at risk

Adverse event: Obstruction, GI: Small bowel NOS
Serious: yes
Organ System: Gastrointestinal disorders
Notes: The Obstruction, GI: Small bowel NOS was not related to Antineoplaston therapy.
Frequency: 1 affected / 40 at risk

Adverse event: Perforation, GI: Duodenum
Serious: yes
Organ System: Gastrointestinal disorders
Notes: The Perforation, GI: Duodenum was not related to Antineoplaston therapy.
Frequency: 1 affected / 40 at risk

Adverse event: Hemorrhage, CNS
Serious: yes
Organ System: Nervous system disorders
Notes: The Hemorrhages, CNS were not related to Antineoplaston therapy.
Frequency: 2 affected / 40 at risk

Adverse event: Hemorrhage, GI: Abdomen NOS
Serious: yes
Organ System: Gastrointestinal disorders
Notes: The Hemorrhage, GI: Abdomen NOS was not related to Antineoplaston therapy.
Frequency: 1 affected / 40 at risk

Adverse event: Infection - Other
Serious: yes
Organ System: Infections and infestations
Notes: The Infection - Other was not related to Antineoplaston therapy.
Frequency: 1 affected / 40 at risk

Adverse event: Infection (documented clinically): Bladder (urinary)
Serious: yes
Organ System: Renal and urinary disorders
Notes: The Infection (documented clinically): Bladder (urinary) was not related to Antineoplaston therapy.
Frequency: 1 affected / 40 at risk

Adverse event: Infection (documented clinically): Blood
Serious: yes
Organ System: Infections and infestations
Notes: The Infections (documented clinically): Blood were not related to Antineoplaston therapy.
Frequency: 5 affected / 40 at risk

Adverse event: Infection (documented clinically): Colon
Serious: yes
Organ System: Infections and infestations
Notes: The Infection (documented clinically): Colon was not related to Antineoplaston therapy.
Frequency: 1 affected / 40 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: 3 affected / 40 at risk

Adverse event: Infection (documented clinically): Skin (cellulitis)
Serious: yes
Organ System: Infections and infestations
Notes: The Infections (documented clinically): Skin (cellulitises) were not related to Antineoplaston therapy.
Frequency: 2 affected / 40 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 / 40 at risk

Adverse event: Hypernatraemia
Serious: yes
Organ System: Investigations
Notes: The Hypernatremias were possibly related to Antineoplaston therapy.
Frequency: 2 affected / 40 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 / 40 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 / 40 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Notes: The Seizures were not related to Antineoplaston therapy.
Frequency: 11 affected / 40 at risk

Adverse event: Somnolence/depressed level of consciousness
Serious: yes
Organ System: Nervous system disorders
Notes: One of the Somnolences/depressed levels of consciousness was possibly related to Antineoplaston therapy.
Frequency: 3 affected / 40 at risk

Adverse event: Pain: Abdomen NOS
Serious: yes
Organ System: Gastrointestinal disorders
Notes: The Pain: Abdomen NOS was not related to Antineoplaston therapy.
Frequency: 1 affected / 40 at risk

Adverse event: Pain: Pain NOS
Serious: yes
Organ System: General disorders
Notes: The Pain: Pain NOS was not related to Antineoplaston therapy.
Frequency: 1 affected / 40 at risk

Adverse event: Dyspnea (shortness of breath)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: The Dyspnea (shortness of breath) was not related to Antineoplaston therapy.
Frequency: 1 affected / 40 at risk

Adverse event: Flu-like syndrome
Serious: yes
Organ System: Infections and infestations
Notes: The Flu-like syndrome was not related to Antineoplaston therapy.
Frequency: 1 affected / 40 at risk

Adverse event: Thrombosis/thrombus/embolism
Serious: yes
Organ System: Vascular disorders
Notes: The Thromboses/thrombi/embolisms were not related to Antineoplaston therapy.
Frequency: 3 affected / 40 at risk

Adverse event: Allergic reaction/hypersensitivity (including drug fever)
Serious: no
Organ System: Immune system disorders
Frequency: 10 affected / 40 at risk

Adverse event: Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 3 affected / 40 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 13 affected / 40 at risk

Adverse event: Leukocytes (total WBC)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 40 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 14 affected / 40 at risk

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 40 at risk

Adverse event: Platelets
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 9 affected / 40 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 40 at risk

Adverse event: Central venous catheter infection
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 40 at risk

Adverse event: Non-functional central venous catheter
Serious: no
Organ System: General disorders
Frequency: 13 affected / 40 at risk

Adverse event: Central venous catheter - Other
Serious: no
Organ System: General disorders
Frequency: 5 affected / 40 at risk

Adverse event: Fatigue (asthenia, lethargy, malaise)
Serious: no
Organ System: General disorders
Frequency: 28 affected / 40 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 5 affected / 40 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 40 at risk

Adverse event: Rigors/chills
Serious: no
Organ System: General disorders
Frequency: 7 affected / 40 at risk

Adverse event: Bruising (in absence of Grade 3 or 4 thrombocytopenia)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 40 at risk

Adverse event: Edema/Fluid retention
Serious: no
Organ System: General disorders
Frequency: 15 affected / 40 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 40 at risk

Adverse event: Dehydration
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 40 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 40 at risk

Adverse event: Dry mouth/salivary gland (xerostomia)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 40 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 40 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 40 at risk

Adverse event: Hemorrhage, CNS
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 40 at risk

Adverse event: Hemorrhage, GU: Urinary NOS
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 40 at risk

Adverse event: Infection (documented clinically): Bladder (urinary)
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 40 at risk

Adverse event: Infection (documented clinically): Blood
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 40 at risk

Adverse event: Infection (documented clinically): Lung (pneumonia)
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 40 at risk

Adverse event: Infection (documented clinically): Mucosa
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 40 at risk

Adverse event: Infection (documented clinically): Sinus
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 40 at risk

Adverse event: Infection (documented clinically): Soft tissue NOS
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 40 at risk

Adverse event: Infection (documented clinically): Upper airway NOS
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 40 at risk

Adverse event: Infection (documented clinically): Urinary tract NOS
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 40 at risk

Adverse event: Opportunistic infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 40 at risk

Adverse event: Albumin, serum-low (hypoalbuminemia)
Serious: no
Organ System: Investigations
Frequency: 5 affected / 40 at risk

Adverse event: Blood alkaline phosphatase
Serious: no
Organ System: Investigations
Frequency: 8 affected / 40 at risk

Adverse event: Bicarbonate, serum-low
Serious: no
Organ System: Investigations
Frequency: 4 affected / 40 at risk

Adverse event: GGT (gamma-Glutamyl transpeptidase)
Serious: no
Organ System: Investigations
Frequency: 7 affected / 40 at risk

Adverse event: Hyperbilirubinaemia
Serious: no
Organ System: Investigations
Frequency: 3 affected / 40 at risk

Adverse event: Hypercholesterolaemia
Serious: no
Organ System: Investigations
Frequency: 6 affected / 40 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Investigations
Frequency: 19 affected / 40 at risk

Adverse event: Hypernatraemia
Serious: no
Organ System: Investigations
Frequency: 26 affected / 40 at risk

Adverse event: Hypertriglyceridaemia
Serious: no
Organ System: Investigations
Frequency: 4 affected / 40 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Investigations
Frequency: 19 affected / 40 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Investigations
Frequency: 7 affected / 40 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Investigations
Frequency: 37 affected / 40 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Investigations
Frequency: 9 affected / 40 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Investigations
Frequency: 3 affected / 40 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Investigations
Frequency: 8 affected / 40 at risk

Adverse event: Metabolic/Laboratory - Other
Serious: no
Organ System: Investigations
Frequency: 4 affected / 40 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Investigations
Frequency: 12 affected / 40 at risk

Adverse event: Aspartate aminotransferase
Serious: no
Organ System: Investigations
Frequency: 13 affected / 40 at risk

Adverse event: Alanine aminotransferase
Serious: no
Organ System: Investigations
Frequency: 14 affected / 40 at risk

Adverse event: Uric acid, serum-high (hyperuricemia)
Serious: no
Organ System: Investigations
Frequency: 3 affected / 40 at risk

Adverse event: Ataxia (incoordination)
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 40 at risk

Adverse event: Confusional state
Serious: no
Organ System: Nervous system disorders
Frequency: 14 affected / 40 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 13 affected / 40 at risk

Adverse event: Memory impairment
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 40 at risk

Adverse event: Mood alteration: Agitation
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 40 at risk

Adverse event: Mood alteration: Anxiety
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 40 at risk

Adverse event: Mood alteration: Depression
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 40 at risk

Adverse event: Neuropathy: motor
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 40 at risk

Adverse event: Neuropathy: sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 40 at risk

Adverse event: Seizure
Serious: no
Organ System: Nervous system disorders
Frequency: 15 affected / 40 at risk

Adverse event: Somnolence/depressed level of consciousness
Serious: no
Organ System: Nervous system disorders
Frequency: 16 affected / 40 at risk

Adverse event: Speech impairment
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 40 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 40 at risk

Adverse event: Vision-blurred vision
Serious: no
Organ System: Eye disorders
Frequency: 7 affected / 40 at risk

Adverse event: Pain: Abdomen NOS
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 40 at risk

Adverse event: Pain: Back
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 40 at risk

Adverse event: Pain: Chest wall
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 40 at risk

Adverse event: Pain: Head/headache
Serious: no
Organ System: Nervous system disorders
Frequency: 18 affected / 40 at risk

Adverse event: Pain: Joint
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 15 affected / 40 at risk

Adverse event: Pain: Muscle
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 11 affected / 40 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 40 at risk

Adverse event: Dyspnea (shortness of breath)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 40 at risk

Adverse event: Incontinence, urinary
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 40 at risk

Adverse event: Urinary frequency/urgency
Serious: no
Organ System: Renal and urinary disorders
Frequency: 10 affected / 40 at risk

Adverse event: Flu-like syndrome
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 40 at risk

Adverse event: Thrombosis/thrombus/embolism
Serious: no
Organ System: Vascular disorders
Frequency: 5 affected / 40 at risk