Study: NCT00003459

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

Adverse event: Central venous catheter infection
Serious: yes
Organ System: Infections and infestations
Notes: None of the central venous catheter infections were related to Antineoplaton therapy.
Frequency: 4 affected / 40 at risk

Adverse event: Fatigue (asthenia, lethargy, malaise)
Serious: yes
Organ System: General disorders
Notes: The fatigue (asthenia, lethargy, malaise) was possibly related to Antineoplaston therapy.
Frequency: 1 affected / 40 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Notes: Neither of the fevers were related to Antineoplaston therapy.
Frequency: 2 affected / 40 at risk

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

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

Adverse event: Dysphagia (difficulty swallowing)
Serious: yes
Organ System: Gastrointestinal disorders
Notes: The dysphagia (difficulty swallowing) was not related to Antineoplaston therapy.
Frequency: 1 affected / 40 at risk

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

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

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

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Neither episode of vomiting was related to Antineoplaston therapy.
Frequency: 2 affected / 40 at risk

Adverse event: Hemorrhage, CNS
Serious: yes
Organ System: Nervous system disorders
Notes: None of the hemorrhages, CNS, were related to Antineoplaston therapy.
Frequency: 4 affected / 40 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Hepatobiliary disorders
Notes: None of the pancreatitises were related to Antineoplaston therapy.
Frequency: 3 affected / 40 at risk

Adverse event: Infection (documented clinically): Blood
Serious: yes
Organ System: Infections and infestations
Notes: None of the Infections (documented clinically): blood, were related to Antineoplaston therapy.
Frequency: 2 affected / 40 at risk

Adverse event: Infection (documented clinically): Lung (pneumonia)
Serious: yes
Organ System: Infections and infestations
Notes: None of the infections (documented clinically): lung (pneumonia), were related to Antineoplaston therapy.
Frequency: 7 affected / 40 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 / 40 at risk

Adverse event: Infection (documented clinically): Upper airway NOS
Serious: yes
Organ System: Infections and infestations
Notes: Neither of the infections (documented clinically): upper airway NOS, were related to Antineoplaston therapy.
Frequency: 2 affected / 40 at risk

Adverse event: Hypernatraemia
Serious: yes
Organ System: Investigations
Notes: Two of the four hypernatremias were possibly related to Antineoplaston therapy.
Frequency: 4 affected / 40 at risk

Adverse event: Hypocalcaemia
Serious: yes
Organ System: Investigations
Notes: The hypocalcemia was not related to Antineoplaston therapy.
Frequency: 1 affected / 40 at risk

Adverse event: Hypophosphataemia
Serious: yes
Organ System: Investigations
Notes: The hypophosphatemia was not related to Antineoplaston therapy.
Frequency: 1 affected / 40 at risk

Adverse event: Extremity-upper (function)
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: The extremity-upper (function) was not related to Antineoplaston therapy.
Frequency: 1 affected / 40 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Nervous system disorders
Notes: The confusion was not related to Antineoplaston therapy.
Frequency: 1 affected / 40 at risk

Adverse event: Hydrocephalus
Serious: yes
Organ System: Nervous system disorders
Notes: None of the hydrocephaluses were related to Antineoplaston therapy.
Frequency: 3 affected / 40 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Notes: None of the seizures were related to Antineoplaston therapy.
Frequency: 4 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: 7 affected / 40 at risk

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

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

Adverse event: Acute respiratory distress syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: The ARDS 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: None of the dyspneas (shortnesses of breath) were related to Antineoplaston therapy.
Frequency: 3 affected / 40 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 / 40 at risk

Adverse event: Allergic reaction/hypersensitivity (including drug fever)
Serious: no
Organ System: Immune system disorders
Frequency: 6 affected / 40 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 15 affected / 40 at risk

Adverse event: Leukocytes (total WBC)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 8 affected / 40 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 9 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: 5 affected / 40 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 40 at risk

Adverse event: Central Venous Catheter Infection
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 40 at risk

Adverse event: Central Venous Catheter Non-functional
Serious: no
Organ System: General disorders
Frequency: 9 affected / 40 at risk

Adverse event: Central Venous Catheter Other
Serious: no
Organ System: General disorders
Frequency: 4 affected / 40 at risk

Adverse event: Central Venous Catheter Pain
Serious: no
Organ System: General disorders
Frequency: 4 affected / 40 at risk

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

Adverse event: Fatigue (asthenia, lethargy, malaise)
Serious: no
Organ System: General disorders
Frequency: 22 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: 4 affected / 40 at risk

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

Adverse event: Weight increased
Serious: no
Organ System: General disorders
Frequency: 8 affected / 40 at risk

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

Adverse event: Cushingoid appearance
Serious: no
Organ System: Endocrine disorders
Frequency: 3 affected / 40 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 40 at risk

Adverse event: Dry mouth/salivary gland (xerostomia)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 40 at risk

Adverse event: Dysphagia (difficulty swallowing)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 40 at risk

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

Adverse event: Taste alteration (dysgeusia)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 40 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 21 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: 4 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: 7 affected / 40 at risk

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

Adverse event: Infection (documented clinically): Upper airway NOS
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 40 at risk

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

Adverse event: Hypernatraemia
Serious: no
Organ System: Investigations
Frequency: 21 affected / 40 at risk

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

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

Adverse event: Hypokalaemia
Serious: no
Organ System: Investigations
Frequency: 33 affected / 40 at risk

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

Adverse event: Hypophosphataemia
Serious: no
Organ System: Investigations
Frequency: 5 affected / 40 at risk

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

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

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

Adverse event: Ataxia (incoordination)
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 40 at risk

Adverse event: Confusional state
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 40 at risk

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

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

Adverse event: Neurology - Other
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 40 at risk

Adverse event: Neuropathy: cranial: CN VII Motor-face; Sensory-taste
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 40 at risk

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

Adverse event: Somnolence/depressed level of consciousness
Serious: no
Organ System: Nervous system disorders
Frequency: 20 affected / 40 at risk

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

Adverse event: Diplopia
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 40 at risk

Adverse event: Pain: Abdomen NOS
Serious: no
Organ System: General disorders
Frequency: 4 affected / 40 at risk

Adverse event: Pain: Head/headache
Serious: no
Organ System: General disorders
Frequency: 13 affected / 40 at risk

Adverse event: Pain: Joint
Serious: no
Organ System: General disorders
Frequency: 12 affected / 40 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 40 at risk

Adverse event: Dyspnea (shortness of breath)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 40 at risk

Adverse event: Incontinence, urinary
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 40 at risk

Adverse event: Urinary frequency/urgency
Serious: no
Organ System: Renal and urinary disorders
Frequency: 18 affected / 40 at risk