Study: NCT00003458

Adverse event: Haemoglobin
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: The hemoglobin was not related to Antineoplaston therapy.
Frequency: 1 affected / 34 at risk

Adverse event: Central Venous Catheter Infection
Serious: yes
Organ System: Infections and infestations
Notes: The central venous catheter infection was not related to Antineoplaston therapy.
Frequency: 2 affected / 34 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Notes: The fever was not related to Antineoplaston therapy.
Frequency: 1 affected / 34 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Notes: The vomiting was not related to Antineoplaston therapy.
Frequency: 1 affected / 34 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: The hemotoma was not related to Antineoplaston therapy.
Frequency: 1 affected / 34 at risk

Adverse event: Hemorrhage, CNS
Serious: yes
Organ System: Nervous system disorders
Notes: Neither of the hemorrhage, CNS were related to Antineoplaston therapy.
Frequency: 2 affected / 34 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 / 34 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 / 34 at risk

Adverse event: Hyperntremia
Serious: yes
Organ System: Investigations
Notes: The hypernatremia was possibly related to Antineoplaston therapy.
Frequency: 1 affected / 34 at risk

Adverse event: Hydrocephalus
Serious: yes
Organ System: Nervous system disorders
Notes: The hydrocephalus was not related to Antineoplason therapy
Frequency: 1 affected / 34 at risk

Adverse event: Neuropathy: motor
Serious: yes
Organ System: Nervous system disorders
Notes: The neuropathy: motor was not related to Antineoplason therapy
Frequency: 1 affected / 34 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Notes: The seizures were not related to Antineoplason therapy
Frequency: 4 affected / 34 at risk

Adverse event: Somnolence/depressed level of consciousness
Serious: yes
Organ System: Nervous system disorders
Notes: One of the somnolence/depressed level of consciousness was possibly related to Antineoplason therapy
Frequency: 9 affected / 34 at risk

Adverse event: Pain: Head/headache
Serious: yes
Organ System: Nervous system disorders
Notes: One of the pain:headache was possibly related to Antineoplason therapy
Frequency: 3 affected / 34 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 therpy
Frequency: 1 affected / 34 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 15 affected / 34 at risk

Adverse event: Leukocytes (total WBC)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 12 affected / 34 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 10 affected / 34 at risk

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 34 at risk

Adverse event: Platelets
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 34 at risk

Adverse event: Central venous catheter infection
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 34 at risk

Adverse event: Non-functional central venous catheter
Serious: no
Organ System: General disorders
Frequency: 13 affected / 34 at risk

Adverse event: Thrombosis/embolism - Central venous catheter
Serious: no
Organ System: General disorders
Frequency: 2 affected / 34 at risk

Adverse event: Fatigue (asthenia, lethargy, malaise)
Serious: no
Organ System: General disorders
Frequency: 24 affected / 34 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 11 affected / 34 at risk

Adverse event: Rigors/chills
Serious: no
Organ System: General disorders
Frequency: 3 affected / 34 at risk

Adverse event: Weight increased
Serious: no
Organ System: General disorders
Frequency: 3 affected / 34 at risk

Adverse event: Bruising (in absence of Grade 3 or 4 thrombocytopenia)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 34 at risk

Adverse event: Pruritus/itching
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 34 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 34 at risk

Adverse event: Edema/Fluid retention
Serious: no
Organ System: General disorders
Frequency: 8 affected / 34 at risk

Adverse event: Cushingoid appearance
Serious: no
Organ System: Endocrine disorders
Frequency: 5 affected / 34 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 34 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 34 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 34 at risk

Adverse event: Distension/bloating, abdominal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 34 at risk

Adverse event: Dry mouth/salivary gland (xerostomia)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 34 at risk

Adverse event: Heartburn/dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 34 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 34 at risk

Adverse event: Taste alteration (dysgeusia)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 34 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 21 affected / 34 at risk

Adverse event: Hemorrhage, CNS
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 34 at risk

Adverse event: Hemorrhage, GU: Bladder
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 34 at risk

Adverse event: Hemorrhage, GU: Urinary NOS
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 34 at risk

Adverse event: Hemorrhage, pulmonary: Nose
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 34 at risk

Adverse event: Petechiae
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 34 at risk

Adverse event: Infection (documented clinically): Lung (pneumonia)
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 34 at risk

Adverse event: Infection (documented clinically): Mucosa
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 34 at risk

Adverse event: Infection (documented clinically): Upper airway NOS
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 34 at risk

Adverse event: Opportunistic infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 34 at risk

Adverse event: Albumin, serum-low (hypoalbuminemia)
Serious: no
Organ System: Investigations
Frequency: 3 affected / 34 at risk

Adverse event: Blood alkaline phosphatase
Serious: no
Organ System: Investigations
Frequency: 6 affected / 34 at risk

Adverse event: Bicarbonate, serum-low
Serious: no
Organ System: Investigations
Frequency: 4 affected / 34 at risk

Adverse event: GGT (gamma-Glutamyl transpeptidase)
Serious: no
Organ System: Investigations
Frequency: 4 affected / 34 at risk

Adverse event: Hypercalcaemia
Serious: no
Organ System: Investigations
Frequency: 3 affected / 34 at risk

Adverse event: Hypercholesterolaemia
Serious: no
Organ System: Investigations
Frequency: 8 affected / 34 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Investigations
Frequency: 13 affected / 34 at risk

Adverse event: Hypermagnesaemia
Serious: no
Organ System: Investigations
Frequency: 2 affected / 34 at risk

Adverse event: Hypernatraemia
Serious: no
Organ System: Investigations
Frequency: 12 affected / 34 at risk

Adverse event: Hypertriglyceridaemia
Serious: no
Organ System: Investigations
Frequency: 4 affected / 34 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Investigations
Frequency: 4 affected / 34 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Investigations
Frequency: 11 affected / 34 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Investigations
Frequency: 27 affected / 34 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Investigations
Frequency: 3 affected / 34 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Investigations
Frequency: 4 affected / 34 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Investigations
Frequency: 5 affected / 34 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Investigations
Frequency: 10 affected / 34 at risk

Adverse event: Aspartate aminotransferase
Serious: no
Organ System: Investigations
Frequency: 7 affected / 34 at risk

Adverse event: Alanine aminotransferase
Serious: no
Organ System: Investigations
Frequency: 10 affected / 34 at risk

Adverse event: Uric acid, serum-high (hyperuricemia)
Serious: no
Organ System: Investigations
Frequency: 5 affected / 34 at risk

Adverse event: Ataxia (incoordination)
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 34 at risk

Adverse event: Confusional state
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 34 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 34 at risk

Adverse event: Memory impairment
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 34 at risk

Adverse event: Neuropathy: CN III Pupil, upper eyelid, extra ocular movements
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 34 at risk

Adverse event: Neuropathy: cranial: CN VI Lateral deviation of eye
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 34 at risk

Adverse event: Neuropathy: cranial: CN VII Motor-face; Sensory-taste
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 34 at risk

Adverse event: Neuropathy: motor
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 34 at risk

Adverse event: Neuropathy: sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 34 at risk

Adverse event: Seizure
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 34 at risk

Adverse event: Somnolence/depressed level of consciousness
Serious: no
Organ System: Nervous system disorders
Frequency: 22 affected / 34 at risk

Adverse event: Speech impairment
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 34 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 34 at risk

Adverse event: Diplopia
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 34 at risk

Adverse event: Pain: Abdomen NOS
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 34 at risk

Adverse event: Pain: Back
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 34 at risk

Adverse event: Pain: Chest wall
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 34 at risk

Adverse event: Pain: Extremity-limb
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 34 at risk

Adverse event: Pain: Head/headache
Serious: no
Organ System: Nervous system disorders
Frequency: 21 affected / 34 at risk

Adverse event: Pain: Joint
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 34 at risk

Adverse event: Pain: Middle ear
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 34 at risk

Adverse event: Pain: Muscle
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 34 at risk

Adverse event: Pain: Neck
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 34 at risk

Adverse event: Pain: Stomach
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 34 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 34 at risk

Adverse event: Dyspnea (shortness of breath)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 34 at risk

Adverse event: Incontinence, urinary
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 34 at risk

Adverse event: Urinary frequency/urgency
Serious: no
Organ System: Renal and urinary disorders
Frequency: 6 affected / 34 at risk