Study: NCT00003475

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: Central venous catheter infection
Serious: yes
Organ System: Infections and infestations
Notes: The Central venous catheter infections were not related to Antineoplaston therapy.
Frequency: 2 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: Perforation, GI: Colon
Serious: yes
Organ System: Gastrointestinal disorders
Notes: The Perforation, GI: Colon 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): Lung (pneumonia)
Serious: yes
Organ System: Infections and infestations
Notes: The Infections (documented clinically): Lung (pneumonias) were not related to Antineoplaston therapy.
Frequency: 4 affected / 40 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 / 40 at risk

Adverse event: Mood alteration: Agitation
Serious: yes
Organ System: Nervous system disorders
Notes: The Mood alteration: Agitation 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: 5 affected / 40 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: 5 affected / 40 at risk

Adverse event: Pain: Back
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: The Pain: Back was not related to Antineoplaston therapy.
Frequency: 1 affected / 40 at risk

Adverse event: Pain: Head/headache
Serious: yes
Organ System: Nervous system disorders
Notes: The Pain: Head/headaches were not related to Antineoplaston therapy.
Frequency: 2 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: 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: 7 affected / 40 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 8 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: 10 affected / 40 at risk

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 40 at risk

Adverse event: Platelets
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 7 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: 5 affected / 40 at risk

Adverse event: Non-functional central venous catheter
Serious: no
Organ System: General disorders
Frequency: 7 affected / 40 at risk

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

Adverse event: PT
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 40 at risk

Adverse event: Fatigue (asthenia, lethargy, malaise)
Serious: no
Organ System: General disorders
Frequency: 20 affected / 40 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 6 affected / 40 at risk

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

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

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

Adverse event: Dry mouth/salivary gland (xerostomia)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 40 at risk

Adverse event: Heartburn/dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 40 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 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: 12 affected / 40 at risk

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

Adverse event: Hemorrhage, GU: Urinary NOS
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 40 at risk

Adverse event: Infection - Other
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: 6 affected / 40 at risk

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

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

Adverse event: Opportunistic infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 40 at risk

Adverse event: Albumin, serum-low (hypoalbuminemia)
Serious: no
Organ System: Investigations
Frequency: 3 affected / 40 at risk

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

Adverse event: Hyperglycaemia
Serious: no
Organ System: Investigations
Frequency: 17 affected / 40 at risk

Adverse event: Hypernatraemia
Serious: no
Organ System: Investigations
Frequency: 24 affected / 40 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Investigations
Frequency: 12 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: 30 affected / 40 at risk

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

Adverse event: Metabolic/Laboratory - Other
Serious: no
Organ System: Investigations
Frequency: 3 affected / 40 at risk

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

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

Adverse event: Alanine aminotransferase
Serious: no
Organ System: Investigations
Frequency: 8 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: 6 affected / 40 at risk

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

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

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

Adverse event: Mood alteration: Depression
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: Seizure
Serious: no
Organ System: Nervous system disorders
Frequency: 11 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: Vision-blurred vision
Serious: no
Organ System: Eye disorders
Frequency: 3 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: Extremity-limb
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 40 at risk

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

Adverse event: Pain: Joint
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 40 at risk

Adverse event: Pain: Muscle
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 40 at risk

Adverse event: Dyspnea (shortness of breath)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 40 at risk

Adverse event: Urinary frequency/urgency
Serious: no
Organ System: Renal and urinary disorders
Frequency: 5 affected / 40 at risk

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