Study: NCT00003479

Adverse event: Haemoglobin
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: The Hemoglobin was not related to Antineoplaston therapy.
Frequency: 1 affected / 9 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: 1 affected / 9 at risk

Adverse event: Rash: erythema multiforme
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: The Rash: erythema multiforme was possibly related to Antineoplaston therapy.
Frequency: 1 affected / 9 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: The Pancreatitis was not related to Antineoplaston therapy.
Frequency: 1 affected / 9 at risk

Adverse event: Infection (documented clinically): Blood
Serious: yes
Organ System: Infections and infestations
Notes: The Infection (documented clinically): Blood was not related to Antineoplaston therapy.
Frequency: 1 affected / 9 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Investigations
Notes: The Hypokalemia was possibly related to Antineoplaston therapy.
Frequency: 1 affected / 9 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Nervous system disorders
Notes: The Confusion was possibly related to Antineoplaston therapy.
Frequency: 1 affected / 9 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Notes: The Seizure was not related to Antineoplaston therapy.
Frequency: 1 affected / 9 at risk

Adverse event: Somnolence/depressed level of consciousness
Serious: yes
Organ System: Nervous system disorders
Notes: The Somnolence/depressed level of consciousness was not related to Antineoplaston therapy.
Frequency: 1 affected / 9 at risk

Adverse event: Pain: Joint
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: The Pain: Joint was possibly related to Antineoplaston therapy.
Frequency: 1 affected / 9 at risk

Adverse event: Pain: Stomach
Serious: yes
Organ System: Gastrointestinal disorders
Notes: The Pain: Stomach was not related to Antineoplaston therapy.
Frequency: 1 affected / 9 at risk

Adverse event: Allergic reaction/hypersensitivity (including drug fever)
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 9 at risk

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

Adverse event: Leukocytes (total WBC)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 9 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 9 at risk

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 9 at risk

Adverse event: Central venous catheter infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 9 at risk

Adverse event: Non-functional central venous catheter
Serious: no
Organ System: General disorders
Frequency: 3 affected / 9 at risk

Adverse event: Fatigue (asthenia, lethargy, malaise)
Serious: no
Organ System: General disorders
Frequency: 4 affected / 9 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 9 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 9 at risk

Adverse event: Rigors/chills
Serious: no
Organ System: General disorders
Frequency: 1 affected / 9 at risk

Adverse event: Weight increased
Serious: no
Organ System: General disorders
Frequency: 1 affected / 9 at risk

Adverse event: Pruritus/itching
Serious: no
Organ System: General disorders
Frequency: 1 affected / 9 at risk

Adverse event: Rash: erythema multiforme
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 9 at risk

Adverse event: Edema/Fluid retention
Serious: no
Organ System: General disorders
Frequency: 1 affected / 9 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 9 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 9 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 9 at risk

Adverse event: Hemorrhage, GU: Bladder
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 9 at risk

Adverse event: Pancreatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: Infection (documented clinically): Bladder (urinary)
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 9 at risk

Adverse event: Infection (documented clinically): Blood
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 9 at risk

Adverse event: Infection (documented clinically): Mucosa
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 9 at risk

Adverse event: Infection (documented clinically): Pharynx
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 9 at risk

Adverse event: Infection (documented clinically): Sinus
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 9 at risk

Adverse event: Infection (documented clinically): Soft tissue NOS
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 9 at risk

Adverse event: Infection (documented clinically): Urinary tract NOS
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 9 at risk

Adverse event: Middle ear (otitis media)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 9 at risk

Adverse event: Skin
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 9 at risk

Adverse event: Upper airway
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 9 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Investigations
Frequency: 2 affected / 9 at risk

Adverse event: Hypernatraemia
Serious: no
Organ System: Investigations
Frequency: 3 affected / 9 at risk

Adverse event: Hyperuricaemia
Serious: no
Organ System: Investigations
Frequency: 1 affected / 9 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Investigations
Frequency: 1 affected / 9 at risk

Adverse event: Hypochloraemia
Serious: no
Organ System: Investigations
Frequency: 1 affected / 9 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Investigations
Frequency: 1 affected / 9 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Investigations
Frequency: 7 affected / 9 at risk

Adverse event: Metabolic/Laboratory - Other
Serious: no
Organ System: Investigations
Frequency: 1 affected / 9 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Investigations
Frequency: 1 affected / 9 at risk

Adverse event: Aspartate aminotransferase
Serious: no
Organ System: Investigations
Frequency: 1 affected / 9 at risk

Adverse event: Alanine aminotransferase
Serious: no
Organ System: Investigations
Frequency: 3 affected / 9 at risk

Adverse event: Apnoea
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 9 at risk

Adverse event: Ataxia (incoordination)
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 9 at risk

Adverse event: Confusional state
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 9 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 9 at risk

Adverse event: Neuropathy: cranial: CN VIII Hearing and balance
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 9 at risk

Adverse event: Neuropathy: sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 9 at risk

Adverse event: Seizure
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 9 at risk

Adverse event: Somnolence/depressed level of consciousness
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 9 at risk

Adverse event: Speech impairment
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 9 at risk

Adverse event: Syncope (fainting)
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 9 at risk

Adverse event: Pain: Dental/teeth/peridontal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: Pain: Head/headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 9 at risk

Adverse event: Pain: Joint
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 9 at risk

Adverse event: Pain: Stomach
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: Dyspnea (shortness of breath)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 9 at risk