Study: NCT00003456

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

Adverse event: The Central venous catheter: Thrombosis/embolism.
Serious: yes
Organ System: General disorders
Notes: The Central venous catheter: Thrombosis/embolism was not related to Antineoplaston therapy.
Frequency: 1 affected / 40 at risk

Adverse event: Fatigue (asthenia, lethargy, malaise)
Serious: yes
Organ System: General disorders
Notes: The Fatigue (asthenia, lethargy, malaise) was not related to Antineoplaston therapy.
Frequency: 1 affected / 40 at risk

Adverse event: Injection site reaction/extravasation changes
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: The Injection site reaction/extravasation changes was/were not related to Antineoplaston therapy.
Frequency: 1 affected / 40 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Notes: The Vomiting 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 Hemorrhage, CNS was not related to Antineoplaston Therapy.
Frequency: 1 affected / 40 at risk

Adverse event: Infection (documented clinically): Bladder (urinary)
Serious: yes
Organ System: Infections and infestations
Notes: The Infection (documented clinically): Bladder (urinary) was not related to Antineoplaston Therapy.
Frequency: 1 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: One of the Hypernatremias was related to Antineoplaston Therapy. One of the Hypernatremias was not related to Antineoplaston Therapy.
Frequency: 2 affected / 40 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Notes: The Seizures were not related to Antineoplaston Therapy.
Frequency: 2 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: 7 affected / 40 at risk

Adverse event: Syncope (fainting)
Serious: yes
Organ System: Nervous system disorders
Notes: The Syncope (fainting) 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: 3 affected / 40 at risk

Adverse event: Dyspnea (shortness of breath)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: The Dyspneas (shortnesses of breath) were not related to Antineoplaston Therapy.
Frequency: 2 affected / 40 at risk

Adverse event: Pleural effusion (non-malignant)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: The Pleural effusion (non-malignant) 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: 2 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: 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: 7 affected / 40 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 40 at risk

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

Adverse event: Central Venous Catheter: Non-functional
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: 4 affected / 40 at risk

Adverse event: Central Venous Catheter: Pain
Serious: no
Organ System: General disorders
Frequency: 2 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: 6 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: 2 affected / 40 at risk

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

Adverse event: Taste alteration (dysgeusia)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 40 at risk

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

Adverse event: Hemorrhage, GU
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 40 at risk

Adverse event: Infection (documented clinically): Bladder (urinary)
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 40 at risk

Adverse event: Infection (documented clinically): Lung (pneumonia)
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 40 at risk

Adverse event: Infection (documented clinically): Mucosa
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: 5 affected / 40 at risk

Adverse event: Infection: Upper airway
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 40 at risk

Adverse event: Hyperbilirubinaemia
Serious: no
Organ System: Investigations
Frequency: 2 affected / 40 at risk

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

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

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

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

Adverse event: Hypokalaemia
Serious: no
Organ System: Investigations
Frequency: 25 affected / 40 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Investigations
Frequency: 2 affected / 40 at risk

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

Adverse event: Alanine aminotransferase
Serious: no
Organ System: Investigations
Frequency: 9 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: 12 affected / 40 at risk

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

Adverse event: Neuropathy: motor
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 40 at risk

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

Adverse event: Somnolence/depressed level of consciousness
Serious: no
Organ System: Nervous system disorders
Frequency: 21 affected / 40 at risk

Adverse event: Speech impairment
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 40 at risk

Adverse event: Pain: Head/headache
Serious: no
Organ System: Nervous system disorders
Frequency: 16 affected / 40 at risk

Adverse event: Pain: Joint
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 40 at risk

Adverse event: Dyspnea (shortness of breath)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 40 at risk

Adverse event: Thrombosis/thrombus/embolism 1 2 3
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 40 at risk