Study: NCT00349622

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 74 affected / 340 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 28 affected / 340 at risk

Adverse event: Infections with unknown ANC: Lung (pneumonia)
Serious: yes
Organ System: Infections and infestations
Frequency: 13 affected / 340 at risk

Adverse event: Thrombosis/thrombus/embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 20 affected / 340 at risk

Adverse event: Line Infection
Serious: yes
Organ System: Infections and infestations
Notes: "Line Infection" was added to the trial database as an adverse event potentially related to the central venous catheter that all subjects received as part of the study.
Frequency: 3 affected / 340 at risk

Adverse event: Renal/Genitourinary - Other
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 10 affected / 340 at risk

Adverse event: PEG Placement (outpatient)
Serious: yes
Organ System: Surgical and medical procedures
Notes: PEG (Percutaneous Endoscopic Gastrostomy) Placement was added as an adverse event term during STAGES 1 and 2 of this study. PEG tube placements are common for people with ALS. In STAGE 3 of the study, these events were coded as Dysphagia.
Frequency: 4 affected / 340 at risk

Adverse event: Aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 340 at risk

Adverse event: Death not associated with CTCAE Term: Disease Progression NOS
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 340 at risk

Adverse event: Cardiac ischemia/infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 340 at risk

Adverse event: Dysphagia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 340 at risk

Adverse event: Fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 340 at risk

Adverse event: Infection with normal ANC or grade 1 or 2 neutrophils: Lung (pneumonia)
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 340 at risk

Adverse event: Catheter Exit Site Infection
Serious: yes
Organ System: Infections and infestations
Notes: "Catheter Exit Site Infection" was added to the trial database as an adverse event potentially related to the central venous catheter that all subjects received as part of the study.
Frequency: 2 affected / 340 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 5 affected / 340 at risk

Adverse event: Allergic reaction/hypersensitivity (including drug fever)
Serious: yes
Organ System: Immune system disorders
Frequency: 4 affected / 340 at risk

Adverse event: Death not associated with CTCAE term: Death NOS
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 340 at risk

Adverse event: Fever (in the absense of neutropenia, where neutropenia is defined as AGC<1.0 x 10e9/L)
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 340 at risk

Adverse event: Infection with normal ANC or grade 1 or 2 neutrophils: Blood
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 340 at risk

Adverse event: Infections with unknown ANC: Blood
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 340 at risk

Adverse event: Pain: Abdomen NOS
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 340 at risk

Adverse event: Pulmonary - Other
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 340 at risk

Adverse event: Colitis infectious (Clostridium difficile)
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 340 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 340 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 340 at risk

Adverse event: Joint-function
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 340 at risk

Adverse event: Blood/Bone Marrow - Other
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 340 at risk

Adverse event: CNS cerebrovascular ischemia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 340 at risk

Adverse event: Death not associated with CTCAE Term: Sudden Death
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 340 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 340 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 340 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 340 at risk

Adverse event: Line break/tear
Serious: yes
Organ System: General disorders
Notes: "Line break/tear" was added to the trial database as an adverse event potentially related to the central venous catheter that all subjects received as part of the study.
Frequency: 2 affected / 340 at risk

Adverse event: Line Displacement
Serious: yes
Organ System: General disorders
Notes: "Line Displacement" was added to the trial database as an adverse event potentially related to the central venous catheter that all subjects received as part of the study.
Frequency: 1 affected / 340 at risk

Adverse event: Mood alteration: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 340 at risk

Adverse event: Musculoskeletal - Other
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 340 at risk

Adverse event: Neurology - Other
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 340 at risk

Adverse event: Obstruction/stenosis of airway: Larynx
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 340 at risk

Adverse event: Pneumonitis/pulmonary infiltrates
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 340 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 340 at risk

Adverse event: Somnolence/depressed level of consciousness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 340 at risk

Adverse event: Atelectasis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 340 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 340 at risk

Adverse event: Cardiac/Arrhythmia Other
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 340 at risk

Adverse event: Cognitive disorder
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 340 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 340 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 340 at risk

Adverse event: Cough
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 340 at risk

Adverse event: Dermatology/Skin - Other
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 340 at risk

Adverse event: Febrile neutropenia (fever of unknown origin w/out clinically/microbiologically documented infection
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 340 at risk

Adverse event: Gastritis (including bile reflux gastritis)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 340 at risk

Adverse event: Hemmorhage, GI: Stomach
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 340 at risk

Adverse event: Hemmorhage, pulmonary/Upper Respiratory: Stoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 340 at risk

Adverse event: Hemorrhage/bleeding associated with surgery, intraoperative or postoperative
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 340 at risk

Adverse event: Hepatobiliary - Other
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 340 at risk

Adverse event: Infection - Other
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 340 at risk

Adverse event: Infection with normal ANC or grade 1 or 2 neutrophils: Bronchus
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 340 at risk

Adverse event: Infection with normal ANC or grade 1 or 2 neutrophils: Vagina
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 340 at risk

Adverse event: Infection with unknown ANC: Abdomen NOS
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 340 at risk

Adverse event: Left ventricular dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 340 at risk

Adverse event: Line Thrombosis
Serious: yes
Organ System: General disorders
Notes: "Line Thrombosis" was added to the trial database as an adverse event potentially related to the central venous catheter that all subjects received as part of the study.
Frequency: 1 affected / 340 at risk

Adverse event: Metabolic/Laboratory - Other
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 340 at risk

Adverse event: Mood alteration: Agitation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 340 at risk

Adverse event: Mood alteration: Anxiety
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 340 at risk

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 340 at risk

Adverse event: Obstruction, GI: Ileum
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 340 at risk

Adverse event: Obstruction, GI: Stomach
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 340 at risk

Adverse event: Pain: chest wall
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 340 at risk

Adverse event: Pain: Chest/thorax NOS
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 340 at risk

Adverse event: Pain: Head/headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 340 at risk

Adverse event: Pain: Stomach
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 340 at risk

Adverse event: Potassium, serum-low (hypokalemia)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 340 at risk

Adverse event: Urinary retention (including nerogenic bladder)
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 340 at risk

Adverse event: Ventricular arrhythmia: Ventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 340 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 340 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 340 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 152 affected / 340 at risk

Adverse event: Cholelithiasis
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 158 affected / 340 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 32 affected / 340 at risk

Adverse event: Neurology - Other
Serious: no
Organ System: Nervous system disorders
Frequency: 97 affected / 340 at risk

Adverse event: Catheter Exit Site Reaction
Serious: no
Organ System: General disorders
Notes: "Catheter Exit Site Reaction" was added to the trial database as an adverse event potentially related to the central venous catheter that all subjects received as part of the study.
Frequency: 98 affected / 340 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 92 affected / 340 at risk

Adverse event: Cholelithiasis
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 100 affected / 340 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 66 affected / 340 at risk

Adverse event: Pain: Abdomen NOS
Serious: no
Organ System: General disorders
Frequency: 75 affected / 340 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 64 affected / 340 at risk

Adverse event: Pain: head/headache
Serious: no
Organ System: Nervous system disorders
Frequency: 53 affected / 340 at risk

Adverse event: Dermatology/Skin - Other
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 57 affected / 340 at risk

Adverse event: Edema: Limb
Serious: no
Organ System: General disorders
Frequency: 54 affected / 340 at risk

Adverse event: Muscle weakness, generalized or specific area (not due to neuropathy): Extremity-lower
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 46 affected / 340 at risk

Adverse event: Pain: Back
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 53 affected / 340 at risk

Adverse event: Pulmonary - Other
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 46 affected / 340 at risk

Adverse event: Pain: Joint
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 47 affected / 340 at risk

Adverse event: Fatigue (asthenia, lethargy, malaise)
Serious: no
Organ System: General disorders
Frequency: 41 affected / 340 at risk

Adverse event: Musculoskeletal - Other
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 45 affected / 340 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 40 affected / 340 at risk

Adverse event: Dysphagia, (difficult swallowing)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 35 affected / 340 at risk

Adverse event: Infection - Other
Serious: no
Organ System: Infections and infestations
Frequency: 42 affected / 340 at risk

Adverse event: Muscle weakness, generalized or specific area (not due to neuropathy): Extremity-upper
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 39 affected / 340 at risk

Adverse event: Renal/Genitourinary - Other
Serious: no
Organ System: Renal and urinary disorders
Frequency: 37 affected / 340 at risk

Adverse event: Mood alteration: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 33 affected / 340 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 41 affected / 340 at risk

Adverse event: Gastrointestinal - Other
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 36 affected / 340 at risk

Adverse event: Mood alteration: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 34 affected / 340 at risk

Adverse event: Pain: Neck
Serious: no
Organ System: General disorders
Frequency: 34 affected / 340 at risk

Adverse event: Pain: Extremity-limb
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 38 affected / 340 at risk

Adverse event: Pruritis/itching
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 33 affected / 340 at risk

Adverse event: Drooling
Serious: no
Organ System: Nervous system disorders
Frequency: 30 affected / 340 at risk

Adverse event: Infection with normal ANC or grade 1 or 2 neutrophils: Urinary Tract NOS
Serious: no
Organ System: Infections and infestations
Frequency: 25 affected / 340 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 25 affected / 340 at risk

Adverse event: Fever (absence of neutropenia, where neutropenia is AGC <1.0x10e9/L)
Serious: no
Organ System: General disorders
Frequency: 27 affected / 340 at risk

Adverse event: ALT SGPT (serum glutamic pyruvic transaminase)
Serious: no
Organ System: Investigations
Frequency: 32 affected / 340 at risk

Adverse event: Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 23 affected / 340 at risk

Adverse event: Pain: chest wall
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 25 affected / 340 at risk

Adverse event: Heartburn/Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 24 affected / 340 at risk

Adverse event: Voice changes/dysarthria (e.g., hoarseness, loss or alteration of voice, laryngitis)
Serious: no
Organ System: Nervous system disorders
Frequency: 25 affected / 340 at risk

Adverse event: Muscle weakness, generalized of specific area (not due to neuropathy): Whole body/generalized
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 27 affected / 340 at risk

Adverse event: Bruising (in absence of grade 3 or 4 thrombocytopenia)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 24 affected / 340 at risk

Adverse event: Fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 24 affected / 340 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 24 affected / 340 at risk

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: no
Organ System: Investigations
Frequency: 30 affected / 340 at risk

Adverse event: Metabolic/Laboratory
Serious: no
Organ System: Investigations
Frequency: 18 affected / 340 at risk

Adverse event: Urinary frquency/urgency
Serious: no
Organ System: Renal and urinary disorders
Frequency: 20 affected / 340 at risk

Adverse event: Line break/tear
Serious: no
Organ System: General disorders
Notes: "Line break/tear" was added to the trial database as an adverse event potentially related to the central venous catheter that all subjects received as part of the study.
Frequency: 19 affected / 340 at risk

Adverse event: Pain - Other
Serious: no
Organ System: General disorders
Frequency: 18 affected / 340 at risk

Adverse event: Infection with unknown ANC: Upper airway NOS
Serious: no
Organ System: Infections and infestations
Frequency: 20 affected / 340 at risk

Adverse event: Infection with unkown ANC: Urinary tract NOS
Serious: no
Organ System: Infections and infestations
Frequency: 17 affected / 340 at risk

Adverse event: AST SGOT (serum glutamic oxaloacetic transaminase)
Serious: no
Organ System: Investigations
Frequency: 23 affected / 340 at risk

Adverse event: Allergic reaction/hypersensitivity (including drug fever)
Serious: no
Organ System: Immune system disorders
Frequency: 19 affected / 340 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 15 affected / 340 at risk

Adverse event: Hepatobiliary - Other
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 20 affected / 340 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 16 affected / 340 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 20 affected / 340 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 34 affected / 173 at risk

Adverse event: Infections with unknown ANC: Lung (pneumonia)
Serious: yes
Organ System: Infections and infestations
Frequency: 12 affected / 173 at risk

Adverse event: Thrombosis/thrombus/embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 173 at risk

Adverse event: Line Infection
Serious: yes
Organ System: Infections and infestations
Notes: "Line Infection" was added to the trial database as an adverse event potentially related to the central venous catheter that all subjects received as part of the study.
Frequency: 9 affected / 173 at risk

Adverse event: Renal/Genitourinary - Other
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 173 at risk

Adverse event: PEG Placement (outpatient)
Serious: yes
Organ System: Surgical and medical procedures
Notes: PEG (Percutaneous Endoscopic Gastrostomy) Placement was added as an adverse event term during STAGES 1 and 2 of this study. PEG tube placements are common for people with ALS. In STAGE 3 of the study, these events were coded as Dysphagia.
Frequency: 5 affected / 173 at risk

Adverse event: Aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 173 at risk

Adverse event: Death not associated with CTCAE Term: Disease Progression NOS
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 173 at risk

Adverse event: Dysphagia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 173 at risk

Adverse event: Fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 173 at risk

Adverse event: Infection with normal ANC or grade 1 or 2 neutrophils: Lung (pneumonia)
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 173 at risk

Adverse event: Catheter Exit Site Infection
Serious: yes
Organ System: Infections and infestations
Notes: "Catheter Exit Site Infection" was added to the trial database as an adverse event potentially related to the central venous catheter that all subjects received as part of the study.
Frequency: 3 affected / 173 at risk

Adverse event: Death not associated with CTCAE term: Death NOS
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 173 at risk

Adverse event: Fever (in the absense of neutropenia, where neutropenia is defined as AGC<1.0 x 10e9/L)
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 173 at risk

Adverse event: Infection with normal ANC or grade 1 or 2 neutrophils: Blood
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 173 at risk

Adverse event: Infections with unknown ANC: Blood
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 173 at risk

Adverse event: Pain: Abdomen NOS
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 173 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 173 at risk

Adverse event: Gastrointestinal - Other
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 173 at risk

Adverse event: Infection with unknown ANC: Urinary tract NOS
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 173 at risk

Adverse event: Joint-function
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 173 at risk

Adverse event: Blood/Bone Marrow - Other
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 173 at risk

Adverse event: CNS cerebrovascular ischemia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 173 at risk

Adverse event: Line Displacement
Serious: yes
Organ System: General disorders
Notes: "Line Displacement" was added to the trial database as an adverse event potentially related to the central venous catheter that all subjects received as part of the study.
Frequency: 1 affected / 173 at risk

Adverse event: Mood alteration: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 173 at risk

Adverse event: Neurology - Other
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 173 at risk

Adverse event: Obstruction/stenosis of airway: Larynx
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 173 at risk

Adverse event: Pneumonitis/pulmonary infiltrates
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 173 at risk

Adverse event: Somnolence/depressed level of consciousness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 173 at risk

Adverse event: FEV (1)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 173 at risk

Adverse event: Heartburn/Dyspepsia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 173 at risk

Adverse event: Hemmorhage, CNS
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 173 at risk

Adverse event: Hemmorhage, GI: Lower GI NOS
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 173 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 173 at risk

Adverse event: Infection (documented clinically or microbiologically) with grade 3 or 4 neutropenia: Lung
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 173 at risk

Adverse event: Infection with unknown ANC: Catheter-related
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 173 at risk

Adverse event: Infection with unknown ANC: Foreign body (e.g. graft, implant, prosthesis, stent)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 173 at risk

Adverse event: Infection with unknown ANC: Soft tissue NOS
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 173 at risk

Adverse event: Leak (including anastomotic), GI: Stomach
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 173 at risk

Adverse event: Obstruction/stenosis of airway: Trachea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 173 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 173 at risk

Adverse event: Sexual/Reproductive Function - Other
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 173 at risk

Adverse event: Stricture/stenosis (including anastomotic), GU: Ureter
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 173 at risk

Adverse event: Supraventricular and nodal arrhythmias: Sinus bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 173 at risk

Adverse event: Thrombosis/embolism (vascular access-related)
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 173 at risk

Adverse event: Weight decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 173 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 41 affected / 173 at risk

Adverse event: Cholelithiasis
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 5 affected / 173 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 24 affected / 173 at risk

Adverse event: Neurology - Other
Serious: no
Organ System: Nervous system disorders
Frequency: 52 affected / 173 at risk

Adverse event: Catheter Exit Site Reaction
Serious: no
Organ System: General disorders
Notes: "Catheter Exit Site Reaction" was added to the trial database as an adverse event potentially related to the central venous catheter that all subjects received as part of the study.
Frequency: 45 affected / 173 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 29 affected / 173 at risk

Adverse event: Cholelithiasis
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 12 affected / 173 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 30 affected / 173 at risk

Adverse event: Pain: Abdomen NOS
Serious: no
Organ System: General disorders
Frequency: 16 affected / 173 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 28 affected / 173 at risk

Adverse event: Pain: head/headache
Serious: no
Organ System: Nervous system disorders
Frequency: 32 affected / 173 at risk

Adverse event: Dermatology/Skin - Other
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 21 affected / 173 at risk

Adverse event: Edema: Limb
Serious: no
Organ System: General disorders
Frequency: 22 affected / 173 at risk

Adverse event: Muscle weakness, generalized or specific area (not due to neuropathy): Extremity-lower
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 26 affected / 173 at risk

Adverse event: Pain: Back
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 17 affected / 173 at risk

Adverse event: Pulmonary - Other
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 20 affected / 173 at risk

Adverse event: Pain: Joint
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 19 affected / 173 at risk

Adverse event: Fatigue (asthenia, lethargy, malaise)
Serious: no
Organ System: General disorders
Frequency: 24 affected / 173 at risk

Adverse event: Musculoskeletal - Other
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 17 affected / 173 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 19 affected / 173 at risk

Adverse event: Dysphagia, (difficult swallowing)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 173 at risk

Adverse event: Infection - Other
Serious: no
Organ System: Infections and infestations
Frequency: 15 affected / 173 at risk

Adverse event: Muscle weakness, generalized or specific area (not due to neuropathy): Extremity-upper
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 19 affected / 173 at risk

Adverse event: Renal/Genitourinary - Other
Serious: no
Organ System: Renal and urinary disorders
Frequency: 13 affected / 173 at risk

Adverse event: Mood alteration: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 21 affected / 173 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 12 affected / 173 at risk

Adverse event: Gastrointestinal - Other
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 173 at risk

Adverse event: Mood alteration: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 14 affected / 173 at risk

Adverse event: Pain: Neck
Serious: no
Organ System: General disorders
Frequency: 15 affected / 173 at risk

Adverse event: Pain: Extremity-limb
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 10 affected / 173 at risk

Adverse event: Pruritis/itching
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 14 affected / 173 at risk

Adverse event: Drooling
Serious: no
Organ System: Nervous system disorders
Frequency: 16 affected / 173 at risk

Adverse event: Infection with normal ANC or grade 1 or 2 neutrophils: Urinary Tract NOS
Serious: no
Organ System: Infections and infestations
Frequency: 17 affected / 173 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 15 affected / 173 at risk

Adverse event: Fever (absence of neutropenia, where neutropenia is AGC <1.0x10e9/L)
Serious: no
Organ System: General disorders
Frequency: 12 affected / 173 at risk

Adverse event: ALT SGPT (serum glutamic pyruvic transaminase)
Serious: no
Organ System: Investigations
Frequency: 5 affected / 173 at risk

Adverse event: Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 14 affected / 173 at risk

Adverse event: Pain: chest wall
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 12 affected / 173 at risk

Adverse event: Heartburn/Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 173 at risk

Adverse event: Voice changes/dysarthria (e.g., hoarseness, loss or alteration of voice, laryngitis)
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 173 at risk

Adverse event: Muscle weakness, generalized of specific area (not due to neuropathy): Whole body/generalized
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 173 at risk

Adverse event: Bruising (in absence of grade 3 or 4 thrombocytopenia)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 10 affected / 173 at risk

Adverse event: Fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 10 affected / 173 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 173 at risk

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: no
Organ System: Investigations
Frequency: 2 affected / 173 at risk

Adverse event: Metabolic/Laboratory
Serious: no
Organ System: Investigations
Frequency: 13 affected / 173 at risk

Adverse event: Urinary frquency/urgency
Serious: no
Organ System: Renal and urinary disorders
Frequency: 11 affected / 173 at risk

Adverse event: Line break/tear
Serious: no
Organ System: General disorders
Notes: "Line break/tear" was added to the trial database as an adverse event potentially related to the central venous catheter that all subjects received as part of the study.
Frequency: 11 affected / 173 at risk

Adverse event: Pain - Other
Serious: no
Organ System: General disorders
Frequency: 12 affected / 173 at risk

Adverse event: Infection with unknown ANC: Upper airway NOS
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 173 at risk

Adverse event: Infection with unkown ANC: Urinary tract NOS
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 173 at risk

Adverse event: AST SGOT (serum glutamic oxaloacetic transaminase)
Serious: no
Organ System: Investigations
Frequency: 4 affected / 173 at risk

Adverse event: Allergic reaction/hypersensitivity (including drug fever)
Serious: no
Organ System: Immune system disorders
Frequency: 7 affected / 173 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 11 affected / 173 at risk

Adverse event: Hepatobiliary - Other
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 5 affected / 173 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 9 affected / 173 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 173 at risk