Study: NCT00582166

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Notes: Infection with grade 3 or 4 neutropenia
Frequency: 1 affected / 16 at risk

Adverse event: Leukocytes (total WBC)
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 16 at risk

Adverse event: Neutrophils/granulocytes
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 16 at risk

Adverse event: Platelets
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 16 at risk

Adverse event: Tranfusion: Platelets
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 16 at risk

Adverse event: Auditory/Ear - Other - Vertigo
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 16 at risk

Adverse event: Blood/Bone Marrow - Other - Anemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 9 affected / 16 at risk

Adverse event: Leukocytes
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 15 affected / 16 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 9 affected / 16 at risk

Adverse event: Neutrophils/granulo-cytes (ANC/AGC)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 9 affected / 16 at risk

Adverse event: Platelets
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 13 affected / 16 at risk

Adverse event: Fatigue (asthenia, lethargy, malaise)
Serious: no
Organ System: General disorders
Frequency: 12 affected / 16 at risk

Adverse event: Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 109/L
Serious: no
Organ System: General disorders
Frequency: 1 affected / 16 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 16 at risk

Adverse event: Rigors/chills
Serious: no
Organ System: General disorders
Frequency: 1 affected / 16 at risk

Adverse event: Weight increased
Serious: no
Organ System: General disorders
Frequency: 1 affected / 16 at risk

Adverse event: Dermatology/Skin - Other - Cold Sore
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 16 at risk

Adverse event: Dermatology/Skin - Other - Knee Puncture
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Subject indicated involvement in a deer attack
Frequency: 1 affected / 16 at risk

Adverse event: Dermatology/Skin - Other - Rash (erythema & scaling)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 16 at risk

Adverse event: Dermatology/Skin - Other - Skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: No other information was provided in the study chart other than "Skin"
Frequency: 2 affected / 16 at risk

Adverse event: Pruritus/Itching
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 16 at risk

Adverse event: Hot Flashes/flushes
Serious: no
Organ System: Endocrine disorders
Frequency: 4 affected / 16 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 16 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 16 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 16 at risk

Adverse event: Vomitting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 16 at risk

Adverse event: Hemmorage/Bleeding - Other - Hemmorage
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 16 at risk

Adverse event: Infection - Dermatology/Skin - Skin (cellulitus)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 16 at risk

Adverse event: Infection - Other - Infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 16 at risk

Adverse event: Infection - Pulmonary/Upper Respiratory - Sinus
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 16 at risk

Adverse event: Infection - Pulmonary/Upper Respiratory - Upper aerodigestive NOS
Serious: no
Organ System: Infections and infestations
Notes: "THRUSH" was documented for all events
Frequency: 1 affected / 16 at risk

Adverse event: Infection - Pulmonary/Upper Respiratory - Upper Airway NOS
Serious: no
Organ System: Infections and infestations
Notes: "INFECTION - URI \[Upper Respiratory Infection\]" was documented in all cases
Frequency: 4 affected / 16 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutropenia - Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 16 at risk

Adverse event: Edema:limb
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 16 at risk

Adverse event: ALT, SGOT (serum glutamic pyruvic transaminase)
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: ALT (aspartate aminotranferase increased) documented
Frequency: 2 affected / 16 at risk

Adverse event: Glucose, serum-high (hyperglycemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 16 at risk

Adverse event: Metabolic/Laboratory - Other - (PT(INR))
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: INR (international normalized ratio) noted on chart
Frequency: 1 affected / 16 at risk

Adverse event: Metabolic/Laboratory - Other (Sodium - low)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 16 at risk

Adverse event: Mood alteration - anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 16 at risk

Adverse event: Neurology - Other - Neuralgia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 16 at risk

Adverse event: Neurology - Other - Neuro-Sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 16 at risk

Adverse event: Ocular/Vision - Other - Vision Problems
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 16 at risk

Adverse event: Ocular/Vision - Other - Worsening Peripheral Vision
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 16 at risk

Adverse event: Pain - Gastrointestinal - Abdomen
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 16 at risk

Adverse event: Pain - Musculoskeletal - Extremity/Limb
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 16 at risk

Adverse event: Pain - Musculoskeletal - Back
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 16 at risk

Adverse event: Pain - Gastrointestinal - Joint
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Subject 2 - hip Subject 4 - wrist
Frequency: 2 affected / 16 at risk

Adverse event: Pain - Neurology - Head/Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 16 at risk

Adverse event: Pain - Other - Other
Serious: no
Organ System: Nervous system disorders
Notes: Only "PAIN" documented
Frequency: 3 affected / 16 at risk

Adverse event: Pain - Other - Splenamalgy
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 16 at risk

Adverse event: Pain - Pulmonary/Upper Respiratory - Pleura
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 16 at risk

Adverse event: Pain - Sexual/Reproductive Function - Pelvis
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 16 at risk

Adverse event: Pain - Musculoskeletal - Muscle
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 16 at risk

Adverse event: Pain - Gastrointestinal - Tooth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 16 at risk

Adverse event: Pain - Hepatobiliary/Pancreas - gallbladder
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 16 at risk

Adverse event: Pain - Ocular - Eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 16 at risk

Adverse event: Pain - Other - Groin
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 16 at risk

Adverse event: Pain - Other - Epigastric
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 16 at risk

Adverse event: Pain - Pulmonary/Upper Respiratory - Throat
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 16 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 16 at risk

Adverse event: Dyspnea (shortness of breath)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 16 at risk

Adverse event: Pulmonary/Upper Respiratory - Other - Asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 16 at risk

Adverse event: Voice changes/dysarthria (e.g., hoarseness, loss or alteration in voice, laryngitis)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 16 at risk

Adverse event: Renal/genitourinary - Other (Dysuria)
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 16 at risk

Adverse event: Erectile dysfunction
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 16 at risk

Adverse event: Gynaecomastia
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 16 at risk