Study: NCT00634270

Adverse event: Vomiting/Anorexia
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grade 3
Frequency: 1 affected / 46 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Notes: Grade 3
Frequency: 1 affected / 46 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grade 2
Frequency: 1 affected / 46 at risk

Adverse event: Infection - Viral
Serious: yes
Organ System: Infections and infestations
Notes: Grade 2
Frequency: 1 affected / 46 at risk

Adverse event: ALT, AST & GGP
Serious: yes
Organ System: Investigations
Notes: Grade 3
Frequency: 1 affected / 46 at risk

Adverse event: Fever due to infection - Viral
Serious: yes
Organ System: Infections and infestations
Notes: Grade 3
Frequency: 1 affected / 46 at risk

Adverse event: Local Complication - Device/Prosthesis (Eye)
Serious: yes
Organ System: Surgical and medical procedures
Notes: Grade 3
Frequency: 1 affected / 46 at risk

Adverse event: Infection with Normal ANC (Pneumonia)
Serious: yes
Organ System: Infections and infestations
Notes: Grade 3
Frequency: 1 affected / 46 at risk

Adverse event: Left Ventricular Systolic Dysfuntion (Grade1) with Admission (Grade 2)
Serious: yes
Organ System: Cardiac disorders
Notes: Grade 2
Frequency: 1 affected / 46 at risk

Adverse event: Pain
Serious: yes
Organ System: General disorders
Notes: Grade 3
Frequency: 1 affected / 46 at risk

Adverse event: Motor Neuropathy - Paraplegia
Serious: yes
Organ System: Nervous system disorders
Notes: Grade 4
Frequency: 1 affected / 46 at risk

Adverse event: Infection - UTI (Normal ANC)
Serious: yes
Organ System: Infections and infestations
Notes: Grade 3
Frequency: 1 affected / 46 at risk

Adverse event: Acute respiratory distress syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 4
Frequency: 1 affected / 46 at risk

Adverse event: NF1 Related Planned Surgery
Serious: yes
Organ System: Surgical and medical procedures
Notes: Left Distal Femur and Left Proximal Tibid Epiphysiodesis (Unrelated to drug) Grade 3
Frequency: 1 affected / 46 at risk

Adverse event: Surgery - Injury to the Musculoskeletal (Lower Extremity)
Serious: yes
Organ System: Surgical and medical procedures
Notes: Grade 3
Frequency: 1 affected / 46 at risk

Adverse event: Hydrocephalus
Serious: yes
Organ System: Nervous system disorders
Notes: Grade 3
Frequency: 1 affected / 46 at risk

Adverse event: Altered Mental State
Serious: yes
Organ System: Nervous system disorders
Notes: Grade 2
Frequency: 1 affected / 46 at risk

Adverse event: Strep Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 3
Frequency: 1 affected / 46 at risk

Adverse event: Influenza Virus Type B
Serious: yes
Organ System: Infections and infestations
Notes: Grade 2
Frequency: 1 affected / 46 at risk

Adverse event: Pain - ABD and Leg
Serious: yes
Organ System: General disorders
Notes: Grade 2
Frequency: 1 affected / 46 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Grade 2
Frequency: 2 affected / 46 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 2
Frequency: 4 affected / 46 at risk

Adverse event: Low ANC
Serious: no
Organ System: Investigations
Notes: Grade 2
Frequency: 1 affected / 46 at risk

Adverse event: Low WBC
Serious: no
Organ System: Investigations
Notes: Grade 2
Frequency: 1 affected / 46 at risk

Adverse event: Pain - Stomach
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 3
Frequency: 1 affected / 46 at risk

Adverse event: Low Leukocytes
Serious: no
Organ System: Investigations
Notes: Grade 2
Frequency: 1 affected / 46 at risk

Adverse event: Stomatitis/Mucositis
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 1
Frequency: 1 affected / 46 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Investigations
Notes: Grade 2
Frequency: 1 affected / 46 at risk

Adverse event: Neutropoenia
Serious: no
Organ System: Investigations
Notes: Grade 2
Frequency: 4 affected / 46 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 2
Frequency: 8 affected / 46 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 3
Frequency: 2 affected / 46 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Investigations
Notes: Grade 2
Frequency: 4 affected / 46 at risk

Adverse event: Ear pain
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Grade 2
Frequency: 1 affected / 46 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 2
Frequency: 1 affected / 46 at risk

Adverse event: Mouth Sores
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 2
Frequency: 4 affected / 46 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Notes: Grade 2
Frequency: 1 affected / 46 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Grade 2
Frequency: 1 affected / 46 at risk

Adverse event: Pain -- Adominal
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 2
Frequency: 3 affected / 46 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 2
Frequency: 2 affected / 46 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 2
Frequency: 4 affected / 46 at risk

Adverse event: Hypercholesterolaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Grade 2
Frequency: 1 affected / 46 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Grade 2
Frequency: 3 affected / 46 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Grade 2
Frequency: 4 affected / 46 at risk

Adverse event: Mood Alteration
Serious: no
Organ System: Psychiatric disorders
Notes: Grade 2
Frequency: 2 affected / 46 at risk

Adverse event: Alanine aminotransferase
Serious: no
Organ System: Investigations
Notes: Grade 3
Frequency: 1 affected / 46 at risk

Adverse event: Aspartate aminotransferase
Serious: no
Organ System: Investigations
Notes: Grade 3
Frequency: 1 affected / 46 at risk

Adverse event: Gamma-glutamyltransferase
Serious: no
Organ System: Investigations
Notes: Grade 3
Frequency: 1 affected / 46 at risk

Adverse event: White blood cell count
Serious: no
Organ System: Investigations
Notes: Grade 2
Frequency: 1 affected / 46 at risk

Adverse event: Lukopenia
Serious: no
Organ System: Investigations
Notes: Grade 2
Frequency: 1 affected / 46 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Investigations
Notes: Grade 3
Frequency: 2 affected / 46 at risk

Adverse event: Allergic Reaction - Bactrim
Serious: no
Organ System: Immune system disorders
Notes: Grade 2
Frequency: 1 affected / 46 at risk

Adverse event: Hirsutism several locations
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Legs, Trunk, Back and Face Grade 2
Frequency: 1 affected / 46 at risk

Adverse event: New Neurofibroma
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: NF on Back - Grade 2
Frequency: 1 affected / 46 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Grade 2
Frequency: 1 affected / 46 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Notes: Grade 2
Frequency: 1 affected / 46 at risk

Adverse event: Infection with Normal ANC - Lung
Serious: no
Organ System: Infections and infestations
Notes: Pneumo Grade 3
Frequency: 1 affected / 46 at risk

Adverse event: Mood Alteration - Depression
Serious: no
Organ System: Psychiatric disorders
Notes: Grade 3
Frequency: 1 affected / 46 at risk

Adverse event: Infection -Derm/Skin
Serious: no
Organ System: Infections and infestations
Notes: Cellulitis Grade 2
Frequency: 1 affected / 46 at risk

Adverse event: Infection w/ Normal ANC
Serious: no
Organ System: Infections and infestations
Notes: Grade 2
Frequency: 2 affected / 46 at risk

Adverse event: Infection w/ Normal ANC: Otitis Media
Serious: no
Organ System: Infections and infestations
Notes: Grade 3
Frequency: 1 affected / 46 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Grade 2
Frequency: 1 affected / 46 at risk

Adverse event: Leukocytes
Serious: no
Organ System: Investigations
Notes: Grade 2
Frequency: 1 affected / 46 at risk

Adverse event: Neutrophil count
Serious: no
Organ System: Investigations
Notes: Grade 2
Frequency: 5 affected / 46 at risk

Adverse event: Pain - Throat
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 2
Frequency: 1 affected / 46 at risk

Adverse event: Neutrophil count
Serious: no
Organ System: Investigations
Notes: Grade 3
Frequency: 2 affected / 46 at risk

Adverse event: Pneumonitis
Serious: no
Organ System: Infections and infestations
Notes: Grade 2
Frequency: 1 affected / 46 at risk

Adverse event: ARDS (Secondary to RSV)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 4
Frequency: 1 affected / 46 at risk

Adverse event: Triglycerides - Serum High
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Grade 2
Frequency: 2 affected / 46 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Notes: Grade 2
Frequency: 1 affected / 46 at risk

Adverse event: LDL Cholesterol 235MG/DL
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Grade 3
Frequency: 1 affected / 46 at risk

Adverse event: Total Cholesterol
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Grade 2
Frequency: 1 affected / 46 at risk

Adverse event: Pain - Back
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Grade 2
Frequency: 1 affected / 46 at risk

Adverse event: Neutrophils/Granulocytes (ANC/AGC)
Serious: no
Organ System: Investigations
Notes: Grade 2
Frequency: 4 affected / 46 at risk

Adverse event: Infection - Upper Airway NOS
Serious: no
Organ System: Infections and infestations
Notes: Grade 2
Frequency: 1 affected / 46 at risk

Adverse event: Neutrophils/Granulocytes Low
Serious: no
Organ System: Investigations
Notes: Grade 3
Frequency: 1 affected / 46 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 2
Frequency: 1 affected / 46 at risk

Adverse event: Hydrocephalus
Serious: no
Organ System: Nervous system disorders
Notes: Grade 3
Frequency: 1 affected / 46 at risk

Adverse event: Otitis - Middle Ear
Serious: no
Organ System: Infections and infestations
Notes: Grade 2
Frequency: 2 affected / 46 at risk

Adverse event: Pain - Leg
Serious: no
Organ System: General disorders
Notes: Grade 2
Frequency: 1 affected / 46 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Investigations
Notes: Grade 3
Frequency: 1 affected / 46 at risk

Adverse event: Infection - Ear
Serious: no
Organ System: Infections and infestations
Notes: Grade 2
Frequency: 1 affected / 46 at risk

Adverse event: Aspartate aminotransferase
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grade 2
Frequency: 1 affected / 12 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grade 3
Frequency: 1 affected / 12 at risk

Adverse event: Alanine aminotransferase
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grade 3
Frequency: 1 affected / 12 at risk

Adverse event: Hydroureteronephrosis
Serious: yes
Organ System: Renal and urinary disorders
Notes: Resulting in Increased Creatinine - Grade 3
Frequency: 1 affected / 12 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Grade 2
Frequency: 1 affected / 12 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 2
Frequency: 2 affected / 12 at risk

Adverse event: Mouth Sores
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 2
Frequency: 2 affected / 12 at risk

Adverse event: Pain -- Adominal
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 2
Frequency: 3 affected / 12 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 2
Frequency: 1 affected / 12 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Grade 2
Frequency: 1 affected / 12 at risk

Adverse event: Alanine aminotransferase
Serious: no
Organ System: Investigations
Notes: Grade 3
Frequency: 1 affected / 12 at risk

Adverse event: Lukopenia
Serious: no
Organ System: Investigations
Notes: Grade 2
Frequency: 1 affected / 12 at risk

Adverse event: Neutrophil count
Serious: no
Organ System: Investigations
Notes: Grade 2
Frequency: 1 affected / 12 at risk

Adverse event: Face Tenderness/Swollen/Headaches/Aches
Serious: no
Organ System: Nervous system disorders
Notes: Grade 2
Frequency: 1 affected / 12 at risk

Adverse event: Aspartate aminotransferase
Serious: no
Organ System: Investigations
Notes: Grade 2
Frequency: 1 affected / 12 at risk

Adverse event: Infection - fever of unknown temperature / Cold
Serious: no
Organ System: Infections and infestations
Notes: Grade 2
Frequency: 1 affected / 12 at risk

Adverse event: High Blood Pressure
Serious: no
Organ System: Vascular disorders
Notes: Grade 2
Frequency: 1 affected / 12 at risk

Adverse event: Mouth Sore - Upper Inner Left Corner
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 2
Frequency: 1 affected / 12 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 2
Frequency: 1 affected / 12 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 2
Frequency: 1 affected / 12 at risk

Adverse event: Edema - Knee Swelling
Serious: no
Organ System: General disorders
Notes: Grade 2
Frequency: 1 affected / 12 at risk

Adverse event: Pain - Knee
Serious: no
Organ System: General disorders
Notes: Grade 2
Frequency: 1 affected / 12 at risk

Adverse event: Low Hemoglobin Delaying Start of Cycle
Serious: no
Organ System: Investigations
Notes: Grade 2
Frequency: 1 affected / 12 at risk

Adverse event: Infection - Thrush w/OK ANC
Serious: no
Organ System: Infections and infestations
Notes: Grade 2
Frequency: 1 affected / 12 at risk