TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT00075023

Adverse event: Increase in oral pain
Serious: no
Organ System: General disorders
Notes: Participant removed from study according to study stopping rules
Frequency: 1 affected / 5 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Subject hospitalized for non-protocol related penumonia and missed signficant doses of the study drug.
Frequency: 1 affected / 5 at risk

Adverse event: Increase in oral pain
Serious: no
Organ System: General disorders
Notes: Participant removed from study according to study stopping rules
Frequency: 1 affected / 5 at risk

Adverse event: Spouse pregnancy
Serious: no
Organ System: Social circumstances
Notes: Subject removed from study because he told research staff his wife was pregnant. He was removed due to concern over the risk of transmission of the study drug to the fetus.
Frequency: 1 affected / 5 at risk

Adverse event: Dyspnea on exertion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: not related to drug
Frequency: 1 affected / 10 at risk

Adverse event: Candida infection
Serious: no
Organ System: General disorders
Frequency: 2 affected / 10 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 10 at risk

Adverse event: Oral pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 10 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 10 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 1 affected / 10 at risk

Adverse event: tired
Serious: no
Organ System: General disorders
Frequency: 1 affected / 10 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: General disorders
Frequency: 1 affected / 10 at risk

Adverse event: loss of appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 1 affected / 10 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 10 at risk
Study: NCT00075088

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 403 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 391 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 40 affected / 40 at risk
Study: NCT00075335

Adverse event: elevated LDH
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 8 at risk

Adverse event: elevated Lymphs (efficacy measure)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 8 at risk

Adverse event: elevated lymphs (expected)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 8 at risk

Adverse event: elevated Monos (expected)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 8 affected / 8 at risk

Adverse event: elevated Polys (expected)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 8 affected / 8 at risk

Adverse event: elevated WBCs (expected)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 8 affected / 8 at risk

Adverse event: Sinus tachycardia (rate 103)
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 8 at risk

Adverse event: auditory (R ear) pain
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 8 at risk

Adverse event: Cramps, abdominal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: feel need to vomit, no nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 2 affected / 8 at risk

Adverse event: Hot feeling
Serious: no
Organ System: General disorders
Frequency: 1 affected / 8 at risk

Adverse event: Swelling, leg
Serious: no
Organ System: General disorders
Frequency: 1 affected / 8 at risk

Adverse event: Injection site (erythema)
Serious: no
Organ System: Immune system disorders
Frequency: 5 affected / 8 at risk

Adverse event: Injection site (induration)
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 8 at risk

Adverse event: Injection site (pain)
Serious: no
Organ System: Immune system disorders
Frequency: 3 affected / 8 at risk

Adverse event: Injection site (pruritus)
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 8 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 8 at risk

Adverse event: paresthesia (facial tingling)
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 8 at risk

Adverse event: Syncope
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 8 at risk
Study: NCT00075608

Adverse event: Sepsis
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Grade IV
Frequency: 2 affected / 12 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Infections and infestations
Notes: Grade III and IV
Frequency: 8 affected / 12 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Notes: Grade IV
Frequency: 2 affected / 12 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Notes: Grade III and IV
Frequency: 8 affected / 12 at risk

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

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grade III
Frequency: 5 affected / 12 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Cardiac disorders
Notes: Grade III
Frequency: 5 affected / 12 at risk

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 12 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 12 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 12 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 12 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 12 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Investigations
Frequency: 2 affected / 12 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Investigations
Frequency: 3 affected / 12 at risk
Study: NCT00075816

Adverse event: Pericarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 260 at risk

Adverse event: Blindness
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 260 at risk

Adverse event: Intra-abdominal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 260 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 260 at risk

Adverse event: Portal vein occlusion
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 260 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 260 at risk

Adverse event: Craniofacial fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 260 at risk

Adverse event: Squamous cell carcinoma of skin
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 260 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 260 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 260 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 260 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 260 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 261 at risk

Adverse event: Retinal tear
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 261 at risk

Adverse event: Retinopathy
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 261 at risk

Adverse event: Sudden death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 261 at risk

Adverse event: Hepatic enzyme increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 261 at risk

Adverse event: Acute respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 261 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 261 at risk

Adverse event: Hypertensive crisis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 261 at risk
Study: NCT00076804

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 9 affected / 137 at risk

Adverse event: DAIDS Grade IV AE
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 137 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 137 at risk

Adverse event: AIDS-Defining Illness
Serious: no
Organ System: General disorders
Frequency: 22 affected / 137 at risk

Adverse event: DAIDS Grade III Event
Serious: no
Organ System: General disorders
Frequency: 17 affected / 137 at risk

Adverse event: New Diagnosis/Worsening Medical Condition
Serious: no
Organ System: General disorders
Frequency: 32 affected / 137 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 20 affected / 137 at risk

Adverse event: DAIDS Grade IV AE
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 137 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: General disorders
Frequency: 7 affected / 137 at risk

Adverse event: AIDS-Defining Illness
Serious: no
Organ System: General disorders
Frequency: 31 affected / 137 at risk

Adverse event: DAIDS Grade III Event
Serious: no
Organ System: General disorders
Frequency: 21 affected / 137 at risk

Adverse event: New Diagnosis/Worsening Medical Condition
Serious: no
Organ System: General disorders
Frequency: 37 affected / 137 at risk
Study: NCT00078286

Adverse event: Cardiovascular
Serious: yes
Organ System: Cardiac disorders
Frequency: 40 affected / 234 at risk

Adverse event: Noncardiovascular and nonpsychiatric
Serious: yes
Organ System: General disorders
Frequency: 17 affected / 234 at risk

Adverse event: Cardiac failure congestive
Serious: no
Organ System: Cardiac disorders
Frequency: 11 affected / 234 at risk

Adverse event: Angina unstable
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 234 at risk

Adverse event: Other Cardiovascular
Serious: no
Organ System: Cardiac disorders
Frequency: 9 affected / 234 at risk

Adverse event: Cardiovascular
Serious: yes
Organ System: Cardiac disorders
Frequency: 44 affected / 235 at risk

Adverse event: Psychiatric
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 235 at risk

Adverse event: Noncardiovascular and nonpsychiatric
Serious: yes
Organ System: General disorders
Frequency: 17 affected / 235 at risk

Adverse event: Cardiac failure congestive
Serious: no
Organ System: Cardiac disorders
Frequency: 10 affected / 235 at risk

Adverse event: Angina unstable
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 235 at risk

Adverse event: Other Cardiovascular
Serious: no
Organ System: Cardiac disorders
Frequency: 11 affected / 235 at risk
Study: NCT00078312

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 323 at risk

Adverse event: Tachycardia paroxysmal
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 323 at risk

Adverse event: Intra-abdominal haematoma
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 323 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 323 at risk

Adverse event: Non-cardiac chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 323 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 323 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 323 at risk

Adverse event: Multiple sclerosis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 323 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 323 at risk

Adverse event: Nephrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 323 at risk

Adverse event: Menometrorrhagia
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 323 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 323 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 323 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 323 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 27 affected / 323 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 33 affected / 323 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 18 affected / 323 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 18 affected / 323 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 55 affected / 323 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 27 affected / 323 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 46 affected / 323 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 21 affected / 323 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 18 affected / 323 at risk
Study: NCT00078325

Adverse event: Colitis ulcerative
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 131 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 131 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 131 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 27 affected / 131 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 131 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 9 affected / 131 at risk

Adverse event: Duodenal ulcer haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 131 at risk

Adverse event: Migraine
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 131 at risk

Adverse event: Affective disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 131 at risk

Adverse event: Personality disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 131 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 131 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 131 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 19 affected / 131 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 131 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 8 affected / 131 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 130 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 130 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 130 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 130 at risk
Study: NCT00078377

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 67 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 67 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 67 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 19 affected / 67 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 67 at risk

Adverse event: Angioedema
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 64 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 64 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 64 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 64 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 64 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 64 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 63 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 63 at risk
Study: NCT00078715

Adverse event: Insomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 6 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 6 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Taste disorder
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Increased urination
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 6 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 6 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk
Study: NCT00079391

Adverse event: Transplant Related Death
Serious: yes
Organ System: Immune system disorders
Frequency: 9 affected / 49 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 49 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Immune system disorders
Frequency: 2 affected / 49 at risk

Adverse event: Death
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 12 affected / 49 at risk

Adverse event: Life threatening
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 49 at risk

Adverse event: Acute GVHD before day 60
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 10 affected / 49 at risk

Adverse event: Chronic GVHD
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 22 affected / 49 at risk

Adverse event: Cystitis haemorrhagic
Serious: no
Organ System: Immune system disorders
Frequency: 4 affected / 49 at risk

Adverse event: Cytomegalovirus disease
Serious: no
Organ System: Immune system disorders
Frequency: 37 affected / 49 at risk

Adverse event: Disease Relapse
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 18 affected / 49 at risk

Adverse event: Acute GVHD after day 60
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 19 affected / 49 at risk
Study: NCT00079417

Adverse event: Device related infection
Serious: yes
Organ System: Infections and infestations
Notes: Grades 3-5
Frequency: 1 affected / 21 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Grades 3-5
Frequency: 1 affected / 21 at risk

Adverse event: Neutrophil count decreased
Serious: yes
Organ System: Investigations
Notes: Grades 3-5
Frequency: 6 affected / 21 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Notes: Grades 3-5
Frequency: 1 affected / 21 at risk

Adverse event: Urticaria
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: Grades 3-5
Frequency: 1 affected / 21 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Notes: Grades 1-2
Frequency: 1 affected / 21 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Notes: Grades 1-2
Frequency: 2 affected / 21 at risk
Study: NCT00079677

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 129 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 19 affected / 129 at risk

Adverse event: Gastro-oesophageal reflux disease
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 130 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 130 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 130 at risk
Study: NCT00080288

Adverse event: Meningitis viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 123 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 123 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 123 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 15 affected / 123 at risk

Adverse event: Depression suicidal
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 122 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 122 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 122 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 12 affected / 122 at risk
Study: NCT00080912

Adverse event: Cardiac ischemia/infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 425 at risk