TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT00755261

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Oral thrush, dehydration, no able to swallow medications. No oral intake x 5 days.
Frequency: 1 affected / 4 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Notes: Known pelvic malignancy; limited urinary sx. Scr creatinine = 0.9. Unable to void 24- 36 hrs. No output with straight catheterization. Creatinine=5.3. Occurred prior to any oral study drug being taken. Not related to treatment.
Frequency: 1 affected / 4 at risk

Adverse event: Candida infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 4 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 4 at risk

Adverse event: dysphagia -unable to swallow medications
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4 at risk
Study: NCT00755274

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 24 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 24 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 24 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 24 at risk

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

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 8 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 8 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 8 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 8 at risk
Study: NCT00755326

Adverse event: GI complaint
Serious: no
Organ System: General disorders
Frequency: 5 affected / 47 at risk

Adverse event: GI complaint
Serious: no
Organ System: General disorders
Frequency: 5 affected / 45 at risk
Study: NCT00756275

Adverse event: substance abuse (hospital or death)
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 60 at risk

Adverse event: accidents (ER or hospital)
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 60 at risk

Adverse event: hospital and respiratory disorder
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: increased depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 60 at risk

Adverse event: substance abuse (hospital or death)
Serious: yes
Organ System: Psychiatric disorders
Frequency: 4 affected / 77 at risk

Adverse event: accidents (ER or hospital)
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 77 at risk

Adverse event: pregnancy complication
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 77 at risk

Adverse event: Diabetic complication
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 77 at risk

Adverse event: Disorientation
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 77 at risk

Adverse event: increased depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 77 at risk
Study: NCT00756470

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grade 3
Frequency: 7 affected / 15 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Grade 3
Frequency: 3 affected / 15 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Grade 3
Frequency: 1 affected / 15 at risk

Adverse event: Rash
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: Grade 3
Frequency: 3 affected / 15 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Notes: Grade 3
Frequency: 3 affected / 15 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 2
Frequency: 2 affected / 15 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 2
Frequency: 2 affected / 15 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Grade 2
Frequency: 5 affected / 15 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 2
Frequency: 1 affected / 15 at risk

Adverse event: Liver dysfunction
Serious: no
Organ System: Hepatobiliary disorders
Notes: Grade 2
Frequency: 3 affected / 15 at risk

Adverse event: Decreased Ejection Fraction
Serious: no
Organ System: Cardiac disorders
Notes: Grade 2
Frequency: 1 affected / 15 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Grade 2
Frequency: 7 affected / 15 at risk
Study: NCT00756548

Adverse event: abdominal cramping
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 186 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 96 affected / 186 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 70 affected / 186 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 86 affected / 186 at risk

Adverse event: Overall discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 116 affected / 186 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 26 affected / 186 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 112 affected / 185 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 79 affected / 185 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 72 affected / 185 at risk

Adverse event: Overall discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 121 affected / 185 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 185 at risk
Study: NCT00756561

Adverse event: discomfort at lidocaine injection site
Serious: no
Organ System: Reproductive system and breast disorders
Notes: reported discomfort from 11/5/08 to 12/2/08. Discomfort usually ends within a few days; this subject habitually bicycled 20 miles per day, and was advised to reduce bicycling for a short time.
Frequency: 1 affected / 11 at risk

Adverse event: bruised ribs
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Subject is security officer and bruised ribs while restraining someone.
Frequency: 1 affected / 11 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Subjects did not take any medications for their colds.
Frequency: 2 affected / 11 at risk
Study: NCT00756717

Adverse event: Mild hot flashes
Serious: no
Organ System: General disorders
Frequency: 8 affected / 20 at risk

Adverse event: Grade 1 Pelvic heaviness & vaginal discharge
Serious: no
Organ System: General disorders
Frequency: 1 affected / 20 at risk

Adverse event: Grade 1 peri-orbital edema and cough
Serious: no
Organ System: General disorders
Frequency: 1 affected / 20 at risk

Adverse event: Grade 1 acneiform facial rash
Serious: no
Organ System: General disorders
Frequency: 4 affected / 20 at risk

Adverse event: Self-limiting nausea, vomiting, and headaches
Serious: no
Organ System: General disorders
Frequency: 1 affected / 20 at risk
Study: NCT00756730

Adverse event: Urosepsis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 25 at risk

Adverse event: Upper Respiratory Infection (URI)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 25 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 25 at risk

Adverse event: possible bowel obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 24 at risk

Adverse event: alcohol withdrawal/suicidal Ideation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 24 at risk

Adverse event: Upper Respiratory Infection (URI)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 24 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 24 at risk

Adverse event: Erectile dysfunction
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 24 at risk
Study: NCT00756977

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 92 affected / 176 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 71 affected / 176 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 74 affected / 176 at risk

Adverse event: overall discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 122 affected / 176 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 19 affected / 176 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 85 affected / 190 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 78 affected / 190 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 75 affected / 190 at risk

Adverse event: overall discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 108 affected / 190 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 190 at risk
Study: NCT00757003

Adverse event: Atelectasis/Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 28 affected / 100 at risk

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 21 affected / 100 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 13 affected / 100 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 12 affected / 100 at risk

Adverse event: change in mental status
Serious: yes
Organ System: Nervous system disorders
Frequency: 11 affected / 100 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 8 affected / 100 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 9 affected / 100 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 7 affected / 100 at risk

Adverse event: Procedural haemorrhage
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 12 affected / 100 at risk

Adverse event: paraplegia/paraparesis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 100 at risk

Adverse event: type I endoleak
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 13 affected / 100 at risk

Adverse event: type II endoleak
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 7 affected / 100 at risk

Adverse event: access failure
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 100 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 4 affected / 100 at risk

Adverse event: Intestinal ischaemia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 100 at risk

Adverse event: Thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 100 at risk

Adverse event: Lymphocele
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 100 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 100 at risk

Adverse event: aortic diameter enlargement
Serious: no
Organ System: Vascular disorders
Frequency: 16 affected / 100 at risk
Study: NCT00757627

Adverse event: Peritoneal adhesion
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 500 at risk

Adverse event: Bacterial infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 500 at risk

Adverse event: Lung abscess, chest pain/tightness and tremor
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 500 at risk

Adverse event: Road traffic accident
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 500 at risk

Adverse event: Urethritis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 500 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 500 at risk

Adverse event: Abdominal distension / flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 500 at risk

Adverse event: Abdominal pain, upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 500 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 500 at risk

Adverse event: Edema , face/eye /hand/leg
Serious: no
Organ System: Vascular disorders
Frequency: 24 affected / 500 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 500 at risk

Adverse event: Hypertension / elevated blood pressure
Serious: no
Organ System: Vascular disorders
Frequency: 9 affected / 500 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 500 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 8 affected / 500 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 500 at risk
Study: NCT00757666

Adverse event: Cardiovascular Adverse Events
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 34 at risk

Adverse event: Cardiovascular Adverse Events
Serious: no
Organ System: Cardiac disorders
Frequency: 8 affected / 34 at risk
Study: NCT00757822

Adverse event: overnight hospitalization secondary to unanticipated extensive surgery
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 3 affected / 92 at risk

Adverse event: overnight hospitalization secondary to urinary retention
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 4 affected / 92 at risk

Adverse event: overnight hospitalization secondary to excessive postoperative pain
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 92 at risk

Adverse event: post-operative overnight hospitalization secondary to low sPO2
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 92 at risk

Adverse event: post-operative complication due to surgery
Serious: yes
Organ System: Surgical and medical procedures
Notes: Patient presented and re-hospitalized due to issues secondary to surgical procedure following discharge (e.g. infection, excessive swelling, suture rupture)
Frequency: 3 affected / 92 at risk

Adverse event: Swelling at incision site
Serious: no
Organ System: Surgical and medical procedures
Notes: AE was noted if participant complained of or was seen for any swelling, redness, or other issues involving incision site and wound healing
Frequency: 2 affected / 92 at risk

Adverse event: overnight hospitalization secondary to unanticipated extensive surgery
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 3 affected / 88 at risk

Adverse event: overnight hospitalization secondary to urinary retention
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 3 affected / 88 at risk

Adverse event: overnight hospitalization secondary to excessive postoperative pain
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 88 at risk

Adverse event: hospitalization due to co-morbid preexisting conditions
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Participant re-hospitalized within 30 days of study follow-up for further GI work-up due to pre-existing conditions.
Frequency: 2 affected / 88 at risk

Adverse event: hospitilization due to co-morbid preexisting conditions
Serious: yes
Organ System: Cardiac disorders
Notes: iatrogenic bradycardia/hypotension
Frequency: 1 affected / 88 at risk

Adverse event: Swelling at incision site
Serious: no
Organ System: Surgical and medical procedures
Notes: AE was noted if participant complained of or was seen for any swelling, redness, or other issues involving incision site and wound healing
Frequency: 6 affected / 88 at risk
Study: NCT00757848

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 26 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 26 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 26 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 26 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 26 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 29 at risk

Adverse event: Lower respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 29 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 29 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 29 at risk

Adverse event: Non-cardiac chest pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 29 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 29 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 29 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 29 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 29 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 29 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 29 at risk
Study: NCT00758069

Adverse event: Overdose
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 27 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 27 at risk

Adverse event: Overdose
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 25 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 25 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 28 at risk
Study: NCT00758459

Adverse event: Pharyngeal cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 35 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 35 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 35 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 35 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 39 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 39 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 39 at risk
Study: NCT00758498

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 142 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 142 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 142 at risk

Adverse event: Medical device site reaction
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 23 affected / 142 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 23 affected / 142 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 142 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 7 affected / 143 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 143 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 143 at risk

Adverse event: Medical device site reaction
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 24 affected / 143 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 36 affected / 143 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 143 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 142 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 142 at risk

Adverse event: Medical device site reaction
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 25 affected / 142 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 16 affected / 142 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 142 at risk
Study: NCT00758576

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Notes: No causality with the test article
Frequency: 1 affected / 64 at risk