TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT00584987

Adverse event: Headaches
Serious: no
Organ System: General disorders
Notes: A headache or cephalalgia is pain anywhere in the region of the head or neck.
Frequency: 2 affected / 15 at risk

Adverse event: Headaches
Serious: no
Organ System: General disorders
Notes: A headache or cephalalgia is pain anywhere in the region of the head or neck.
Frequency: 4 affected / 16 at risk

Adverse event: Headaches
Serious: no
Organ System: General disorders
Notes: A headache or cephalalgia is pain anywhere in the region of the head or neck.
Frequency: 2 affected / 17 at risk

Adverse event: Headaches
Serious: no
Organ System: General disorders
Notes: A headache or cephalalgia is pain anywhere in the region of the head or neck.
Frequency: 2 affected / 16 at risk
Study: NCT00585169

Adverse event: Light-headed/dizzy
Serious: no
Organ System: General disorders
Frequency: 2 affected / 29 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 3 affected / 29 at risk

Adverse event: Light-headed/dizzy
Serious: no
Organ System: General disorders
Frequency: 4 affected / 24 at risk

Adverse event: Lethargic or tired
Serious: no
Organ System: General disorders
Frequency: 1 affected / 24 at risk

Adverse event: Decreased libido
Serious: no
Organ System: General disorders
Frequency: 1 affected / 24 at risk

Adverse event: Light-headed/dizzy
Serious: no
Organ System: General disorders
Frequency: 2 affected / 16 at risk

Adverse event: Lethargic or tired
Serious: no
Organ System: General disorders
Frequency: 3 affected / 16 at risk

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

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 2 affected / 16 at risk
Study: NCT00585351

Adverse event: Subarachnoid Hemorrhage (SAH) resulting in Death
Serious: yes
Organ System: Nervous system disorders
Notes: Subject was randomized to Advanced Notification + Ranitidine. Subject's admitting diagnosis was SAH. Did receive study drug, but did not improve, so family pursued palliative care and subject passed away. Event deemed not related to study drug.
Frequency: 1 affected / 5 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Notes: Subject was randomized to Advanced Notification + Placebo. Subject's admitting diagnosis was intracranial hemorrhage, and had myocardial infarction. Received study drug, but passed away from cardiac arrest. Event deemed not related to study drug.
Frequency: 1 affected / 7 at risk

Adverse event: Pneumonia aspiration
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: One subject in the advanced notification + placebo group developed aspiration pneumonia.
Frequency: 1 affected / 7 at risk
Study: NCT00585533

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 40 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 40 at risk

Adverse event: Deep vein thrombosis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 40 at risk

Adverse event: Paronychia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 40 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 40 at risk
Study: NCT00585585

Adverse event: Mild to Moderate Gastrointestinal irritation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1 at risk
Study: NCT00585637

Adverse event: hypercalcemia at 1 month
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 23 at risk

Adverse event: hypercalcemia at 1 month
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 16 at risk

Adverse event: hypercalcemia at 3 months
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 31 at risk
Study: NCT00585650

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 8 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 12 at risk
Study: NCT00585780

Adverse event: Ligtheadedness/dizzy
Serious: no
Organ System: Cardiac disorders
Notes: Dizzy and/or lightheadedness
Frequency: 1 affected / 21 at risk

Adverse event: Pain
Serious: no
Organ System: Nervous system disorders
Notes: subjective rating of pain
Frequency: 2 affected / 21 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: subjective reporting of headache
Frequency: 1 affected / 21 at risk

Adverse event: Cold and Flu
Serious: no
Organ System: Infections and infestations
Notes: Patient report of cold and flu-like symptoms
Frequency: 1 affected / 21 at risk

Adverse event: Ligtheadedness/dizzy
Serious: no
Organ System: Cardiac disorders
Notes: Dizzy and/or lightheadedness
Frequency: 1 affected / 23 at risk

Adverse event: Pain
Serious: no
Organ System: Nervous system disorders
Notes: subjective rating of pain
Frequency: 1 affected / 23 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: subjective reporting of headache
Frequency: 1 affected / 23 at risk

Adverse event: Cold and Flu
Serious: no
Organ System: Infections and infestations
Notes: Patient report of cold and flu-like symptoms
Frequency: 2 affected / 23 at risk

Adverse event: Alcohol poisoning
Serious: yes
Organ System: Psychiatric disorders
Notes: Patient was admitted overnight after arriving at the ER with a blood alcohol concentration of 49mg/dl. Patient was referred back to the clinic the next morning to engage in treatment.
Frequency: 1 affected / 34 at risk

Adverse event: Ligtheadedness/dizzy
Serious: no
Organ System: Cardiac disorders
Notes: Dizzy and/or lightheadedness
Frequency: 2 affected / 34 at risk

Adverse event: Pain
Serious: no
Organ System: Nervous system disorders
Notes: subjective rating of pain
Frequency: 4 affected / 34 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: subjective reporting of headache
Frequency: 2 affected / 34 at risk

Adverse event: Cold and Flu
Serious: no
Organ System: Infections and infestations
Notes: Patient report of cold and flu-like symptoms
Frequency: 3 affected / 34 at risk

Adverse event: weakness and fainting
Serious: yes
Organ System: Social circumstances
Notes: Patient was admitted to the ER overnight after complaints of feeling faint and weakness with reports of being stressed and overwhelmed.
Frequency: 1 affected / 22 at risk

Adverse event: Ligtheadedness/dizzy
Serious: no
Organ System: Cardiac disorders
Notes: Dizzy and/or lightheadedness
Frequency: 1 affected / 22 at risk

Adverse event: Pain
Serious: no
Organ System: Nervous system disorders
Notes: subjective rating of pain
Frequency: 2 affected / 22 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: subjective reporting of headache
Frequency: 2 affected / 22 at risk

Adverse event: Cold and Flu
Serious: no
Organ System: Infections and infestations
Notes: Patient report of cold and flu-like symptoms
Frequency: 2 affected / 22 at risk
Study: NCT00585910

Adverse event: Loss of Appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 67 at risk

Adverse event: Gastro-Intestinal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 34 affected / 67 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 10 affected / 67 at risk

Adverse event: Headaches
Serious: no
Organ System: General disorders
Frequency: 19 affected / 67 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 11 affected / 67 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 29 affected / 67 at risk

Adverse event: Rhinitis
Serious: no
Organ System: General disorders
Frequency: 17 affected / 67 at risk

Adverse event: Loss of Appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 22 affected / 50 at risk

Adverse event: Gastro-Intestinal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 50 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 25 affected / 50 at risk

Adverse event: Headaches
Serious: no
Organ System: General disorders
Frequency: 11 affected / 50 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 16 affected / 50 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 3 affected / 50 at risk

Adverse event: Rhinitis
Serious: no
Organ System: General disorders
Frequency: 11 affected / 50 at risk
Study: NCT00585923

Adverse event: Instrument Failure - Screw Breakage
Serious: yes
Organ System: Surgical and medical procedures
Notes: Breakage of 2 screws
Frequency: 1 affected / 56 at risk

Adverse event: Instrument Failure - Screw Back-out
Serious: yes
Organ System: Surgical and medical procedures
Notes: Screw backed out of the plate
Frequency: 1 affected / 56 at risk

Adverse event: Mild Wound Drainage
Serious: no
Organ System: Infections and infestations
Notes: Patient experienced a mild wound drainage
Frequency: 1 affected / 56 at risk
Study: NCT00585975

Adverse event: Skin necrosis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 266 at risk

Adverse event: Abnormal Skin Odor
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 266 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 266 at risk

Adverse event: Conjunctival hyperaemia
Serious: no
Organ System: Eye disorders
Frequency: 13 affected / 266 at risk

Adverse event: Anterior chamber inflammation
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 278 at risk

Adverse event: Abdominal pain upper
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 278 at risk

Adverse event: Kidney infection
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 278 at risk

Adverse event: Conjunctival hyperaemia
Serious: no
Organ System: Eye disorders
Frequency: 19 affected / 278 at risk
Study: NCT00586066

Adverse event: Gastric reflux
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 24 at risk
Study: NCT00586157

Adverse event: Loss of Appetite
Serious: no
Organ System: General disorders
Frequency: 13 affected / 30 at risk

Adverse event: Other
Serious: no
Organ System: General disorders
Notes: MTS (feeling sad, shaky, dizzy; increase in tics/tremors; increase in energy; itchy eyes infected molluscum); PTS (feeling week, shaky, sad; upper respiratory infection)
Frequency: 10 affected / 30 at risk

Adverse event: Gastro-Intestinal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 30 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 8 affected / 30 at risk

Adverse event: Headaches
Serious: no
Organ System: General disorders
Frequency: 5 affected / 30 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 5 affected / 30 at risk

Adverse event: Pruritis at site
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 30 at risk

Adverse event: Rhinitis
Serious: no
Organ System: General disorders
Frequency: 3 affected / 30 at risk

Adverse event: Other
Serious: no
Organ System: General disorders
Notes: MTS (feeling sad, shaky, dizzy; increase in tics/tremors; increase in energy; itchy eyes infected molluscum); PTS (feeling week, shaky, sad; upper respiratory infection)
Frequency: 3 affected / 29 at risk

Adverse event: Headaches
Serious: no
Organ System: General disorders
Frequency: 1 affected / 29 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 1 affected / 29 at risk

Adverse event: Rhinitis
Serious: no
Organ System: General disorders
Frequency: 2 affected / 29 at risk
Study: NCT00586170

Adverse event: Unrelated complication - anxiety
Serious: no
Organ System: Psychiatric disorders
Notes: increased anxiety due to cast reported 3 weeks post-surgery. Patient recovered.
Frequency: 1 affected / 5 at risk

Adverse event: unrelated complication - hernia
Serious: no
Organ System: Gastrointestinal disorders
Notes: patient had vomiting and hernia obstruction 6 weeks post-surgery; had hernia surgery and recovered
Frequency: 1 affected / 5 at risk

Adverse event: unrelated complication - allergic reaction
Serious: no
Organ System: General disorders
Notes: patient had sick stomach on surgery day, 3 days later reported allergic reaction - increased swelling of the face, hands and legs. Discontinued medication and swelling discontinued. Vomiting and diarrhea reported 3 wks post-surgery. patient recovered
Frequency: 1 affected / 5 at risk

Adverse event: Unrelated complication - leg bruising, breast lump
Serious: no
Organ System: Investigations
Notes: 2 months post surgery patient had a lump in left breast and severe bruising on right leg. Could not be associated with device use.
Frequency: 1 affected / 3 at risk
Study: NCT00586196

Adverse event: Serious Adverse Event
Serious: yes
Organ System: General disorders
Notes: Serious adverse events were collected non-specifically and all were deemed unlikely to study participation
Frequency: 2 affected / 7 at risk

Adverse event: Insomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 7 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 7 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 7 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 7 at risk

Adverse event: Syncope
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 7 at risk

Adverse event: Frequency of Urination
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 7 at risk

Adverse event: Insomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 9 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 9 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 9 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 9 at risk
Study: NCT00586209

Adverse event: Sickle cell anaemia with crisis
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 5 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 5 at risk

Adverse event: Sickle cell anaemia with crisis
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 5 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 5 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 5 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 5 at risk

Adverse event: Fungal infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 5 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 5 at risk

Adverse event: Cardiac murmur
Serious: no
Organ System: Investigations
Frequency: 1 affected / 5 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 5 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 5 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 5 at risk

Adverse event: Sickle cell anaemia with crisis
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 4 affected / 10 at risk

Adverse event: Haemoglobin decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 10 at risk

Adverse event: Sickle cell anaemia with crisis
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 4 affected / 10 at risk

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

Adverse event: Oral pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk

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

Adverse event: Clostridium difficile colitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 10 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 10 at risk

Adverse event: Haemoglobin decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 10 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 10 at risk

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

Adverse event: Endodontic procedure
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 10 at risk
Study: NCT00586261

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Endocrine disorders
Notes: One patient got low blood glucoses and discontinued the medication
Frequency: 1 affected / 17 at risk

Adverse event: Oedema
Serious: no
Organ System: Vascular disorders
Notes: One patient got edema resulting in discontinuation.
Frequency: 1 affected / 17 at risk
Study: NCT00586326

Adverse event: Cerebral Vascular Accident
Serious: yes
Organ System: Vascular disorders
Notes: Subject 09-001 suffered a cerebral vascular accident (CVA) and Subject 09-014 experienced a CVA. Both were determined to be 'Not Related'.
Frequency: 2 affected / 118 at risk

Adverse event: Lung cancer with metastases to the brain
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Subject 09-013 developed lung cancer with metastases to the brain and subsequently died. The event was determined to be 'Not Related'.
Frequency: 1 affected / 118 at risk

Adverse event: Abnormal uterine bleeding
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: Subject 01-002 had abnormal uterine bleeding requiring hysterectomy. The event was determined to be 'Not Related'.
Frequency: 1 affected / 118 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Notes: Subject 11-011 was admitted to the hospital for evaluation of pain, swelling, fever \& chills and was diagnosed with cellulitis \& started on IV antibiotics. Event was believed unlikely related \& was reported as serious due to hospitalization.
Frequency: 1 affected / 118 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Notes: One subject in the ITT population experienced an event of infection (Subject 11-014). This event was reported as serious, probably related to the device and after treatment, resolved without sequelae.
Frequency: 1 affected / 118 at risk

Adverse event: Seroma
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 38 affected / 118 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 118 at risk

Adverse event: Fat necrosis
Serious: no
Organ System: General disorders
Frequency: 14 affected / 118 at risk

Adverse event: Telangiectasia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 22 affected / 118 at risk

Adverse event: Fibrosis
Serious: no
Organ System: General disorders
Frequency: 41 affected / 118 at risk

Adverse event: Induration
Serious: no
Organ System: General disorders
Frequency: 30 affected / 118 at risk

Adverse event: Breast pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 29 affected / 118 at risk

Adverse event: Retraction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 118 at risk

Adverse event: Radiation Dermatitis
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 7 affected / 118 at risk

Adverse event: Hyperpigmentation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 19 affected / 118 at risk

Adverse event: Musculoskeletal chest pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 118 at risk
Study: NCT00586573

Adverse event: Dizzy/Lightheaded
Serious: no
Organ System: General disorders
Frequency: 8 affected / 34 at risk

Adverse event: Gastrointestinal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 34 at risk

Adverse event: Musculoskeletal
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 34 at risk

Adverse event: Headaches
Serious: no
Organ System: General disorders
Frequency: 5 affected / 34 at risk

Adverse event: Sedation
Serious: no
Organ System: General disorders
Frequency: 4 affected / 34 at risk

Adverse event: Decreased Energy
Serious: no
Organ System: General disorders
Frequency: 3 affected / 34 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 34 at risk

Adverse event: Cold/infection/allergy
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 34 at risk

Adverse event: Hearing change
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 34 at risk

Adverse event: Impaired concentration
Serious: no
Organ System: General disorders
Frequency: 2 affected / 34 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 34 at risk

Adverse event: Asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 34 at risk

Adverse event: Change in sexual function
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 34 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 34 at risk

Adverse event: Increased energy
Serious: no
Organ System: General disorders
Frequency: 1 affected / 34 at risk

Adverse event: Injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 34 at risk

Adverse event: Mucosal dryness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 34 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 34 at risk

Adverse event: Tense/jittery
Serious: no
Organ System: General disorders
Frequency: 1 affected / 34 at risk

Adverse event: Vision/ocular
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 34 at risk
Study: NCT00586625

Adverse event: Mild Taste
Serious: no
Organ System: Nervous system disorders
Frequency: 146 affected / 575 at risk

Adverse event: Mild Taste
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 286 at risk