TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT00705575

Adverse event: Haemorrhoids
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 349 at risk

Adverse event: Tendon rupture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 349 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 19 affected / 349 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 14 affected / 349 at risk

Adverse event: Vertigo
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 339 at risk

Adverse event: Fracture displacement
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 339 at risk

Adverse event: Radius fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 339 at risk

Adverse event: Nephrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 339 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 339 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 29 affected / 339 at risk
Study: NCT00705757

Adverse event: Recurrence of iritis at 6 week visit
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 32 at risk
Study: NCT00706004

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

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

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

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

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 1 affected / 7 at risk

Adverse event: Migraine
Serious: no
Organ System: General disorders
Frequency: 1 affected / 7 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 7 at risk

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

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 7 at risk

Adverse event: Transient chest tightness
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 7 at risk
Study: NCT00706134

Adverse event: Vertigo
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 186 at risk

Adverse event: Concussion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 186 at risk

Adverse event: Contusion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 186 at risk

Adverse event: Wrist fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 186 at risk

Adverse event: Erysipelas
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 191 at risk

Adverse event: Osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 191 at risk

Adverse event: Glaucoma
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 189 at risk

Adverse event: Haemorrhoidal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 189 at risk

Adverse event: Haemorrhagic stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 189 at risk
Study: NCT00706238

Adverse event: Diabetes mellitus
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 5 at risk

Adverse event: Inflammation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 5 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 3 affected / 5 at risk

Adverse event: Injection site reaction
Serious: no
Organ System: General disorders
Frequency: 2 affected / 5 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 5 at risk

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

Adverse event: Diabetes mellitus
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 5 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 5 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 5 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: General disorders
Frequency: 1 affected / 5 at risk

Adverse event: Exfoliative rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 5 at risk
Study: NCT00706550

Adverse event: CHF, arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 43 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 43 at risk

Adverse event: Mental health related
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 43 at risk

Adverse event: Other infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 43 at risk

Adverse event: Respiratory tract infection
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 43 at risk

Adverse event: Skin infection
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 43 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 43 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 43 at risk

Adverse event: CHF, arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 64 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 64 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 64 at risk

Adverse event: Dehydration, electrolite abnormalities
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 64 at risk

Adverse event: Elective surgery
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 64 at risk

Adverse event: Gastrointestinal infections and other disorders
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 64 at risk

Adverse event: Other infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 64 at risk

Adverse event: Respiratory tract infection
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 64 at risk

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

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 64 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 64 at risk
Study: NCT00706563

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 61 at risk

Adverse event: Induration
Serious: no
Organ System: General disorders
Frequency: 19 affected / 61 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 36 affected / 61 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 24 affected / 61 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 16 affected / 61 at risk

Adverse event: Arthralgia
Serious: no
Organ System: General disorders
Frequency: 6 affected / 61 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 10 affected / 61 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 8 affected / 61 at risk

Adverse event: Myalgia
Serious: no
Organ System: General disorders
Frequency: 15 affected / 61 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 4 affected / 61 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: General disorders
Frequency: 5 affected / 61 at risk

Adverse event: Induration
Serious: no
Organ System: General disorders
Frequency: 7 affected / 59 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 22 affected / 59 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 11 affected / 59 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 6 affected / 59 at risk

Adverse event: Arthralgia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 59 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 8 affected / 59 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 8 affected / 59 at risk

Adverse event: Myalgia
Serious: no
Organ System: General disorders
Frequency: 7 affected / 59 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 5 affected / 59 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: General disorders
Frequency: 4 affected / 59 at risk
Study: NCT00706719

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 7 at risk

Adverse event: vasomotor flushing
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 7 at risk

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

Adverse event: Erythema
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 5 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 5 at risk

Adverse event: worsening depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 5 at risk
Study: NCT00706784

Adverse event: Displacement of Vaginal Ring
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Two subjects reported displacement of the vaginal ring associated with Valsava (forceful exhalation with a closed nose and mouth).
Frequency: 2 affected / 3 at risk
Study: NCT00706810

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

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 7 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 7 at risk

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

Adverse event: decreased eye acuity
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 7 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 7 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 7 at risk

Adverse event: Oedema
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 7 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 7 at risk

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

Adverse event: heart palpatations
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 7 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 7 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 7 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 7 at risk

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

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 7 at risk

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

Adverse event: Exophthalmos
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 7 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 7 at risk

Adverse event: strep throat
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 7 at risk

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

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 7 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 7 at risk

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

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 7 at risk

Adverse event: Ligament sprain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 7 at risk
Study: NCT00706823

Adverse event: Oropharyngeal discomfort
Serious: no
Organ System: Surgical and medical procedures
Notes: Oropharyngeal discomfort, including sore throat, hoarseness, and dysphagia
Frequency: 6 affected / 25 at risk

Adverse event: Oropharyngeal discomfort
Serious: no
Organ System: Surgical and medical procedures
Notes: Oropharyngeal discomfort, including sore throat, hoarseness, and dysphagia
Frequency: 10 affected / 25 at risk
Study: NCT00706836

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: Dizziness or lightheadedness
Frequency: 4 affected / 16 at risk
Study: NCT00706901

Adverse event: Suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Notes: A participant indicated positively that he was experiencing suicidal ideation. Participant was evaluated by a VA psychiatrist who determined that the patient should be hospitalized for stabilization. This was reported to the IRB.
Frequency: 1 affected / 59 at risk

Adverse event: Death due to throat cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Participant had throat cancer and died during follow up
Frequency: 1 affected / 59 at risk
Study: NCT00706914

Adverse event: Drug withdrawal convulsions
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 63 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 62 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 31 at risk
Study: NCT00706966

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

Adverse event: Decreased ejaculate volume
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 3 affected / 10 at risk
Study: NCT00706979

Adverse event: Nausea/stomach upset (dyspepsia)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 80 affected / 426 at risk

Adverse event: Throat irritation
Serious: no
Organ System: General disorders
Frequency: 60 affected / 426 at risk

Adverse event: Hiccups
Serious: no
Organ System: General disorders
Frequency: 45 affected / 426 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 23 affected / 426 at risk

Adverse event: Death
Serious: yes
Organ System: Renal and urinary disorders
Notes: We were notified of the death of a participant from bladder cancer in the control group(PQA Only group, did not receive nicotine replacement therapy) by the participant's wife.
Frequency: 1 affected / 423 at risk
Study: NCT00707174

Adverse event: Inflammatory Response
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 46 at risk

Adverse event: Inflammatory Response
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 44 at risk
Study: NCT00707434

Adverse event: Bleeding at device insertion site
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 6 at risk
Study: NCT00707486

Adverse event: Alveolar osteitis
Serious: no
Organ System: General disorders
Frequency: 19 affected / 71 at risk

Adverse event: Packed Food
Serious: no
Organ System: General disorders
Frequency: 1 affected / 71 at risk
Study: NCT00708032

Adverse event: Non-signficant Corneal Event
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 36 at risk

Adverse event: Non-signficant Corneal Event
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 38 at risk
Study: NCT00708071

Adverse event: Basal cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 45 at risk

Adverse event: Oedema
Serious: no
Organ System: General disorders
Frequency: 3 affected / 45 at risk

Adverse event: Haematoma
Serious: no
Organ System: Vascular disorders
Frequency: 7 affected / 45 at risk

Adverse event: Oedema
Serious: no
Organ System: General disorders
Frequency: 3 affected / 45 at risk
Study: NCT00708097

Adverse event: Gingival erythema
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 50 at risk

Adverse event: Gingival erythema
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 52 at risk

Adverse event: Gingival erythema
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 53 at risk

Adverse event: Gingival erythema
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 53 at risk

Adverse event: Gingival erythema
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 51 at risk

Adverse event: Gingival erythema
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 57 at risk
Study: NCT00708123

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 56 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 54 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 55 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 56 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 54 at risk
Study: NCT00708227

Adverse event: Asthma exacerbation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Participant developed worsening asthma after methacholine challenge at Visit 2. The PCP started the participant on prednisone and oxygen.
Frequency: 1 affected / 26 at risk
Study: NCT00708422

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 116 at risk

Adverse event: Gastrointestinal disorder
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 115 at risk
Study: NCT00708851

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: adverse reaction consisted of one report of mild post-NB-UVB erythema, which appeared uniformly on both sides of the body, regardless of treatment condition.
Frequency: 1 affected / 12 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Treatment-related adverse reactions consisted of two reports of moderate post-UVB erythema which appeared uniformly on both sides of the body.
Frequency: 2 affected / 12 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: adverse reaction consisted of one report of mild post-NB-UVB erythema, which appeared uniformly on both sides of the body, regardless of treatment condition.
Frequency: 1 affected / 12 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Treatment-related adverse reactions consisted of two reports of moderate post-UVB erythema which appeared uniformly on both sides of the body.
Frequency: 2 affected / 12 at risk
Study: NCT00708916

Adverse event: Lichenoid keratosis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 8 at risk

Adverse event: Neuraopathy Sensory
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 8 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 8 at risk

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

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