TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT00392288

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 172 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 172 at risk

Adverse event: Asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 18 affected / 172 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 172 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 172 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 17 affected / 172 at risk

Adverse event: Forearm fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 174 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 12 affected / 174 at risk

Adverse event: Asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 174 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 174 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 174 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 174 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 175 at risk

Adverse event: Asthmatic crisis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 175 at risk

Adverse event: Electric shock
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 175 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 175 at risk

Adverse event: Asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 175 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 175 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 175 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 175 at risk
Study: NCT00392379

Adverse event: Reflux
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 136 at risk

Adverse event: Sleep disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 136 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 136 at risk

Adverse event: Reflux
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 134 at risk

Adverse event: Sleep disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 134 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 134 at risk
Study: NCT00392769

Adverse event: Rash
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 33 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 13 affected / 33 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 33 at risk

Adverse event: Headache
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 33 at risk

Adverse event: Pain (all sites)
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 33 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 33 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 24 affected / 33 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 21 affected / 33 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 33 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 8 affected / 33 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 33 at risk

Adverse event: Pain (all sites)
Serious: no
Organ System: General disorders
Frequency: 8 affected / 33 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 33 at risk
Study: NCT00392808

Adverse event: Febrile seizures
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 87 at risk

Adverse event: cutaneous abscess
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 87 at risk

Adverse event: Ataxia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 87 at risk

Adverse event: Febrile seizures
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 89 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 89 at risk

Adverse event: Leishmaniasis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 89 at risk

Adverse event: Asthma
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 89 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 89 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 109 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 109 at risk

Adverse event: local reactions: pain, induration
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 109 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 109 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 104 at risk

Adverse event: local reactions: pain, induration
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 104 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 104 at risk

Adverse event: acropustulosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 104 at risk
Study: NCT00392951

Adverse event: Vasculitis
Serious: yes
Organ System: Nervous system disorders
Notes: This adverse event was determined not to be related to study treatment.
Frequency: 1 affected / 30 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 30 at risk

Adverse event: Elevated triglycerides and cholesterol
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 30 at risk

Adverse event: Acne
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Photosensitivity reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Gastro-esophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk
Study: NCT00393380

Adverse event: Death
Serious: yes
Organ System: General disorders
Notes: Death
Frequency: 8 affected / 13 at risk

Adverse event: Death
Serious: no
Organ System: General disorders
Frequency: 8 affected / 13 at risk
Study: NCT00393848

Adverse event: Mastectomy for breast cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 9 at risk
Study: NCT00393861

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 29 at risk

Adverse event: HEARTBURN/DYSPEPSIA
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 29 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 29 at risk

Adverse event: TASTE ALTERATION (DYSGEUSIA)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 29 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 29 at risk

Adverse event: FATIGUE (ASTHENIA, LETHARGY, MALAISE)
Serious: no
Organ System: General disorders
Frequency: 10 affected / 29 at risk

Adverse event: FEVER (IN THE ABSENCE OF NEUTROPENIA, WHERE NEUTROPENIA IS DEFINED AS ANC <1.0 X 10E9/L)
Serious: no
Organ System: General disorders
Frequency: 2 affected / 29 at risk

Adverse event: INJECTION SITE REACTION/EXTRAVASATION CHANGES
Serious: no
Organ System: General disorders
Frequency: 2 affected / 29 at risk

Adverse event: PAIN - OTHER
Serious: no
Organ System: General disorders
Frequency: 4 affected / 29 at risk

Adverse event: HEMORRHAGE, PULMONARY/UPPER RESPIRATORY - NOSE
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 29 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 29 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 29 at risk

Adverse event: Insomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 29 at risk

Adverse event: NEUROPATHY: SENSORY
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 29 at risk

Adverse event: MOOD ALTERATION - DEPRESSION
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 29 at risk

Adverse event: PAIN - HEAD/HEADACHE
Serious: no
Organ System: General disorders
Frequency: 2 affected / 29 at risk

Adverse event: PAIN - ABDOMEN NOS
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 29 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 29 at risk

Adverse event: DYSPNEA (SHORTNESS OF BREATH)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 29 at risk

Adverse event: PRURITUS/ITCHING
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 29 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 29 at risk
Study: NCT00393874

Adverse event: Headache, drowsiness
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 15 at risk

Adverse event: Headache, drowsiness
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 13 at risk

Adverse event: Headache, drowsiness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 13 at risk
Study: NCT00393978

Adverse event: Pregnancy
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 37 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Psychiatric disorders
Notes: Exacerbation of illness
Frequency: 5 affected / 37 at risk

Adverse event: Difficulty falling asleep
Serious: no
Organ System: General disorders
Frequency: 20 affected / 37 at risk

Adverse event: Difficulty staying asleep
Serious: no
Organ System: General disorders
Frequency: 20 affected / 37 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Frequency: 30 affected / 37 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Psychiatric disorders
Notes: Exacerbation of illness
Frequency: 4 affected / 38 at risk

Adverse event: Increased Suicidal Ideation
Serious: yes
Organ System: Psychiatric disorders
Notes: Increased suicidal ideation during hospitalization
Frequency: 1 affected / 38 at risk

Adverse event: Difficulty falling asleep
Serious: no
Organ System: General disorders
Frequency: 12 affected / 38 at risk

Adverse event: Difficulty staying asleep
Serious: no
Organ System: General disorders
Frequency: 12 affected / 38 at risk

Adverse event: Agitation
Serious: no
Organ System: General disorders
Frequency: 5 affected / 38 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Frequency: 23 affected / 38 at risk
Study: NCT00394095

Adverse event: Hyperthermia malignant
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 16 at risk

Adverse event: Suicide attempt
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 16 at risk

Adverse event: Gastrointestinal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 16 at risk

Adverse event: Muscle aches
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 16 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 16 at risk

Adverse event: Upper extremity paresthesia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 16 at risk

Adverse event: Headaches
Serious: no
Organ System: General disorders
Frequency: 6 affected / 16 at risk

Adverse event: Back and/or neck pain
Serious: no
Organ System: General disorders
Frequency: 3 affected / 16 at risk

Adverse event: Ocular/visual blurriness
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 16 at risk

Adverse event: Worsening of mood
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 16 at risk

Adverse event: Increased aggression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 14 at risk

Adverse event: Gastrointestinal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 14 at risk

Adverse event: Ear pain
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 14 at risk

Adverse event: Muscle aches
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 14 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 14 at risk

Adverse event: Headaches
Serious: no
Organ System: General disorders
Frequency: 5 affected / 14 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 3 affected / 14 at risk

Adverse event: Back and/or neck pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 14 at risk

Adverse event: Ocular/visual blurriness
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 14 at risk

Adverse event: Worsening of mood
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 14 at risk

Adverse event: Sedation
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 14 at risk
Study: NCT00394212

Adverse event: Adhesion-related intestinal obstruction (from prior surgery)
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Adhesion from initial gastric bypass surgery
Frequency: 1 affected / 48 at risk

Adverse event: Pulmonary edema secondary to fluid overload
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: edema secondary to fluid overload following study procedure
Frequency: 1 affected / 48 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 48 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 48 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 48 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 48 at risk

Adverse event: Laryngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 48 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 48 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 29 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 29 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 29 at risk

Adverse event: Laryngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 29 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 29 at risk
Study: NCT00394329

Adverse event: Treatment failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Treatment failure was defined as the requirement for a second dose of prednisone within any 6-month period.
Frequency: 4 affected / 71 at risk

Adverse event: Treatment failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Treatment failure was defined as the requirement for a second dose of prednisone within any 6-month period.
Frequency: 2 affected / 72 at risk

Adverse event: Treatment failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Treatment failure was defined as the requirement for a second dose of prednisone within any 6-month period.
Frequency: 6 affected / 71 at risk

Adverse event: Treatment failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Treatment failure was defined as the requirement for a second dose of prednisone within any 6-month period.
Frequency: 17 affected / 74 at risk
Study: NCT00394472

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 122 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 122 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 122 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 122 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 7 affected / 122 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 122 at risk

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

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

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 7 affected / 122 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 122 at risk
Study: NCT00394524

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Endocrine disorders
Notes: Severe Hypoglycemia is defined as blood glucose levels \<40 mg/dL
Frequency: 3 affected / 77 at risk

Adverse event: Mild Hypoglycemia
Serious: no
Organ System: Endocrine disorders
Notes: Mild hypoglycemia is defined as blood glucose level \<60 mg/dL
Frequency: 33 affected / 77 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Endocrine disorders
Notes: Hyperglycemia is defined as blood glucose level of \>200 mg/dL
Frequency: 9 affected / 77 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Endocrine disorders
Notes: Severe Hypoglycemia is defined as blood glucose levels \<40 mg/dL
Frequency: 4 affected / 76 at risk

Adverse event: Mild Hypoglycemia
Serious: no
Organ System: Endocrine disorders
Notes: Mild hypoglycemia is defined as blood glucose level \<60 mg/dL
Frequency: 23 affected / 76 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Endocrine disorders
Notes: Hyperglycemia is defined as blood glucose level of \>200 mg/dL
Frequency: 18 affected / 76 at risk
Study: NCT00394914

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 154 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 157 at risk
Study: NCT00395044

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 25 at risk

Adverse event: Insomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 25 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 25 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 25 at risk

Adverse event: Fatigue
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 25 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 25 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 25 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 25 at risk

Adverse event: Appetite decrease
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 25 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 25 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 25 at risk

Adverse event: Insomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 25 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 25 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 25 at risk

Adverse event: Pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 25 at risk

Adverse event: Fatigue
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 25 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 25 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 25 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 25 at risk

Adverse event: Appetite decrease
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 25 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 25 at risk
Study: NCT00395226

Adverse event: gastrointestinal disorders
Serious: no
Organ System: Gastrointestinal disorders
Notes: stomach upset, including nausea, discomfort, gas, diarrhea, constipation, and increased bowel movements
Frequency: 12 affected / 25 at risk

Adverse event: rosacea outbreak
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: including redness and itching
Frequency: 3 affected / 25 at risk

Adverse event: Hypersensitivity
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 27 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 27 at risk

Adverse event: gastrointestinal disorders
Serious: no
Organ System: Gastrointestinal disorders
Notes: stomach upset, including nausea, discomfort, gas, diarrhea, constipation, and increased bowel movements
Frequency: 15 affected / 27 at risk