TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT00627705

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 14 at risk

Adverse event: Nausea/Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 14 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 14 at risk

Adverse event: Increased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 14 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 14 at risk

Adverse event: Akathisia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 14 at risk

Adverse event: Excitement/ Agitation
Serious: no
Organ System: General disorders
Frequency: 2 affected / 14 at risk

Adverse event: Increased Motor Activity
Serious: no
Organ System: General disorders
Frequency: 2 affected / 14 at risk

Adverse event: Depressive Affect
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 14 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: General disorders
Frequency: 4 affected / 14 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 15 at risk

Adverse event: Nausea/Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 15 at risk

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

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 15 at risk

Adverse event: Excitement/ Agitation
Serious: no
Organ System: General disorders
Frequency: 3 affected / 15 at risk

Adverse event: Increased Motor Activity
Serious: no
Organ System: General disorders
Frequency: 3 affected / 15 at risk

Adverse event: Tremor
Serious: no
Organ System: General disorders
Frequency: 1 affected / 15 at risk

Adverse event: Syncope/Dizziness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 15 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: General disorders
Frequency: 6 affected / 15 at risk

Adverse event: Salivary hypersecretion
Serious: no
Organ System: General disorders
Frequency: 2 affected / 15 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 15 at risk
Study: NCT00627861

Adverse event: Leukocytosis
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 1 at risk
Study: NCT00628355

Adverse event: Ecchymosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 3.4 and 5.1 centimeter of extension that resolved spontaneously within 4 and 6 weeks after, respectively
Frequency: 2 affected / 15 at risk
Study: NCT00628394

Adverse event: Decreased appetite
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 10 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 9 at risk
Study: NCT00628589

Adverse event: Exacerbation of schizophrenia
Serious: yes
Organ System: Psychiatric disorders
Notes: A 45 year-old white male assigned to the Placebo group experienced a severe exacerbation of schizophrenia and was hospitalized.
Frequency: 1 affected / 115 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 115 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 115 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 115 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 16 affected / 115 at risk

Adverse event: Sedation
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 115 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 116 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 116 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 116 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 116 at risk

Adverse event: Sedation
Serious: no
Organ System: Nervous system disorders
Frequency: 15 affected / 116 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: A 37 year-old female assigned to the Staccato Loxapine 10-mg group had severe gastroenteritis that resulted in hospitalization. This event was reported as an SAE, was judged unrelated to study treatment
Frequency: 1 affected / 113 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 113 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 113 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 12 affected / 113 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 113 at risk

Adverse event: Sedation
Serious: no
Organ System: Nervous system disorders
Frequency: 12 affected / 113 at risk
Study: NCT00628628

Adverse event: Haemolysis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 40 at risk

Adverse event: Tumour lysis syndrome
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 14 affected / 40 at risk

Adverse event: Hyperuricaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 13 affected / 40 at risk

Adverse event: Hyperphosphataemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 16 affected / 40 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 28 affected / 40 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 40 at risk

Adverse event: Renal events requiring dialysis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 40 at risk

Adverse event: Leukaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 40 at risk

Adverse event: Lymphoma
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 40 at risk

Adverse event: Methaemoglobinaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 40 at risk

Adverse event: Tumour lysis syndrome
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 40 at risk

Adverse event: Tumour lysis syndrome
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 11 affected / 40 at risk

Adverse event: Hyperuricaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 11 affected / 40 at risk

Adverse event: Hyperphosphataemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 12 affected / 40 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 20 affected / 40 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 40 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 40 at risk

Adverse event: Renal events requiring dialysis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 40 at risk
Study: NCT00628758

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 209 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 209 at risk

Adverse event: Lower limb fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 221 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 221 at risk
Study: NCT00628862

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 206 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 206 at risk

Adverse event: Prostate Caner
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 206 at risk

Adverse event: Diabetes mellitus
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 206 at risk

Adverse event: Cardiopulmonary failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 206 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 206 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 24 affected / 206 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 199 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 199 at risk

Adverse event: Gastric cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 199 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 199 at risk

Adverse event: Hypoglycaemic unconsciousness
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 199 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 199 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 199 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 25 affected / 199 at risk

Adverse event: Bladder cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 208 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 208 at risk

Adverse event: Ileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 208 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 15 affected / 208 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 20 affected / 208 at risk
Study: NCT00629018

Adverse event: Death
Serious: yes
Organ System: Cardiac disorders
Frequency: 8 affected / 55 at risk

Adverse event: Ventricular tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 55 at risk

Adverse event: Death
Serious: yes
Organ System: Cardiac disorders
Frequency: 19 affected / 55 at risk
Study: NCT00629083

Adverse event: Gastrointestinal disorder
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 228 at risk

Adverse event: Respiratory disorder
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 228 at risk
Study: NCT00629122

Adverse event: Bitter taste in mouth
Serious: no
Organ System: Gastrointestinal disorders
Notes: Bitter taste of the tacrolimus powder for sublingual administration.
Frequency: 2 affected / 2 at risk

Adverse event: Bitter taste in mouth
Serious: no
Organ System: Gastrointestinal disorders
Notes: Bitter taste of the tacrolimus powder for sublingual administration.
Frequency: 3 affected / 3 at risk
Study: NCT00629239

Adverse event: Deep Venous Thrombosis Left Lower Leg
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 33 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 33 at risk

Adverse event: Chronic obstructuve pulmonary disease
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 33 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 33 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 33 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 33 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 33 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 33 at risk

Adverse event: Chronic obstructuve pulmonary disease
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 32 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 32 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 32 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 32 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 32 at risk
Study: NCT00629499

Adverse event: Fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Patient fell down flight of stairs causing multiple fractures. Event unrelated to protocol therapy.
Frequency: 1 affected / 63 at risk

Adverse event: Mental Status
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 63 at risk

Adverse event: Hemorrhage - GI
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 63 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 63 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Anemia
Frequency: 14 affected / 63 at risk

Adverse event: Neutrophil count
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Neutropenia
Frequency: 48 affected / 63 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 26 affected / 63 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 63 at risk

Adverse event: Arthralgia/Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 21 affected / 63 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 63 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 63 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Notes: Peripheral Neuropathy
Frequency: 5 affected / 63 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 63 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 31 affected / 63 at risk
Study: NCT00629707

Adverse event: altered mental status
Serious: yes
Organ System: Nervous system disorders
Notes: Alteration in mental status during DKA treatment of sufficient severity for suspicion of clinically-apparent cerebral edema
Frequency: 1 affected / 10 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Endocrine disorders
Notes: blood glucose level below 70 mg/dL during DKA treatment
Frequency: 1 affected / 10 at risk
Study: NCT00630565

Adverse event: Relapse
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Relapse of acute promyelocytic leukaemia (APL)
Frequency: 1 affected / 12 at risk
Study: NCT00630838

Adverse event: Hirschsprung Associated Enterocolitis (HAEC)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 32 at risk

Adverse event: Hirschsprung Associated Enterocolitis (HAEC)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 28 at risk
Study: NCT00630955

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

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 34 at risk

Adverse event: vomit
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 34 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 9 affected / 34 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 34 at risk

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

Adverse event: Nervousness
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 34 at risk

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

Adverse event: Confusional state
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 34 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 37 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 37 at risk

Adverse event: vomit
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 37 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 12 affected / 37 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 37 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 5 affected / 37 at risk

Adverse event: Nervousness
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 37 at risk

Adverse event: Insomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 37 at risk

Adverse event: Confusional state
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 37 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 40 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 40 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 16 affected / 40 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 12 affected / 40 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 9 affected / 40 at risk

Adverse event: Insomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 40 at risk

Adverse event: Confusional state
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 40 at risk
Study: NCT00630994

Adverse event: Ascites
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: Clostridial infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 4 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 4 at risk

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

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 4 at risk

Adverse event: Blood bilirubin
Serious: no
Organ System: Investigations
Frequency: 1 affected / 4 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Investigations
Frequency: 2 affected / 4 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 4 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 4 at risk

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

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 4 at risk
Study: NCT00631020

Adverse event: Rash-like reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 34 at risk

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

Adverse event: Craving
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 34 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 34 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 34 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 34 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 34 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 34 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 34 at risk

Adverse event: Anhedonia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 34 at risk

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

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

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

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 34 at risk

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

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

Adverse event: Shaky
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 34 at risk

Adverse event: Strep throat
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 34 at risk

Adverse event: Stress
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 34 at risk

Adverse event: Toe pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 34 at risk

Adverse event: Peritonsillar abscess
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 34 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 34 at risk

Adverse event: Abnormal dreams
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 34 at risk
Study: NCT00631137

Adverse event: rash: acne/acneiform
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: grade 1
Frequency: 1 affected / 1 at risk