TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT01046136

Adverse event: Arrhythmia supraventricular
Serious: yes
Organ System: Cardiac disorders
Notes: SAE considered not related to study medication. All SAEs in this study were for one patient and related to one event that occurred 17 days prior to treatment start date.
Frequency: 1 affected / 188 at risk

Adverse event: Endocarditis
Serious: yes
Organ System: Infections and infestations
Notes: SAE considered not related to study medication. All SAEs in this study were for one patient and related to one event that occurred 17 days prior to treatment start date.
Frequency: 1 affected / 188 at risk

Adverse event: Lymphatic duct injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: SAE considered not related to study medication. All SAEs in this study were for one patient and related to one event that occurred 17 days prior to treatment start date.
Frequency: 1 affected / 188 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: SAE considered not related to study medication. All SAEs in this study were for one patient and related to one event that occurred 17 days prior to treatment start date.
Frequency: 1 affected / 188 at risk
Study: NCT01046396

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Notes: The subjects in the Differin® Cream arm who experienced a head cold were the same as the subjects who experienced a head cold in the Differin® Lotion arm.
Frequency: 5 affected / 69 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Notes: The subjects in the Differin® Cream arm who experienced a head cold were the same as the subjects who experienced a head cold in the Differin® Lotion arm.
Frequency: 5 affected / 69 at risk
Study: NCT01046643

Adverse event: Claustrophobia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 9 at risk

Adverse event: Side effects of hormone use
Serious: no
Organ System: General disorders
Frequency: 1 affected / 7 at risk

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

Adverse event: Side effects of hormone use
Serious: no
Organ System: General disorders
Frequency: 1 affected / 7 at risk

Adverse event: Side effects of hormone use
Serious: no
Organ System: General disorders
Frequency: 1 affected / 7 at risk
Study: NCT01046682

Adverse event: Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 9 affected / 20 at risk

Adverse event: Hypertransaminasaemia
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 8 affected / 20 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 2 affected / 20 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 20 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 20 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 20 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 20 at risk
Study: NCT01046695

Adverse event: TENS interfered with cardiac monitor
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 22 at risk
Study: NCT01046877

Adverse event: occluded tube/blood in ear
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Subject presented with blood in ear and a case of influenza
Frequency: 1 affected / 25 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 25 at risk
Study: NCT01047189

Adverse event: Burning sensation on facial skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 13 at risk
Study: NCT01047241

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 50 at risk
Study: NCT01047306

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 19 at risk

Adverse event: Procedural nausea
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 19 at risk

Adverse event: Procedural headache
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 19 at risk

Adverse event: Procedural vomiting
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 19 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 1 affected / 19 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 19 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 19 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 19 at risk

Adverse event: Laryngospasm
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 19 at risk

Adverse event: Wheezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 19 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Post lumbar puncture syndrome
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 6 at risk

Adverse event: Ear haemorrhage
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 6 at risk
Study: NCT01047358

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

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

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

Adverse event: Pain in extremity
Serious: no
Organ System: General disorders
Frequency: 4 affected / 206 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 3 affected / 206 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 206 at risk

Adverse event: Hyperbilirubinaemia
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 3 affected / 206 at risk

Adverse event: SERUM GLUTAMIC OXALOACETIC TRANSAMINASE INCREASED
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 5 affected / 206 at risk

Adverse event: SERUM GLUTAMIC PYRUVIC TRANSAMINASE INCREASED
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 4 affected / 206 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 206 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 206 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 206 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 206 at risk

Adverse event: Bone pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 206 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 206 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 206 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 206 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 206 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 206 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 206 at risk

Adverse event: Lymphoedema
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 206 at risk
Study: NCT01047436

Adverse event: Diarrhoae
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 16 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 16 at risk

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

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

Adverse event: Malaria reinfection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 16 at risk

Adverse event: Staphylococcal infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 16 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 16 at risk

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

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 16 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 16 at risk

Adverse event: Malaria reinfection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 15 at risk

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

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 15 at risk

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

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 4 affected / 15 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 5 affected / 15 at risk

Adverse event: Bacterial infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 15 at risk

Adverse event: Malaria reinfection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 15 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 15 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 15 at risk
Study: NCT01047527

Adverse event: Intraductal proliferative breast lesion
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 180 at risk

Adverse event: Nephrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 180 at risk

Adverse event: Calculus of Galbladder; chlecystits; pneumonia
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 180 at risk

Adverse event: Death
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 180 at risk

Adverse event: Ovarian cysts
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 173 at risk

Adverse event: Lung neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 173 at risk

Adverse event: Localised infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 172 at risk

Adverse event: Kidney Disease
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 172 at risk

Adverse event: Pericarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 172 at risk

Adverse event: High Blood pressure/cholesterol/blood clots
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 172 at risk

Adverse event: COPD/Pneumonia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 172 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 172 at risk

Adverse event: Severe Abdominal Pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 172 at risk

Adverse event: Death
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 172 at risk
Study: NCT01047683

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 76 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 76 at risk

Adverse event: Eructation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 76 at risk

Adverse event: Non-cardiac chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 76 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 76 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 76 at risk

Adverse event: Eructation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 76 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 77 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 77 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 77 at risk
Study: NCT01048242

Adverse event: Skin ulcer
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Skin ulcer--unrelated to study drug treatment, not serious
Frequency: 1 affected / 8 at risk

Adverse event: Paranasal sinusitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Sinusitis--unrelated to study drug treatment, not serious
Frequency: 1 affected / 8 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Diarrhea--unrelated to study drug treatment, not serious
Frequency: 1 affected / 8 at risk

Adverse event: Fracture
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Musculoskeletal fracture after being hit by a bicyclist----unrelated to study drug treatment, not serious
Frequency: 1 affected / 8 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: Abdominal pain--unrelated to study drug treatment, not serious
Frequency: 1 affected / 13 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Nausea--unrelated to study drug treatment, not serious
Frequency: 1 affected / 13 at risk
Study: NCT01048424

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

Adverse event: Increased Fatigue Issues
Serious: no
Organ System: General disorders
Frequency: 1 affected / 8 at risk

Adverse event: Light-Headedness Issues
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 8 at risk

Adverse event: Rapid Heart Beat Issues
Serious: no
Organ System: Investigations
Frequency: 1 affected / 8 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Investigations
Frequency: 1 affected / 8 at risk

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

Adverse event: Cough
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 8 at risk

Adverse event: Headache Issues
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 8 at risk

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

Adverse event: Lower Back Pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 8 at risk

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

Adverse event: Swelling of both feet
Serious: no
Organ System: General disorders
Frequency: 1 affected / 8 at risk
Study: NCT01048502

Adverse event: > 2g drop in Hgb from baseline
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 24 at risk

Adverse event: cold/allergy symptoms
Serious: no
Organ System: General disorders
Notes: Subjects reported having illnesses that were unrelated to study but that occurred during participation.
Frequency: 3 affected / 24 at risk

Adverse event: > 2g drop in Hgb from baseline
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 23 at risk

Adverse event: cold/allergy symptoms
Serious: no
Organ System: General disorders
Notes: Subjects reported having illnesses that were unrelated to study but that occurred during participation.
Frequency: 2 affected / 23 at risk

Adverse event: > 2g drop in Hgb from baseline
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 28 at risk

Adverse event: cold/allergy symptoms
Serious: no
Organ System: General disorders
Notes: Subjects reported having illnesses that were unrelated to study but that occurred during participation.
Frequency: 4 affected / 28 at risk

Adverse event: > 2g drop in Hgb from baseline
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 25 at risk

Adverse event: cold/allergy symptoms
Serious: no
Organ System: General disorders
Notes: Subjects reported having illnesses that were unrelated to study but that occurred during participation.
Frequency: 7 affected / 25 at risk
Study: NCT01048541

Adverse event: Burning in the urethra
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 36 at risk
Study: NCT01048593

Adverse event: Nasopharyngitis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 3 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 3 at risk

Adverse event: Skin infection
Serious: no
Organ System: General disorders
Frequency: 1 affected / 2 at risk

Adverse event: Rash
Serious: no
Organ System: General disorders
Frequency: 1 affected / 1 at risk
Study: NCT01048658

Adverse event: Blood loss and unterine atony
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 80 at risk

Adverse event: Uterine cervical laceration
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 80 at risk

Adverse event: Unterine atony
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 80 at risk

Adverse event: Uterine cervical laceration
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 80 at risk
Study: NCT01048697

Adverse event: Epistaxis
Serious: no
Organ System: General disorders
Notes: Nosebleed occurred after ethambutol administration and judged to be unreleated to ethambutol dose by the investigators.
Frequency: 1 affected / 18 at risk
Study: NCT01048723

Adverse event: Platelets
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 2 at risk

Adverse event: Leukocytes (total WBC)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 2 at risk

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 2 at risk

Adverse event: Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 2 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 2 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 2 at risk

Adverse event: Mucositis/stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 2 at risk

Adverse event: Glucose, serum-high (hyperglycemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 2 at risk

Adverse event: Dyspnea (shortness of breath)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 2 at risk
Study: NCT01048905

Adverse event: Pain
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 13 at risk

Adverse event: Acute chest syndrome
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 13 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 13 at risk

Adverse event: Sexually Transmitted Disease Related Pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 13 at risk
Study: NCT01048944

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Notes: Self-reported "dry mouth" on standard questionnaire
Frequency: 13 affected / 32 at risk

Adverse event: Sleep disorder
Serious: no
Organ System: Psychiatric disorders
Notes: Self-reported "sleep disturbance" on standard questionnaire.
Frequency: 13 affected / 32 at risk

Adverse event: Headaches
Serious: no
Organ System: Nervous system disorders
Notes: Self-reported "headaches"
Frequency: 3 affected / 32 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 32 at risk

Adverse event: Dizzyness
Serious: no
Organ System: Nervous system disorders
Notes: Self-reported "dizziness"
Frequency: 3 affected / 32 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Notes: Self-reported "dry mouth" on standard questionnaire
Frequency: 13 affected / 38 at risk

Adverse event: Sleep disorder
Serious: no
Organ System: Psychiatric disorders
Notes: Self-reported "sleep disturbance" on standard questionnaire.
Frequency: 15 affected / 38 at risk

Adverse event: Headaches
Serious: no
Organ System: Nervous system disorders
Notes: Self-reported "headaches"
Frequency: 3 affected / 38 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 38 at risk

Adverse event: Dizzyness
Serious: no
Organ System: Nervous system disorders
Notes: Self-reported "dizziness"
Frequency: 1 affected / 38 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Notes: Self-reported "dry mouth" on standard questionnaire
Frequency: 9 affected / 35 at risk

Adverse event: Sleep disorder
Serious: no
Organ System: Psychiatric disorders
Notes: Self-reported "sleep disturbance" on standard questionnaire.
Frequency: 17 affected / 35 at risk

Adverse event: Headaches
Serious: no
Organ System: Nervous system disorders
Notes: Self-reported "headaches"
Frequency: 3 affected / 35 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 35 at risk

Adverse event: Dizzyness
Serious: no
Organ System: Nervous system disorders
Notes: Self-reported "dizziness"
Frequency: 5 affected / 35 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Notes: Self-reported "dry mouth" on standard questionnaire
Frequency: 2 affected / 21 at risk

Adverse event: Sleep disorder
Serious: no
Organ System: Psychiatric disorders
Notes: Self-reported "sleep disturbance" on standard questionnaire.
Frequency: 2 affected / 21 at risk

Adverse event: Headaches
Serious: no
Organ System: Nervous system disorders
Notes: Self-reported "headaches"
Frequency: 3 affected / 21 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 21 at risk