TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT03984305

Adverse event: Inpatient Hospitalization
Serious: yes
Organ System: Renal and urinary disorders
Notes: Inpatient hospitalization due to either urinary tract infection(1), kidney stone(1) or ureteral mass with renal retention(1)
Frequency: 2 affected / 23 at risk

Adverse event: Inpatient Hospitalization
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 23 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Fall that did not require medical attention or treatment
Frequency: 6 affected / 23 at risk

Adverse event: Orthostatic hypotension
Serious: no
Organ System: Vascular disorders
Notes: Orthostatic Hypotension
Frequency: 4 affected / 23 at risk

Adverse event: Bothersome Hallucinations
Serious: no
Organ System: Psychiatric disorders
Notes: Bothersome Hallucinations
Frequency: 1 affected / 23 at risk

Adverse event: Emergency Room Visit
Serious: no
Organ System: General disorders
Notes: Emergency Room Visit due to neck pain
Frequency: 1 affected / 23 at risk

Adverse event: Urgent Care Visit
Serious: no
Organ System: Infections and infestations
Notes: Urgent Care Visit due to either sinusitis or upper respiratory infection
Frequency: 2 affected / 23 at risk

Adverse event: Unanticipated Clinic Visit
Serious: no
Organ System: Gastrointestinal disorders
Notes: Unanticipated Clinic Visit due to gastrointestinal pain
Frequency: 1 affected / 23 at risk

Adverse event: Inpatient Hospitalization
Serious: yes
Organ System: Renal and urinary disorders
Notes: Inpatient hospitalization due to either urinary tract infection(1), kidney stone(1) or ureteral mass with renal retention(1)
Frequency: 1 affected / 18 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Fall that did not require medical attention or treatment
Frequency: 1 affected / 18 at risk

Adverse event: Orthostatic hypotension
Serious: no
Organ System: Vascular disorders
Notes: Orthostatic Hypotension
Frequency: 2 affected / 18 at risk
Study: NCT03984487

Adverse event: Self Injury
Serious: yes
Organ System: Psychiatric disorders
Notes: 10/21/2019 - Pt took knife from kitchen drawer during group session and attempted to cut forearm. The wound was superficial and not life-threatening.
Frequency: 1 affected / 31 at risk

Adverse event: Inpatient stay
Serious: yes
Organ System: Psychiatric disorders
Notes: Participant was admitted to in-patient psychiatric ward until 12/4/19 for cutting.
Frequency: 1 affected / 31 at risk
Study: NCT03984812

Adverse event: Injection site hypersensitivity
Serious: no
Organ System: General disorders
Frequency: 3 affected / 6 at risk

Adverse event: Folliculitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 6 at risk

Adverse event: Transaminases increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 6 at risk

Adverse event: Injection site hypersensitivity
Serious: no
Organ System: General disorders
Frequency: 2 affected / 6 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 6 at risk

Adverse event: Skin abrasion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 6 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 6 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Drug eruption
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 6 at risk

Adverse event: Injection site hypersensitivity
Serious: no
Organ System: General disorders
Frequency: 3 affected / 6 at risk

Adverse event: Injection site bruising
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Vessel puncture site pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Viral upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 6 at risk

Adverse event: Arthropod bite
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 6 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 6 at risk

Adverse event: Dysmenorrhoea
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 6 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 6 at risk

Adverse event: Vessel puncture site swelling
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 6 at risk

Adverse event: Drug eruption
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 6 at risk

Adverse event: Miliaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 6 at risk
Study: NCT03984825

Adverse event: Transaminases increased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 23 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 23 at risk

Adverse event: Intermenstrual bleeding
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 23 at risk

Adverse event: Transaminases increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 21 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 21 at risk

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

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 21 at risk

Adverse event: Infrequent bowel movements
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 21 at risk

Adverse event: Intermenstrual bleeding
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 21 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 21 at risk
Study: NCT03984838

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

Adverse event: Vessel puncture site bruise
Serious: no
Organ System: General disorders
Frequency: 1 affected / 16 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 16 at risk
Study: NCT03986944

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 28 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 28 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 28 at risk

Adverse event: Ovarian cyst
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 28 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 28 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 28 at risk

Adverse event: COVID-19
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 29 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 29 at risk

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

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 29 at risk

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

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

Adverse event: Vaginal haemorrhage
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 29 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 29 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 29 at risk

Adverse event: COVID-19
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 27 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 27 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 27 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 27 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 27 at risk

Adverse event: Chest discomfort
Serious: no
Organ System: General disorders
Frequency: 2 affected / 27 at risk
Study: NCT03987022

Adverse event: Intraoperative Complication: Cystotomy
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: An injury to the bladder during the surgery. The occurrences of these injuries happened prior to the patients randomization in the study.
Frequency: 3 affected / 36 at risk

Adverse event: Emergency Room Visit Post-operatively - Pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Uncontrolled postoperative pain requiring an emergency room visit
Frequency: 1 affected / 36 at risk

Adverse event: Emergency Room Visit - Intraoperative complication
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Emergency room visit for urgent follow up on an intraoperative complication
Frequency: 2 affected / 36 at risk

Adverse event: Intraoperative complication: bowel repair
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: An injury to the bowel during the surgery that required repair. The occurrence of this injury happened prior to the patients randomization in the study.
Frequency: 1 affected / 36 at risk

Adverse event: Intraoperative Complication: Cystotomy
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: An injury to the bladder during the surgery. The occurrences of these injuries happened prior to the patients randomization in the study.
Frequency: 1 affected / 30 at risk

Adverse event: Emergency Room Visit Post-Operatively - Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Postoperative constipation requiring an emergency room visit
Frequency: 1 affected / 30 at risk

Adverse event: Emergency Room Visit Post-operatively - Pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Uncontrolled postoperative pain requiring an emergency room visit
Frequency: 1 affected / 30 at risk
Study: NCT03987191

Adverse event: AE unrelated to the study
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Common cold
Frequency: 2 affected / 13 at risk
Study: NCT03987620

Adverse event: Gastrointestinal bacterial infection
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 298 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 28 affected / 298 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 25 affected / 298 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 22 affected / 298 at risk

Adverse event: Diabetic ketoacidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 151 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 151 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 151 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 151 at risk
Study: NCT03987854

Adverse event: Nephrolithiasis
Serious: no
Organ System: Renal and urinary disorders
Notes: Two participants developed kidney stones, one within 2 weeks of starting the intervention and the other 2 months into the intervention.
Frequency: 2 affected / 29 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Notes: A participant reported continuous muscle cramping and blurry vision 2 months into the intervention; symptoms subsided after consulting with their physician.
Frequency: 1 affected / 29 at risk

Adverse event: muscle cramping
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: A participant reported continuous muscle cramping and blurry vision 2 months into the intervention; symptoms subsided after consulting with their physician.
Frequency: 1 affected / 29 at risk
Study: NCT03988049

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

Adverse event: Transient Crusting or Blistering
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 22 affected / 22 at risk

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

Adverse event: Transient Crusting or Blistering
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 22 affected / 22 at risk
Study: NCT03988088

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 11 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 11 at risk

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

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

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

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 3 affected / 7 at risk

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

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

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 7 at risk

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

Adverse event: Confusional state
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 7 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 7 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 2 at risk
Study: NCT03988166

Adverse event: Myocardial Infarction (MI)
Serious: yes
Organ System: Cardiac disorders
Notes: CK MB ≥ three times (3X) ULN
Frequency: 27 affected / 150 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Notes: CK MB ≥ ten times (10X) ULN
Frequency: 9 affected / 150 at risk

Adverse event: Death
Serious: yes
Organ System: Cardiac disorders
Notes: Cardiac Death
Frequency: 1 affected / 150 at risk

Adverse event: Arterial revascularisation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 150 at risk
Study: NCT03988374

Adverse event: Primary discomforts
Serious: no
Organ System: General disorders
Notes: Mild oral mucosal sloughing
Frequency: 1 affected / 103 at risk

Adverse event: Primary discomforts
Serious: no
Organ System: General disorders
Notes: Mild Dry Mouth
Frequency: 3 affected / 103 at risk

Adverse event: Primary discomforts
Serious: no
Organ System: General disorders
Notes: Mild oral mucosal sloughing
Frequency: 11 affected / 105 at risk

Adverse event: Primary discomforts
Serious: no
Organ System: General disorders
Notes: Mild Dry Mouth
Frequency: 1 affected / 105 at risk

Adverse event: Primary discomforts
Serious: no
Organ System: General disorders
Notes: Mild oral tingling/burning sensation
Frequency: 2 affected / 105 at risk

Adverse event: Primary discomforts
Serious: no
Organ System: General disorders
Notes: Mild sensitive/irritated gums/teeth
Frequency: 3 affected / 105 at risk

Adverse event: Primary discomforts
Serious: no
Organ System: General disorders
Notes: Mild sensitive/irritated gums/teeth
Frequency: 2 affected / 107 at risk
Study: NCT03988426

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

Adverse event: Food poisoning
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 25 at risk

Adverse event: Condition aggravated
Serious: no
Organ System: General disorders
Frequency: 5 affected / 25 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 25 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 25 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 25 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 25 at risk

Adverse event: Blood and Lymphatic Infection
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 25 at risk

Adverse event: Investigations
Serious: no
Organ System: Investigations
Frequency: 2 affected / 25 at risk
Study: NCT03988647

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

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

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

Adverse event: Alanine transferase increase
Serious: no
Organ System: Investigations
Frequency: 1 affected / 1 at risk

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

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

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

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

Adverse event: Chest pain
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1 at risk
Study: NCT03988907

Adverse event: Extrasystoles
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 8 at risk

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

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

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 27 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 27 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 27 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 27 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 27 at risk

Adverse event: Sneezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 27 at risk

Adverse event: Upper-airway cough syndrome
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 27 at risk
Study: NCT03991013

Adverse event: severe COVID-19
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 65 at risk

Adverse event: Acute psychosis
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 65 at risk

Adverse event: Acute psychosis
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 65 at risk

Adverse event: incident pulmonary tuberculosis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 65 at risk

Adverse event: raised random glucose
Serious: no
Organ System: Endocrine disorders
Frequency: 2 affected / 65 at risk

Adverse event: Acute kidney injury
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 65 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 65 at risk

Adverse event: fractured tibia
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 62 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 62 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 62 at risk

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

Adverse event: stab chest
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 62 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 62 at risk

Adverse event: Gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 62 at risk

Adverse event: Anal abscess
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 62 at risk

Adverse event: Anogenital warts
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 62 at risk

Adverse event: Acute kidney injury
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 62 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 62 at risk

Adverse event: Blood pressure increased
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 62 at risk
Study: NCT03991988

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

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

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

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

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

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

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