TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT01795105

Adverse event: Neuritis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 648 at risk

Adverse event: Somnolence
Serious: no
Organ System: Psychiatric disorders
Frequency: 16 affected / 648 at risk

Adverse event: Appetite increased
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 648 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 648 at risk

Adverse event: Apathy
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 648 at risk

Adverse event: Nervousness
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 648 at risk

Adverse event: Emotional liability
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 648 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 648 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 648 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 648 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 648 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 648 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 648 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 648 at risk

Adverse event: Enteritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 648 at risk

Adverse event: Extrapyramidal disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 648 at risk

Adverse event: Hyperkinesia
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 648 at risk

Adverse event: Hypertonia
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 648 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 648 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 648 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 648 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 648 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 648 at risk

Adverse event: Weight increased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 648 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 648 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 648 at risk
Study: NCT01795638

Adverse event: Hypernatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: three infants receiving intervention contemporaneously with maintainence intravenous fluids developed hypernatremia (range 150-151mmol/L) and were withdrawn from the study, per defined protocol.
Frequency: 3 affected / 27 at risk
Study: NCT01795716

Adverse event: nausea and vomit
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 21 at risk

Adverse event: nausea and vomit
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 21 at risk
Study: NCT01795859

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 45 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 45 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 45 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 45 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 6 affected / 45 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 45 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 45 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 45 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 45 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 45 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 45 at risk

Adverse event: Sleep disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 45 at risk

Adverse event: Cholecystitis chronic
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 45 at risk

Adverse event: Agitated depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 45 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 45 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 45 at risk

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

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

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 45 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 45 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 45 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 45 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 45 at risk
Study: NCT01796548

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 15 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 15 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 15 at risk

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

Adverse event: Laryngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 15 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 15 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 15 at risk

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

Adverse event: Orthostatic hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 15 at risk

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

Adverse event: Cystitis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 15 at risk

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

Adverse event: Nerve compression
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 15 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 15 at risk
Study: NCT01796665

Adverse event: Skull Fracture, Brain Injury
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 474 at risk

Adverse event: Affective Disorder, Attention Deficit/Hyperactivity Disorder, and Oppositional Defiant Disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 474 at risk

Adverse event: Pharyngitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 237 at risk
Study: NCT01797029

Adverse event: Respiratory SAEs
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 1174 at risk

Adverse event: Non respiratory SAEs
Serious: yes
Organ System: General disorders
Frequency: 31 affected / 1174 at risk

Adverse event: Any SOC
Serious: no
Organ System: General disorders
Frequency: 68 affected / 1174 at risk

Adverse event: Respiratory SAEs
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 587 at risk

Adverse event: Non respiratory SAEs
Serious: yes
Organ System: General disorders
Frequency: 11 affected / 587 at risk

Adverse event: Any SOC
Serious: no
Organ System: General disorders
Frequency: 35 affected / 587 at risk
Study: NCT01797081

Adverse event: Cerebral infarction
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 151 at risk

Adverse event: Diverticulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 151 at risk

Adverse event: Herpes zoster
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 151 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 23 affected / 151 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 143 at risk

Adverse event: Intervertebral disc protrusion
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 143 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 39 affected / 143 at risk

Adverse event: Inguinal hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 97 at risk

Adverse event: Pneumothorax spontaneous
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 97 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 97 at risk
Study: NCT01797094

Adverse event: Hepatitis A
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 47 at risk

Adverse event: Injection site haemorrhage
Serious: no
Organ System: General disorders
Frequency: 9 affected / 47 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 47 at risk

Adverse event: Eyelid ptosis
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 47 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 47 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 53 at risk

Adverse event: Bartholin's cyst
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: Female population only.
Frequency: 1 affected / 48 at risk

Adverse event: Benign female reproductive tract neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Female population only.
Frequency: 1 affected / 48 at risk

Adverse event: Peritonitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 53 at risk

Adverse event: Supraventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 53 at risk

Adverse event: Injection site haemorrhage
Serious: no
Organ System: General disorders
Frequency: 6 affected / 53 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 53 at risk

Adverse event: Eyelid ptosis
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 53 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 53 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 53 at risk
Study: NCT01797263

Adverse event: Suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 129 at risk

Adverse event: Thoughts of self-harm
Serious: no
Organ System: Psychiatric disorders
Frequency: 26 affected / 129 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Notes: Suffered a stroke requiring hospitalization and treatment
Frequency: 1 affected / 127 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 127 at risk

Adverse event: Road traffic accident
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 127 at risk

Adverse event: Suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 127 at risk

Adverse event: Thoughts of self-harm
Serious: no
Organ System: Psychiatric disorders
Frequency: 29 affected / 127 at risk
Study: NCT01797432

Adverse event: Bronchitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 14 at risk

Adverse event: Herpes zoster
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 14 at risk

Adverse event: Cystitis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 14 at risk

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

Adverse event: Cold Sore
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 14 at risk

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

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 14 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 14 at risk

Adverse event: Pain at Injection Site
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 14 at risk

Adverse event: Menstruation irregular
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 14 at risk

Adverse event: Cold/flu
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 14 at risk

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

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

Adverse event: Diarrhoea infectious
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 14 at risk

Adverse event: Acne
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 14 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 14 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 14 at risk

Adverse event: Urticaria
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 14 at risk

Adverse event: Bump on Head
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 14 at risk
Study: NCT01797471

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

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1 at risk

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

Adverse event: Fatigue (asthenia, lethargy, malaise)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 1 at risk
Study: NCT01797536

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

Adverse event: Alcohol withdrawal syndrome
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 11 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Electrolyte imbalance
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 11 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 11 at risk
Study: NCT01797575

Adverse event: Skin irritation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Skin Irritation / Rash - Experience by a patient (determined likely due to citrus allergy) who was re-randomized after week 8. the same patient experienced the rash while taking Aspirin and then while on Placebo.
Frequency: 1 affected / 9 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Psychiatric disorders
Notes: Manic Episode of Bipolar I Disorder
Frequency: 1 affected / 14 at risk

Adverse event: Pregnancy test positive
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Positive pregnancy test at final study visit. All preceding pregnancy tests were negative throughout the study visits.
Frequency: 1 affected / 14 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Psychiatric disorders
Notes: Depression/Suicidal Ideations
Frequency: 1 affected / 25 at risk

Adverse event: Skin irritation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Skin Irritation / Rash - Experience by a patient (determined likely due to citrus allergy) who was re-randomized after week 8. the same patient experienced the rash while taking Aspirin and then while on Placebo.
Frequency: 1 affected / 25 at risk
Study: NCT01798316

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 52 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 52 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 52 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 52 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 53 at risk

Adverse event: Drowziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 53 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 53 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 53 at risk
Study: NCT01798394

Adverse event: Hospitalization for post-cesarean section infection
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 22 at risk
Study: NCT01798498

Adverse event: Uterin Polyp
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 48 at risk

Adverse event: Haematoma
Serious: no
Organ System: General disorders
Frequency: 9 affected / 48 at risk

Adverse event: Contusion
Serious: no
Organ System: General disorders
Frequency: 3 affected / 48 at risk
Study: NCT01798589

Adverse event: Dermatitis, contact
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 16 at risk

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

Adverse event: Seborrhoeic dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 16 at risk
Study: NCT01798641

Adverse event: Subdural haematoma
Serious: no
Organ System: Surgical and medical procedures
Frequency: 3 affected / 38 at risk

Adverse event: hygroma
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 38 at risk
Study: NCT01798966

Adverse event: Mild blurred vision
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 10 at risk

Adverse event: Mild hyperemia and palpebral conjunctiva
Serious: no
Organ System: Eye disorders
Frequency: 10 affected / 10 at risk

Adverse event: Punctate keratitis
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 10 at risk
Study: NCT01799135

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 6 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 6 at risk
Study: NCT01799213

Adverse event: Chest pain
Serious: yes
Organ System: Cardiac disorders
Notes: Chest pain; one patient occurrence resolved without work-up; one resulted in need for cardiac cath; one resulted in coronary artery bypass graft surgery (CABG) and withdrawal from study
Frequency: 1 affected / 180 at risk

Adverse event: Ischaemic stroke
Serious: yes
Organ System: Vascular disorders
Notes: Pt suffered ischemic stroke. Had been randomized to and taking placebo and had not taken Meloxicam for the past month. Pt withdrawn from Study per his request.
Frequency: 1 affected / 180 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Notes: Patient presented to emergency department (ED) with shortness of breath (SOB)/chest pain in Afib but discharged in sinus rhythm and was placed on Coumadin for 7days; study medication held as long as coumadin therapy was continued.
Frequency: 1 affected / 180 at risk

Adverse event: Bleeding hemorrhoid
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Patient represented with bleeding hemorrhoid requiring surgery and discontinuation of study drug (Meloxicam).
Frequency: 1 affected / 184 at risk

Adverse event: Chest pain
Serious: yes
Organ System: Cardiac disorders
Notes: Chest pain; one patient occurrence resolved without work-up; one resulted in need for cardiac cath; one resulted in coronary artery bypass graft surgery (CABG) and withdrawal from study
Frequency: 2 affected / 184 at risk

Adverse event: Arm celluitis
Serious: yes
Organ System: Infections and infestations
Notes: Patient with prior breast cancer and axially node resection presented with arm swelling/redness and treated for infectious cellulitis
Frequency: 1 affected / 184 at risk
Study: NCT01799226

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

Adverse event: Tissue slough
Serious: no
Organ System: General disorders
Frequency: 2 affected / 16 at risk

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

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

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

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

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

Adverse event: Herpetic lesion
Serious: no
Organ System: General disorders
Frequency: 2 affected / 16 at risk