Adverse Events Module

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Adverse Events Module

For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.

Adverse Events Module path is as follows:

Study -> Results Section -> Adverse Events Module -> Event Groups

Study -> Results Section -> Adverse Events Module -> Serious Events

Study -> Results Section -> Adverse Events Module -> Other Events

Adverse Events Module

Ignite Creation Date: 2025-12-24 @ 4:42 PM
Ignite Modification Date: 2025-12-25 @ 2:30 PM
NCT ID: NCT00310466
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT00310466
Study Brief: Efficacy and Safety Trial of SLITone(TM) Birch in Subjects With Hayfever
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
SLITone Birch Birch pollen extract for sublingual administration None None 4 113 81 113 View
Placebo Corresponding placebo for sublingual administration None None 2 113 87 113 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Road traffic accident None Injury, poisoning and procedural complications MedDRA View
Nephrolithiasis None Renal and urinary disorders MedDRA View
Cholecystectomy None Surgical and medical procedures MedDRA View
Tonsillectomy None Surgical and medical procedures MedDRA View
Oesophagitis None Gastrointestinal disorders MedDRA View
Radius fracture None Injury, poisoning and procedural complications MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Eye irritation None Eye disorders MedDRA View
Eye pruritus None Eye disorders MedDRA View
Eye redness None Eye disorders MedDRA View
Eye swelling None Eye disorders MedDRA View
Lacrimation increased None Eye disorders MedDRA View
Abdominal discomfort None Gastrointestinal disorders MedDRA View
Abdominal pain None Gastrointestinal disorders MedDRA View
Abdominal pain upper None Gastrointestinal disorders MedDRA View
Aphthous stomatitis None Gastrointestinal disorders MedDRA View
Oedema mucosal None General disorders MedDRA View
Oedema peripheral None General disorders MedDRA View
Pyrexia None General disorders MedDRA View
Sensation of foreign body None General disorders MedDRA View
Biliary colic None Hepatobiliary disorders MedDRA View
Allergy to arthropod sting None Immune system disorders MedDRA View
Anaphylactic reaction None Immune system disorders MedDRA View
Hypersensitivity None Immune system disorders MedDRA View
Seasonal allergy None Immune system disorders MedDRA View
Rhinitis infective None Infections and infestations MedDRA View
Sinobronchitis None Infections and infestations MedDRA View
Sinusitis None Infections and infestations MedDRA View
Tinea pedis None Infections and infestations MedDRA View
Tinea versicolour None Infections and infestations MedDRA View
Tonsilitis None Infections and infestations MedDRA View
Joint surgery None Surgical and medical procedures MedDRA View
Lipoma excision None Surgical and medical procedures MedDRA View
Nausea None Gastrointestinal disorders MedDRA View
Oedema mouth None Gastrointestinal disorders MedDRA View
Oesophagitis None Gastrointestinal disorders MedDRA View
Oral discomfort None Gastrointestinal disorders MedDRA View
Oral pruritus None Gastrointestinal disorders MedDRA View
Toothache None Gastrointestinal disorders MedDRA View
Vomiting None Gastrointestinal disorders MedDRA View
Application site anaesthesia None General disorders MedDRA View
Application site eczema None General disorders MedDRA View
Application site papules None General disorders MedDRA View
Chest discomfort None General disorders MedDRA View
Fatigue None General disorders MedDRA View
Feeling cold None General disorders MedDRA View
Mucous membrane disorders None General disorders MedDRA View
Acute sinusitis None Infections and infestations MedDRA View
Bladder infection None Infections and infestations MedDRA View
Bronchitis None Infections and infestations MedDRA View
Cystitis None Infections and infestations MedDRA View
Folliculitis None Infections and infestations MedDRA View
Gastroenteritis None Infections and infestations MedDRA View
Gastrointestinal infection None Infections and infestations MedDRA View
Herpes simplex None Infections and infestations MedDRA View
Herpes soster None Infections and infestations MedDRA View
Hordeolum None Infections and infestations MedDRA View
Infected naevus None Infections and infestations MedDRA View
Influenza None Infections and infestations MedDRA View
Laryngitis None Infections and infestations MedDRA View
Laryngitis viral None Infections and infestations MedDRA View
Localised infection None Infections and infestations MedDRA View
Nasopharyngitis None Infections and infestations MedDRA View
Otitis media None Infections and infestations MedDRA View
Pharyngitis None Infections and infestations MedDRA View
Pneumonia None Infections and infestations MedDRA View
Respiratory tract infection None Infections and infestations MedDRA View
Upper respiratory tract infection None Infections and infestations MedDRA View
Vaginitis None Infections and infestations MedDRA View
Viral diarrhoea None Infections and infestations MedDRA View
Viral infection None Infections and infestations MedDRA View
Anaemia postoperative None Injury, poisoning and procedural complications MedDRA View
Contusion None Injury, poisoning and procedural complications MedDRA View
Eye injury None Injury, poisoning and procedural complications MedDRA View
facial bones fracture None Injury, poisoning and procedural complications MedDRA View
Injury corneal None Injury, poisoning and procedural complications MedDRA View
Joint injury None Injury, poisoning and procedural complications MedDRA View
Limb injury None Injury, poisoning and procedural complications MedDRA View
Meniscus lesion None Injury, poisoning and procedural complications MedDRA View
Muscle rupture None Injury, poisoning and procedural complications MedDRA View
Radius fracture None Injury, poisoning and procedural complications MedDRA View
Road traffic accident None Injury, poisoning and procedural complications MedDRA View
Gout None Metabolism and nutrition disorders MedDRA View
Hyperuricaemia None Metabolism and nutrition disorders MedDRA View
Arthralgia None Musculoskeletal and connective tissue disorders MedDRA View
Back pain None Musculoskeletal and connective tissue disorders MedDRA View
Bone spur None Musculoskeletal and connective tissue disorders MedDRA View
Intervertebral disc protrusion None Musculoskeletal and connective tissue disorders MedDRA View
Pain in extremity None Musculoskeletal and connective tissue disorders MedDRA View
Rheumatoid arthritis None Musculoskeletal and connective tissue disorders MedDRA View
Tenosynovitis None Musculoskeletal and connective tissue disorders MedDRA View
Basal cell carcinoma None Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Lung neoplasm malignant None Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Polyp None Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Burning sensation None Nervous system disorders MedDRA View
Disturbance in attention None Nervous system disorders MedDRA View
Dizziness None Nervous system disorders MedDRA View
Headache None Nervous system disorders MedDRA View
Oral dysaesthesia None Nervous system disorders MedDRA View
Paraesthesia oral None Nervous system disorders MedDRA View
Insomnia None Psychiatric disorders MedDRA View
Haematuria None Renal and urinary disorders MedDRA View
Nephrolithiasis None Renal and urinary disorders MedDRA View
Gynaecomastia None Reproductive system and breast disorders MedDRA View
Menopausal symptoms None Reproductive system and breast disorders MedDRA View
Pelvic pain None Reproductive system and breast disorders MedDRA View
Uterine cyst None Reproductive system and breast disorders MedDRA View
Asthma None Respiratory, thoracic and mediastinal disorders MedDRA View
Asthma exercise induced None Respiratory, thoracic and mediastinal disorders MedDRA View
Cough None Respiratory, thoracic and mediastinal disorders MedDRA View
Dyspnoea None Respiratory, thoracic and mediastinal disorders MedDRA View
Epistaxis None Respiratory, thoracic and mediastinal disorders MedDRA View
Maxillary sinusitis None Respiratory, thoracic and mediastinal disorders MedDRA View
Nasal congestion None Respiratory, thoracic and mediastinal disorders MedDRA View
Nasal mucosal disorder None Respiratory, thoracic and mediastinal disorders MedDRA View
Nasal passage irritation None Respiratory, thoracic and mediastinal disorders MedDRA View
Oropharyngeal swelling None Respiratory, thoracic and mediastinal disorders MedDRA View
Pharyngeal oedema None Respiratory, thoracic and mediastinal disorders MedDRA View
Pharyngolaryngeal pain None Respiratory, thoracic and mediastinal disorders MedDRA View
Rhinitis None Respiratory, thoracic and mediastinal disorders MedDRA View
Rhinitis allergic None Respiratory, thoracic and mediastinal disorders MedDRA View
Rhinitis seasonal None Respiratory, thoracic and mediastinal disorders MedDRA View
Rhinorrhoea None Respiratory, thoracic and mediastinal disorders MedDRA View
Sneezing None Respiratory, thoracic and mediastinal disorders MedDRA View
Throat irritation None Respiratory, thoracic and mediastinal disorders MedDRA View
Angioneurotic oedema None Skin and subcutaneous tissue disorders MedDRA View
Dermal cyst None Skin and subcutaneous tissue disorders MedDRA View
Dermatitis None Skin and subcutaneous tissue disorders MedDRA View
Dermatitis allergic None Skin and subcutaneous tissue disorders MedDRA View
Dermatitis atopic None Skin and subcutaneous tissue disorders MedDRA View
Dermatitis medicamentosa None Skin and subcutaneous tissue disorders MedDRA View
Eczema None Skin and subcutaneous tissue disorders MedDRA View
Erythema None Skin and subcutaneous tissue disorders MedDRA View
Exanthem None Skin and subcutaneous tissue disorders MedDRA View
Leukocytoclastic vasculitis None Skin and subcutaneous tissue disorders MedDRA View
Neurodermatitis None Skin and subcutaneous tissue disorders MedDRA View
Panniculitis None Skin and subcutaneous tissue disorders MedDRA View
Pruritus None Skin and subcutaneous tissue disorders MedDRA View
Swelling face None Skin and subcutaneous tissue disorders MedDRA View
Urticaria None Skin and subcutaneous tissue disorders MedDRA View
Urticaria papular None Skin and subcutaneous tissue disorders MedDRA View
Cholecystectomy None Surgical and medical procedures MedDRA View
Colon polypectomy None Surgical and medical procedures MedDRA View
Dental operation None Surgical and medical procedures MedDRA View
Sinus operation None Surgical and medical procedures MedDRA View
Skin neoplasm excision None Surgical and medical procedures MedDRA View
Tonsillectomy None Surgical and medical procedures MedDRA View
Tooth extraction None Surgical and medical procedures MedDRA View
Flushing None Vascular disorders MedDRA View
Thrombosis None Vascular disorders MedDRA View
Lymphadenopathy None Blood and lymphatic system disorders MedDRA View
Arrhytmia None Cardiac disorders MedDRA View
Tachycardia None Cardiac disorders MedDRA View
Ear pain None Ear and labyrinth disorders MedDRA View
Ear pruritus None Ear and labyrinth disorders MedDRA View
Tinnitus None Ear and labyrinth disorders MedDRA View
Abnormal sensation in eye None Eye disorders MedDRA View
Conjunctivitis None Eye disorders MedDRA View
Conjunctivitis allergic None Eye disorders MedDRA View
Cheilitis None Gastrointestinal disorders MedDRA View
Diarrhoea None Gastrointestinal disorders MedDRA View
Gastritis None Gastrointestinal disorders MedDRA View
Glossodynia None Gastrointestinal disorders MedDRA View
Hypoaesthesia oral None Gastrointestinal disorders MedDRA View
Intestinal polyp None Gastrointestinal disorders MedDRA View