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 @ 9:43 PM
Ignite Modification Date: 2025-12-25 @ 7:24 PM
NCT ID: NCT00624832
Description: None
Frequency Threshold: 5
Time Frame: 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
Study: NCT00624832
Study Brief: A Study of Efficacy of New Doses of Xolair to Protect From Allergen Challenge in Groups of Asthma Patients Defined by IgE Levels
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Xolair (IgE= 30- 300 IU/mL) Patients with screening IgE levels= 30-300 IU/mL. Participants received subcutaneous injections of Xolair(Omalizumab) every 2 weeks or every 4 weeks; dosage dependent on IgE level and body weight. None None 1 18 9 18 View
Xolair (IgE= 700- 2000 IU/mL) Patients with screening IgE levels= 700- 2000 IU/mL. Participants received subcutaneous injections of Xolair(Omalizumab) every 2 weeks; dosage dependent on IgE level and body weight. None None 1 16 15 16 View
Xolair (IgE= 301- 699 IU/mL) Patients with screening IgE levels= 301- 699 IU/mL. Participants received subcutaneous injections of Xolair(Omalizumab) every 2 weeks; dosage dependent on IgE level and body weight. None None 0 10 6 10 View
Placebo Comparator Placebo comparator None None 0 16 12 16 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Malignant melanoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Papilloma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Ear pain SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA View
Conjunctivitis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Infusion site swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Infusion site warmth SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Injection site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Tonsillitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Bronchial obstruction SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Bronchospasm SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Lymphadenopathy SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Conjunctivitis allergic SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Eye irritation SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Eye pruritus SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Gastrointestinal disorder SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Toothache SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Infusion site erythema SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Infusion site haematoma SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Infusion site induration SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Infusion site irritation SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Injection site swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Seasonal allergy SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Eczema infected SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Herpes virus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Infectious mononucleosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Laryngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Oral herpes SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Oral infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pilonidal cyst SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Rhinitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Tinea pedis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Viral infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Excoriation SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Road traffic accident SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Sunburn SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Tooth injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Wound complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Blood pressure diastolic increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Blood pressure systolic increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Myosclerosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Sleep disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Dysmenorrhoea SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Productive cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Rhinitis allergic SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Dermatitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Dermographism SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Neurodermatitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Photosensitivity reaction SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View