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: 2025-12-25 @ 3:57 AM
Ignite Modification Date: 2025-12-26 @ 2:49 AM
NCT ID: NCT00267202
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00267202
Study Brief: Study to Evaluate the Effect of Omalizumab on Improving the Tolerability of Specific Immunotherapy in Patients With Persistent Allergic Asthma
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo The dose of placebo was determined according to the omalizumab US product label using a dosing table nomogram that ensures patients receive at least 0.016 mg/kg/IgE (IU/ml) per 4 weeks. The study drug was administered by subcutaneous injection every 2 or 4 weeks according to the dosing table nomogram. None None 3 136 91 136 View
Omalizumab The dose of omalizumab was determined according to the omalizumab US product label using a dosing table nomogram that ensures patients receive at least 0.016 mg/kg/IgE (IU/ml) per 4 weeks. The study drug was administered by subcutaneous injection every 2 or 4 weeks according to the dosing table nomogram. None None 4 139 88 139 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Rectal cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Anaphylactic reaction SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA View
Food allergy SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA View
Cellulitis staphylococcal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Benign neoplasm of spinal cord SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Pharyngeal oedema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Sexual abuse SYSTEMATIC_ASSESSMENT Social circumstances MedDRA View
Abortion induced SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA View
Swollen tongue SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Injection site erythema SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Injection site urticaria SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Injection site induration SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Injection site pruritus SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Injection site reaction SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Injection site swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Viral upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View