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 @ 7:43 PM
Ignite Modification Date: 2025-12-25 @ 5:21 PM
NCT ID: NCT04090203
Description: None
Frequency Threshold: 0
Time Frame: All reportable events will be recorded with start dates occurring any time after informed consent is obtained until 7 days (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Study participation could last for a maximum of up to 35 weeks.
Study: NCT04090203
Study Brief: Boiled Peanut Oral Immunotherapy
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Boiled Peanut Powder Boiled Peanut Powder Boiled Peanut Powder: Oral Immunotherapy will be administered utilizing a powder derived from boiled peanuts. Treatment will begin with an initial escalation day in which dosing is begun at 0.1 mg peanut protein and escalated to a final dose of 6 mg peanut protein. Doses are ingested orally. The subjects will continue daily oral ingestion of doses at home and return for updosing every 2 weeks to a final maintenance dose of 300 mg peanut protein. The subjects will continue daily oral ingestion of the peanut product for a minimum duration of 28 days before undergoing exit DBPCFC. At the conclusion of the study, patients will be offered continued maintenance therapy off study in line with current specialty standards. 0 None 2 8 8 8 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anaphylaxis - Hives; redness and swelling of eyes; cough; difficulty breathing SYSTEMATIC_ASSESSMENT Immune system disorders None View
Coughing and wheezing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Globus sensation; audible change in voice; dysphagia SYSTEMATIC_ASSESSMENT Immune system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal Pain, Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal Pain, Facial Flushing, Head Pain, Pruritus, Malaise SYSTEMATIC_ASSESSMENT Immune system disorders None View
Abdominal Pain, Non-Cardiac Chest Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal Pain, Upset Stomach, Reflux SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Belching SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Cough, Urticaria, Lip/Mouth Pruritus, Vomiting SYSTEMATIC_ASSESSMENT Immune system disorders None View
Cough, Wheezing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Eczema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Eczema, Pruritus SYSTEMATIC_ASSESSMENT Immune system disorders None View
Eczema, Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Eyelid Dysfunction (Redness/Swelling) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Facial Rash, Mucositis Oral SYSTEMATIC_ASSESSMENT Immune system disorders None View
Fever, Vomiting SYSTEMATIC_ASSESSMENT Infections and infestations None View
Gastrointestinal Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Lip/Mouth Pruritus SYSTEMATIC_ASSESSMENT Immune system disorders None View
Lip/Mouth Pruritus, Abdominal Pain, Throat Pruritus SYSTEMATIC_ASSESSMENT Immune system disorders None View
Lip/Mouth Pruritus, Eye Pruritus, Vomiting SYSTEMATIC_ASSESSMENT Immune system disorders None View
Lip/Mouth Pruritus, Nausea SYSTEMATIC_ASSESSMENT Immune system disorders None View
Lip/Mouth Pruritus, Rash Maculo-Papular SYSTEMATIC_ASSESSMENT Immune system disorders None View
Lip/Mouth Pruritus, Throat Pruritus SYSTEMATIC_ASSESSMENT Immune system disorders None View
Lip/Mouth Pruritus, Throat Pruritus, Nausea SYSTEMATIC_ASSESSMENT Immune system disorders None View
Nasal Congestion, Urticaria SYSTEMATIC_ASSESSMENT Immune system disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pruritus SYSTEMATIC_ASSESSMENT Immune system disorders None View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Pruritus, Cough SYSTEMATIC_ASSESSMENT Immune system disorders None View
Respiratory SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Rhinitis SYSTEMATIC_ASSESSMENT General disorders None View
Rhinitis, Nasal Congestion SYSTEMATIC_ASSESSMENT General disorders None View
Rhinorrhea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Serous Otitis SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Throat Pruritus SYSTEMATIC_ASSESSMENT Immune system disorders None View
Urticaria SYSTEMATIC_ASSESSMENT Immune system disorders None View
Urticaria, Cough SYSTEMATIC_ASSESSMENT Immune system disorders None View
Urticaria, Eye Pruritus, Nasal Congestion SYSTEMATIC_ASSESSMENT Immune system disorders None View
Urticaria, Periorbital Edema SYSTEMATIC_ASSESSMENT Immune system disorders None View
Urticaria, Rash Maculo-Papular SYSTEMATIC_ASSESSMENT Immune system disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting, Abdominal Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting, Nasal Congestion, Chest Wall Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting, Urticaria SYSTEMATIC_ASSESSMENT Immune system disorders None View