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 @ 4:12 AM
Ignite Modification Date: 2025-12-26 @ 3:10 AM
NCT ID: NCT00978120
Description: None
Frequency Threshold: 5
Time Frame: Enrollment through last day of followup (Day 201, target last day)
Study: NCT00978120
Study Brief: Safety and Efficacy of an H1N1 Influenza Vaccine in People With 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
Mild/Moderate Asthma, Low Dose Vaccine (15 Mcg) Participants with mild/moderate asthma received one 15 mcg dose of unadjuvanted, inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21. None None 4 110 29 110 View
Mild/Moderate Asthma, High Dose Vaccine (30mcg) Participants with mild/moderate asthma received two 15 mcg doses of unadjuvanted, inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21. None None 4 107 15 107 View
Severe Asthma, Low Dose Vaccine (15mcg) Participants with severe asthma received one 15 mcg dose of unadjuvanted, inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21. None None 12 87 25 87 View
Severe Asthma, High Dose Vaccine (30mcg) Participants with severe asthma received two 15 mcg doses of unadjuvanted, inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21. None None 6 86 25 86 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Ovarian cyst SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 12.1 View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.1 View
Drug rehabilitation SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 12.1 View
Hysterectomy SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 12.1 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.1 View
Death SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.1 View
Diverticulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.1 View
Localised infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.1 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.1 View
Road traffic accident SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.1 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.1 View
Spinal osteoarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.1 View
Breast cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.1 View
Thyroid cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.1 View
Pancreatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.1 View
Abasia SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.1 View
Small intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.1 View
Umbilical hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.1 View
Atrial flutter SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.1 View
Forced expiratory volume decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12.1 View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.1 View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.1 View