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 @ 12:36 AM
Ignite Modification Date: 2025-12-25 @ 10:45 PM
NCT ID: NCT03005067
Description: All treatment emergent adverse events and serious adverse were reported.
Frequency Threshold: 1
Time Frame: Approximately 8 days
Study: NCT03005067
Study Brief: To Evaluate the Efficacy and Safety of 1146A Nasal Spray in Adult Participants With Symptoms of Common Cold
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Test Product Participants were administered test product (nasal spray) containing carbomer 980 gel (1146A). 0 None 1 87 32 87 View
Placebo Nasal Spray Participants were administered placebo nasal spray containing vehicle without carbomer 980. 0 None 0 81 34 81 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
BIPOLAR DISORDER SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
COUGH SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
NASAL CONGESTION SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
NASAL DISCOMFORT SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
FEELING COLD SYSTEMATIC_ASSESSMENT General disorders None View
NECK PAIN SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
BRONCHITIS SYSTEMATIC_ASSESSMENT Infections and infestations None View
VULVOVAGINAL MYCOTIC INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations None View
BACK INJURY SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
HYPERTENSION SYSTEMATIC_ASSESSMENT Vascular disorders None View
VERTIGO SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
LACRIMATION INCREASED SYSTEMATIC_ASSESSMENT Eye disorders None View
BLOOD PRESSURE SYSTOLIC INCREASED SYSTEMATIC_ASSESSMENT Investigations None View
PREGNANCY SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
PRODUCT TASTE ABNORMAL SYSTEMATIC_ASSESSMENT Product Issues None View
BIPOLAR DISORDER SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
POLLAKIURIA SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
RHINORRHOEA SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
SNEEZING SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
NASAL DRYNESS SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
WHEEZING SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
DYSPNOEA SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
INTRANASAL HYPOAESTHESIA SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
NASAL MUCOSAL EROSION SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
NASAL MUCOSAL ULCER SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
RHINALGIA SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
HEADACHE SYSTEMATIC_ASSESSMENT Nervous system disorders None View
DIZZINESS SYSTEMATIC_ASSESSMENT Nervous system disorders None View
BURNING SENSATION SYSTEMATIC_ASSESSMENT Nervous system disorders None View
SINUS HEADACHE SYSTEMATIC_ASSESSMENT Nervous system disorders None View
SOMNOLENCE SYSTEMATIC_ASSESSMENT Nervous system disorders None View
ADMINISTRATION SITE PAIN SYSTEMATIC_ASSESSMENT General disorders None View
APPLICATION SITE PAIN SYSTEMATIC_ASSESSMENT General disorders None View
CHILLS SYSTEMATIC_ASSESSMENT General disorders None View
CHEST DISCOMFORT SYSTEMATIC_ASSESSMENT General disorders None View
FEELING JITTERY SYSTEMATIC_ASSESSMENT General disorders None View
PYREXIA SYSTEMATIC_ASSESSMENT General disorders None View
MYALGIA SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
ARTHRALGIA SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
BACK PAIN SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
NAUSEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
DRY MOUTH SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
RETCHING SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
VOMITING SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
ABSCESS OF EYELID SYSTEMATIC_ASSESSMENT Infections and infestations None View
LARYNGITIS SYSTEMATIC_ASSESSMENT Infections and infestations None View
TOOTH INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations None View
EXCORIATION SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
PRURITUS SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
SEBORRHOEIC DERMATITIS SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
EPISTAXIS SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
OROPHARYNGEAL PAIN SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View