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 @ 12:43 AM
Ignite Modification Date: 2025-12-25 @ 10:55 PM
NCT ID: NCT00688467
Description: Adverse events were collected for all participants who received \>=1 dose of study drug in either treatment period. Adverse events were reported based on the study drug taken at the time of the event.
Frequency Threshold: 5
Time Frame: Up to 48 days (the day of the last dose of study drug in Treatment Period 2)
Study: NCT00688467
Study Brief: Efficacy and Safety of Navarixin (SCH 527123) in Participants With Allergen-Induced Asthma (P05363)
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 Placebo 30 mg capsule to be taken by mouth once daily in the morning for 10 days None None 1 17 8 17 View
Navarixin Navarixin 30 mg capsule to be taken by mouth once daily in the morning for 10 days None None 0 16 8 16 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Lymphadenopathy SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 11.1 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 11.1 View
Procedural pain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.1 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.1 View
Migraine SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.1 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 11.1 View
Menstruation irregular SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 11.1 View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.1 View
Sinus congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.1 View
Dermatitis contact SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.1 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
Menstruation delayed SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 11.1 View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.1 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.1 View