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 @ 2:17 AM
Ignite Modification Date: 2025-12-26 @ 12:46 AM
NCT ID: NCT01478360
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT01478360
Study Brief: Safety, Tolerability, and Efficacy of AIN457 in Patients With Uncontrolled 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
AIN457 10 mg/kg AIN457 10 mg/kg None None 1 31 21 31 View
Placebo Placebo None None 2 15 13 15 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
WRIST FRACTURE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
INTERVERTEBRAL DISC PROTRUSION SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
BASAL CELL CARCINOMA SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
TINNITUS SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA View
ABDOMINAL PAIN UPPER SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
ABDOMINAL RIGIDITY SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
CONSTIPATION SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
DIARRHOEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
NAUSEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
VOMITING SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
CHILLS SYSTEMATIC_ASSESSMENT General disorders MedDRA View
FATIGUE SYSTEMATIC_ASSESSMENT General disorders MedDRA View
FEELING COLD SYSTEMATIC_ASSESSMENT General disorders MedDRA View
VESSEL PUNCTURE SITE BRUISE SYSTEMATIC_ASSESSMENT General disorders MedDRA View
CYSTITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
LOWER RESPIRATORY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
NASOPHARYNGITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
OTITIS EXTERNA SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
RESPIRATORY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
VIRAL INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
CONTUSION SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
NAIL INJURY SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
PERIORBITAL CONTUSION SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
BODY TEMPERATURE INCREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA View
WEIGHT INCREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA View
IRON DEFICIENCY SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
ARTHRALGIA SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
MUSCLE SPASMS SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
PAIN IN EXTREMITY SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
DIZZINESS SYSTEMATIC_ASSESSMENT Nervous system disorders 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
DYSPNOEA SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
HAEMOPTYSIS SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
OROPHARYNGEAL PAIN SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
RHINORRHOEA SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
RASH SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
XANTHOMA SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View