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 @ 12:23 AM
Ignite Modification Date: 2025-12-25 @ 10:27 PM
NCT ID: NCT02427958
Description: At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Frequency Threshold: 5
Time Frame: Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Week 100) after the last dose of study drug
Study: NCT02427958
Study Brief: A Study to Assess the Safety and Efficacy of Leuprorelin in Central Precocious Puberty in Chinese Participants
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Leuprorelin Participants with body weight greater than or equal to (\>=) 20 kilogram (kg) received the recommended initial dose of leuprorelin 3.75 milligram (mg), injection, subcutaneously, once every 4 weeks for 96 weeks. Participants with body weight less than (\<) 20 kg received leuprorelin 1.88 mg, injection, subcutaneously, once every 4 weeks for 96 weeks. The dose was adjusted based on participant's condition and investigator's judgment in alignment with the product label in China. 0 None 12 307 189 307 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (21.0) View
Pneumonia mycoplasmal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (21.0) View
Tonsillitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (21.0) View
Appendicitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (21.0) View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (21.0) View
Chronic tonsillitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (21.0) View
Otitis media SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (21.0) View
Comminuted fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (21.0) View
Epiphyseal injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (21.0) View
Peripheral nerve injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (21.0) View
Post procedural haemorrhage SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (21.0) View
Skin abrasion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (21.0) View
Tibia fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (21.0) View
Tonsillar hypertrophy SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (21.0) View
Dermatitis allergic SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (21.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (21.0) View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (21.0) View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA (21.0) View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (21.0) View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (21.0) View
Tonsillitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (21.0) View
Pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (21.0) View