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: 2025-12-24 @ 5:03 PM
Ignite Modification Date: 2025-12-25 @ 2:43 PM
NCT ID: NCT01187550
Description: Pre-Treatment:Medical conditions present at initial study visit that did not worsen in severity or frequency during study;Treatment-Emergent: If onset date of AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of AE was post 4 weeks after drug administration for participants who completed the study.
Frequency Threshold: 0
Time Frame: Adverse Events (AEs) are collected on an ongoing basis from day of written informed consent. All new AEs must be recorded until 4 weeks post drug administration. AEs are classified as pre-treatment, treatment-emergent and post-treatment.
Study: NCT01187550
Study Brief: Predictive Markers in Chinese Growth Hormone Deficiency (GHD) Children Treated With Saizen®
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Appropriate for Gestational Age (AGA) Participants in AGA group received Saizen (recombinant human growth hormone, r-hGH) subcutaneously (sc) at the daily dose of 0.033 milligram/kilogram (mg/kg) body weight for 4 weeks. None None 1 175 27 175 View
Small for Gestational Age (SGA) Participants in SGA group received Saizen (r-hGH) sc at the daily dose of 0.033 mg/kg body weight for 4 weeks. None None 0 30 3 30 View
Serious Events(If Any):

Serious Events

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

Other Events

Term Type Organ System Vocab View
Conjunctivitis NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (11.1) View
Eye Oedema NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (11.1) View
Ocular Hypertension NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (11.1) View
Abdominal Pain Upper NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (11.1) View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (11.1) View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (11.1) View
Hyperhidrosis NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (11.1) View
Injection Site Dermatitis NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (11.1) View
Injection Site Reaction NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (11.1) View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (11.1) View
Liver Function Test Abnormal NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA (11.1) View
Anorexia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (11.1) View
Pain In Extremity NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (11.1) View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (11.1) View
Bronchitis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (11.1) View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (11.1) View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (11.1) View
Rhinorrhoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (11.1) View
Tonsillitis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (11.1) View
Upper Respiratory Tract Infection NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (11.1) View
Skin Infection NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (11.1) View