Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 10:06 PM
Ignite Modification Date: 2025-12-25 @ 7:43 PM
NCT ID: NCT03811535
Description: Safety analysis set included all randomized participants exposed to at least one dose of randomized treatment.
Frequency Threshold: 5
Time Frame: From week -2 up to week 52
Study: NCT03811535
Study Brief: A Research Study in Children With a Low Level of Hormone to Grow. Treatment is Somapacitan Once a Week Compared to Norditropin® Once a Day (REAL4)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Norditropin Participants received 0.034 milligrams/kilogram (mg/kg) norditropin subcutaneously (s.c.; under the skin) by FlexPro pen-injector once daily for 52 weeks (main trial period). Participants completing the main trial period will receive 0.16 mg/kg somapacitan once weekly for 3 years (extension period). 0 None 2 68 22 68 View
Somapacitan Participants received 0.16 mg/kg somapacitan s.c. once weekly by PDS290 pen-injector for 52 weeks (main trial period). Participants completing the main trial period will receive 0.16 mg/kg somapacitan once weekly for 3 years (extension period). 0 None 6 132 46 132 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Adrenocortical insufficiency acute SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 24 View
Adenoidal hypertrophy SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24 View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24 View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24 View
Cryptorchism SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA 24 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24 View
Otitis media SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24 View
Umbilical hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 24 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24 View