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 @ 10:03 PM
Ignite Modification Date: 2025-12-25 @ 7:40 PM
NCT ID: NCT05723835
Description: An AE is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of study drug, whether or not considered related to the study treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an study treatment. Safety analysis set included all participants who were exposed to study treatment.
Frequency Threshold: 5
Time Frame: From Baseline (Week 0) up to Week 94 (approximately, Data cut off date: 24Nov2024)
Study: NCT05723835
Study Brief: A Research Study Looking at How Safe Somapacitan is and How Well it Works in Children Who Need Help to Grow - REAL 9
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
SGA_somapacitan (GH Treatment Naïve) Participants with small for gestational age who were treatment naïve subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I. 0 None 0 4 3 4 View
SGA_somapacitan (Previously Treated With GH) Participants with small for gestational age who were previously treated with GH, subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I. 0 None 1 8 5 8 View
TS_somapacitan (GH Treatment Naïve) Participants with Turner syndrome who were treatment naïve subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I. 0 None 0 3 2 3 View
TS_somapacitan (Previously Treated With GH) Participants with Turner syndrome who were previously treated with GH, subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I. 0 None 1 8 7 8 View
NS_somapacitan (GH Treatment Naïve) Participants with Noonan syndrome who were treatment naïve subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I. 0 None 0 6 4 6 View
NS_somapacitan (Previously Treated With GH) Participants with Noonan syndrome who were previously treated with GH, subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I. 0 None 0 7 6 7 View
ISS_somapacitan (GH Treatment Naïve) Participants with idiopathic short stature who were treatment naïve subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I. 0 None 0 2 2 2 View
ISS_somapacitan (Previously Treated With GH) Participants with idiopathic short stature who were were previously treated with GH, subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I. 0 None 1 9 8 9 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Conduction disorder SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 27.1 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.1 View
Gastrointestinal microorganism overgrowth SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Gastrooesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.1 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.1 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.1 View
Accidental overdose SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27.1 View
Accidental underdose SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27.1 View
Acne SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 27.1 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.1 View
Aortic valve incompetence SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 27.1 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 27.1 View
Asthma exercise induced SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.1 View
Avulsion fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27.1 View
Blood thyroid stimulating hormone increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.1 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Cardiac imaging procedure abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.1 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.1 View
Coccydynia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 27.1 View
Concussion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27.1 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.1 View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27.1 View
Costochondritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 27.1 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.1 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.1 View
Dysuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 27.1 View
Ear infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Ear swelling SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 27.1 View
Epilepsy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.1 View
Erythema infectiosum SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27.1 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.1 View
Fungal skin infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Groin pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 27.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.1 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Ingrowing nail SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 27.1 View
Injection site bruising SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.1 View
Insulin-like growth factor increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.1 View
Intellectual disability SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.1 View
Iron deficiency anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 27.1 View
Lethargy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.1 View
Ligament sprain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27.1 View
Limb injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27.1 View
Lipodystrophy acquired SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 27.1 View
Lower respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Medication error SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27.1 View
Molluscum contagiosum SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Muscle strain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27.1 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 27.1 View
Myopia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 27.1 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Norovirus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Odynophagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.1 View
Onychomycosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.1 View
Osteitis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 27.1 View
Otitis media acute SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 27.1 View
Pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Pneumonia viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Precocious puberty SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 27.1 View
Product administration error SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27.1 View
Productive cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.1 View
Psoriasis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 27.1 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.1 View
Respiratory syncytial virus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Rhinitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Rhinorrhoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.1 View
Scarlet fever SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Scoliosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 27.1 View
Seasonal allergy SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 27.1 View
Serum ferritin decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.1 View
Sports injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27.1 View
Tendon pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 27.1 View
Tonsillitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Viral pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.1 View
Wheezing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.1 View