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 @ 7:52 PM
Ignite Modification Date: 2025-12-25 @ 5:27 PM
NCT ID: NCT02968004
Description: None
Frequency Threshold: 2
Time Frame: 1 year for Main Study Phase. Up to 6 years for OLE Phase.
Study: NCT02968004
Study Brief: Safety and Efficacy Phase 3 Study of Long-acting hGH (MOD-4023) in Growth Hormone Deficient Children
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
MOD-4023 Once weekly subcutaneous injection of long acting r-hGH (MOD-4023) MOD-4023: Once weekly subcutaneous injection using pre-filled pen device. 0 None 3 109 92 109 View
Genotropin Once daily subcutaneous injection of somatropin (r-hGH; Genotropin) Somatropin: Once daily subcutaneous injection of Genotropin 0 None 2 115 90 115 View
MOD-4023 in OLE Phase Once weekly subcutaneous injection of long acting r-hGH (MOD-4023) MOD-4023: Once weekly subcutaneous injection using pre-filled pen device. 0 None 14 212 175 212 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Lymphadenitis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Adrenal Insufficiency SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Delayed Puberty SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Abdominal Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Noninfective Sialoadenitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Appendicitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Croup Infectious SYSTEMATIC_ASSESSMENT Infections and infestations None View
Diverticulitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Peritonitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pharyngitis Streptococcal SYSTEMATIC_ASSESSMENT Infections and infestations None View
Chronic tonsillitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Tonsillitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Ureterolithiasis SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Scrotal Varicose Veins SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Adenoidal Hypertrophy SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Urticaria SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Kawasaki's Disease SYSTEMATIC_ASSESSMENT Vascular disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Basophilia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Eosinophilia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Iron Deficiency Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Ear Pain SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Hypothyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Conjunctivitis Allergic SYSTEMATIC_ASSESSMENT Eye disorders None View
Myopia SYSTEMATIC_ASSESSMENT Eye disorders None View
Abdominal Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal Pain Upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dental Caries SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Toothache SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Injection Site Erythema SYSTEMATIC_ASSESSMENT General disorders None View
Injection Site Induration SYSTEMATIC_ASSESSMENT General disorders None View
Injection Site Pain SYSTEMATIC_ASSESSMENT General disorders None View
Injection Site Pruritus SYSTEMATIC_ASSESSMENT General disorders None View
Injection Site Swelling SYSTEMATIC_ASSESSMENT General disorders None View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders None View
Vaccination Site Pain SYSTEMATIC_ASSESSMENT General disorders None View
Seasonal Allergy SYSTEMATIC_ASSESSMENT Immune system disorders None View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Conjunctivitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Corona Virus Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Enterobiasis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Gastroenteritis Viral SYSTEMATIC_ASSESSMENT Infections and infestations None View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations None View
Molluscum Contagiosum SYSTEMATIC_ASSESSMENT Infections and infestations None View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Otitis Externa SYSTEMATIC_ASSESSMENT Infections and infestations None View
Otitis Media SYSTEMATIC_ASSESSMENT Infections and infestations None View
Otitis Media Acute SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pharyngitis Streptococcal SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Rhinitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Tonsillitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Upper Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Viral Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Viral Pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Viral Upper Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Arthropod Bite SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Ligament Sprain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Limb Injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Skin Abrasion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Traumatic Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Blood Creatine Phosphokinase Increased SYSTEMATIC_ASSESSMENT Investigations None View
Blood Thyroid Stimulating Hormone Decreased SYSTEMATIC_ASSESSMENT Investigations None View
Coronavirus Test Positive SYSTEMATIC_ASSESSMENT Investigations None View
Free Fatty Acids Increased SYSTEMATIC_ASSESSMENT Investigations None View
Insulin-Like Growth Factor Increased SYSTEMATIC_ASSESSMENT Investigations None View
Low Density Lipoprotein Decreased SYSTEMATIC_ASSESSMENT Investigations None View
Thyroxine Free Decreased SYSTEMATIC_ASSESSMENT Investigations None View
Hypertriglyceridaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypoinsulinaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Iron Deficiency SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Oropharyngeal Pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Rhinitis Allergic SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Rhinorrhoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rash generalised SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Urticaria SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Pain In Extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Scoliosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Attention Deficit/Hyperactivity Disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Nasal Congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View