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 @ 12:20 PM
Ignite Modification Date: 2025-12-25 @ 12:03 PM
NCT ID: NCT01927861
Description: All presented AEs are TEAEs. A TEAE (for the entire trial) was defined as an event that had onset date on or after the date of visit 2 (week 0; start of treatment) and no later than 7 days after the last day of trial product administration. Results are based on the SAS, which included all participants receiving at least one dose of trial product.
Frequency Threshold: 5
Time Frame: Week 0 to week 234 (208 weeks treatment period + 26 weeks extended treatment period) + 7 days (follow-up period).
Study: NCT01927861
Study Brief: Investigating the Long-term Efficacy and Safety of Two Doses of NN-220 (Somatropin) in Short Stature Due to Noonan Syndrome
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
0.033 mg/kg/Day Participants received s.c. injection of NN-220, 0.033 mg/kg/day once daily for 234 weeks (104 weeks of pivotal phase + 104 weeks of extension phase + 26 weeks extended treatment phase). 0 None 9 25 24 25 View
0.066 mg/kg/Day Participants received s.c. injection of NN-220, 0.066 mg/kg/day once daily for 234 weeks (104 weeks of pivotal phase + 104 weeks of extension phase + 26 weeks extended treatment phase). 0 None 10 26 26 26 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Arnold-Chiari malformation SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA 18 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18 View
Conductive deafness SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 18 View
Craniosynostosis SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA 18 View
Dental caries SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18 View
Febrile convulsion SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18 View
Hamartoma SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA 18 View
Head banging SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 18 View
Phimosis SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA 18 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18 View
Pneumonia mycoplasmal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18 View
Polymyositis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18 View
Pulmonary artery therapeutic procedure SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 18 View
Salivary gland calculus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18 View
Supernumerary teeth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18 View
Testicular swelling SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 18 View
Tonsillitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18 View
Velopharyngeal incompetence SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18 View
Arthropod bite SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18 View
Arthropod sting SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18 View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18 View
Attention deficit/hyperactivity disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 18 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18 View
Bronchitis bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18 View
Chillblains SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18 View
Conjunctivitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18 View
Conjunctivitis allergic SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 18 View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18 View
Dental caries SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18 View
Dermatitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18 View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18 View
Eczema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18 View
Enteritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18 View
Gingivitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18 View
Hordeolum SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18 View
Hyperinsulinaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18 View
Hyperkeratosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18 View
Impetigo SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18 View
Miliaria SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18 View
Molluscum contagiosum SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18 View
Otitis media SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18 View
Otitis media acute SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18 View
Pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18 View
Pharyngitis streptococcal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 18 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18 View
Rhinitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18 View
Rhinitis allergic SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18 View
Rhinorrhoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18 View
Seasonal allergy SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 18 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18 View
Skin abrasion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18 View
Skin papilloma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 18 View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18 View
Streptococcal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18 View
Thermal burn SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18 View
Tinea pedis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18 View
Toothache SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18 View
Upper respiratory tract inflammation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18 View
Urticaria SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18 View
Varicella SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18 View