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 @ 11:45 PM
Ignite Modification Date: 2025-12-25 @ 9:37 PM
NCT ID: NCT02229851
Description: All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.
Frequency Threshold: 5
Time Frame: Weeks 0-88
Study: NCT02229851
Study Brief: Trial to Compare the Efficacy and Safety of NNC0195-0092 (Somapacitan) With Placebo and Norditropin® FlexPro® (Somatropin) in Adults With Growth Hormone Deficiency.
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo - Main Phase Participants received placebo for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. 1 None 5 61 29 61 View
Somapacitan - Main Phase Participants received somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. 0 None 7 120 53 120 View
Norditropin - Main Phase Participants received Norditropin® for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. 1 None 12 119 55 119 View
Somapacitan - Extension Phase The extension phase treatment period was 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment). This reporting group shows data from the extension phase for the following listed participants: 1) participants who received placebo in the main phase, and switched to receive somapacitan in the extension phase. 2) Participants who received somapacitan in the main phase were continued to receive somapacitan in the extension phase. 3) Participants who received Norditropin® in the main phase and re-randomised at the end of the main phase to receive somapacitan in the extension phase (randomisation was done in a 1:1 manner to receive either somapacitan and Norditropin®). 2 None 15 220 85 220 View
Norditropin- Extension Phase The extension phase treatment period was 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment). This reporting group shows data from the extension phase for the participants who received Norditropin® in the main phase and re-randomised at the end of the main phase to receive Norditropin® in the extension phase (randomisation was done in a 1:1 manner to receive either somapacitan and Norditropin®). 1 None 3 52 27 52 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Chronic kidney disease SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 21 View
Clostridium difficile infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21 View
Death SYSTEMATIC_ASSESSMENT General disorders MedDRA 21 View
Delirium SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 21 View
Dental cyst SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21 View
Depressed level of consciousness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21 View
Dermatitis atopic SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21 View
Diabetes insipidus SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 21 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21 View
Drug dispensing error SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21 View
Dyspnoea exertional SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21 View
Electrocardiogram T wave abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA 21 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 21 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21 View
Gastroenteritis viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21 View
Haemoconcentration SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 21 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21 View
Herpes simplex SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21 View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21 View
Hypopituitarism SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 21 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21 View
Inguinal hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21 View
Nephrolithiasis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 21 View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 21 View
Pancreatitis acute SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21 View
Plasma cell myeloma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 21 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21 View
Pneumonia aspiration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21 View
Pneumonia viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 21 View
Secondary adrenocortical insufficiency SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 21 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21 View
Sleep apnoea syndrome SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21 View
Spinal compression fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21 View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21 View
Tibia fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21 View
Tooth fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21 View
Toxicity to various agents SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21 View
Umbilical hernia repair SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 21 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21 View
Urosepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21 View
Ventricular extrasystoles SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21 View
Ventricular fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21 View
Viral infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21 View
Viral upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21 View
Adrenocortical insufficiency acute SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 21 View
Appendicitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21 View
Arterial stent insertion SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 21 View
Bladder transitional cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 21 View
Blood testosterone increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 21 View
Cardiogenic shock SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21 View
Cholangiogram SYSTEMATIC_ASSESSMENT Investigations MedDRA 21 View
Cholecystectomy SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 21 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 21 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21 View
Injection site bruising SYSTEMATIC_ASSESSMENT General disorders MedDRA 21 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 21 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21 View
Tooth abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21 View
Visual impairment SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 21 View