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:
2025-12-25 @ 5:19 AM
Ignite Modification Date:
2025-12-26 @ 4:26 AM
NCT ID:
NCT00571727
Description:
The safety population consisted of all participants who had received at least 1 dose of mecasermin treatment. Adverse events were not collected per dose level as pre-specified.
Frequency Threshold:
5
Time Frame:
Treatment-emergent adverse events were collected from first date of mecasermin intake until last dose, approximately 19 years
Study:
NCT00571727
Study Brief:
Long-Term Treatment With rhIGF-1 in GHIS
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Mecasermin | Participants who were entered from previous studies continued to receive mecasermin 80 to 120 mcg/kg SC twice daily and naïve-to-treatment participants were administered mecasermin 60 to 80 mcg/kg SC twice daily for 1 to 2 weeks, and then increased to 120 mcg/kg as tolerated. | 0 | None | 18 | 92 | 73 | 92 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Infectious pleural effusion | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (14.1) | View |
| Radius fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (14.1) | View |
| Appendicitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (14.1) | View |
| Haematemesis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (14.1) | View |
| Adenoidal hypertrophy | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | View |
| Benign intracranial hypertension | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (14.1) | View |
| Epiphysiolysis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (14.1) | View |
| Dilatation ventricular | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (14.1) | View |
| Grand mal convulsion | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (14.1) | View |
| Diabetes mellitus | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (14.1) | View |
| Febrile convulsion | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (14.1) | View |
| Skull fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (14.1) | View |
| Nephrolithiasis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (14.1) | View |
| Hypoglycaemic seizure | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (14.1) | View |
| Flank pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (14.1) | View |
| Tonsillar hypertrophy | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Hypoglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (14.1) | View |
| Hypoglycaemic seizure | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (14.1) | View |
| Injection site hypertrophy | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (14.1) | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (14.1) | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (14.1) | View |
| Injection site haematoma | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (14.1) | View |
| Hypertrophy | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (14.1) | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (14.1) | View |
| Chest pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (14.1) | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (14.1) | View |
| Otitis media | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (14.1) | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (14.1) | View |
| Influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (14.1) | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (14.1) | View |
| Ear infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (14.1) | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (14.1) | View |
| Pharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (14.1) | View |
| Respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (14.1) | View |
| Tonsillitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (14.1) | View |
| Varicella | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (14.1) | View |
| Snoring | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | View |
| Tonsillar hypertrophy | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | View |
| Adenoidal hypertrophy | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | View |
| Nasal congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (14.1) | View |
| Dental caries | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (14.1) | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (14.1) | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (14.1) | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (14.1) | View |
| Abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (14.1) | View |
| Tooth crowding | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (14.1) | View |
| Toothache | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (14.1) | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (14.1) | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (14.1) | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | View |
| Acne | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (14.1) | View |
| Dry skin | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (14.1) | View |
| Skin hypertrophy | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (14.1) | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (14.1) | View |
| Conductive deafness | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (14.1) | View |
| Middle ear effusion | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (14.1) | View |
| Deafness | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (14.1) | View |
| Ear pain | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (14.1) | View |
| Ear discomfort | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (14.1) | View |
| Cardiac murmur | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (14.1) | View |
| Thymus enlargement | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (14.1) | View |
| Lymphadenopathy | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (14.1) | View |
| Papilloedema | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (14.1) | View |
| Tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (14.1) | View |
| Gynaecomastia | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (14.1) | View |
| Ear tube insertion | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (14.1) | View |
| Dental operation | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (14.1) | View |