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 @ 3:38 PM
Ignite Modification Date:
2025-12-25 @ 1:49 PM
NCT ID:
NCT02890992
Description:
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
Frequency Threshold:
5
Time Frame:
All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Study:
NCT02890992
Study Brief:
An 8-Week Dose-Finding Study to Evaluate the Efficacy and Safety of Alirocumab in Children and Adolescents With Heterozygous Familial Hypercholesterolemia
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Cohort 2 - Alirocumab 40 mg Q2W: <50 kg | Participants with body weight \< 50 kg received SC injection of alirocumab 40 mg administered Q2W up to the switch of dosage added to LMT. | 0 | None | 0 | 4 | 1 | 4 | View |
| Cohort 1 - Alirocumab 30 mg Q2W: <50 kg | Participants with body weight \< 50 kg received SC injection of alirocumab 30 mg administered Q2W up to the switch of dosage added to LMT. | 0 | None | 0 | 4 | 4 | 4 | View |
| Cohort 1 - Alirocumab 50 mg Q2W: >=50 kg | Participants with body weight \>= 50 kg received SC injection of alirocumab 50 mg administered Q2W up to the switch of dosage added to LMT. | 0 | None | 0 | 6 | 5 | 6 | View |
| Cohort 2 - Alirocumab 75 mg Q2W: >=50 kg | Participants with body weight \>= 50 kg received SC injection of alirocumab 75 mg administered Q2W up to the switch of dosage added to LMT. | 0 | None | 0 | 6 | 4 | 6 | View |
| Cohort 3 - Alirocumab 75 mg Q4W: <50 kg | Participants with body weight \< 50 kg received SC injection of alirocumab 75 mg administered Q4W up to the switch of dosage added to LMT. | 0 | None | 0 | 6 | 5 | 6 | View |
| Cohort 3 - Alirocumab 150 mg Q4W: >=50 kg | Participants with body weight \>= 50 kg received SC injection of alirocumab 150 mg administered Q4W up to the switch of dosage added to LMT. | 0 | None | 0 | 5 | 3 | 5 | View |
| Cohort 4 - Alirocumab 150 mg Q4W: <50 kg | Participants with body weight \< 50 kg received SC injection of alirocumab 150 mg administered Q4W up to the end of the OLE period (up to 130 weeks) added to LMT. | 0 | None | 0 | 6 | 3 | 6 | View |
| Cohort 4 - Alirocumab 300 mg Q4W: >=50 kg | Participants with body weight \>= 50 kg received SC injection of alirocumab 300 mg administered Q4W up to the end of the OLE period (up to 130 weeks) added to LMT. | 0 | None | 0 | 5 | 4 | 5 | View |
| Alirocumab 40 Q2W Post-switch | Participants with body weight \< 50 kg from cohort 1, 2 and 3 switched to dosage and received SC injection of alirocumab 40 mg administered Q2W from the switch up to the end of the OLE period (up to 130 weeks) added to LMT. | 0 | None | 0 | 10 | 7 | 10 | View |
| Alirocumab 75 Q2W Post-switch | Participants from Cohort 1 (7 participants), Cohort 2 and Cohort 3 (11 participants) switched to dosage and received SC injection of alirocumab 75 mg administered Q2W up to the end of the OLE period (up to 130 weeks) added to LMT. | 0 | None | 0 | 18 | 9 | 18 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Influenza Like Illness | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 21.1 | View |
| Injection Site Reaction | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 21.1 | View |
| Food Allergy | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 21.1 | View |
| Abscess Limb | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Cystitis Bacterial | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Cytomegalovirus Hepatitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Ear Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Gastroenteritis Viral | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Infectious Mononucleosis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Otitis Externa | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Otitis Media | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Pharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Pharyngitis Streptococcal | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Post Procedural Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Pyelonephritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Tonsillitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Upper Respiratory Tract Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Urinary Tract Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Varicella | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Viral Upper Respiratory Tract Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Vulvovaginal Mycotic Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Animal Scratch | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 21.1 | View |
| Arthropod Bite | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 21.1 | View |
| Concussion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 21.1 | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 21.1 | View |
| Hand Fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 21.1 | View |
| Ligament Sprain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 21.1 | View |
| Post-Traumatic Pain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 21.1 | View |
| Radius Fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 21.1 | View |
| Road Traffic Accident | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 21.1 | View |
| Traumatic Haematoma | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 21.1 | View |
| Blood Follicle Stimulating Hormone Decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 21.1 | View |
| Blood Luteinising Hormone Decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 21.1 | View |
| Low Density Lipoprotein Decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 21.1 | View |
| Type 1 Diabetes Mellitus | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 21.1 | View |
| Vitamin D Deficiency | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 21.1 | View |
| Arthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | View |
| Flank Pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | View |
| Muscle Spasms | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | View |
| Tendon Pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | View |
| Pyogenic Granuloma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 21.1 | View |
| Hypoaesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 21.1 | View |
| Presyncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 21.1 | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 21.1 | View |
| Thoracic Outlet Syndrome | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 21.1 | View |
| Alcohol Abuse | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 21.1 | View |
| Anxiety Disorder | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 21.1 | View |
| Depressed Mood | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 21.1 | View |
| Premenstrual Pain | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 21.1 | View |
| Asthma | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | View |
| Epistaxis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | View |
| Oropharyngeal Pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | View |
| Sinus Congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | View |
| Acne | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 21.1 | View |
| Pallor | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 21.1 | View |
| Lymphadenopathy | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 21.1 | View |
| Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 21.1 | View |
| Excessive Eye Blinking | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 21.1 | View |
| Abdominal Discomfort | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 21.1 | View |
| Abdominal Pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 21.1 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 21.1 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 21.1 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 21.1 | View |
| Toothache | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 21.1 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 21.1 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 21.1 | View |