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 @ 10:45 PM
Ignite Modification Date:
2025-12-25 @ 8:15 PM
NCT ID:
NCT02776735
Description:
Analysis was performed on the safety analysis set.
Frequency Threshold:
5
Time Frame:
From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3.
Study:
NCT02776735
Study Brief:
An Open-label, Ascending, Repeated Dose-finding Study of Sarilumab in Children and Adolescents With Polyarticular-course Juvenile Idiopathic Arthritis (pcJIA)
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 1: >= 30 kg and <= 60 kg | Participants with body weight \>= 30 kg and \<= 60 kg received sarilumab 2 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants entered extension phase (up to 144 weeks) and continued to receive 2 mg/kg SC injection q2w until the selected dose 2 (3 mg/kg) was defined. | 0 | None | 2 | 7 | 7 | 7 | View |
| Cohort 2 (From Baseline): >= 30 kg and <= 60 kg | Participants with body weight \>= 30 kg and \<= 60 kg received sarilumab 3 mg/kg SC injection q2w during the entire treatment period. | 0 | None | 3 | 42 | 39 | 42 | View |
| Cohort 1 Portion 1, Post Dose-adjustment From Dose 1: >= 30 kg and <= 60 kg | Participants with body weight \>= 30 kg and \<= 60 kg received sarilumab 3 mg/kg SC injection q2w after switched from Dose/Cohort 1 to selected Dose 2. | 0 | None | 0 | 4 | 4 | 4 | View |
| Cohort 3 Portion 1, Post Dose-adjustment From Dose 3: >= 30 kg and <= 60 kg | Participants with body weight \>= 30 kg and \<= 60 kg received sarilumab 3 mg/kg SC injection q2w after switched from Dose/Cohort 3 to selected Dose 2. | 0 | None | 0 | 6 | 5 | 6 | View |
| Cohort 3: >= 30 kg and <= 60 kg | Participants with body weight \>= 30 kg and \<= 60 kg received sarilumab 2 mg/kg SC injection qw for 12 weeks in core treatment phase. Eligible participants entered extension phase (up to 144 weeks) and continued to receive 2 mg/kg SC injection q2w until the selected dose 2 (3 mg/kg) was defined. | 0 | None | 0 | 6 | 5 | 6 | View |
| Cohort 1: < 30 kg and >= 10 kg | Participants with body weight \< 30 kg and \>= 10 kg received sarilumab 2.5 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants entered extension phase (up to 144 weeks) and continued to receive 2 mg/kg SC injection q2w until the selected dose 2 (3 mg/kg) was defined. | 0 | None | 0 | 6 | 6 | 6 | View |
| Cohort 2 (From Baseline): < 30 kg and >= 10 kg | Participants with body weight \< 30 kg and \>= 10 kg received sarilumab 4 mg/kg SC injection q2w during the entire treatment period. | 0 | None | 3 | 31 | 29 | 31 | View |
| Cohort 1 Portion 1, Post Dose-adjustment From Dose 1: < 30 kg and >= 10 kg | Participants with body weight \< 30 kg and \>= 10 kg received sarilumab 4 mg/kg SC injection q2w after switched from Dose/Cohort 1 to selected Dose 2. | 0 | None | 0 | 5 | 5 | 5 | View |
| Cohort 3 Portion 1, Post Dose-adjustment From Dose 3: < 30 kg and >= 10 kg | Participants with body weight \< 30 kg and \>= 10 kg received sarilumab 4 mg/kg SC injection q2w after switched from Dose/Cohort 3 to selected Dose 2. | 0 | None | 0 | 5 | 5 | 5 | View |
| Cohort 3: < 30 kg and >= 10 kg | Participants with body weight \< 30 kg and \>= 10 kg received sarilumab 2.5 mg/kg SC injection qw for 12 weeks in core treatment phase. Eligible participants entered extension phase (up to 144 weeks) and continued to receive 2 mg/kg SC injection q2w until the selected dose 2 (3 mg/kg) was defined. | 0 | None | 0 | 9 | 9 | 9 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Inguinal Hernia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 26.1 | View |
| Pancreatic Pseudocyst | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 26.1 | View |
| Pancreatitis Acute | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 26.1 | View |
| Acute Sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 26.1 | View |
| Bone Tuberculosis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 26.1 | View |
| Ligament Rupture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDra 26.1 | View |
| Juvenile Idiopathic Arthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDra 26.1 | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDra 26.1 | View |
| Tonsillar Hypertrophy | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 26.1 | View |
| Infectious Mononucleosis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 26.1 | View |
| Meniscus Injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDra 26.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Leukopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDra 26.1 | View |
| Lymphadenopathy | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDra 26.1 | View |
| Lymphopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDra 26.1 | View |
| Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDra 26.1 | View |
| Cardiovascular Disorder | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDra 26.1 | View |
| Ear Pain | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDra 26.1 | View |
| Keratitis | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDra 26.1 | View |
| Uveitis | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDra 26.1 | View |
| Abdominal Pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 26.1 | View |
| Abdominal Pain Upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 26.1 | View |
| Aphthous Ulcer | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 26.1 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 26.1 | View |
| Dental Discomfort | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 26.1 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 26.1 | View |
| Mouth Ulceration | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 26.1 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 26.1 | View |
| Pulpless Tooth | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 26.1 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 26.1 | View |
| Administration Site Erythema | SYSTEMATIC_ASSESSMENT | General disorders | MedDra 26.1 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDra 26.1 | View |
| Gait Disturbance | SYSTEMATIC_ASSESSMENT | General disorders | MedDra 26.1 | View |
| Injection Site Erythema | SYSTEMATIC_ASSESSMENT | General disorders | MedDra 26.1 | View |
| Injection Site Haemorrhage | SYSTEMATIC_ASSESSMENT | General disorders | MedDra 26.1 | View |
| Injection Site Pruritus | SYSTEMATIC_ASSESSMENT | General disorders | MedDra 26.1 | View |
| Injection Site Reaction | SYSTEMATIC_ASSESSMENT | General disorders | MedDra 26.1 | View |
| Injection Site Urticaria | SYSTEMATIC_ASSESSMENT | General disorders | MedDra 26.1 | View |
| Malaise | SYSTEMATIC_ASSESSMENT | General disorders | MedDra 26.1 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDra 26.1 | View |
| Hyperbilirubinaemia | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDra 26.1 | View |
| Allergy To Arthropod Bite | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDra 26.1 | View |
| Acute Sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 26.1 | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 26.1 | View |
| Covid-19 | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 26.1 | View |
| Cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 26.1 | View |
| Conjunctivitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 26.1 | View |
| Conjunctivitis Bacterial | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 26.1 | View |
| Cystitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 26.1 | View |
| Dengue Fever | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 26.1 | View |
| Ear Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 26.1 | View |
| Eczema Impetiginous | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 26.1 | View |
| Escherichia Urinary Tract Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 26.1 | View |
| Gastritis Viral | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 26.1 | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 26.1 | View |
| Gastrointestinal Bacterial Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 26.1 | View |
| Gastrointestinal Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 26.1 | View |
| Groin Abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 26.1 | View |
| Impetigo | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 26.1 | View |
| Infected Bite | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 26.1 | View |
| Infectious Mononucleosis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 26.1 | View |
| Influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 26.1 | View |
| Laryngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 26.1 | View |
| Molluscum Contagiosum | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 26.1 | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 26.1 | View |
| Oral Candidiasis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 26.1 | View |
| Oral Herpes | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 26.1 | View |
| Otitis Externa | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 26.1 | View |
| Otitis Media | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 26.1 | View |
| Otitis Media Acute | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 26.1 | View |
| Paronychia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 26.1 | View |
| Pharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 26.1 | View |
| Pharyngitis Bacterial | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 26.1 | View |
| Pharyngitis Streptococcal | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 26.1 | View |
| Pharyngotonsillitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 26.1 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 26.1 | View |
| Pyelonephritis Acute | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 26.1 | View |
| Respiratory Syncytial Virus Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 26.1 | View |
| Rhinitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 26.1 | View |
| Scarlet Fever | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 26.1 | View |
| Sinobronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 26.1 | View |
| Sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 26.1 | View |
| Tinea Pedis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 26.1 | View |
| Tonsillitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 26.1 | View |
| Tracheitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 26.1 | View |
| Upper Respiratory Tract Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 26.1 | View |
| Upper Respiratory Tract Infection Bacterial | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 26.1 | View |
| Urinary Tract Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 26.1 | View |
| Varicella | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 26.1 | View |
| Viral Pharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 26.1 | View |
| Viral Upper Respiratory Tract Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 26.1 | View |
| Accidental Overdose | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDra 26.1 | View |
| Arthropod Bite | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDra 26.1 | View |
| Contusion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDra 26.1 | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDra 26.1 | View |
| Hand Fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDra 26.1 | View |
| Ligament Sprain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDra 26.1 | View |
| Thermal Burn | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDra 26.1 | View |
| Traumatic Haematoma | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDra 26.1 | View |
| Alanine Aminotransferase Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDra 26.1 | View |
| Aspartate Aminotransferase Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDra 26.1 | View |
| Blood Alkaline Phosphatase Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDra 26.1 | View |
| Blood Bilirubin Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDra 26.1 | View |
| Blood Pressure Systolic Decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDra 26.1 | View |
| Eosinophil Count Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDra 26.1 | View |
| Lymphocyte Count Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDra 26.1 | View |
| Mean Cell Volume Decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDra 26.1 | View |
| Monocyte Count Decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDra 26.1 | View |
| Monocyte Count Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDra 26.1 | View |
| Neutrophil Count Decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDra 26.1 | View |
| Transaminases Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDra 26.1 | View |
| Vitamin D Deficiency | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDra 26.1 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDra 26.1 | View |
| Juvenile Idiopathic Arthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDra 26.1 | View |
| Pain In Extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDra 26.1 | View |
| Skin Papilloma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 26.1 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDra 26.1 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDra 26.1 | View |
| Affective Disorder | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDra 26.1 | View |
| Major Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDra 26.1 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 26.1 | View |
| Epistaxis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 26.1 | View |
| Increased Bronchial Secretion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 26.1 | View |
| Rhinitis Allergic | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 26.1 | View |
| Acne | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDra 26.1 | View |
| Alopecia | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDra 26.1 | View |
| Dermatitis Allergic | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDra 26.1 | View |
| Ingrowing Nail | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDra 26.1 | View |
| Pityriasis Alba | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDra 26.1 | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDra 26.1 | View |
| Rash Papular | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDra 26.1 | View |
| Rash Pruritic | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDra 26.1 | View |
| Skin Reaction | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDra 26.1 | View |
| Urticaria | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDra 26.1 | View |
| Urticaria Chronic | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDra 26.1 | View |
| Essential Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDra 26.1 | View |