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 @ 4:49 AM
Ignite Modification Date:
2025-12-26 @ 3:51 AM
NCT ID:
NCT01844518
Description:
Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Frequency Threshold:
5
Time Frame:
Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 113 months). SAEs and Other AEs were assessed from first dose to 168 days after last dose of study therapy (assessed up to approximately 113 months).
Study:
NCT01844518
Study Brief:
Pharmacokinetics, Efficacy and Safety of Abatacept Administered Subcutaneously (SC) in Children and Adolescents With Active Polyarticular Juvenile Idiopathic Arthritis (pJIA) and Inadequate Response (IR) to Biologic or Non Biologic Disease Modifying Anti-rheumatic Drugs (DMARDs)
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| SC Abatacept Ages 6 to 17 | Subcutaneous (SC) abatacept administered by prefilled syringe (PFS) once weekly according to the following weight-tiered dosing regimen: 10 to less than (\<) 25 kilogram (kg) (50 milligram \[mg\] in 0.4 milliliter \[mL\] PFS), 25 to \< 50 kg (87.5 mg in 0.7 mL PFS) and 50 kg (125 mg in 1 mL PFS). | 0 | None | 18 | 173 | 127 | 173 | View |
| SC Abatacept Ages 2 to 5 | SC abatacept administered by PFS once weekly according to the following weight-tiered dosing regimen: 10 to \< 25 kg (50 mg in 0.4 mL PFS), 25 to \< 50 kg (87.5 mg in 0.7 mL PFS) and 50 kg (125 mg in 1 mL PFS). | 0 | None | 6 | 46 | 44 | 46 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | 25.1 | View |
| Tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | 25.1 | View |
| Vertigo | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | 25.1 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 25.1 | View |
| Small intestinal obstruction | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 25.1 | View |
| Chest pain | SYSTEMATIC_ASSESSMENT | General disorders | 25.1 | View |
| Abscess limb | SYSTEMATIC_ASSESSMENT | Infections and infestations | 25.1 | View |
| Appendicitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 25.1 | View |
| Cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 25.1 | View |
| Complicated appendicitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 25.1 | View |
| Latent tuberculosis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 25.1 | View |
| Molluscum contagiosum | SYSTEMATIC_ASSESSMENT | Infections and infestations | 25.1 | View |
| Peritonitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 25.1 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | 25.1 | View |
| Pyelonephritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 25.1 | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 25.1 | View |
| Sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 25.1 | View |
| Hand fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 25.1 | View |
| Limb injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 25.1 | View |
| Overdose | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 25.1 | View |
| Radius fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 25.1 | View |
| Hypomagnesaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 25.1 | View |
| Joint hyperextension | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 25.1 | View |
| Synovitis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 25.1 | View |
| Tendon disorder | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 25.1 | View |
| Ovarian germ cell teratoma stage III | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 25.1 | View |
| Autonomic nervous system imbalance | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 25.1 | View |
| Febrile convulsion | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 25.1 | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 25.1 | View |
| Calculus urinary | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | 25.1 | View |
| Nephrolithiasis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | 25.1 | View |
| Erythema multiforme | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 25.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 25.1 | View |
| Aphthous ulcer | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 25.1 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 25.1 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | 25.1 | View |
| Conjunctivitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 25.1 | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 25.1 | View |
| Molluscum contagiosum | SYSTEMATIC_ASSESSMENT | Infections and infestations | 25.1 | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 25.1 | View |
| Pharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 25.1 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | 25.1 | View |
| Rhinitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 25.1 | View |
| Scarlet fever | SYSTEMATIC_ASSESSMENT | Infections and infestations | 25.1 | View |
| Sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 25.1 | View |
| Tonsillitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 25.1 | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 25.1 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 25.1 | View |
| Varicella | SYSTEMATIC_ASSESSMENT | Infections and infestations | 25.1 | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | 25.1 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 25.1 | View |
| Oropharyngeal pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 25.1 | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 25.1 | View |
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | 25.1 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 25.1 | View |
| Dental caries | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 25.1 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 25.1 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 25.1 | View |
| Impetigo | SYSTEMATIC_ASSESSMENT | Infections and infestations | 25.1 | View |
| Influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | 25.1 | View |
| Otitis media | SYSTEMATIC_ASSESSMENT | Infections and infestations | 25.1 | View |
| Tooth abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | 25.1 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 25.1 | View |