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 @ 12:28 AM
Ignite Modification Date:
2025-12-25 @ 10:34 PM
NCT ID:
NCT03301467
Description:
An adverse event is considered treatment-emergent if the start date/time of the event is on or after the date/time of first study drug treatment up to the final observation in the double-blind treatment period (week 26).
Frequency Threshold:
5
Time Frame:
From day 1 throughout the study period (day 182/week 26)
Study:
NCT03301467
Study Brief:
Controlled Trial Evaluating Avacopan in C3 Glomerulopathy
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 Group | Avacopan-matching placebo capsules x 3 administered twice daily during the 26 week blinded treatment period period Avacopan-matching placebo: Orally administered The safety population included all subjects who were randomized and had received at least one dose of study drug. | 0 | None | 3 | 29 | 24 | 29 | View |
| Avacopan Group | Avacopan (formerly CCX168) 10 mg capsules x 3 administered twice daily during the blinded 26 week blinded treatment period Avacopan: Orally administered The safety population included all subjects who were randomized and had received at least one dose of study drug. | 0 | None | 3 | 28 | 25 | 28 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Neutropenic sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.1 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.1 | View |
| Bacterial parotitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.1 | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.1 | View |
| Neutrophil count decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 20.1 | View |
| Sjogren's syndrome | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | View |
| Acute kidney injury | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 20.1 | View |
| Alcohol withdrawal syndrome | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 20.1 | View |
| Gastroenteritis salmonella | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Oedema peripheral | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 20.1 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 20.1 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 20.1 | View |
| Influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.1 | View |
| Lower respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.1 | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.1 | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.1 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.1 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.1 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.1 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.1 | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.1 | View |
| Mouth ulceration | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.1 | View |
| Blood creatine phosphokinase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 20.1 | View |
| Blood creatinine increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 20.1 | View |
| Weight decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 20.1 | View |
| Lipase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 20.1 | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 20.1 | View |
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 20.1 | View |
| Lymphopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 20.1 | View |
| Hand fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 20.1 | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | View |
| Muscle spasms | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 20.1 | View |
| Tremor | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 20.1 | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 20.1 | View |
| Hypokalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 20.1 | View |
| Hyperkalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 20.1 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | View |
| Oropharyngeal pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | View |
| Acne | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 20.1 | View |
| Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 20.1 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 20.1 | View |
| Orthostatic hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 20.1 | View |