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 @ 2:46 AM
Ignite Modification Date:
2025-12-26 @ 1:26 AM
NCT ID:
NCT04620733
Description:
All-cause mortality: All-Randomized Analysis Set was defined all participants randomized in the study.
Adverse events: The Safety Analysis Set was defined as any participant who received at least 1 dose of study drug.
There was only 1 participant who was down-titrated to the 5 mg seladelpar dose during the study. Therefore, the data for adverse events at 5 mg dose were not reported due to participant's confidentiality reasons.
Frequency Threshold:
5
Time Frame:
All-cause mortality: Up to 20.6 months; Adverse events: Up to last dose plus 30 days (Up to 13.4 months)
Study:
NCT04620733
Study Brief:
RESPONSE: Response to Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Control to or an Intolerance to Ursodeoxycholic Acid (UDCA)
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 | Participants received placebo to match seladelpar, orally, once daily, for a duration of up to 12 months. | 0 | None | 4 | 65 | 40 | 65 | View |
| Seladelpar | Participants received seladelpar 10 mg, orally, once daily, for a duration of up to 12 months. | 0 | None | 9 | 128 | 66 | 128 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Coagulopathy | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | 24.0 | View |
| Coronary artery disease | SYSTEMATIC_ASSESSMENT | Cardiac disorders | 24.0 | View |
| Duodenal obstruction | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 24.0 | View |
| Oesophageal varices haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 24.0 | View |
| Covid-19 | SYSTEMATIC_ASSESSMENT | Infections and infestations | 24.0 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | 24.0 | View |
| Femur fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 24.0 | View |
| Rotator cuff syndrome | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 24.0 | View |
| Bladder cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 24.0 | View |
| Invasive ductal breast carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 24.0 | View |
| Papillary thyroid cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 24.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 24.0 | View |
| Presyncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 24.0 | View |
| Suicide attempt | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | 24.0 | View |
| Acute respiratory failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 24.0 | View |
| Chronic obstructive pulmonary disease | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 24.0 | View |
| Dyspnoea exertional | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 24.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Vertigo positional | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | 24.0 | View |
| Abdominal distension | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 24.0 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 24.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 24.0 | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | 24.0 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | 24.0 | View |
| Covid-19 | SYSTEMATIC_ASSESSMENT | Infections and infestations | 24.0 | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 24.0 | View |
| Pharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 24.0 | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 24.0 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 24.0 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 24.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 24.0 | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 24.0 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | 24.0 | View |