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 @ 7:30 PM
Ignite Modification Date:
2025-12-25 @ 5:11 PM
NCT ID:
NCT06790303
Description:
Safety Population included all participants who received at least one dose of treatment.
Frequency Threshold:
5
Time Frame:
All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 29 weeks.
Study:
NCT06790303
Study Brief:
Platform Trial of Novel Regimens Versus Standard of Care (SoC) in Participants With Non-small Cell Lung Cancer (NSCLC) - Sub-study 2
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Feladilimab + Ipilimumab | Participants with Non-Small Cell Lung Cancer (NSCLC) received 24 milligram (mg) Feladilimab first as a 30-minute intravenous (IV) infusion followed by 1 mg/ kilogram (kg) Ipilimumab as IV infusion (started at least 30 minutes following the end of the feladilimab) once every 3 weeks (Q3W). | 4 | None | 3 | 8 | 8 | 8 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | v24.1 | View |
| Pneumonia staphylococcal | SYSTEMATIC_ASSESSMENT | Infections and infestations | v24.1 | View |
| Overdose | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | v24.1 | View |
| Hypercalcaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | v24.1 | View |
| Spinal cord compression | SYSTEMATIC_ASSESSMENT | Nervous system disorders | v24.1 | View |
| Subacute inflammatory demyelinating polyneuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | v24.1 | View |
| Confusional state | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | v24.1 | View |
| Pneumonia aspiration | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | v24.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Abdominal distension | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | v24.1 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | v24.1 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | v24.1 | View |
| General physical health deterioration | SYSTEMATIC_ASSESSMENT | General disorders | v24.1 | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | v24.1 | View |
| Oral fungal infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | v24.1 | View |
| Pneumonia klebsiella | SYSTEMATIC_ASSESSMENT | Infections and infestations | v24.1 | View |
| Hypercalcaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | v24.1 | View |
| Hypoalbuminaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | v24.1 | View |
| Hyponatraemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | v24.1 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | v24.1 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | v24.1 | View |
| Cerebellar ataxia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | v24.1 | View |
| Memory impairment | SYSTEMATIC_ASSESSMENT | Nervous system disorders | v24.1 | View |
| Nervous system disorder | SYSTEMATIC_ASSESSMENT | Nervous system disorders | v24.1 | View |
| Confusional state | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | v24.1 | View |
| Psychomotor retardation | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | v24.1 | View |
| Pleuritic pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | v24.1 | View |
| Pneumonitis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | v24.1 | View |
| Dry skin | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | v24.1 | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | v24.1 | View |
| Urticaria | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | v24.1 | View |
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | v24.1 | View |
| Lymphopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | v24.1 | View |