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 @ 12:44 AM
Ignite Modification Date:
2025-12-25 @ 10:57 PM
NCT ID:
NCT05507567
Description:
Unsolicited Treatment Emergent Adverse Events were collected by open and non-leading verbal questioning from Day -3 to Day 28.
Solicited adverse events were collected using participant completed questionnaires 1 hour and 12 hours after each dose of study medication from Day -3 to Day -1.
Frequency Threshold:
0
Time Frame:
From the intake of the first dose of IMP on Day -3 to Day 28
Study:
NCT05507567
Study Brief:
Safety, Tolerability and Prophylactic Antiviral Activity of Neumifil Against Influenza Via a Human Viral Challenge Model
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Neumifil Multiple Dose Prophylactic Treatment | Neumifil intranasal spray administered as 3 single daily doses prior to viral challenge Neumifil: Liquid for intranasal spray administration | 0 | None | 0 | 32 | 30 | 32 | View |
| Neumifil Single Dose Prophylactic Treatment | Neumifil intranasal spray administered as a single daily dose on Day -3 and blinded by placebo administered as two single daily doses. All administrations completed prior to viral challenge Neumifil: Liquid for intranasal spray administration Placebo: Liquid for intranasal spray administration | 0 | None | 0 | 31 | 25 | 31 | View |
| Placebo | Intranasal spray administered as 3 single daily doses prior to viral challenge Placebo: Liquid for intranasal spray administration | 0 | None | 0 | 41 | 34 | 41 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Upper respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.0 | View |
| Covid-19 | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.0 | View |
| Nasopharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.0 | View |
| Otitis externa | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.0 | View |
| Tonsilitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.0 | View |
| Aspartate aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 25.0 | View |
| Blood creatine phosphokinase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 25.0 | View |
| C-reactive protein increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 25.0 | View |
| Alanine aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 25.0 | View |
| Electrocardiogram T wave abnormal | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 25.0 | View |
| Electrocardiogram T wave biphasic | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 25.0 | View |
| Forced expiratory volume decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 25.0 | View |
| Hepatic enzyme abnormal | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 25.0 | View |
| Lymphopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 25.0 | View |
| Neutropenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 25.0 | View |
| Lymphadenopathy | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 25.0 | View |
| Myalgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | View |
| Arthralgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | View |
| Back pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | View |
| Pain in extremity | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | View |
| Rhabdomyolysis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | View |
| Axillary pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 25.0 | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 25.0 | View |
| Peripheral swelling | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 25.0 | View |
| Asthenopia | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 25.0 | View |
| Blepharitis | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 25.0 | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.0 | View |
| Toothache | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.0 | View |
| Contusion | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 25.0 | View |
| Thermal burn | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 25.0 | View |
| Anosmia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 25.0 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 25.0 | View |
| Oropharyngeal pain | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | View |
| Sinus pain | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | View |
| Rash papular | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 25.0 | View |
| Bleeding from the nose | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | Diary card | View |
| Burning sensation or sensation of heat/hotness in the nose | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | Diary card | View |
| General irritation in the nose | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | Diary card | View |
| Marked change in sense of smell or taste | SYSTEMATIC_ASSESSMENT | Nervous system disorders | Diary card | View |
| Pain or stinging in the nose | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | Diary card | View |
| Sensation of needing to blow your nose | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | Diary card | View |
| Sneezing | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | Diary card | View |
| Unpleasant taste | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | Diary card | View |