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 @ 11:43 PM
Ignite Modification Date:
2025-12-25 @ 9:35 PM
NCT ID:
NCT05448651
Description:
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
Frequency Threshold:
5
Time Frame:
24 weeks
Study:
NCT05448651
Study Brief:
Safety and Biologic Impact (Pharmacodynamics) of Repeated Injections and Increasing Amounts of UPB-101 in Asthmatics
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Active Substance 1 | UPB-101 Cohort 1 (100 mg) | 0 | None | 0 | 6 | 5 | 6 | View |
| Active Substance 2 | UPB-101 Cohort 2 (200 mg) | 0 | None | 0 | 6 | 6 | 6 | View |
| Active Substance 3 | UPB-101 Cohort 3 (300 mg) | 0 | None | 0 | 6 | 5 | 6 | View |
| Active Substance 4 | UPB-101 Cohort 4 (25 mg) | 0 | None | 0 | 6 | 3 | 6 | View |
| Placebo | Placebo: Subcutaneous injection | 0 | None | 0 | 8 | 6 | 8 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Rhinitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 25.0 | View |
| COVID-19 | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 25.0 | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 25.0 | View |
| Ear infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 25.0 | View |
| Hordeolum | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 25.0 | View |
| Lower respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 25.0 | View |
| Tinea infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 25.0 | View |
| Tooth abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 25.0 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.0 | View |
| Nasal congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.0 | View |
| Asthma | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.0 | View |
| Oropharyngeal pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.0 | View |
| Asthma exercise induced | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.0 | View |
| Productive cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.0 | View |
| Rhinorrhoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 25.0 | View |
| Migraine | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 25.0 | View |
| Paraesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 25.0 | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 25.0 | View |
| Ligament sprain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 25.0 | View |
| Face injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 25.0 | View |
| Heat stroke | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 25.0 | View |
| Post-traumatic neck syndrome | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 25.0 | View |
| Skin laceration | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 25.0 | View |
| Thermal burn | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 25.0 | View |
| Wrist fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 25.0 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 25.0 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 25.0 | View |
| Musculoskeletal pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 25.0 | View |
| Musculoskeletal stiffness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 25.0 | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 25.0 | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 25.0 | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 25.0 | View |
| Depressed mood | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 25.0 | View |
| Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 25.0 | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 25.0 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 25.0 | View |
| Atrioventricular block first degree | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 25.0 | View |
| Palpitations | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 25.0 | View |
| Chest discomfort | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 25.0 | View |
| Influenza like illness | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 25.0 | View |
| Seasonal allergy | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA Version 25.0 | View |
| Eczema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 25.0 | View |
| Dermal cyst | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 25.0 | View |
| Skin reaction | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 25.0 | View |
| Heart rate increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 25.0 | View |
| Menopausal symptoms | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA Version 25.0 | View |
| Viral upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 25.0 | View |