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 @ 7:08 PM
Ignite Modification Date:
2025-12-25 @ 4:42 PM
NCT ID:
NCT01472757
Description:
None
Frequency Threshold:
0
Time Frame:
12 weeks
Study:
NCT01472757
Study Brief:
Clinical Study to Evaluate the Efficacy of VR506 Using a New Inhaler for the Treatment of Asthma
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 | Placebo: Placebo delivered via a new dry powder inhaler | 0 | None | 0 | 91 | 47 | 91 | View |
| VR506 50 mcg | VR506 50 mcg inhalation powder delivered via a new dry powder inhaler | 0 | None | 1 | 93 | 42 | 93 | View |
| VR506 100 mcg | VR506 100 mcg inhalation powder delivered via a new dry powder inhaler | 0 | None | 1 | 95 | 40 | 95 | View |
| VR506 250 mcg | VR506 250 mcg inhalation powder delivered via a new dry powder inhaler | 0 | None | 0 | 94 | 33 | 94 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| DYSPNOEA | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | View |
| PHARYNGEAL INFLAMMATION | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | View |
| RHINORRHOEA | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | View |
| DYSPHONIA | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | View |
| NASAL CONGESTION | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | View |
| OROPHARYNGEAL PAIN | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | View |
| THROAT IRRITATION | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | View |
| UPPER-AIRWAY COUGH SYNDROME | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | View |
| ALLERGIC COUGH | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | View |
| DYSPNOEA EXERTIONAL | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | View |
| PARANASAL SINUS HYPERSECRETION | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | View |
| RHINITIS ALLERGIC | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | View |
| SPUTUM RETENTION | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | View |
| NASOPHARYNGITIS | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 14.0 | View |
| UPPER RESPIRATORY TRACT INFECTION | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 14.0 | View |
| PHARYNGITIS | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 14.0 | View |
| RESPIRATORY TRACT INFECTION | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 14.0 | View |
| SINUSITIS | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 14.0 | View |
| ORAL CANDIDIASIS | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 14.0 | View |
| ACUTE TONSILLITIS | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 14.0 | View |
| GASTROENTERITIS VIRAL | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 14.0 | View |
| ACUTE SINUSITIS | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 14.0 | View |
| APPENDICITIS | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 14.0 | View |
| CANDIDIASIS | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 14.0 | View |
| GASTROENTERITIS | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 14.0 | View |
| TONSILLITIS | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 14.0 | View |
| URINARY TRACT INFECTION | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 14.0 | View |
| VIRAL INFECTION | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 14.0 | View |
| VIRAL UPPER RESPIRATORY TRACT INFECTION | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 14.0 | View |
| FUNGAL INFECTION | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 14.0 | View |
| INFLUENZA | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 14.0 | View |
| LOWER RESPIRATORY TRACT INFECTION | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 14.0 | View |
| TRACHEITIS | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 14.0 | View |
| HEADACHE | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 14.0 | View |
| SINUS HEADACHE | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 14.0 | View |
| APHTHOUS STOMATITIS | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.0 | View |
| DYSPEPSIA | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.0 | View |
| ENTEROCOLITIS | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.0 | View |
| GASTRITIS | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.0 | View |
| GASTRODUODENITIS | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.0 | View |
| HYPERCHLORHYDRIA | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.0 | View |
| NAUSEA | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.0 | View |
| TOOTHACHE | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.0 | View |
| GINGIVITIS | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.0 | View |
| DERMATITIS CONTACT | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 14.0 | View |
| ECZEMA | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 14.0 | View |
| PRURITUS | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 14.0 | View |
| SEBORRHOEA | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 14.0 | View |
| COSTOCHONDRITIS | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | View |
| FOOT DEFORMITY | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | View |
| OSTEOARTHRITIS | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | View |
| TORTICOLLIS | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | View |
| MUSCULOSKELETAL CHEST PAIN | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | View |
| PAIN IN EXTREMITY | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | View |
| FATIGUE | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 14.0 | View |
| PYREXIA | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 14.0 | View |
| CHEST DISCOMFORT | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 14.0 | View |
| MALAISE | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 14.0 | View |
| PAIN | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 14.0 | View |
| HYPOGLYCAEMIA | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 14.0 | View |
| HYPERTENSION | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 14.0 | View |
| IRON DEFICIENCY ANAEMIA | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 14.0 | View |
| BUNDLE BRANCH BLOCK RIGHT | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 14.0 | View |
| INJURY | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 14.0 | View |
| THERMAL BURN | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 14.0 | View |
| WEIGHT INCREASED | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 14.0 | View |
| NEPHROLITHIASIS | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 14.0 | View |
| VAGINAL HAEMORRHAGE | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 14.0 | View |
| LACRIMATION INCREASED | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 14.0 | View |
| CYTOLYTIC HEPATITIS | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 14.0 | View |
| GALLBLADDER PAIN | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 14.0 | View |
| BRONCHITIS | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 14.0 | View |
| DENGUE FEVER | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 14.0 | View |
| PARAESTHESIA ORAL | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.0 | View |
| TYPE 2 DIABETES MELLITUS | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 14.0 | View |
| ASTHMA | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | View |
| COUGH | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | View |