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 @ 9:19 PM
Ignite Modification Date:
2025-12-25 @ 7:07 PM
NCT ID:
NCT00972504
Description:
All subject population was used.
Frequency Threshold:
0
Time Frame:
AEs and SAEs were reported throughout the study (approximately up to 63 days).
Study:
NCT00972504
Study Brief:
723/726 Proof of Concept Study in Allergen Challenge Chamber in Hannover
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| GSK1004723 1000 µg Once Daily | Participants randomized to this arm received once daily GSK1004723 1000 µg nasal spray solution for 3 days, plus placebos to match both GSK835726 and cetirizine as per randomization schedule in the morning of each day. Each participant dosed at the same time each day relative to Day 1. Each treatment period was separated by at least 4 days washout period and there was at least 7 days between ECC days. | 0 | None | 0 | 54 | 53 | 54 | View |
| Placebo | Participants randomized to this arm received placebo once daily for 3 days (to match GSK1004723, GSK835726 and cetirizine) as per randomization schedule in the morning of each day. Each participant dosed at the same time each day relative to Day 1. Each treatment period was separated by at least 4 days washout period and there was at least 7 days between ECC days. | 0 | None | 0 | 52 | 15 | 52 | View |
| GSK835726 10 mg Once Daily | Participants randomized to this arm received once daily oral tablet of GSK835726 10 mg for 3 days, plus placebos to match both GSK1004723 and cetirizine as per randomization schedule in the morning of each day. Each participant dosed at the same time each day relative to Day 1. Each treatment period was separated by at least 4 days washout period and there was at least 7 days between ECC days. | 0 | None | 0 | 53 | 13 | 53 | View |
| Cetirizine 10 mg Once Daily | Participants randomized to this arm received once daily oral capsule of cetirizine 10 mg for 3 days, plus placebos to match both GSK1004723 and GSK835726 as per randomization schedule in the morning of each day. Each participant dosed at the same time each day relative to Day 1. Each treatment period was separated by at least 4 days washout period and there was at least 7 days between ECC days. | 0 | None | 0 | 52 | 17 | 52 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Nasal discomfort | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version | View |
| Nasal congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version | View |
| Nasal dryness | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version | View |
| Epistaxis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version | View |
| Oropharyngeal pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version | View |
| Rhinorrhoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version | View |
| Sneezing | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version | View |
| Nasal mucosal disorder | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version | View |
| Throat irritation | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version | View |
| Somnolence | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version | View |
| Hypotonia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version | View |
| Migraine | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version | View |
| Tremor | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version | View |
| Lacrimation increased | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA version | View |
| Eye irritation | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA version | View |
| Aphthous stomatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version | View |
| Glossodynia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version | View |
| Oral discomfort | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA version | View |
| Muscle spasms | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA version | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA version | View |
| Herpes simplex | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version | View |
| Oral herpes | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version | View |
| Vulvovaginal mycotic infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version | View |
| Vertigo | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA version | View |
| Sunburn | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version | View |
| Blister | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA version | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA version | View |
| Hot flush | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA version | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA version | View |
| Palpitations | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA version | View |
| Forced expiratory volume decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA version | View |
| Dysmenorrhoea | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA version | View |