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 @ 7:04 PM
Ignite Modification Date:
2025-12-25 @ 4:37 PM
NCT ID:
NCT00857857
Description:
All subject population used.
Frequency Threshold:
0
Time Frame:
AE and SAE were reported from the start of investigational product and until the follow-up contact (up to 17 weeks)
Study:
NCT00857857
Study Brief:
A Study to Evaluate the Effect of GW870086X on Allergen Challenge in Mild 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 |
|---|---|---|---|---|---|---|---|---|
| Fluticasone Propionate 0.25 mg BID | Participants were assigned to take fluticasone propionate 0.25 mg BID for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Fluticasone propionate was provided as MDPI and administered via DISKUS inhaler. There was at least 14 days of washout from Day 13 dose. | 0 | None | 0 | 12 | 3 | 12 | View |
| Placebo | Participants were assigned to take matching placebo of GW870086 or fluticasone propionate for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Placebo of GW870086 was provided as ROTADISK, while placebo of fluticasone propionate as MDPI. Placebo of GW870086 was administered via DISKHALER, while placebo of fluticasone propionate via DISKUS inhaler. There was a at least 14 days of washout from Day 13 dose. | 0 | None | 0 | 24 | 8 | 24 | View |
| GW870086 0.25 mg OD | Participants were assigned to take GW870086 0.25 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was a at least 14 days of washout from Day 13 dose. | 0 | None | 0 | 12 | 4 | 12 | View |
| GW870086 1 mg OD | Participants were assigned to take GW870086 1 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose. | 0 | None | 0 | 12 | 7 | 12 | View |
| GW870086 3 mg OD | Participants were assigned to take GW870086 3 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose. | 0 | None | 0 | 12 | 4 | 12 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA | View |
| Migraine | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |
| Herpes simplex | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |
| Oral herpes | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |
| Bronchospasm | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA | View |
| Asthma | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA | View |
| Dysphonia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA | View |
| Oropharyngeal pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA | View |
| Aphthous stomatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA | View |
| Oral pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA | View |
| Conjunctivitis | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA | View |
| Skin laceration | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA | View |
| Prostatitis | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA | View |