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 @ 5:43 PM
Ignite Modification Date:
2025-12-25 @ 3:11 PM
NCT ID:
NCT00464568
Description:
On-treatment Serious adverse events (SAE) and non-serious adverse events (nSAE) are reported for the All Subjects population which comprised of all participants randomized to treatment who received at least one dose of study treatment (including placebo).
Frequency Threshold:
0
Time Frame:
Up to 9 weeks
Study:
NCT00464568
Study Brief:
A 5-way Treatment Period Trial of Single Doses of Intranasal GSK256066 in Patients With Rhinitis
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 | Participants received a single dose of aqueous nasal spray of GSK256066 matching placebo via intranasal route, 1 puff per nostril. The total duration of the study per participant was approximately 8 to 9 weeks (up to 4 weeks Screening and 3 weeks dosing (including washout) plus a Follow-up visit at least 7 days (and no more than 14 days) after the last treatment. | None | None | 0 | 31 | 7 | 31 | View |
| GSK256066 1 mcg | Participants received a single dose of GSK256066 1 mcg aqueous nasal spray via intranasal route, 1 puff of 0.5 mcg per nostril. The total duration of the study per participant was approximately 8 to 9 weeks (up to 4 weeks Screening and 3 weeks dosing (including washout) plus a Follow-up visit at least 7 days (and no more than 14 days) after the last treatment. | None | None | 0 | 30 | 6 | 30 | View |
| GSK256066 10 mcg | Participants received a single dose of GSK256066 10 mcg aqueous nasal spray via intranasal route, 1 puff of 5 mcg per nostril. The total duration of the study per participant was approximately 8 to 9 weeks (up to 4 weeks Screening and 3 weeks dosing (including washout) plus a Follow-up visit at least 7 days (and no more than 14 days) after the last treatment. | None | None | 0 | 32 | 6 | 32 | View |
| GSK256066 50 mcg | Participants received a single dose of GSK256066 50 mcg aqueous nasal spray via intranasal route, 1 puff of 25 mcg per nostril. The total duration of the study per participant was approximately 8 to 9 weeks (up to 4 weeks Screening and 3 weeks dosing (including washout) plus a Follow-up visit at least 7 days (and no more than 14 days) after the last treatment. | None | None | 0 | 30 | 8 | 30 | View |
| GSK256066 200 mcg | Participants received a single dose of GSK256066 200 mcg aqueous nasal spray via intranasal route, 1 puff of 100 mcg per nostril. The total duration of the study per participant was approximately 8 to 9 weeks (up to 4 weeks Screening and 3 weeks dosing (including washout) plus a Follow-up visit at least 7 days (and no more than 14 days) after the last treatment. | None | None | 0 | 31 | 10 | 31 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 10.0 | View |
| Dysgeusia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 10.0 | View |
| Rhinitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.0 | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.0 | View |
| Sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.0 | View |
| Epistaxis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | View |
| Throat irritation | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | View |
| Nasal necrosis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | View |
| Pharyngolaryngeal pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | View |
| Eye pruritus | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 10.0 | View |
| Ocular hyperaemia | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 10.0 | View |
| Photophobia | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 10.0 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 10.0 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 10.0 | View |
| Dry mouth | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 10.0 | View |
| Gingivitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 10.0 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 10.0 | View |
| Acne | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 10.0 | View |
| Heat rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 10.0 | View |
| Idioventricular rhythm | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 10.0 | View |
| Skin laceration | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 10.0 | View |
| Listless | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 10.0 | View |
| Postmenopausal haemorrhage | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 10.0 | View |