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 @ 5:53 PM
Ignite Modification Date:
2025-12-25 @ 3:18 PM
NCT ID:
NCT01899768
Description:
SAEs and non-serious AEs were collected in participants of the All Subjects Population, comprised of all participants who received at least one dose of study medication.
Frequency Threshold:
5
Time Frame:
Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until follow-up (up to 8 weeks).
Study:
NCT01899768
Study Brief:
GSK2339345 Hypertussive Challenge Study
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 two doses of placebo as a solution administered via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar. | None | None | 0 | 16 | 10 | 16 | View |
| GSK2339345 1000 µg | Participants received two doses of GSK2339345 1000 µg via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar. | None | None | 0 | 14 | 5 | 14 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Tongue disclouration | None | Gastrointestinal disorders | MedDRA, version 17.1 | View |
| Vomiting | None | Gastrointestinal disorders | MedDRA, version 17.1 | View |
| Electrocardiogram QT prolonged | None | Investigations | MedDRA, version 17.1 | View |
| QRS axis abnormal | None | Investigations | MedDRA, version 17.1 | View |
| Musculoskeletal pain | None | Musculoskeletal and connective tissue disorders | MedDRA, version 17.1 | View |
| Dizziness | None | Nervous system disorders | MedDRA, version 17.1 | View |
| Dysgeusia | None | Nervous system disorders | MedDRA, version 17.1 | View |
| Headache | None | Nervous system disorders | MedDRA, version 17.1 | View |
| Hypoaesthesia oral | None | Nervous system disorders | MedDRA, version 17.1 | View |
| Paraesthesia oral | None | Nervous system disorders | MedDRA, version 17.1 | View |
| Cough | None | Respiratory, thoracic and mediastinal disorders | MedDRA, version 17.1 | View |
| Dyspnoea | None | Respiratory, thoracic and mediastinal disorders | MedDRA, version 17.1 | View |
| Rhinorrhoea | None | Respiratory, thoracic and mediastinal disorders | MedDRA, version 17.1 | View |
| Throat irritation | None | Respiratory, thoracic and mediastinal disorders | MedDRA, version 17.1 | View |
| Oropharyngeal pain | None | Respiratory, thoracic and mediastinal disorders | MedDRA, version 17.1 | View |