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:
2025-12-25 @ 2:59 AM
Ignite Modification Date:
2025-12-26 @ 1:40 AM
NCT ID:
NCT04455633
Description:
The safety population included those participants who took at least 1 dose of study drug during the double-blind treatment period. Adverse events reported occurred at a frequency \>=5% in any treatment group. AEs were collected and reported for treatment period and safety follow up period separately.
Frequency Threshold:
5
Time Frame:
First dose of study drug after randomization up to the end of study (up to Week 11)
Study:
NCT04455633
Study Brief:
Efficacy, Safety, and PK of LX9211 in Participants With Diabetic Peripheral Neuropathic Pain
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 (Double-blind Treatment Period) | Following a 2-week single-blind Run-in period, participants were randomized to receive a single loading dose of LX9211 matching placebo tablet, orally, on Day 1 and maintenance doses, orally, once daily from Day 2 to Week 6 during the 6-week double-blind treatment period. | 1 | None | 1 | 107 | 9 | 107 | View |
| LX9211 100 mg/10 mg (Double-blind Treatment Period) | Following a 2-week Single-blind Run-in period, participants were randomized to receive a single loading dose of 100 mg tablet, orally, on Day 1 and maintenance doses of 10 mg, orally, once daily from Day 2 to Week 6 during the 6-week double-blind treatment period. | 0 | None | 0 | 106 | 39 | 106 | View |
| Placebo (Single-blind Follow-up Period) | Following completion of the 6-week double-blind treatment period, all participants entered the 5-week single-blind follow-up period and received a daily dose of LX9211 matching placebo tablet, orally. | 0 | None | 1 | 104 | 4 | 104 | View |
| LX9211 100 mg/10 mg (Single-blind Follow-up Period) | Following completion of the 6-week double-blind treatment period, all participants entered the 5-week single-blind follow-up period and received a daily dose of LX9211 matching placebo tablet, orally. | 0 | None | 1 | 99 | 2 | 99 | View |
| LX9211 200 mg/20 mg Single-blind Follow-up Period) | Following completion of the 6-week double-blind treatment period, all participants entered the 5-week single-blind follow-up period and received a daily dose of LX9211 matching placebo tablet, orally. | 0 | None | 1 | 92 | 6 | 92 | View |
| LX9211 200 mg/20 mg (Double-blind Treatment Period) | Following a 2-week Single-blind Run-in period, participants were randomized to receive a single loading dose of 200 mg tablet, orally, on Day 1 and maintenance doses of 20 mg, orally, once daily from Day 2 to Week 6 during the 6-week double-blind treatment period. | 1 | None | 2 | 106 | 44 | 106 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| COVID-19 | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.0) | View |
| Type 1 diabetes mellitus | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (23.0) | View |
| Orthopnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | View |
| Atrial fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (23.0) | View |
| Supraventricular tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (23.0) | View |
| Abdominal pain lower | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (23.0) | View |
| Oedema peripheral | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (23.0) | View |
| Coronavirus infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (23.0) | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (23.0) | View |
| Balance disorder | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (23.0) | View |
| Somnolence | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (23.0) | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (23.0) | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (23.0) | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (23.0) | View |