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 @ 10:45 PM
Ignite Modification Date:
2025-12-25 @ 8:16 PM
NCT ID:
NCT04292535
Description:
The clinicaltrials.gov definitions for adverse events was used. Indications of onset of an issue related to hypoglycemia were stopping criteria for the study protocol and are considered herein as Non serious adverse events.
Frequency Threshold:
0
Time Frame:
Only during the two 90 minute sessions.
Study:
NCT04292535
Study Brief:
Safety and Efficacy of Combining Intranasal Insulin & Acute Exercise
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Passive Control - Placebo | 20 minute sedentary control period during which participants watched an emotionally neutral video. Placebo into the intranasal mucosa: 6 doses of 0.2mL saline solution administered into the intranasal mucosa using the MAD Nasal Atomizer | 0 | None | 0 | 8 | 0 | 8 | View |
| Passive Control - 20 IU | 20 minute sedentary control period during which participants watched an emotionally neutral video. 20 IU NovoLog Insulin aspart into the intranasal mucosa: 5 doses of 0.2mL saline solution, 1 dose of 0.2mL NovoLog Insulin aspart (20 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 0 | None | 0 | 8 | 0 | 8 | View |
| Passive Control - 40 IU | 20 minute sedentary control period during which participants watched an emotionally neutral video. 40 IU NovoLog Insulin aspart into the intranasal mucosa: 4 doses of 0.2mL saline solution, 2 doses of 0.2mL NovoLog Insulin aspart (40 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 0 | None | 0 | 9 | 0 | 9 | View |
| Passive Control - 60 IU | 20 minute sedentary control period during which participants watched an emotionally neutral video. 60 IU NovoLog Insulin aspart into the intranasal mucosa: 3 doses of 0.2mL saline solution, 3 doses of 0.2mL NovoLog Insulin aspart (60 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 0 | None | 0 | 8 | 0 | 8 | View |
| Passive Control - 80 IU | 20 minute sedentary control period during which participants watched an emotionally neutral video. 80 IU NovoLog Insulin aspart into the intranasal mucosa: 2 doses of 0.2mL saline solution, 4 doses of 0.2mL NovoLog Insulin aspart (80 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 0 | None | 0 | 8 | 0 | 8 | View |
| Passive Control - 100 IU | 20 minute sedentary control period during which participants watched an emotionally neutral video. 100 IU NovoLog Insulin aspart into the intranasal mucosa: 1 dose of 0.2mL saline solution, 5 doses of 0.2mL NovoLog Insulin aspart (100 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 0 | None | 0 | 9 | 0 | 9 | View |
| Passive Control - 120 IU | 20 minute sedentary control period during which participants watched an emotionally neutral video. 120 IU NovoLog Insulin aspart into the intranasal mucosa: 6 doses of 0.2mL NovoLog Insulin aspart (120 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 0 | None | 0 | 8 | 0 | 8 | View |
| Acute Exercise - Placebo | 20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate. Placebo into the intranasal mucosa: 6 doses of 0.2mL saline solution administered into the intranasal mucosa using the MAD Nasal Atomizer | 0 | None | 0 | 10 | 1 | 10 | View |
| Acute Exercise - 20 IU | 20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate. 20 IU NovoLog Insulin aspart into the intranasal mucosa: 5 doses of 0.2mL saline solution, 1 dose of 0.2mL NovoLog Insulin aspart (20 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 0 | None | 0 | 8 | 0 | 8 | View |
| Acute Exercise - 40 IU | 20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate. 40 IU NovoLog Insulin aspart into the intranasal mucosa: 4 doses of 0.2mL saline solution, 2 doses of 0.2mL NovoLog Insulin aspart (40 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 0 | None | 0 | 8 | 0 | 8 | View |
| Acute Exercise - 60 IU | 20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate. 60 IU NovoLog Insulin aspart into the intranasal mucosa: 3 doses of 0.2mL saline solution, 3 doses of 0.2mL NovoLog Insulin aspart (60 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 0 | None | 0 | 7 | 0 | 7 | View |
| Acute Exercise - 80 IU | 20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate. 80 IU NovoLog Insulin aspart into the intranasal mucosa: 2 doses of 0.2mL saline solution, 4 doses of 0.2mL NovoLog Insulin aspart (80 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 0 | None | 0 | 7 | 0 | 7 | View |
| Acute Exercise - 100 IU | 20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate. 100 IU NovoLog Insulin aspart into the intranasal mucosa: 1 dose of 0.2mL saline solution, 5 doses of 0.2mL NovoLog Insulin aspart (100 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 0 | None | 0 | 9 | 1 | 9 | View |
| Acute Exercise - 120 IU | 20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate. 120 IU NovoLog Insulin aspart into the intranasal mucosa: 6 doses of 0.2mL NovoLog Insulin aspart (120 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 0 | None | 0 | 9 | 2 | 9 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Hypoglycemic event | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |