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 @ 7:16 PM
Ignite Modification Date:
2025-12-25 @ 4:53 PM
NCT ID:
NCT03949803
Description:
None
Frequency Threshold:
0
Time Frame:
Adverse events were collected for each arm in the three conditions (Morning, Evening/Night, Control) during two weeks each, along with washout periods of one week between conditions. In total, adverse events were reported for up to eight weeks.
Study:
NCT03949803
Study Brief:
Eating Chocolate at the Right Time Benefits the Circadiam Sytem and Metabolic Efficiency.
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Morning Chocolate First, Second Evening/Night Chocolate and Control Chocolate: Morning Condition | The intervention is eating chocolate within one hour of habitual waketime. Evening/Night Chocolate and Control Chocolate: Behavioral: Evening/Night Chocolate Eating 100gr of milk chocolate within (1 hours of habitual bedtime) Behavioral: Control Chocolate Eating no milk chocolate or other chocolate | 0 | None | 0 | 3 | 0 | 3 | View |
| Morning Chocolate First, Second Control Chocolate and Evening/Night Chocolate: Morning Condition | The intervention is eating chocolate within one hour of habitual waketime. Control Chocolate and Evening/Night Chocolate: Behavioral: Control Chocolate Eating no milk chocolate or other chocolate Behavioral: Evening/Night Chocolate Eating 100gr of milk chocolate (within 1 hours of habitual bedtime) | 0 | None | 0 | 3 | 0 | 3 | View |
| Evening/Night Chocolate First, Second Morning Chocolate and Control Chocolate: Morning Condition | The intervention is eating chocolate within one hour of habitual waketime. Morning Chocolate and Control Chocolate: Behavioral: Morning Chocolate Eating 100gr of milk chocolate (within 1 hours of habitual waketime) Behavioral: Control Chocolate Eating no milk chocolate or other chocolate | 0 | None | 0 | 5 | 0 | 5 | View |
| Evening/Night Chocolate First, Second Control Chocolate and Morning Chocolate: Morning Condition | The intervention is eating chocolate within one hour of habitual waketime. Control Chocolate and Morning Chocolate: Behavioral: Control Chocolate Eating no milk chocolate or other chocolate. Behavioral: Morning Chocolate Eating 100gr of milk chocolate (within 1 hours of habitual waketime) | 0 | None | 0 | 2 | 0 | 2 | View |
| Control Chocolate First, Second Morning Chocolate and Evening/Night Chocolate: Morning Condition | The intervention is eating chocolate within one hour of habitual waketime. Morning Chocolate and Evening/Night Chocolate: Behavioral: Morning Chocolate Eating 100gr of milk chocolate (within 1 hours of habitual waketime) Behavioral: Evening/Night Chocolate Eating 100gr of milk chocolate (within 1 hours of habitual bedtime) | 0 | None | 0 | 3 | 0 | 3 | View |
| Control Chocolate First, Second Evening/Night Chocolate and Morning Chocolate: Morning Condition | The intervention is eating chocolate within one hour of habitual waketime. Evening/Night Chocolate and Morning Chocolate: Behavioral: Evening/Night Chocolate Eating 100gr of milk chocolate (within 1 hours of habitual bedtime) Behavioral: Morning Chocolate Eating 100gr of milk chocolate (within 1 hours of habitual waketime) | 0 | None | 0 | 3 | 0 | 3 | View |
| Morning Chocolate First, Second Evening/Night Chocolate and Control Chocolate: Evening Condition | The intervention is eating chocolate within one hour of habitual waketime. Evening/Night Chocolate and Control Chocolate: Behavioral: Evening/Night Chocolate Eating 100gr of milk chocolate within (1 hours of habitual bedtime) Behavioral: Control Chocolate Eating no milk chocolate or other chocolate | 0 | None | 0 | 3 | 0 | 3 | View |
| Morning Chocolate First, Second Control Chocolate and Evening/Night Chocolate: Evening Condition | The intervention is eating chocolate within one hour of habitual waketime. Control Chocolate and Evening/Night Chocolate: Behavioral: Control Chocolate Eating no milk chocolate or other chocolate Behavioral: Evening/Night Chocolate Eating 100gr of milk chocolate (within 1 hours of habitual bedtime) | 0 | None | 0 | 3 | 0 | 3 | View |
| Evening/Night Chocolate First, Second Morning Chocolate and Control Chocolate: Evening Condition | The intervention is eating chocolate within one hour of habitual waketime. Morning Chocolate and Control Chocolate: Behavioral: Morning Chocolate Eating 100gr of milk chocolate (within 1 hours of habitual waketime) Behavioral: Control Chocolate Eating no milk chocolate or other chocolate | 0 | None | 0 | 5 | 0 | 5 | View |
| Evening/Night Chocolate First, Second Control Chocolate and Morning Chocolate: Evening Condition | The intervention is eating chocolate within one hour of habitual waketime. Control Chocolate and Morning Chocolate: Behavioral: Control Chocolate Eating no milk chocolate or other chocolate. Behavioral: Morning Chocolate Eating 100gr of milk chocolate (within 1 hours of habitual waketime) | 0 | None | 0 | 2 | 0 | 2 | View |
| Control Chocolate First, Then Morning Chocolate and Evening/Night Chocolate: Evening Condition | The intervention is eating chocolate within one hour of habitual waketime. Morning Chocolate and Evening/Night Chocolate: Behavioral: Morning Chocolate Eating 100gr of milk chocolate (within 1 hours of habitual waketime) Behavioral: Evening/Night Chocolate Eating 100gr of milk chocolate (within 1 hours of habitual bedtime) | 0 | None | 0 | 3 | 0 | 3 | View |
| Control Chocolate First, Second Evening/Night Chocolate and Morning Chocolate: Evening Condition | The intervention is eating chocolate within one hour of habitual waketime. Evening/Night Chocolate and Morning Chocolate: Behavioral: Evening/Night Chocolate Eating 100gr of milk chocolate (within 1 hours of habitual bedtime) Behavioral: Morning Chocolate Eating 100gr of milk chocolate (within 1 hours of habitual waketime) | 0 | None | 0 | 3 | 0 | 3 | View |
| Morning Chocolate First, Second Evening/Night Chocolate and Control Chocolate: Control Condition | The intervention is eating chocolate within one hour of habitual waketime. Evening/Night Chocolate and Control Chocolate: Behavioral: Evening/Night Chocolate Eating 100gr of milk chocolate within (1 hours of habitual bedtime) Behavioral: Control Chocolate Eating no milk chocolate or other chocolate | 0 | None | 0 | 3 | 0 | 3 | View |
| Morning Chocolate First, Second Control Chocolate and Evening/Night Chocolate: Control Condition | The intervention is eating chocolate within one hour of habitual waketime. Control Chocolate and Evening/Night Chocolate: Behavioral: Control Chocolate Eating no milk chocolate or other chocolate Behavioral: Evening/Night Chocolate Eating 100gr of milk chocolate (within 1 hours of habitual bedtime) | 0 | None | 0 | 3 | 0 | 3 | View |
| Evening/Night Chocolate First, Second Morning Chocolate and Control Chocolate: Control Condition | The intervention is eating chocolate within one hour of habitual waketime. Morning Chocolate and Control Chocolate: Behavioral: Morning Chocolate Eating 100gr of milk chocolate (within 1 hours of habitual waketime) Behavioral: Control Chocolate Eating no milk chocolate or other chocolate | 0 | None | 0 | 5 | 0 | 5 | View |
| Evening/Night Chocolate First, Second Control Chocolate and Morning Chocolate: Control Condition | The intervention is eating chocolate within one hour of habitual waketime. Control Chocolate and Morning Chocolate: Behavioral: Control Chocolate Eating no milk chocolate or other chocolate. Behavioral: Morning Chocolate Eating 100gr of milk chocolate (within 1 hours of habitual waketime) | 0 | None | 0 | 2 | 0 | 2 | View |
| Control Chocolate First, Second Morning Chocolate and Evening/Night Chocolate: Control Condition | The intervention is eating chocolate within one hour of habitual waketime. Morning Chocolate and Evening/Night Chocolate: Behavioral: Morning Chocolate Eating 100gr of milk chocolate (within 1 hours of habitual waketime) Behavioral: Evening/Night Chocolate Eating 100gr of milk chocolate (within 1 hours of habitual bedtime) | 0 | None | 0 | 3 | 0 | 3 | View |
| Control Chocolate First, Second Evening/Night Chocolate and Morning Chocolate: Control Condition | The intervention is eating chocolate within one hour of habitual waketime. Evening/Night Chocolate and Morning Chocolate: Behavioral: Evening/Night Chocolate Eating 100gr of milk chocolate (within 1 hours of habitual bedtime) Behavioral: Morning Chocolate Eating 100gr of milk chocolate (within 1 hours of habitual waketime) | 0 | None | 0 | 3 | 0 | 3 | View |
Serious Events(If Any):
Other Events(If Any):