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
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Nicotine Corrective Control | A factual message about nicotine that does not contain a causal explanation for what actually causes tobacco-caused disease or an explanation for why the misperception that nicotine causes cancer may have come to be believed. Coherent corrective messages: Participants will be randomized to one of four message conditions: condition 1 will not contain either component of the coherence; condition 2 will contain one element of coherence (a causal explanation for why the corrective information is accurate); condition 3 will contain the other element of coherence (an explanation for why the misinformation came to be believed); condition 4 will include both elements of coherence. | 0 | None | 0 | 42 | 0 | 42 | View |
| Nicotine Corrective With Causal Explanation | A factual message about nicotine that contain a causal explanation for what actually causes tobacco-caused disease: tar and chemicals created in tobacco smoke when tobacco is lit on fire. Coherent corrective messages: Participants will be randomized to one of four message conditions: condition 1 will not contain either component of the coherence; condition 2 will contain one element of coherence (a causal explanation for why the corrective information is accurate); condition 3 will contain the other element of coherence (an explanation for why the misinformation came to be believed); condition 4 will include both elements of coherence. | 0 | None | 0 | 53 | 0 | 53 | View |
| Nicotine Corrective With Reason for Misperception | A factual message about nicotine that contains an explanation for why the misperception may have come to be believed: that health messaging often discuses nicotine and tobacco-caused disease at the same time and people incorrectly make the connection that nicotine causes cancer. Coherent corrective messages: Participants will be randomized to one of four message conditions: condition 1 will not contain either component of the coherence; condition 2 will contain one element of coherence (a causal explanation for why the corrective information is accurate); condition 3 will contain the other element of coherence (an explanation for why the misinformation came to be believed); condition 4 will include both elements of coherence. | 0 | None | 0 | 56 | 0 | 56 | View |
| Nicotine Corrective With Both Components of Coherence | A factual message about nicotine that contains both a causal explanation for what actually causes tobacco-caused disease and an explanation for why the misperception may have come to be believed. Coherent corrective messages: Participants will be randomized to one of four message conditions: condition 1 will not contain either component of the coherence; condition 2 will contain one element of coherence (a causal explanation for why the corrective information is accurate); condition 3 will contain the other element of coherence (an explanation for why the misinformation came to be believed); condition 4 will include both elements of coherence. | 0 | None | 0 | 42 | 0 | 42 | View |