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 @ 4:28 AM
Ignite Modification Date:
2025-12-26 @ 3:31 AM
NCT ID:
NCT05499520
Description:
None
Frequency Threshold:
0
Time Frame:
1 month
Study:
NCT05499520
Study Brief:
Project RESIST: Evaluating the Effects of Anti-smoking Inoculation Messages Among Young Adult Sexual Minority Women
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Currently Smoking, No Message Condition | Participants will receive no anti-smoking messages. They will receive the threat message during the baseline survey. Outcomes will be measured before and immediately after seeing the threat message, and at 1 month. | 0 | None | 0 | 210 | 0 | 210 | View |
| Currently Smoking, Single Message Immediate | Participants will receive a single anti-smoking message followed by the threat message during the baseline survey. Outcomes will be measured before seeing the anti-smoking message and threat message, immediately after seeing the threat message, and at 1 month. Culturally Tailored Anti-Smoking Messages: Anti-smoking messages will be administered online via a Qualtrics survey. | 0 | None | 0 | 103 | 0 | 103 | View |
| Currently Smoking, Single Message 1 Week Delay | Participants will receive a single anti-smoking message during the baseline survey, followed by the threat message one week later in a separate survey. Outcomes will be measured before seeing the anti-smoking message at baseline, immediately after seeing the threat message at 1 week, and at 1 month. Culturally Tailored Anti-Smoking Messages: Anti-smoking messages will be administered online via a Qualtrics survey. | 0 | None | 0 | 113 | 0 | 113 | View |
| Currently Smoking, Single Message 1 Month Delay | Participants will receive a single anti-smoking message during the baseline survey, followed by the threat message one month later in a separate survey. Outcomes will be measured before seeing the anti-smoking message at baseline, and immediately after seeing the threat message at 1 month. Culturally Tailored Anti-Smoking Messages: Anti-smoking messages will be administered online via a Qualtrics survey. | 0 | None | 0 | 107 | 0 | 107 | View |
| Currently Smoking, Single Message 1 Month Delay, Repeated Exposure | Participants will receive a single anti-smoking message during the baseline survey, followed by the threat message one month later. Participants will also receive repeated exposures of a single anti-smoking message at 1, 2, and 3 weeks in separate surveys. Outcomes will be measured before seeing the anti-smoking message at baseline and immediately after seeing the threat message at 1 month. Culturally Tailored Anti-Smoking Messages: Anti-smoking messages will be administered online via a Qualtrics survey. | 0 | None | 0 | 110 | 0 | 110 | View |
| Currently Smoking, Three Messages Immediate | Participants will receive three anti-smoking messages, followed by the threat message during the baseline survey. Outcomes will be measured before seeing the anti-smoking messages and threat message, immediately after seeing the threat message, and at 1 month. Culturally Tailored Anti-Smoking Messages: Anti-smoking messages will be administered online via a Qualtrics survey. | 0 | None | 0 | 107 | 0 | 107 | View |
| Currently Smoking, Three Messages 1 Week Delay | Participants will receive three anti-smoking messages during the baseline survey, followed by the threat message one week later in a separate survey. Outcomes will be measured before seeing the anti-smoking messages at baseline, immediately after seeing the threat message at 1 week, and at 1 month. Culturally Tailored Anti-Smoking Messages: Anti-smoking messages will be administered online via a Qualtrics survey. | 0 | None | 0 | 112 | 0 | 112 | View |
| Currently Smoking, Three Messages 1 Month Delay | Participants will receive three anti-smoking messages during the baseline survey, followed by the threat message one month later in a separate survey. Outcomes will be measured before seeing the anti-smoking messages at baseline, and immediately after seeing the threat message at 1 month. Culturally Tailored Anti-Smoking Messages: Anti-smoking messages will be administered online via a Qualtrics survey. | 0 | None | 0 | 106 | 0 | 106 | View |
| Currently Smoking, Three Messages 1 Month Delay Repeat Exposure | Participants will receive three anti-smoking messages during the baseline survey, followed by the threat message one month later. Participants will also receive repeated exposures of three anti-smoking messages at 1, 2, and 3 weeks in separate surveys. Outcomes will be measured before seeing the anti-smoking messages at baseline and immediately after seeing the threat message at 1 month. Culturally Tailored Anti-Smoking Messages: Anti-smoking messages will be administered online via a Qualtrics survey. | 0 | None | 0 | 107 | 0 | 107 | View |
| Not Currently Smoking, No Message Condition | Participants will receive no anti-smoking messages. They will receive the threat message during the baseline survey. Outcomes will be measured before and immediately after seeing the threat message, and at 1 month. | 0 | None | 0 | 305 | 0 | 305 | View |
| Not Currently Smoking, Single Message Immediate | Participants will receive a single anti-smoking message followed by the threat message during the baseline survey. Outcomes will be measured before seeing the anti-smoking message and threat message, immediately after seeing the threat message, and at 1 month. Culturally Tailored Anti-Smoking Messages: Anti-smoking messages will be administered online via a Qualtrics survey. | 0 | None | 0 | 155 | 0 | 155 | View |
| Not Currently Smoking, Single Message 1 Week Delay | Participants will receive a single anti-smoking message during the baseline survey, followed by the threat message one week later in a separate survey. Outcomes will be measured before seeing the anti-smoking message at baseline, immediately after seeing the threat message at 1 week, and at 1 month. Culturally Tailored Anti-Smoking Messages: Anti-smoking messages will be administered online via a Qualtrics survey. | 0 | None | 0 | 146 | 0 | 146 | View |
| Not Currently Smoking, Single Message 1 Month Delay | Participants will receive a single anti-smoking message during the baseline survey, followed by the threat message one month later in a separate survey. Outcomes will be measured before seeing the anti-smoking message at baseline, and immediately after seeing the threat message at 1 month. Culturally Tailored Anti-Smoking Messages: Anti-smoking messages will be administered online via a Qualtrics survey. | 0 | None | 0 | 150 | 0 | 150 | View |
| Not Currently Smoking, Single Message 1 Month Delay, Repeated Exposure | Participants will receive a single anti-smoking message during the baseline survey, followed by the threat message one month later. Participants will also receive repeated exposures of a single anti-smoking message at 1, 2, and 3 weeks in separate surveys. Outcomes will be measured before seeing the anti-smoking message at baseline and immediately after seeing the threat message at 1 month. Culturally Tailored Anti-Smoking Messages: Anti-smoking messages will be administered online via a Qualtrics survey. | 0 | None | 0 | 156 | 0 | 156 | View |
| Not Currently Smoking, Three Messages Immediate | Participants will receive three anti-smoking messages, followed by the threat message during the baseline survey. Outcomes will be measured before seeing the anti-smoking messages and threat message, immediately after seeing the threat message, and at 1 month. Culturally Tailored Anti-Smoking Messages: Anti-smoking messages will be administered online via a Qualtrics survey. | 0 | None | 0 | 146 | 0 | 146 | View |
| Not Currently Smoking, Three Messages 1 Week Delay | Participants will receive three anti-smoking messages during the baseline survey, followed by the threat message one week later in a separate survey. Outcomes will be measured before seeing the anti-smoking messages at baseline, immediately after seeing the threat message at 1 week, and at 1 month. Culturally Tailored Anti-Smoking Messages: Anti-smoking messages will be administered online via a Qualtrics survey. | 0 | None | 0 | 154 | 0 | 154 | View |
| Not Currently Smoking, Three Messages 1 Month Delay | Participants will receive three anti-smoking messages during the baseline survey, followed by the threat message one month later in a separate survey. Outcomes will be measured before seeing the anti-smoking messages at baseline, and immediately after seeing the threat message at 1 month. Culturally Tailored Anti-Smoking Messages: Anti-smoking messages will be administered online via a Qualtrics survey. | 0 | None | 0 | 150 | 0 | 150 | View |
| Not Currently Smoking, Three Messages 1 Month Delay Repeat Exposure | Participants will receive three anti-smoking messages during the baseline survey, followed by the threat message one month later. Participants will also receive repeated exposures of three anti-smoking messages at 1, 2, and 3 weeks in separate surveys. Outcomes will be measured before seeing the anti-smoking messages at baseline and immediately after seeing the threat message at 1 month. Culturally Tailored Anti-Smoking Messages: Anti-smoking messages will be administered online via a Qualtrics survey. | 0 | None | 0 | 154 | 0 | 154 | View |
Serious Events(If Any):
Other Events(If Any):