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 @ 7:34 PM
Ignite Modification Date:
2025-12-25 @ 5:16 PM
NCT ID:
NCT02382003
Description:
Adverse events were investigated by researchers regularly.
Frequency Threshold:
0
Time Frame:
Adverse event data was monitored throughout the study, through study completion (during the weeks of active study sessions and at 2 month follow-up).
Study:
NCT02382003
Study Brief:
Web-based Interpretation Training For Anxiety
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Positive Training+Anxious Imagery Prime | Positive Cognitive Bias Modification - Interpretation training paired with a preceding Anxious Imagery Prime Positive Cognitive Bias Modification - Interpretation: Training involves presenting participants with brief scenarios that introduce an ambiguous potential threat. Critically, the ambiguity regarding how the situation is resolved remains until the last word of the scenario, which is presented as a word fragment that the participant must solve, which will then assign a benign (rather than threatening) meaning to the scenario. Anxious Imagery Prime: We will test whether priming anxious concerns and feared negative outcomes on the web via the addition of a guided anxious imagery prime at the start of each session will enhance effects. | 0 | None | 0 | 111 | 0 | 111 | View |
| Positive Training+Neutral Imagery Prime | Positive Cognitive Bias Modification - Interpretation training paired with a preceding Neutral Imagery Prime Positive Cognitive Bias Modification - Interpretation: Training involves presenting participants with brief scenarios that introduce an ambiguous potential threat. Critically, the ambiguity regarding how the situation is resolved remains until the last word of the scenario, which is presented as a word fragment that the participant must solve, which will then assign a benign (rather than threatening) meaning to the scenario. Neutral Imagery Prime: At the start of each session, participants will complete a neutral control imagery exercise where they do a guided imagery exercise imagining upcoming mundane tasks, like brushing one's teeth. | 0 | None | 0 | 141 | 0 | 141 | View |
| 50/50 Training+Neutral Imagery Prime | 50/50 Cognitive Bias Modification - Interpretation (half positive \& half negative scenarios) paired with a preceding Neutral Imagery Prime 50/50 Cognitive Bias Modification - Interpretation: This condition follows the same design and content as the Positive Training conditions, except the word fragments differ; rather than consistently resolving the scenario in a positive direction, half of the scenarios will end with a negative (anxiety-congruent) word fragment, and half will end with a positive word fragment. Neutral Imagery Prime: At the start of each session, participants will complete a neutral control imagery exercise where they do a guided imagery exercise imagining upcoming mundane tasks, like brushing one's teeth. | 0 | None | 0 | 144 | 0 | 144 | View |
| No Scenario+Anxious Imagery Prime | No scenarios paired with a preceding Anxious Imagery Prime Anxious Imagery Prime: We will test whether priming anxious concerns and feared negative outcomes on the web via the addition of a guided anxious imagery prime at the start of each session will enhance effects. | 0 | None | 0 | 136 | 0 | 136 | View |
| No Scenario+Neutral Imagery Prime | No scenarios paired with a preceding Neutral Imagery Prime Neutral Imagery Prime: At the start of each session, participants will complete a neutral control imagery exercise where they do a guided imagery exercise imagining upcoming mundane tasks, like brushing one's teeth. | 0 | None | 0 | 154 | 0 | 154 | View |
| 50/50 Training+Anxious Imagery Prime | 50/50 Cognitive Bias Modification - Interpretation (half positive \& half negative scenarios) paired with a preceding Anxious Imagery Prime 50/50 Cognitive Bias Modification - Interpretation: This condition follows the same design and content as the Positive Training conditions, except the word fragments differ; rather than consistently resolving the scenario in a positive direction, half of the scenarios will end with a negative (anxiety-congruent) word fragment, and half will end with a positive word fragment. Anxious Imagery Prime: We will test whether priming anxious concerns and feared negative outcomes on the web via the addition of a guided anxious imagery prime at the start of each session will enhance effects. | 0 | None | 0 | 121 | 0 | 121 | View |
Serious Events(If Any):
Other Events(If Any):