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 @ 11:57 PM
Ignite Modification Date:
2025-12-25 @ 9:54 PM
NCT ID:
NCT03498651
Description:
No difference
Frequency Threshold:
0
Time Frame:
Adverse event data was monitored throughout the study, through study completion (during the 5-6 weeks of active study sessions and at 2 month follow-up).
Study:
NCT03498651
Study Brief:
Interpretation Training to Reduce Anxiety: Evaluating Technology-based Delivery Models and Methods to Reduce Attrition
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Received CBM-I and Classified High Attrition and no Coach Given | Computer- or phone-based Cognitive Bias Modification - Interpretation training Cognitive Bias Modification - Interpretation training: 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 typically then assign a benign (rather than threatening) meaning to the scenario. | 0 | None | 0 | 265 | 0 | 265 | View |
| Received CBM-I and Classified High Attrition and Given a Coach | Computer- or phone-based Cognitive Bias Modification - Interpretation training + Coaching Cognitive Bias Modification - Interpretation training: 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 typically then assign a benign (rather than threatening) meaning to the scenario. Coaching: Participants identified as high risk for attrition will receive low-intensity coaching, which includes a mix of brief phone calls, texts, and/or emails with a trained member of the study team to help address challenges with adherence to and application of the training. | 0 | None | 0 | 282 | 0 | 282 | View |
| Received CBM-I and Not Classified as High/Low Risk for Attrition | This group started treatment (and had been Stage 1 randomized to CBM-I) but did not complete Session 1 of CBM-I training plus assessments, so was not classified as high/low risk for attrition and thus not randomized for Stage 2 of SMART design | 0 | None | 0 | 149 | 0 | 149 | View |
| Received CBM-I and Classified Low Attrition | Computer- or phone-based Cognitive Bias Modification - Interpretation training Cognitive Bias Modification - Interpretation training: 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 typically then assign a benign (rather than threatening) meaning to the scenario. | 0 | None | 0 | 288 | 0 | 288 | View |
| Psychoeducation | Online psychoeducation about anxiety Online psychoeducation about anxiety: Participants will review webpages that describe information about symptoms and causes of anxiety, including the nature of biased thinking in anxiety | 0 | None | 0 | 242 | 0 | 242 | View |
| Psychoeducation, Lacking Classification Measures | This group started treatment (and had been Stage 1 randomized to psychoeducation) but did not complete Session 1 of psychoeducation plus assessments, so is not part of the classification measure completer sample | 0 | None | 0 | 13 | 0 | 13 | View |
| Not Randomized to Treatment | Completed consent but didn't complete baseline assessments or reach point of Stage 1 randomization to a treatment arm | 0 | None | 0 | 509 | 0 | 509 | View |
Serious Events(If Any):
Other Events(If Any):