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 @ 1:46 AM
Ignite Modification Date:
2025-12-26 @ 12:04 AM
NCT ID:
NCT03834194
Description:
Data on adverse events, consistent with the clinicaltrials.gov definition, were collected at data collection visits and as reported by participants in the interim
Frequency Threshold:
0
Time Frame:
Baseline to 36 weeks gestation
Study:
NCT03834194
Study Brief:
Gestational Weight and Incentive Research Study
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Lottery + Overall Weight | Participants will be eligible for a daily lottery if they have weighed themselves in the previous day on the e-scale. For each day of the study, participants will be informed of the study's randomly-generated winning lottery number and their winnings ($0, $2, $15 or not eligible for lottery due to lack of weighing). Participants will be given the Institute of Medicine gestational weight gain recommendation based on their body mass index at randomization, adjusted for data collection at 36 weeks. If they achieve the goal at 36 weeks, they will receive $112 after the data collection visit. Lottery + Overall Weight: Lottery for daily self-weighing. Incentives for gaining weight within a recommended (by Institute of Medicine) by the end of the study. | 0 | None | 1 | 5 | 0 | 5 | View |
| Lottery + Overall Weight + Exercise | Participants will be eligible for a daily lottery if they have weighed themselves in the previous day on the e-scale. For each day of the study, participants will be informed of the study's randomly-generated winning lottery number and their winnings if any. Participants will be given the IOM GWG recommendation based on their body mass index at randomization, adjusted for data collection at 36 weeks. If they achieve the goal at 36 weeks, they will receive $112 after the data collection visit. Participants will be asked to engage in 150 minutes of exercise each week based on the guideline from the ACOG. They will receive $3.50 if they meet their activity goal for the week. Otherwise, they will be notified that they would have received $3.50 had they meet their activity goal. Lottery + Overall Weight + Exercise: Lottery for daily self-weighing. Incentives for gaining weight within a recommended (by Institute of Medicine) by the end of the study. Incentives for meeting an exercise goal of 150 minutes of moderate physical activity per week, as recommended by the American College of Obstetricians and Gynecologists. | 0 | None | 0 | 5 | 0 | 5 | View |
| Lottery + Monthly Weight + Exercise | Participants will be eligible for a daily lottery if they have weighed themselves in the previous day on the e-scale. For each day of the study, participants will be informed of the study's randomly-generated winning lottery number and their winnings if any. Participants will receive $14 per month if they have gained within the recommended monthly range for their BMI category. Otherwise, they will be notified that they would have received $14 had they had gained within the recommendation for the month. Participants will be asked to engage in 150 minutes of exercise each week based on the guideline from the ACOG. They will receive $3.50 if they meet their activity goal for the week. Otherwise, they will be notified that they would have received $3.50 had they meet their activity goal. Lottery + Monthly Weight + Exercise: Lottery for daily self-weighing. Incentives for gaining weight within a recommended (by Institute of Medicine) on a monthly basis. Incentives for meeting an exercise goal of 150 minutes of moderate physical activity per week, as recommended by the American College of Obstetricians and Gynecologists. | 0 | None | 1 | 5 | 0 | 5 | View |
| Loss + Monthly Weight | Participants randomized to an arm that contains the self-weighing (certain loss) component will have a balance of $3.50 at the beginning of each week of the the study and each day that they do not weigh, $0.50 will be subtracted from this account. Participants will receive $14 per month if they have gained within the recommended monthly range for their BMI category. Otherwise, participants will be specifically notified that they would have received $14 had they had gained within the recommended range for the month, drawing on research showing that loss aversion can be motivating. Loss + Monthly Weight: Certain loss for not engaging in daily self-weighing. Incentives for gaining weight within a recommended (by Institute of Medicine) on a monthly basis. | 0 | None | 0 | 5 | 0 | 5 | View |
| Loss + Overall Weight + Exercise | Participants randomized to an arm that contains the self-weighing (certain loss) component will have a balance of $3.50 at the beginning of each week of the study and each day that they do not weigh, $0.50 will be subtracted from this account. Participants will be given the IOM GWG recommendation based on their body mass index at randomization, adjusted for data collection at 36 weeks. If they achieve the goal at 36 weeks, they will receive $112 after the data collection visit. Participants will be asked to engage in 150 minutes of exercise each week based on the guideline from the ACOG. They will receive $3.50 if they meet their activity goal for the week. Otherwise, they will be notified that they would have received $3.50 had they meet their activity goal. Loss + Overall Weight + Exercise: Certain loss for not engaging in daily self-weighing. Incentives for gaining weight within a recommended (by Institute of Medicine) by the end of the study. Incentives for meeting an exercise goal of 150 minutes of moderate physical activity per week, as recommended by the American College of Obstetricians and Gynecologists. | 0 | None | 0 | 5 | 0 | 5 | View |
| Loss + Overall Weight | Participants randomized to an arm that contains the self-weighing (certain loss) component will have a balance of $3.50 at the beginning of each week of the the study and each day that they do not weigh, $0.50 will be subtracted from this account. Participants will be given the Institute of Medicine gestational weight gain recommendation based on their body mass index at randomization, adjusted for data collection at 36 weeks. If they achieve the goal at 36 weeks, they will receive $112 after the data collection visit. Loss + Overall Weight: Certain loss for not engaging in daily self-weighing. Incentives for gaining weight within a recommended (by Institute of Medicine) by the end of the study. | 0 | None | 0 | 5 | 0 | 5 | View |
| Loss + Monthly Weight + Exercise | Participants randomized to an arm that contains the self-weighing (certain loss) component will have a balance of $3.50 at the beginning of each week of the study and each day that they do not weigh, $0.50 will be subtracted from this account. Participants will receive $14 per month if they have gained within the recommended monthly range for their BMI category. Otherwise, they will be notified that they would have received $14 had they had gained within the recommendation for the month. Participants will be asked to engage in 150 minutes of exercise each week based on the guideline from the ACOG. They will receive $3.50 if they meet their activity goal for the week. Otherwise, they will be notified that they would have received $3.50 had they meet their activity goal. Loss + Monthly Weight + Exercise: Certain loss for not engaging in daily self-weighing. Incentives for gaining weight within a recommended (by Institute of Medicine) on a monthly basis. Incentives for meeting an exercise goal of 150 minutes of moderate physical activity per week, as recommended by the American College of Obstetricians and Gynecologists. | 0 | None | 0 | 5 | 0 | 5 | View |
| Lottery + Monthly Weight | Participants will be eligible for a daily lottery if they have weighed themselves in the previous day on the e-scale. For each day of the study, participants will be informed of the study's randomly-generated winning lottery number and their winnings ($0, $2, $15 or not eligible for lottery due to lack of weighing). Participants will receive $14 per month if they have gained within the recommended monthly range for their BMI category. Otherwise, participants will be specifically notified that they would have received $14 had they had gained within the recommended range for the month, drawing on research showing that loss aversion can be motivating. Lottery + Monthly Weight: Lottery for daily self-weighing. Incentives for gaining weight within a recommended (by Institute of Medicine) on a monthly basis. | 0 | None | 1 | 4 | 0 | 4 | View |
Other Events(If Any):