Adverse Events Module

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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 @ 4:12 PM
Ignite Modification Date: 2025-12-25 @ 2:12 PM
NCT ID: NCT03000166
Description: Adverse events were defined as serious or not serious.
Frequency Threshold: 0
Time Frame: Data related to adverse events were collected over the duration of the time each participant was on study. Participants were considered on study from the date of enrollment through the completion of completion of post-study data collection. The average time for each participant to be on study was 15 weeks, but ranged from 10-23 weeks due to variations in the timing of their chemotherapy as well as completion of post-study measures.
Study: NCT03000166
Study Brief: Step-Up Intervention for Self-Management of Fatigue in Young Adults Receiving Chemotherapy
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Step-up Intervention Group Participants assigned to the Step-up intervention group will receive a 12-week physical activity intervention which includes components of education, negotiated collaboration to set individual physical activity goals during chemotherapy cycles, and tools for self-monitoring of physical activity. Step-Up Intervention: Intervention group participants will meet with a study facilitator during 5 regularly scheduled visits for chemotherapy. The facilitator will provide education about the benefits of physical activity and strategies to overcome barriers to physical activity, help the participants to set physical activity goals based on ability and preferences, and educate the participant on using a physical activity tracker. 0 None 0 25 0 25 View
Attention Control Group Participants assigned to the attention control group will receive usual guidance about maintaining physical activity during chemotherapy from their oncology providers. 0 None 0 22 0 22 View
Serious Events(If Any):
Other Events(If Any):