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 @ 4:43 PM
Ignite Modification Date: 2025-12-25 @ 2:31 PM
NCT ID: NCT03494166
Description: Averse events/serious adverse events were identified during the implementation of the experimental protocols and were monitored by the Investigators in several ways: 1) Interviewers could identify both serious adverse events and/or adverse events during the completion of telephone interviews or telephone calls to schedule telephone interviews; 2) The interventionists could identify both serious adverse events and/or adverse events during their telephone contacts with the participants.
Frequency Threshold: 0
Time Frame: Each participant was assessed for adverse events at baseline (week 0) and weekly for 13 weeks or up until their attrition date if applicable.
Study: NCT03494166
Study Brief: Post-chemotherapy Symptom Management SMART
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Low Need Benchmark or Follow-up In the low need benchmark or follow-up group, participants received baseline and 13-week assessments (about 30-40 minutes) over the telephone. A brief assessment (about 5 minutes) was done at week 4 over the telephone to assess symptoms. Approximately 35% of all participants were in this group. 0 None 0 71 0 71 View
High Need A-SMH or TIP-C Participants were mailed the printed Symptom Management and Survivorship Handbook (SMSH). The Group A participant was called every week for 4 weeks to ask about symptoms and suggest strategies from the SMSH to relieve symptoms. Calls were approximately 10 minutes. After 4 weeks, participants were re-randomized to continue in SMSH for 8 more weeks or to add Telephone Interpersonal Counseling (TIP-C) Intervention for the subsequent 8 weeks. If the TIP-C was added, the counselor called the participant once per week for about 35-40 minutes to assess and discuss strategies for managing symptoms, provide survivorship education, and discuss interpersonal relationships, communication, and social support. At week 13, the participant was called to complete the second assessment. Telephone Interpersonal Counseling (TIP-C): See arm/group descriptions 1 None 0 282 0 282 View
High Need B-TIP-C+SMH Participant was called every week for the first 8 weeks using a combination of TIP-C and SMSH. The counselor assessed and discussed interpersonal relationships, communication, social support, managing symptoms, and survivorship. At the end of 8 weeks, the final 4 calls were focused on the SMSH protocol. At week 13, the second assessment was conducted. Telephone Interpersonal Counseling (TIP-C): See arm/group descriptions 3 None 0 93 0 93 View
Serious Events(If Any):
Other Events(If Any):