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 @ 12:05 PM
Ignite Modification Date:
2025-12-25 @ 11:58 AM
NCT ID:
NCT02261961
Description:
None
Frequency Threshold:
5
Time Frame:
Adverse event data was collected from participants at every interaction (in-person, phone contact, or monitoring of electronic health record prior to in-person appointment) from the point of informed consent until 30 days after participant completion of study, which averaged 62 weeks total.
Study:
NCT02261961
Study Brief:
Immune Function and Muscle Adaptations to Resistance Exercise in Older Adults
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Nutritional Supplement | Subjects in the supplement group will consume orange-flavored Muscle Armor according to the manufacturer's directions beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation. TDAP: Both arms will receive the tetanus, diptheria, and pertussis vaccination after two weeks of treatment with supplement or placebo Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks. Post-training Follow-up: Both arms will continue to receive treatment with supplement or placebo for approximately 26 weeks after completion of the exercise training. | 0 | None | 4 | 22 | 11 | 22 | View |
| Placebo | Subjects in the placebo group will consume orange-flavored Kool-Aid (Kraft Foods) according to the manufacturer's directions beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation. TDAP: Both arms will receive the tetanus, diptheria, and pertussis vaccination after two weeks of treatment with supplement or placebo Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks. Post-training Follow-up: Both arms will continue to receive treatment with supplement or placebo for approx 26 wks after completion of the ex training. | 0 | None | 7 | 22 | 16 | 22 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| SAE | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| gallstones | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | None | View |
| lost name and address | SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Cardiovascular Event | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| colon polyps | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| knee surgery | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| unknown surgery | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| biopsy pain or bruise | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| bodily wound | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| cold, flu, or infection | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| gastrointestinal distress | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| skin irritation, rash, or numbness | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| musculoskeletal soreness, strain, or pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |