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: 2025-12-25 @ 12:02 AM
Ignite Modification Date: 2025-12-25 @ 10:00 PM
NCT ID: NCT03683758
Description: Adverse event collection was performed for the intervention group via Co-Investigator's (MW) presence at all performance testing sessions and all practices and games over the eight week intervention period. Adverse events collection for the control group was performed by monitoring participant attendance on a weekly basis. If three or more warm-ups were missed, Co-Investigator (MW) would follow up with the control group regarding the reason a player may not be in attendance.
Frequency Threshold: 5
Time Frame: Adverse event data was collected from the pre-testing phase, through the 8 week intervention, up until the end of the post-testing phase for a total of 9 weeks (i.e. up to 3 days before and 3 days after the intervention period).
Study: NCT03683758
Study Brief: Effects of the FIFA11+ Warm-up Program on Speed, Agility, and Vertical Jump Performance in Adult Female Amateur Soccer Players
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
FIFA11+ / Intervention Group This group will complete the FIFA11+ warm-up three times per week for eight weeks. FIFA11+: The FIFA11+ has three parts and consist of 15 exercises. Part 1 consists of active stretching, running and controlled partner contact drills. Part 2 has three difficulty levels for 6 sets of exercises. The exercises consist of core and leg strength exercises, balance and plyometric drills. The exercises in this section are perhaps the most unique element to the FIFA11+ warm-up, as strength-specific exercises like the Nordic Hamstring Curl are not generally included in soccer warm-ups. Part 3 consists of higher intensity running drills, compared to those covered in Part 1. Unlike many soccer warm-ups, the FIFA11+ has been studied rigorously in terms of its injury reduction potential. 0 None 1 11 0 11 View
Typical Warm-up / Control Group This group will complete their usual warm-up three times per week for eight weeks 'Usual' Soccer Warm-up: This warm-up is time-matched to the FIFA11+ (approximately 20 minutes) and is considered 'usual' for the team. This warm-up consists of stretching, running and agility drills, in addition to "small sided" games with a soccer ball, which is not included in the FIFA11+. The 'usual' warm-up is decided by the coach with no standardization nor any formal research on its effectiveness in injury reduction or performance enhancement. 0 None 0 10 0 10 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
ACL Injury SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Other Events(If Any):