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 @ 2:20 AM
Ignite Modification Date: 2025-12-26 @ 12:51 AM
NCT ID: NCT02868034
Description: None
Frequency Threshold: 0
Time Frame: Adverse events were collected over the 12 week period from baseline to final assessment including both Phase I and Phase II (post-randomization). Events reported by Phase II treatment group may have occurred at any point over the 12-week study period. Among the 32 participants who withdrew before randomization, 4 participants reported 5 adverse events. All events were an increase in symptoms of back pain, spasm or stiffness.
Study: NCT02868034
Study Brief: Optimization of Spinal Manipulative Therapy Protocols
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
SMT With Activating Exercise Component Participants received SMT and activating exercises in weeks 2-4. 0 None 0 30 12 30 View
SMT With Mobilizing Exercise Component Participants received SMT and mobilizing exercises in weeks 2-4. 0 None 0 29 7 29 View
No Further Treatment Participants received no additional treatment in weeks 2-4 0 None 0 30 3 30 View
Extended SMT Participants received 2 sessions per week of additional SMT in weeks 2-4 0 None 0 29 8 29 View
Activating Exercise Component Only Participants received activating exercises only in weeks 2-4. 0 None 0 30 9 30 View
Mobilizing Exercise Component Only Participants received mobilizing exercises only in weeks 2-4. 0 None 0 31 10 31 View
Activating Exercise and Mobilizing Exercise Components Participants received activating exercises and mobilizing exercises in weeks 2-4. 0 None 0 30 5 30 View
SMT With Activating Exercise and Mobilizing Exercise Components Participants received SMT with both activating exercises and mobilizing exercises in weeks 2-4. 0 None 0 32 13 32 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Accident NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Increased low back symptoms from treatment NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Surgical procedures NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Reinjured Low Back NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View