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 @ 7:47 PM
Ignite Modification Date: 2025-12-25 @ 5:24 PM
NCT ID: NCT02668003
Description: None
Frequency Threshold: 0
Time Frame: 2 years
Study: NCT02668003
Study Brief: The Maintaining Musculoskeletal Health Study
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Cognitive Behavioural Therapy Brief Cognitive Behavioural Therapy delivered by telephone Cognitive Behavioural Therapy: The CBT intervention, delivered by telephone, will consist of an initial assessment, 6 weekly sessions, and then booster sessions at 3 and 6 months. The intervention will be delivered by trained and accredited therapists. Participants will be supported by a self-management CBT manual. There will be a patient-centred assessment by the therapist for problem identification, risk assessment and development of a shared formulation of the current health problem. The sessions will involve education about musculoskeletal pain, somatic symptoms and specific CBT techniques such as pacing of activity, behavioural activation, diary keeping, identifying and challenging negative and unhelpful thinking patterns and the development of a longer term management plan. 3 None 0 501 3 501 View
Treatment as Usual The group allocated to usual care will receive no additional intervention - this will reflect the fact there is no specific intervention provided to patients currently for the prevention of CWP. Participants in this group will receive usual care and there will be no restriction on what this can involve. CBT is not readily available within the NHS and is generally restricted to persons who have developed specific conditions rather than persons at risk of those conditions. 9 None 0 501 0 501 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Participant expressing thoughts that might be considered suicidal to therapist or on questionnaire NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Cancer NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View