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
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| General Practice Control | For each MPN case one GP control will be randomly selected and frequency matched to the distribution of cases by 5-year age band, geographic location (Belfast and Southampton) and gender. The following patient groups will be excluded. Those: * younger than 18 years old. * where the clinician/GP does not provide consent. * incapable of giving informed consent. * physically or cognitively incapable of completing the questionnaire. * too ill to participate. The WHO performance evaluation scale will be used at the stage of participant identification. Only those scoring 0-3 will be considered eligible for inclusion in the study. Those scoring 3 are described as "Symptomatic \>50% in bed but not bedbound". | None | None | 0 | 0 | 0 | 0 | View |
| Non-blood Relative or Family Control | Recruitment of 100 non-blood relative/friend controls will be undertaken by asking cases to pass on a flyer to up to 2 or 3 non-blood relatives/friends aged 18 years or older. Methodological pens: Randomisation of branded pen, non-branded pen and no pen Methodological compensation: Randomisation of a £10 monetary reimbursement for expenses on completion of the study | None | None | 0 | 0 | 0 | 0 | View |
| Myeloproliferative Neoplasm Case | Patients with Polycythemia vera (PV), essential thrombocythemia (ET) and primary myelofibrosis (PMF) will be recruited based on the WHO diagnostic criteria. Exclusion Criteria * younger than 18 years old. * where the clinician/General Practitioner (GP) does not provide consent. * incapable of giving informed consent. * physically or cognitively incapable of completing the questionnaire. * too ill to participate. Methodological pens: Randomisation of branded pen, non-branded pen and no pen Methodological compensation: Randomisation of a £10 monetary reimbursement for expenses on completion of the study Methodological trolley tokens: Trolley tokens to be randomly assigned to half of cases and General Practice controls. | None | None | 0 | 0 | 0 | 0 | View |