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 @ 5:00 PM
Ignite Modification Date: 2025-12-25 @ 2:41 PM
NCT ID: NCT04810650
Description: Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.
Frequency Threshold: 0
Time Frame: Between 30 days and 48 weeks depending on the primary outcome measure.
Study: NCT04810650
Study Brief: SEARCH SAPPHIRE Phase A: A Multisectoral Strategy to Address Persistent Drivers of the HIV Epidemic in East Africa
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
PREP/PEP at Outpatient Clinics Dynamic Prevention Intervention PrEP/PEP at Outpatient Clinics: Intervention delivered at Outpatient Clinics: Counseling and education on and choice between prevention modalities (e.g. PrEP, PEP, condoms), choice of service location, provision of a clinical officer's or nurse's mobile telephone number for immediate PEP starts any day of the week, routine assessment of barriers to initiation or adherence to PrEP/PEP, including the offer of personalized potential solutions such as choice of in-clinic or offsite service delivery, psychologic supports for traumatic experiences, and offer of concurrent, additional health or prevention related services 0 None 7 197 0 0 View
PREP/PEP at Outpatient Clinics Control Standard of Care: Local country standard of care protocols 0 None 0 206 0 0 View
PREP/PEP at Antenatal Clinics Dynamic Prevention Intervention PrEP/PEP at Antenatal Clinics: Intervention delivered at Antenatal Clinics: Counseling and education on choice between prevention modalities (e.g. PrEP, PEP, condoms), choice of service location, provision of a clinical officer's or nurse's mobile telephone number for immediate PEP starts any day of the week, routine assessment of barriers to initiation or adherence to PrEP/PEP, including the offer of personalized potential solutions such as choice of in-clinic or offsite service delivery, psychologic supports for traumatic experiences, and offer of concurrent, additional health or prevention related services 0 None 17 203 0 0 View
PREP/PEP at Antenatal Clinics Control Standard of Care: Local country standard of care protocols 0 None 2 197 0 0 View
PREP/PEP at Community Households Dynamic Prevention Intervention PrEP/PEP at Community Households: Intervention delivered in community by village health team: Counseling and education on and choice between prevention modalities (e.g. PrEP, PEP, condoms), choice of service location, provision of a clinical officer's or nurse's mobile telephone number for immediate PEP starts any day of the week, routine assessment of barriers to initiation or adherence to PrEP/PEP, including the offer of personalized potential solutions such as choice of in-clinic or offsite service delivery, psychologic supports for traumatic experiences, and offer of concurrent, additional health or prevention related services 0 None 4 212 0 0 View
PREP/PEP at Community Households Control Standard of Care: Local country standard of care protocols 0 None 1 217 0 0 View
Mobility Dynamic Treatment Intervention Mobility Dynamic Treatment Intervention: 1) Access to a mobility coordinator who will assist with transfers, rescheduling, and out-of-facility refills; 2) Provision of a "travel pack" with alternative ART packaging options (e.g. ziplock bags, envelopes, pill boxes), a packing list and mobility coordinator phone contact for unplanned travel; 3) Screening at every clinic visit for planned mobility; 4) Mobile number and mobile minutes for unexpected travel; 5) Provision of longer refills (up to 6-months) for planned travel 2 None 3 102 0 0 View
Mobility Control Standard of Care: Local country standard of care protocols 2 None 2 99 0 0 View
Healthy Living for Heavy Alcohol Users Intervention Health Living Intervention for Heavy Alcohol Users: 1) Two in-person alcohol counseling sessions with support from a clinical psychologist; 2) Monthly booster phone calls 0 None 3 197 0 0 View
Heavy Alcohol Users Control Standard of Care: Local country standard of care protocols 1 None 1 203 0 0 View
Hypertension Linkage Intervention Hypertension Linkage: 1) Travel voucher (financial incentive) conditional on linkage to hypertensive care; 2) Phone call reminders for missed visits 0 None 5 100 0 0 View
Hypertension Linkage Control Standard of Care: Local country standard of care protocols 0 None 0 99 0 0 View
Hypertension Community Intervention Hypertension Community: Hypertension care delivered at home with clinician telehealth, facilitated by lay health worker to measure blood pressure and deliver medications 2 None 5 98 0 0 View
Hypertension Community Control Standard of Care: Local country standard of care protocols 1 None 1 102 0 0 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Death of premature infant NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
Emergency caesarian section NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
Incarcerated inguinal hernia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Miscarriage NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
Intimate partner violence NON_SYSTEMATIC_ASSESSMENT Social circumstances None View
Pre-term delivery NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
Injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Diabetes Type 2 NON_SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Uterine fibroids NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Suicidal ideation NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Death due to unknown illness NON_SYSTEMATIC_ASSESSMENT General disorders None View
Hydatidiform mole NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
Lumbar spondylosis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Incomplete abortion NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
Cryptococcal meningitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pulmonary tuberculosis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Homicide NON_SYSTEMATIC_ASSESSMENT Social circumstances None View
Urine retention NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Severe hypertension NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Chronic renal failure NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Right inguinal hernia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Other Events(If Any):