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 @ 5:38 PM
Ignite Modification Date: 2025-12-25 @ 3:08 PM
NCT ID: NCT01691768
Description: None
Frequency Threshold: 5
Time Frame: Between 2012 and 2015, up to 28 months.
Study: NCT01691768
Study Brief: Implementation Effectiveness and Safety of Tenofovir Gel Provision Through Family Planning Services
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Intervention 1% tenofovir gel provision through a public sector family planning services with 2-3 monthly provision and monitoring and the use of QI methodology to promote reliable service delivery 1% tenofovir gel: Participants will be randomized to receive 1% tenofovir gel through either: * Public sector family planning services with 2-3 monthly provision and monitoring of 1% tenofovir gel and the use of QI methodology to promote reliable service delivery (intervention arm), or * The CAPRISA research clinics with monthly provision and monitoring of 1% tenofovir gel (control arm). 0 None 13 189 166 189 View
Control monthly 1% tenofovir gel provision and monitoring through CAPRISA research clinics 1% tenofovir gel: Participants will be randomized to receive 1% tenofovir gel through either: * Public sector family planning services with 2-3 monthly provision and monitoring of 1% tenofovir gel and the use of QI methodology to promote reliable service delivery (intervention arm), or * The CAPRISA research clinics with monthly provision and monitoring of 1% tenofovir gel (control arm). 2 None 17 183 181 183 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Investigation NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.0 View
Neutropenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 15.0 View
Cardiac failure congestive NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 15.0 View
Anal sphincter atony NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Crohn's disease NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Gastritis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Cholecystitis NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 15.0 View
Acute sinusitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Oesophageal candidiasis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Post procedural sepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Postoperative wound infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Ankle fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.0 View
Hand fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.0 View
Diabetic ketoacidosis NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 15.0 View
Soft tissue mass NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.0 View
Ameloblastoma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 15.0 View
Cerebrovascular accident NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.0 View
Complication of pregnancy NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA 15.0 View
Gestational hypertension NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA 15.0 View
Pre-eclampsia NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA 15.0 View
Premature labour NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA 15.0 View
Ruptured ectopic pregnancy NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA 15.0 View
Completed suicide NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 15.0 View
Schizoaffective disorder NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 15.0 View
Calculus ureteric NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 15.0 View
Neurogenic bladder NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 15.0 View
Anoplasty NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 15.0 View
Caesarean section NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 15.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Conjunctivitis allergic NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 15.0 View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Abdominal pain lower NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Body tinea NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Gastroenteritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Influenza NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Pelvic inflammatory disease NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Tonsillitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Vaginitis bacterial NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Vulvovaginitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Blood pressure diastolic increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.0 View
Blood pressure increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.0 View
Blood pressure systolic increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.0 View
Abnormal loss of weight NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 15.0 View
Arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.0 View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.0 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.0 View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.0 View
Genital ulceration NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 15.0 View
Vaginal discharge NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 15.0 View
Hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 15.0 View