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 @ 2:00 AM
Ignite Modification Date: 2025-12-26 @ 12:23 AM
NCT ID: NCT04274894
Description: None
Frequency Threshold: 0
Time Frame: All-cause mortality is reported from enrollment to 30 days after the last dose of study drug; the median time on follow-up was 176 days. TEAEs and SAEs were collected from the first dose of study drug until 30 days after the last dose of study drug; mean duration on study drug was 114 days.
Study: NCT04274894
Study Brief: A Study of the Effect of Topical Testosterone Replacement Therapy on Blood Pressure in Adult Male Participants With Hypogonadism
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
AndroGel 1.62% AndroGel 1.62% was applied topically once daily in the morning beginning at the Day 1 Visit after confirmed valid ambulatory blood pressure monitoring (ABPM) assessment and was applied at approximately the same time each day after that during the study for approximately 16 weeks. The starting dose of AndroGel 1.62% was 40.5 mg of T (2 pump actuations, applied to the upper arms and shoulders) and was titrated up or down by 20.25 mg or remained the same as assessed by morning serum T levels at Weeks 2 and 4. 0 None 8 246 43 246 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
ACUTE MYOCARDIAL INFARCTION SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.1 View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
COVID-19 PNEUMONIA SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
ISCHAEMIC STROKE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
COUGH SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.1 View
HYPOTENSION SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 24.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
VERTIGO SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 24.1 View
DIARRHOEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
DIVERTICULUM GASTRIC SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
NAUSEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
VOMITING SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
NON-CARDIAC CHEST PAIN SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
OEDEMA PERIPHERAL SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
PYREXIA SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
ABSCESS LIMB SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
BRONCHITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
COVID-19 PNEUMONIA SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
CELLULITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
GASTROENTERITIS VIRAL SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
INFLUENZA SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
OTITIS EXTERNA CANDIDA SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
OTITIS MEDIA SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
CONTUSION SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.1 View
LIP INJURY SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.1 View
SKIN LACERATION SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.1 View
BLOOD PRESSURE INCREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
BLOOD PRESSURE SYSTOLIC INCREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
HEART RATE INCREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
LIVER FUNCTION TEST INCREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
PROSTATIC SPECIFIC ANTIGEN INCREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
GOUT SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.1 View
HYPERCHOLESTEROLAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.1 View
HYPERGLYCAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.1 View
TYPE 2 DIABETES MELLITUS SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.1 View
ARTHRALGIA SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.1 View
SYNOVIAL CYST SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.1 View
BASAL CELL CARCINOMA SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.1 View
DIZZINESS SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
HEADACHE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
PARAESTHESIA SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
PAROSMIA SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
DEPRESSION SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24.1 View
INSOMNIA SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24.1 View
IRRITABILITY SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24.1 View
DYSURIA SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24.1 View
NIPPLE PAIN SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 24.1 View
PRIAPISM SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 24.1 View
COUGH SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.1 View
ALOPECIA SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.1 View
DERMATITIS SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.1 View
PRURITUS SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.1 View
SKIN DISCOLOURATION SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.1 View
SKIN EXFOLIATION SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.1 View
HYPERTENSION SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 24.1 View