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 @ 4:12 PM
Ignite Modification Date: 2025-12-25 @ 2:11 PM
NCT ID: NCT04418466
Description: None
Frequency Threshold: 0
Time Frame: Group 1 (6-month implant group): Up to 8-months (Includes oral phase, implant phase, and follow up). Group 2 (12-month implant group): Up to 15-months (Includes oral phase, implant phase, and follow up).
Study: NCT04418466
Study Brief: Safety, Tolerability, and Pharmacokinetics of Switching From Oral Risperidone to Risperidone Implant
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
DLP-114 Alpha-4 (6-months) 2 360mg Risperidone Implants Risperidone: Risperidone Implant 0 None 0 14 10 14 View
DLP-114 Alpha-7 (12-months) 2 435mg Risperidone Implants Risperidone: Risperidone Implant 0 None 1 14 12 14 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Oedema Peripheral NON_SYSTEMATIC_ASSESSMENT General disorders MeDRA 23.1 View
Weight Increase NON_SYSTEMATIC_ASSESSMENT Investigations MeDRA 23.1 View
Ascites NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MeDRA 23.1 View
Cardiac Failure Congestive NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MeDRA 23.1 View
Dyspnoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MeDRA 23.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Back Pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MeDRA 23.1 View
Implant site haemorrhage NON_SYSTEMATIC_ASSESSMENT General disorders MeDRA 23.1 View
Injection Site Scar NON_SYSTEMATIC_ASSESSMENT General disorders MeDRA 23.1 View
Implant site pain NON_SYSTEMATIC_ASSESSMENT General disorders MeDRA 23.1 View
Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MeDRA 23.1 View
Arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MeDRA 23.1 View
Somnolence NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MeDRA 23.1 View
Chest Pain NON_SYSTEMATIC_ASSESSMENT General disorders MeDRA 23.1 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MeDRA 23.1 View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MeDRA 23.1 View
Ecchymosis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MeDRA 23.1 View
Weight increased NON_SYSTEMATIC_ASSESSMENT Investigations MeDRA 23.1 View
Implant Site pruritus NON_SYSTEMATIC_ASSESSMENT General disorders MeDRA 23.1 View
Ankle Fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MeDRA 23.1 View
Injection site discomfort NON_SYSTEMATIC_ASSESSMENT General disorders MeDRA 23.1 View
Paresthesia Oral NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MeDRA 23.1 View
Abdominal Discomfort NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MeDRA 23.1 View
Contusion NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MeDRA 23.1 View
Anxiety NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MeDRA 23.1 View
Toothache NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MeDRA 23.1 View
Abdominal Pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MeDRA 23.1 View
Increased appetite NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MeDRA 23.1 View
Ear infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MeDRA 23.1 View
Abnormal behavior NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MeDRA 23.1 View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MeDRA 23.1 View
Tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MeDRA 23.1 View
Pruritus NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MeDRA 23.1 View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MeDRA 23.1 View
Pain in Extremity NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MeDRA 23.1 View
Gastroenteritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MeDRA 23.1 View
Polycythaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MeDRA 23.1 View
Thrombocytopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MeDRA 23.1 View
Arthropod bite NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MeDRA 23.1 View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MeDRA 23.1 View
Urticaria NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MeDRA 23.1 View
Ligament Sprain NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MeDRA 23.1 View
Testicular pain NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MeDRA 23.1 View
Pulmonary embolism NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MeDRA 23.1 View
Hordeolum NON_SYSTEMATIC_ASSESSMENT Infections and infestations MeDRA 23.1 View