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 @ 2:40 AM
Ignite Modification Date: 2025-12-26 @ 1:18 AM
NCT ID: NCT04191733
Description: The safety population set consisted of all enrolled participants who signed the informed consent document and attempted treatment according to the actual treatment received.
Frequency Threshold: 0
Time Frame: From Baseline (Day 0) up to end of study (up to 31 months)
Study: NCT04191733
Study Brief: Anterior Advantage With KINCISE
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Arm 1: KINCISE Participants indicated to receive primary uncemented total hip arthroplasty (THA) underwent Anterior Advantage approach in THA using KINCISE surgical automated system. 0 None 0 117 21 117 View
Arm 2: MALLET Participants indicated to receive primary uncemented THA underwent Anterior Advantage approach in THA using MALLET (a surgical hammer like instrument, without KINCISE surgical automated system). 1 None 3 111 8 111 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Wound infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 22.0 View
Lung cancer metastatic SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA Version 22.0 View
Cerebrovascular accident SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 22.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA Version 22.0 View
Groin pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA Version 22.0 View
Joint stiffness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA Version 22.0 View
Joint swelling SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA Version 22.0 View
Muscle spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA Version 22.0 View
Muscular weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA Version 22.0 View
Musculoskeletal discomfort SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA Version 22.0 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA Version 22.0 View
Tendonitis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA Version 22.0 View
Extraskeletal ossification SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA Version 22.0 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA Version 22.0 View
Femur fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA Version 22.0 View
Muscle strain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA Version 22.0 View
Wound dehiscence SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA Version 22.0 View
Cerebrospinal fluid leakage SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 22.0 View
Meralgia paraesthetica SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 22.0 View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 22.0 View
Swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 22.0 View
Peripheral swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 22.0 View