Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 2:59 PM
Ignite Modification Date: 2025-12-25 @ 1:23 PM
NCT ID: NCT03299959
Description: None
Frequency Threshold: 0
Time Frame: Adverse events were collected from surgery through the end of study, approximately 60 months
Study: NCT03299959
Study Brief: Agili-C™ Implant Performance Evaluation
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Agili-C™ Participants randomized to the investigational arm that received the Agili-C™ implant following arthroscopy via a mini-arthrotomy or arthrotomy approach 1 None 49 167 120 167 View
Surgical Standard of Care (SSOC) Participants randomized to the control arm received surgical standard of care (SSOC) that included two procedures, microfracture (MFX) and debridement (Deb). 0 None 25 84 68 84 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
cholecystitis chronic SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
cholelithiasis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
allergy to metals SYSTEMATIC_ASSESSMENT Immune system disorders None View
covid-19 SYSTEMATIC_ASSESSMENT Infections and infestations None View
covid-19 pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
ankle fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
cartilage injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
hand fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
limb injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
meniscus injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
nerve injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
post procedural haematoma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
road traffic accident SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
spinal compression fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
tendon rupture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
traumatic arthropathy SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
ankylosing spondylitis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
cervical spinal stenosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
intervertebral disc degeneration SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
osteoarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
osteochondrosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
patellofemoral pain syndrome SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
rotator cuff syndrome SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
spinal synovial cyst SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
breast cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
choroid neoplasm SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
sciatica SYSTEMATIC_ASSESSMENT Nervous system disorders None View
foetal hypokinesia SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
device breakage SYSTEMATIC_ASSESSMENT Product Issues None View
nephrolithiasis SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
menometrorrhagia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
vaginal haemorrhage SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
acute respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
ligament operation SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
thrombophlebitis SYSTEMATIC_ASSESSMENT Vascular disorders None View
Decreased range of motion compared to baseline SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Deep Vein Thrombosis (DVT) and related complications SYSTEMATIC_ASSESSMENT Vascular disorders None View
Increased transient or chronic pain in the operated joint, compared to baseline SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Infection & related symptoms SYSTEMATIC_ASSESSMENT Infections and infestations None View
Progression of osteoarthritis compared to baseline SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
coronary artery disease SYSTEMATIC_ASSESSMENT Cardiac disorders None View
myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders None View
conductive deafness SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
abdominal hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
haemorrhoids SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
inguinal hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
asthenia SYSTEMATIC_ASSESSMENT General disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
atrioventricular block second degree SYSTEMATIC_ASSESSMENT Cardiac disorders None View
arteriovenous malformation SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders None View
middle ear effusion SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
hypothyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders None View
secondary hypogonadism SYSTEMATIC_ASSESSMENT Endocrine disorders None View
blepharospasm SYSTEMATIC_ASSESSMENT Eye disorders None View
cataract SYSTEMATIC_ASSESSMENT Eye disorders None View
eye irritation SYSTEMATIC_ASSESSMENT Eye disorders None View
eye pain SYSTEMATIC_ASSESSMENT Eye disorders None View
eyelid ptosis SYSTEMATIC_ASSESSMENT Eye disorders None View
retinal vein occlusion SYSTEMATIC_ASSESSMENT Eye disorders None View
vision blurred SYSTEMATIC_ASSESSMENT Eye disorders None View
abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
anal fissure SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
anal fistula SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
colitis ulcerative SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
crohn's disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
gastrooesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
inguinal hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
umbilical hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
adverse drug reaction SYSTEMATIC_ASSESSMENT General disorders None View
chest pain SYSTEMATIC_ASSESSMENT General disorders None View
influenza like illness SYSTEMATIC_ASSESSMENT General disorders None View
thermal burn SYSTEMATIC_ASSESSMENT General disorders None View
cholelithiasis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
drug hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders None View
covid-19 SYSTEMATIC_ASSESSMENT Infections and infestations None View
coxsackie viral infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
diverticulitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
ear infection fungal SYSTEMATIC_ASSESSMENT Infections and infestations None View
folliculitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations None View
influenza SYSTEMATIC_ASSESSMENT Infections and infestations None View
molluscum contagiosum SYSTEMATIC_ASSESSMENT Infections and infestations None View
nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
oesophageal candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations None View
onychomycosis SYSTEMATIC_ASSESSMENT Infections and infestations None View
orchitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
otitis media SYSTEMATIC_ASSESSMENT Infections and infestations None View
pharyngitis streptococcal SYSTEMATIC_ASSESSMENT Infections and infestations None View
pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
stitch abscess SYSTEMATIC_ASSESSMENT Infections and infestations None View
suspected covid-19 SYSTEMATIC_ASSESSMENT Infections and infestations None View
tooth abscess SYSTEMATIC_ASSESSMENT Infections and infestations None View
tooth infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
viral infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
animal bite SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
cartilage injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
chemical burns of eye SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
epicondylitis SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
facial bones fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
hand fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
head injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
iatrogenic injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
iliotibial band syndrome SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
inadequate osteointegration SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
joint injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
ligament sprain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
limb fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
limb injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
muscle rupture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
muscle strain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
neck injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
post-traumatic neck syndrome SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
procedural pain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
repetitive strain injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
rib fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
road traffic accident SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
sciatic nerve injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
skin laceration SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
tooth fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
wrist fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
abnormal weight gain SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
gout SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
hyperlipidaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
obesity SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
type 2 diabetes mellitus SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
bursitis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
chondropathy SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
foot deformity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
haemarthrosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
intervertebral disc degeneration SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
intervertebral disc disorder SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
joint effusion SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
joint instability SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
joint swelling SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
muscle tightness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
muscular weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
musculoskeletal chest pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
musculoskeletal stiffness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
osteoarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
osteochondrosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
patellofemoral pain syndrome SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
plantar fasciitis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
spinal osteoarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
spondylolisthesis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
synovial cyst SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
temporomandibular joint syndrome SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
tendon disorder SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
tendonitis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
tenosynovitis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
trigger finger SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
colon adenoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
giant cell tumour of tendon sheath SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
neuroma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
burning sensation SYSTEMATIC_ASSESSMENT Nervous system disorders None View
carpal tunnel syndrome SYSTEMATIC_ASSESSMENT Nervous system disorders None View
cervical radiculopathy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
migraine without aura SYSTEMATIC_ASSESSMENT Nervous system disorders None View
peroneal nerve palsy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
post-traumatic headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
sciatica SYSTEMATIC_ASSESSMENT Nervous system disorders None View
syncope SYSTEMATIC_ASSESSMENT Nervous system disorders None View
thoracic outlet syndrome SYSTEMATIC_ASSESSMENT Nervous system disorders None View
haemorrhage in pregnancy SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
claustrophobia SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
depression SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
dysmenorrhoea SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
menometrorrhagia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
menopausal symptoms SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
pelvic pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
penile discharge SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
prostatism SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
vulvovaginal discomfort SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
acute respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
bronchiectasis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
pulmonary fibrosis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
sleep apnoea syndrome SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
dermal cyst SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
dermatitis contact SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
psoriasis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
skin discolouration SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
urticaria SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
lymphoedema SYSTEMATIC_ASSESSMENT Vascular disorders None View
phlebitis SYSTEMATIC_ASSESSMENT Vascular disorders None View
thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders None View
varicose vein SYSTEMATIC_ASSESSMENT Vascular disorders None View
Decreased range of motion compared to baseline SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Increased swelling (or effusion) in the operated joint, compared to baseline SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Increased transient or chronic pain in the operated joint, compared to baseline SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Joint locking SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Muscle atrophy compared to baseline SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Progression of osteoarthritis compared to baseline SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Vascular damage SYSTEMATIC_ASSESSMENT Vascular disorders None View
Wound complications (wound dehiscence, hematoma, site drainage or superficial infection) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View