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 @ 7:57 PM
Ignite Modification Date: 2025-12-25 @ 5:32 PM
NCT ID: NCT03823404
Description: None
Frequency Threshold: 5
Time Frame: Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
Study: NCT03823404
Study Brief: GAIN Trial: Phase 2/3 Study of COR388 in Subjects With Alzheimer's Disease
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
COR388 40 mg BID (Twice Daily) COR388 capsule: BID 1 None 20 212 150 212 View
Placebo BID (Twice Daily) Placebo capsule: BID 0 None 19 217 88 217 View
COR388 80 mg BID (Twice Daily) COR388 capsule: BID 5 None 25 214 139 214 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.0 View
clostridium difficile colitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
dementia Alzheimer's type SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.0 View
cardiac arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.0 View
sinus node dysfunction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.0 View
vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 24.0 View
colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
gastric perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
gastric ulcer haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
small intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
general physical health deterioration SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
cholecystitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 24.0 View
cholecystitis acute SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 24.0 View
cholecystitis acute SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 24.0 View
abdominal abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
appendicitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
COVID-19 pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
diverticulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
ophthalmic herpes zoster SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
septic shock SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
urosepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
clavicle fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
femoral neck fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
femur fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
hip fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
multiple fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
subdural haematoma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
liver function test abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.0 View
electrolyte imbalance SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.0 View
foot deformity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
osteoarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
bladder cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.0 View
cholangiocarcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.0 View
gastrointestinal cancer metastatic SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.0 View
lung cancer metastatic SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.0 View
oesophageal carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.0 View
prostate cancer stage II SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.0 View
cerebral haemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
ischaemic stroke SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
metabolic encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
transient ischaemic attack SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
aggression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24.0 View
agitation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24.0 View
anxiety disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24.0 View
confusional state SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24.0 View
hallucination SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24.0 View
intentional self-injury SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24.0 View
mental status changes SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24.0 View
psychotic behaviour SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24.0 View
renal mass SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24.0 View
urinary retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24.0 View
benign prostatic hyperplasia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 24.0 View
hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 24.0 View
acute respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
amylase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.0 View
ALT increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
AST increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
lipase increased SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
agitation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24.0 View
fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View