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 @ 3:45 PM
Ignite Modification Date: 2025-12-25 @ 1:53 PM
NCT ID: NCT03815292
Description: None
Frequency Threshold: 0
Time Frame: During the study - 28 weeks.
Study: NCT03815292
Study Brief: Clinical Trial of Efficacy and Safety of MMH-MAP in the Treatment of Mild Cognitive Impairment in Early Recovery Stage After Ischemic Stroke
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
MMH-MAP Tablet for oral use. Dose per administration: 2 tablets. 2 tablets twice daily (4 tablets/day). The tablets should be held in mouth without chewing until complete dissolution. The duration of treatment will be 24 weeks. MMH-MAP: Oral administration 0 None 4 135 37 135 View
Placebo Placebo for 24 weeks, according to the MMH-MAP dosing regimen. Placebo: Oral administration 1 None 3 140 39 140 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Limb vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Nosocomial pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Deep vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Cerebral infarction SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Vertebrobasilar stroke SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Acute coronary syndrome SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Recurrent stroke SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Acute coronary syndrome SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Heartbeat SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Hypertensive crisis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Labile blood pressure SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hypercholesterolemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Deep vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Oral herpes SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Tonsillitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Dysphonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Itchy rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Limb pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Muscle spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Periarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Cognitive impairment SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Memory disorder SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Paresthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Lumbar radiculopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Cerebral infarction SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA View
Gallbladder polyp SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA View
Liver steatosis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA View
Proteinuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Metrorrhagia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Protein in urine SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Oxalates in urine SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Abnormal urine test results SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Increased blood pressure SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Increased liver enzyme levels SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Blood pressure decrease SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Weight gain SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Hunger SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Affective lability SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Increased libido SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Low mood SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Sense of anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Hematoma due to trauma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Ligament sprain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Limb vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Pain in the upper abdomen SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Acute abdomen SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Abdominal discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View