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 @ 12:09 AM
Ignite Modification Date: 2025-12-25 @ 10:08 PM
NCT ID: NCT02061358
Description: Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
Frequency Threshold: 5
Time Frame: From time of the first dose administration through 9 ± 1 days after dosing
Study: NCT02061358
Study Brief: Study to Determine the Safety, Tolerability and Pharmacokinetics of UV-4B Solution Administered Orally in Healthy Subjects
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
3 mg UV-4B UV-4B 3 mg oral, single dose None None 0 6 5 6 View
10 mg UV-4B UV-4B 10 mg oral, single dose None None 0 6 6 6 View
30 mg UV-4B UV-4B 30 mg oral, single dose None None 0 6 5 6 View
90 mg UV-4B UV-4B 90 mg oral, single dose None None 0 6 6 6 View
180 mg UV-4B UV-4B 180 mg oral, single dose None None 0 6 6 6 View
360 mg UV-4B UV-4B 360 mg oral, single dose None None 0 6 5 6 View
720 mg UV-4B UV-4B 720 mg oral, single dose None None 0 6 6 6 View
1000 mg UV-4B UV-4B 1000 mg oral, single dose None None 0 6 5 6 View
Placebo Placebo oral, single dose None None 0 16 12 16 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Local swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA 16.1 View
Lymphopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 16.1 View
Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 16.1 View
Supraventricular tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 16.1 View
Ear pain SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 16.1 View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 16.1 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16.1 View
Vessel puncture site bruise SYSTEMATIC_ASSESSMENT General disorders MedDRA 16.1 View
Arthropod sting SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 16.1 View
Chemical eye injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 16.1 View
APTT prolonged SYSTEMATIC_ASSESSMENT Investigations MedDRA 16.1 View
ALT increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 16.1 View
AST increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 16.1 View
Blood calcium decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 16.1 View
Blood creatine phosphokinase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 16.1 View
Blood pressure decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 16.1 View
Blood urea increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 16.1 View
Haemoglobin decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 16.1 View
Heart rate decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 16.1 View
Lipase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 16.1 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 16.1 View
Protein total decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 16.1 View
Prothrombin time prolonged SYSTEMATIC_ASSESSMENT Investigations MedDRA 16.1 View
Respiratory rate increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 16.1 View
WBC decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 16.1 View
WBC increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 16.1 View
Hypocalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 16.1 View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 16.1 View
Hypokaelemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 16.1 View
Hypomagnaesemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 16.1 View
Hypophosphaetemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 16.1 View
Hypoproteinaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 16.1 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 16.1 View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 16.1 View
Balance disorder SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 16.1 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 16.1 View
Dizziness postural SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 16.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 16.1 View
Presyncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 16.1 View
Tension headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 16.1 View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 16.1 View
Proteinuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 16.1 View
Tachypnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 16.1 View
Hot flush SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 16.1 View
Ventricular tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 16.1 View
Vessel puncture site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 16.1 View
Eosinophilia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 16.1 View