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 @ 4:55 PM
Ignite Modification Date: 2025-12-25 @ 2:38 PM
NCT ID: NCT02465450
Description: None
Frequency Threshold: 0
Time Frame: For treatment groups lenabasum 1 mg QD, lenabasum 5 mg QD and placebo QD, adverse events were collected from Days 1 - 28. For treatment groups lenabasum 20 mg QD, lenabasum 20 mg BID and placebo BID, adverse events were collected from Days 29 - 84.
Study: NCT02465450
Study Brief: Safety, Tolerability, Pharmacokinetics, and Efficacy of JBT-101 (Lenabasum) in Cystic Fibrosis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
JBT101 1 mg QD JBT-101: 1 mg once a day on Days 1-28 0 None 1 26 13 26 View
JBT-101 5 mg QD JBT-101: 5 mg once a day on Days 1-28. 0 None 0 26 13 24 View
Placebo QD Placebo: Subjects received placebo on Days 1 - 28. 0 None 2 37 15 35 View
JBT-101 20 mg QD JBT-101: 20 mg once a day on Days 29 - 84. JBT-101: Subjects in this analysis group could have received 1 mg, 5 mg, or placebo during Days 1 - 28. 0 None 3 30 21 30 View
JBT-101 20 mg BID JBT-101: 20 mg twice a day on Days 29 - 84. JBT-101: Subjects in this analysis group could have received 1 mg, 5 mg, or placebo during Days 1 - 28. 0 None 2 28 19 28 View
Placebo BID Placebo administered twice daily. Subjects in this analysis group received placebo on Days 1 - 28. 0 None 1 23 14 23 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Infective pulmonary exacerbation of cystic fibrosis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Thrombosis in device SYSTEMATIC_ASSESSMENT General disorders None View
hand fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Sputum increased SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dry Mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Malaise SYSTEMATIC_ASSESSMENT General disorders None View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders None View
Respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Lethargy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Haemoptysia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastroeosophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Cholelithiasis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Hand fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Wrist fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations None View
Glucose tolerance impaired SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Dysphonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Sweat discoloration SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Food allergy SYSTEMATIC_ASSESSMENT Immune system disorders None View
Hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders None View
Seasonal allergy SYSTEMATIC_ASSESSMENT Immune system disorders None View
Muscle strain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Migraine SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Nervous system disorder SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Initial insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Gastrostomy SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Apathy SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Depressed mood SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Disorientation SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Irritability SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Sleep disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Paranasal sinus hypersecretion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Rales SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Sinus congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Sneezing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Sputum discoloured SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Bradykinesia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hypersomnia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Memory impairment SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Sinus headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Stupor SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Feeling abnormal SYSTEMATIC_ASSESSMENT General disorders None View
Thirst SYSTEMATIC_ASSESSMENT General disorders None View
Thrombosis SYSTEMATIC_ASSESSMENT General disorders None View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Fungal infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Gastrointestinal infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Lower respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Oral candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Viral infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Viral upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Bone contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Blood alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations None View
Blood glucose increased SYSTEMATIC_ASSESSMENT Investigations None View
Chest discomfort SYSTEMATIC_ASSESSMENT General disorders None View
Asthenia SYSTEMATIC_ASSESSMENT General disorders None View
Dyspnoea exertional SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations None View
Osteopenia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Infective pulmonary exacerbation of cystic fibrosis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Cognitive disorder SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Respiratory tract congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View