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 @ 3:39 PM
Ignite Modification Date:
2025-12-25 @ 1:50 PM
NCT ID:
NCT03486392
Description:
Safety analysis set included all randomized participants who had received at least one dose of study drug.
Frequency Threshold:
5
Time Frame:
Up to 30 Weeks
Study:
NCT03486392
Study Brief:
A Study to Evaluate the Safety and Efficacy of JNJ-64565111 in Non-diabetic Severely Obese Participants
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Double Blind: Placebo | Participants self-administered the matching placebo of JNJ-64565111 subcutaneously (SC) once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug. | 0 | None | 4 | 60 | 33 | 60 | View |
| Double Blind: JNJ-64565111 7.4 mg | Participants self-administered 7.4 mg JNJ-64565111 SC once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug. | 0 | None | 2 | 118 | 106 | 118 | View |
| Double Blind: JNJ-64565111 10.0 mg | Participants self-administered 10.0 mg JNJ-64565111 SC once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug. | 0 | None | 4 | 118 | 104 | 118 | View |
| Open Label: Liraglutide 3.0 mg | Participant self-administered liraglutide at a starting dose of 0.6 mg SC once-daily on Day 1, followed by dose titration up to 1.2, 1.8, 2.4, and 3.0 mg in Weeks 2, 3, 4, and 5 (with 0.6 mg weekly increment up to the full dosage of 3.0 mg by Week 5). Participants then continued the 3.0 mg once-daily dosage until Week 26 or until early drug discontinuation. | 1 | None | 4 | 119 | 81 | 119 | View |
| Double Blind: JNJ-64565111 5.0 mg | Participants self-administered 5.0 milligram (mg) JNJ-64565111 SC once weekly throughout the 26-week treatment phase or until early discontinuation of study drug. | 0 | None | 3 | 59 | 43 | 59 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Myocardial Infarction | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 21.1 | View |
| Stress Cardiomyopathy | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 21.1 | View |
| Ileus | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 21.1 | View |
| Pancreatitis Acute | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 21.1 | View |
| Umbilical Hernia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 21.1 | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 21.1 | View |
| Biliary Colic | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA Version 21.1 | View |
| Cholelithiasis | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA Version 21.1 | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 21.1 | View |
| Dehydration | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 21.1 | View |
| Hyponatraemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 21.1 | View |
| Obesity | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 21.1 | View |
| Osteoarthritis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 21.1 | View |
| Abortion Spontaneous | NON_SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA Version 21.1 | View |
| Major Depression | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 21.1 | View |
| Menorrhagia | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA Version 21.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Abdominal Discomfort | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 21.1 | View |
| Abdominal Distension | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 21.1 | View |
| Abdominal Pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 21.1 | View |
| Abdominal Pain Upper | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 21.1 | View |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 21.1 | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 21.1 | View |
| Dry Mouth | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 21.1 | View |
| Dyspepsia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 21.1 | View |
| Eructation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 21.1 | View |
| Gastrooesophageal Reflux Disease | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 21.1 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 21.1 | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 21.1 | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 21.1 | View |
| Injection Site Bruising | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 21.1 | View |
| Gastroenteritis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 21.1 | View |
| Nasopharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 21.1 | View |
| Pharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 21.1 | View |
| Upper Respiratory Tract Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 21.1 | View |
| Urinary Tract Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 21.1 | View |
| Hepatic Enzyme Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 21.1 | View |
| Decreased Appetite | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 21.1 | View |
| Dysgeusia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 21.1 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 21.1 | View |