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 @ 9:15 PM
Ignite Modification Date: 2025-12-25 @ 7:04 PM
NCT ID: NCT05118204
Description: A structured form was used to collect adverse event information at week 1, 4, 12, 24 study visits. A researcher asked participants whether they had experienced: abscess, asthenia, chills, fever, flu syndrome, headache, infection, injury/accident, pain, abdominal pain, back pain, withdrawal syndrome, constipation, diarrhea, dyspepsia, nausea, vomiting, anxiety, depression, dizziness, insomnia, nervousness, somnolence, cough, pharyngitis, rhinitis, sweating, lacrimation, vasodilation, fatigue.
Frequency Threshold: 0
Time Frame: Up to approximately 6 months (24 weeks)
Study: NCT05118204
Study Brief: Randomized Trial of Buprenorphine Microdose Inductions During Hospitalization
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
BUP Microdose Induction Participants in this arm will receive a novel BUP microdose induction protocol. BUP microdose induction: Participants will be started on a 5-day BUP microdose induction protocol (without stopping full agonists). Day 1: participants will receive buprenorphine (Belbuca) 225 mcg mg every 12 hours Day 2: participants will receive buprenorphine (Belbuca) 450 mcg every 8 hours Day 3: participants will receive buprenorphine-naloxone 2-0.5 mg every 8 hours Day 4: participants will receive buprenorphine-naloxone 4-1 mg every 8 hours Day 5: participants will receive buprenorphine-naloxone 8-2 mg every 12 hours Linkage to outpatient BUP treatment: Participants will be given an expedited appointment (within 2 weeks) to continue BUP treatment at a Montefiore community health center 0 None 8 12 12 12 View
Treatment As Usual (TAU) Participants in this arm will receive standard BUP induction protocol. TAU: 2-day standard BUP induction protocol (with stopping full agonists) Day 1: hold all opioids Day 2: buprenorphine-naloxone 2-0.5 mg every 6 hours Day 3: buprenorphine-naloxone 8-2 mg every 12 hours Linkage to outpatient BUP treatment: Participants will be given an expedited appointment (within 2 weeks) to continue BUP treatment at a Montefiore community health center 1 None 6 11 11 11 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hospitalization SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Overdose SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Suicidal ideation SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abscess SYSTEMATIC_ASSESSMENT Infections and infestations None View
Asthenia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Chills SYSTEMATIC_ASSESSMENT General disorders None View
Fever SYSTEMATIC_ASSESSMENT General disorders None View
Flu Syndrome SYSTEMATIC_ASSESSMENT Infections and infestations None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Accidental Injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Pain - general SYSTEMATIC_ASSESSMENT General disorders None View
Pain - abdominal SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pain - back SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Withdrawal syndrome SYSTEMATIC_ASSESSMENT General disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Acid Reflux SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Dizziness SYSTEMATIC_ASSESSMENT General disorders None View
Insomnia SYSTEMATIC_ASSESSMENT General disorders None View
Nervousness SYSTEMATIC_ASSESSMENT General disorders None View
Somnolence SYSTEMATIC_ASSESSMENT General disorders None View
Coughing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Rhinitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Sweating SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Lacrimation SYSTEMATIC_ASSESSMENT Eye disorders None View
Vasodilation SYSTEMATIC_ASSESSMENT Vascular disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View