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 @ 1:33 AM
Ignite Modification Date: 2025-12-25 @ 11:46 PM
NCT ID: NCT03996694
Description: N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
Frequency Threshold: 0
Time Frame: 44 days
Study: NCT03996694
Study Brief: Single Dose Crossover Study to Compare the Respiratory Drive After Administration of Belbuca, Oxycodone and Placebo.
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Treatment B: Belbuca 600 µg and Oral Placebo Subjects treated with Belbuca 600 µg and oral placebo will be randomized to 1 of 6 treatment sequences in a 1:1:1:1:1:1 ratio. Belbuca 600 µg: Belbuca 600 µg buccal film 0 None 0 16 12 16 View
Treatment D: Oxycodone 30 mg and Buccal Placebo Subjects treated with Oxycodone 30 mg and buccal placebo will be randomized to 1 of 6 treatment sequences in a 1:1:1:1:1:1 ratio. Oxycodone 30 mg: Oxycodone 30 mg capsule 0 None 0 15 9 15 View
Treatment E: Oxycodone 60 mg and Buccal Placebo Subjects treated with Oxycodone 60 mg and buccal placebo will be randomized to 1 of 6 treatment sequences in a 1:1:1:1:1:1 ratio. Oxycodone 60 mg: Oxycodone 60 mg capsule 0 None 0 16 14 16 View
Treatment F: Oral Placebo and Buccal Placebo Subjects treated with oral placebo and buccal placebo will be randomized to 1 of 6 treatment sequences in a 1:1:1:1:1:1 ratio. Placebo: placebo buccal film and oral placebo 0 None 0 16 2 16 View
Treatment A: Belbuca 300 µg and Oral Placebo Subjects treated with Belbuca 300 µg and oral placebo will be randomized to 1 of 6 treatment sequences in a 1:1:1:1:1:1 ratio. Belbuca 300 µg: Belbuca 300 µg buccal film 0 None 0 16 8 16 View
Treatment C: Belbuca 900 µg and Oral Placebo Subjects treated with Belbuca 900 µg and oral placebo will be randomized to 1 of 6 treatment sequences in a 1:1:1:1:1:1 ratio. Belbuca 900 µg: Belbuca 900 µg buccal film 0 None 0 17 12 17 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Supraventricular extrasystoles SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Rhythm idioventricular SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Visual Impairment SYSTEMATIC_ASSESSMENT Eye disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dry Mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Peripheral swelling SYSTEMATIC_ASSESSMENT General disorders None View
Feeling of relaxation SYSTEMATIC_ASSESSMENT General disorders None View
Feeling hot SYSTEMATIC_ASSESSMENT General disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sunburn SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Hand fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Lipase increased SYSTEMATIC_ASSESSMENT Investigations None View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Mental Impairment SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Euphoric Mood SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Hyperhidrosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Photosensitivity reaction SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Hot flush SYSTEMATIC_ASSESSMENT Vascular disorders None View
Irritability SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Restlessness SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Nasal Pruritus SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View