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 @ 1:38 AM
Ignite Modification Date:
2025-12-25 @ 11:53 PM
NCT ID:
NCT02044094
Description:
All adverse events that occurred between Day 1 to Day 91 are reported under the Depot Buprenorphine treatment arm.
Adverse events that occurred on the day of a hydromorphone challenge are also reported under the appropriate hydromorphone challenge treatment arm.
Frequency Threshold:
5
Time Frame:
Depot Buprenorphine: Day 1 to Day 91. Hydromorphone Challenges: the three hydromorphone challenge levels (0 mg, 6 mg and 18 mg) were randomly assigned to one day in each of the three-day groupings spanning 12 weeks: Days 5-7, 11-14, 19-21, 26-28, 33-35, 40-42, 47-49, 54-56, 61-63, 68-70, 75-77, and 82-84.
Study:
NCT02044094
Study Brief:
Multiple Dose Study of Blockade of Opioid Effects by Injections of Buprenorphine in Participants With Opioid Disorder
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Depot Buprenorphine | Participants were treated with RBP-6000 300 mg in a single subcutaneous injection on Days 1 and 29. | 0 | None | 0 | 39 | 34 | 39 | View |
| Placebo Challenge | Participants received three hydromorphone challenges each week, one challenge on each of three consecutive days/week in this 12 week study. Participants and clinical facility staff were blinded to the specific dose of hydromorphone being administered during each challenge. The placebo challenge consisted of an intramuscular injection of placebo (hydromorphone 0mg). | 0 | None | 0 | 38 | 23 | 38 | View |
| Hydromorphone 6 mg Challenge | Participants received three hydromorphone challenges each week, one challenge on each of three consecutive days/week in this 12 week study. Participants and clinical facility staff were blinded to the specific dose of hydromorphone being administered during each challenge. The hydromorphone 6 mg challenge consisted of an intramuscular injection of 6 mg hydromorphone. | 0 | None | 0 | 38 | 18 | 38 | View |
| Hydromorphone 18 mg Challenge | Participants received three hydromorphone challenges each week, one challenge on each of three consecutive days/week in this 12 week study. Participants and clinical facility staff were blinded to the specific dose of hydromorphone being administered during each challenge. The hydromorphone 18 mg challenge consisted of an intramuscular injection of 18 mg hydromorphone. | 0 | None | 0 | 38 | 19 | 38 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Injection site erythema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (16.1) | View |
| Injection site pruritis | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (16.1) | View |
| Local swelling | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (16.1) | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (16.1) | View |
| Sedation | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (16.1) | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (16.1) | View |
| Paraesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (16.1) | View |
| Constipation | 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 |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.1) | View |
| Toothache | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.1) | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (16.1) | View |
| Abnormal dreams | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (16.1) | View |
| Musculoskeletal pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (16.1) | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (16.1) | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.1) | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.1) | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (16.1) | View |
| Hot flush | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (16.1) | View |
| Dermatitis contact | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (16.1) | View |
| Tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (16.1) | View |
| Leukocyturia | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (16.1) | View |
| Weight decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (16.1) | View |