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 @ 2:49 AM
Ignite Modification Date:
2025-12-26 @ 1:30 AM
NCT ID:
NCT02032433
Description:
Treatment emergent adverse events are those that occurred after study day of induction for those participants were inducted onto study medication.
Frequency Threshold:
0
Time Frame:
Weeks 0-36
Study:
NCT02032433
Study Brief:
Extended-Release Naltrexone vs. Buprenorphine for Opioid Treatment
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Extended-Release Naltrexone | Extended-Release Naltrexone (Vivitrol) Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®) | 3 | None | 41 | 283 | 118 | 283 | View |
| Buprenorphine-Naloxone | Buprenorphine-Naloxone (Suboxone) Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®) | 4 | None | 31 | 287 | 135 | 287 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Psychiatric | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (19.0) | View |
| Infections and infestations | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.0) | View |
| Pregnancy | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA (19.0) | View |
| Injury, poisoning and procedural complications | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (19.0) | View |
| General disorders and administration site conditions | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.0) | View |
| Gastrointestinal disorders | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.0) | View |
| Respiratory, thoracic, and mediastinal disorders | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | View |
| Nervous system disorders | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (19.0) | View |
| Musculoskeletal and connective tissue disorders | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | View |
| Metabolism and nutrition disorders | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (19.0) | View |
| Hepatobiliary disorders | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (19.0) | View |
| Eye disorders | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (19.0) | View |
| Reproductive system and breast disorders | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (19.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Gastrointestinal | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.0) | View |
| Psychiatric | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (19.0) | View |
| Injury poisoning and procedural complications | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (19.0) | View |
| Infections and infestations | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.0) | View |
| Nervous system disorders | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (10.0) | View |
| General Disorders and Administration Site Conditions | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.0) | View |
| Musculoskeletal and connective tissue disorders | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | View |
| Investigations | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (19.0) | View |
| Respiratory, thoracic and mediastinal disorders | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | View |
| Skin and subcutaneous tissue disorders | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (19.0) | View |
| Metabolism and nutrition | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (19.0) | View |
| Eye disorders | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (19.0) | View |
| Renal and urinary disorders | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (19.0) | View |
| Vascular disorders | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (19.0) | View |
| Reproductive system and breast disorders | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (19.0) | View |
| Surgical and medical procedures | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (19.0) | View |
| Hepatbiliary disorders | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (19.0) | View |
| Ear and labyrinth disorders | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (19.0) | View |
| Immune system disorders | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (19.0) | View |
| Cardiac disorders | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (19.0) | View |
| Social circumstances | SYSTEMATIC_ASSESSMENT | Social circumstances | MedDRA (19.0) | View |
| Blood and lymphatic system disorders | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (19.0) | View |
| Product issues | SYSTEMATIC_ASSESSMENT | Product Issues | MedDRA (19.0) | View |