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:
2025-12-26 @ 10:34 AM
Ignite Modification Date:
2025-12-26 @ 10:34 AM
NCT ID:
NCT02617628
Description:
The definition is the same as clinicaltrials.gov.
Collection:
Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.
Frequency Threshold:
0
Time Frame:
2 years, 2 months
Study:
NCT02617628
Study Brief:
Outcomes of Opioid Addicted Prisoners With Extended-Release Injectable Naltrexone
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Before Re-entry | Extended Release Naltrexone, 380 mg injection, 1x monthly for 4 months Extended Release Naltrexone is currently marketed in the US for use in adults with alcohol dependence. It will be administered in this study at the currently marketed dose of 380 mgs. Subjects will be randomized to receive one injection of 380 mg of extended release naltrexone, at baseline, before they leave the prison. Both groups will receive three additional monthly doses of 380 mgs while enrolled in intensive outpatient treatment for six months. Subjects will also receive weekly psychosocial counseling. | 1 | None | 10 | 74 | 35 | 74 | View |
| After Re-entry | Extended Release Naltrexone, 380 mg injection, 1x monthly for 4 months Extended Release Naltrexone is currently marketed in the US for use in adults with alcohol dependence. It will be administered in this study at the currently marketed dose of 380 mgs. Subjects will be randomized to receive one injection of 380 mg of extended release naltrexone after they are released from prison. Both groups will receive three additional monthly doses of 380 mgs while enrolled in intensive outpatient treatment for six months. Subjects will also receive weekly psychosocial counseling. | 3 | None | 13 | 72 | 21 | 72 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| overdose | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | View |
| abdominal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 10.0 | View |
| kidney pain | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 10.0 | View |
| panic attack | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 10.0 | View |
| broken rib | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | View |
| suicidal ideation | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 10.0 | View |
| pregnancy | NON_SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA 10.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| abdominal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 10.0 | View |
| anxiety | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 10.0 | View |
| anxiousness | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 10.0 | View |
| back pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | View |
| back pain-lower | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | View |
| nose bleed | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 10.0 | View |
| blurry vision | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 10.0 | View |
| achey joints | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | View |
| allergy in left eye | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 10.0 | View |
| arthritis in leg | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | View |
| body aches | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | View |
| bronchitis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | View |
| chest pain-cardiac | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 10.0 | View |
| common cold | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | View |
| depression | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 10.0 | View |
| injection site reaction | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 10.0 | View |
| malaise | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 10.0 | View |
| diarrhea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 10.0 | View |
| headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 10.0 | View |
| toothache | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 10.0 | View |
| breathing problems | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | View |
| urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 10.0 | View |
| wrist pain | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 10.0 | View |
| nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 10.0 | View |
| nausea with vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 10.0 | View |
| flu like symptoms | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 10.0 | View |
| eye infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.0 | View |
| suicidal ideation | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 10.0 | View |
| decreased appetite | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 10.0 | View |
| dry mouth | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 10.0 | View |
| deep vein thrombosis | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 10.0 | View |
| decreased sex drive | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 10.0 | View |
| fibrois mass on ovary | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 10.0 | View |
| increased urine | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 10.0 | View |
| hip and left femor ache | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | View |
| infected boil | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.0 | View |
| heart burn | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 10.0 | View |
| insomnia | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 10.0 | View |
| insect bite swelling | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 10.0 | View |
| accidental inury, arm and knuckle | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 10.0 | View |
| dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 10.0 | View |
| excessive sweating | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 10.0 | View |
| withdrawn feeling | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 10.0 | View |
| foot pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | View |
| hernia pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 10.0 | View |
| hip arthrosis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | View |
| hot-cold sweats | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 10.0 | View |
| irritable | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 10.0 | View |
| lethargic | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 10.0 | View |
| miscarriage of pregnancy | NON_SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA 10.0 | View |
| muscle ache | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | View |
| neck pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | View |
| pregnancy | NON_SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA 10.0 | View |
| restless | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 10.0 | View |
| runny nose | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | View |
| breathing abnormality | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | View |
| sore throat | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 10.0 | View |
| tooth extraction | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 10.0 | View |