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 @ 12:01 AM
Ignite Modification Date:
2025-12-25 @ 9:59 PM
NCT ID:
NCT01218958
Description:
None
Frequency Threshold:
5
Time Frame:
Events were recorded starting at baseline through 42 days after the last dose of study drug.
Study:
NCT01218958
Study Brief:
ALK21-003: Study of Medisorb® Naltrexone (VIVITROL®) in Alcohol-Dependent Adults
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Placebo Groups (Pooled) | Results for the two groups that received placebo were pooled together for reporting purposes. | None | None | 15 | 209 | 181 | 209 | View |
| Medisorb Naltrexone 190 mg | None | None | None | 10 | 210 | 190 | 210 | View |
| Medisorb Naltrexone 380 mg | None | None | None | 11 | 205 | 187 | 205 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Alcoholism | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 4.1 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 4.1 | View |
| Alcohol withdrawal syndrome | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 4.1 | View |
| Emotional distress | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 4.1 | View |
| Psychotic disorder NOS | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 4.1 | View |
| Pneumonia NOS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 4.1 | View |
| Interstitial pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 4.1 | View |
| Atrial fibrillation aggravated | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 4.1 | View |
| Myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 4.1 | View |
| Gastrointestinal haemorrhage NOS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 4.1 | View |
| Perirectal abscess | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 4.1 | View |
| Chest tightness | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 4.1 | View |
| Head injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 4.1 | View |
| Jaw fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 4.1 | View |
| Inflammatory carcinoma of the breast | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 4.1 | View |
| Laryngeal cancer NOS | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 4.1 | View |
| Cholelithiasis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 4.1 | View |
| Intervertebral disc herniation | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 4.1 | View |
| Abortion missed | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA 4.1 | View |
| Eosinophilic pneumonia acute | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 4.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 4.1 | View |
| Diarrhoea NOS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 4.1 | View |
| Vomiting NOS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 4.1 | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 4.1 | View |
| Injection site pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 4.1 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 4.1 | View |
| Injection site induration | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 4.1 | View |
| Abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 4.1 | View |
| Abdominal pain NOS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 4.1 | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 4.1 | View |
| Upper respiratory tract infection NOS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 4.1 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 4.1 | View |
| Anxiety NEC | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 4.1 | View |
| Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 4.1 | View |
| Libido decreased | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 4.1 | View |
| Headache NOS | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 4.1 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 4.1 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 4.1 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 4.1 | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 4.1 | View |
| Pain in limb | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 4.1 | View |
| Appetite decreased NOS | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 4.1 | View |