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
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Galantamine and CBT | Drug: Galantamine Daily 8 mg galantamine capsule Other Names: Nivalin, Razadyne, Razadyne ER, Reminyl, Lycoremine Behavioral: Computer Assisted Cognitive Behavioral Therapy (CBT) CBT a psychotherapeutic approach that addresses dysfunctional emotions, maladaptive behaviors and cognitive processes and contents through a number of goal-oriented, explicit systematic procedures. The name refers to behavior therapy, cognitive therapy, and to therapy based upon a combination of basic behavioral and cognitive principles and research. | None | None | 4 | 28 | 15 | 28 | View |
| Galantamine | Drug: Galantamine Daily 8 mg galantamine capsule Other Names: Nivalin, Razadyne, Razadyne ER, Reminyl, Lycoremine | None | None | 6 | 27 | 10 | 27 | View |
| Placebo and CBT | Computer assisted CBT plus placebo. All participants assigned to this condition will also be offered up to 60 minutes per week to work with the CBT for CBT program, onsite at the clinic, in a private space and using a computer provided by the research project. Patients will have the choice of how they choose to use the computer, that is, in two 30-minute sessions or one one-hour session. | None | None | 6 | 38 | 16 | 38 | View |
| Placebo Only | Standard Treatment plus placebo for cocaine abusing or dependent methadone-maintained individuals. This consists of daily methadone visits plus one individual and one group session per week, and patients may participate in additional treatments such as HIV education and treatment. The counseling program's theoretical orientation is described as client-centered. | None | None | 5 | 27 | 14 | 27 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Inpatient Substance Use Treatment Hospitalization | None | Psychiatric disorders | None | View |
| Inpatient Psychiatric Hospitalization | None | Psychiatric disorders | None | View |
| Medical hospitalization | None | Gastrointestinal disorders | None | View |
| Medical hospitalization | None | Surgical and medical procedures | None | View |
| Medical Hospitalization | None | General disorders | None | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Fatigue | None | General disorders | None | View |
| agitation | None | General disorders | None | View |
| headache | None | General disorders | None | View |
| Tremors | None | General disorders | None | View |
| Dizziness | None | General disorders | None | View |
| Nausea | None | Gastrointestinal disorders | None | View |
| indigestion | None | Gastrointestinal disorders | None | View |
| Blood in Stool | None | General disorders | None | View |
| Abdominal Pain | None | General disorders | None | View |
| Loss of Appetite | None | General disorders | None | View |
| Diarrhea or Constipation | None | Gastrointestinal disorders | None | View |
| Weight Loss | None | General disorders | None | View |
| Rash | None | Skin and subcutaneous tissue disorders | None | View |