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:
2025-12-24 @ 2:54 PM
Ignite Modification Date:
2025-12-25 @ 1:19 PM
NCT ID:
NCT01027559
Description:
None
Frequency Threshold:
5
Time Frame:
None
Study:
NCT01027559
Study Brief:
fMRI Study of Treatment Changes in Major Depression
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Depressed Group: CBT | Depressed participants randomized to receive Cognitive Behavioral Therapy (CBT) for treatment. fMRI scan session occurs immediately prior to starting treatment, and a second fMRI scan will occur following 12 weeks of therapy. Cognitive Behavioral Therapy: Visits for the CBT sessions will occur on or about Day = 3,Day = 7,Day = 10,Day 14, Day 21, Day 28, Day 35, Day 42, Day 49, Day 56, Day 63, Day 70, Day 77, and Day 84. Visits to check for progress and HAMD administration will occur at Day = 0 and on or about Day = 14, Day 28, Day 42, Day 56, Day 70 and Day 84. | None | None | 0 | 26 | 7 | 26 | View |
| Healthy Control Group | Healthy controls will an fMRI scan session and their second fMRI scan session will occur approximately 12 weeks after. | None | None | 0 | 34 | 2 | 34 | View |
| Depressed Group: SSRI (Selective Serotonin Re-Uptake Inhibitor | Depressed participants randomized to receive setraline (SRT) for treatment. fMRI scan session occurs immediately prior to starting treatment, and a second fMRI scan will occur following 12 weeks of therapy. Sertraline: Visits will involve dispensing medication, side effects assessment and HAMD administration occurring at Day = 0 and on or about Day = 14, Day 28, Day 42, Day 56, Day 70 and Day 84. Depressed patients treated with SRT will titrate up to a maximum dose of 200 mg daily depending on tolerability and inadequate antidepressant response. | None | None | 0 | 31 | 21 | 31 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Constipation | None | Gastrointestinal disorders | None | View |
| Sedation/Drowsiness | None | Nervous system disorders | None | View |
| Headache | None | Nervous system disorders | None | View |
| Nausea/Vomitting | None | Gastrointestinal disorders | None | View |
| Stomach/Abdominal Pain | None | Gastrointestinal disorders | None | View |
| Irritability | None | Nervous system disorders | None | View |
| Muscle Twitching | None | Nervous system disorders | None | View |
| Tremor | None | Nervous system disorders | None | View |
| Decreased Appetite | None | Nervous system disorders | None | View |
| Increased Appetite | None | Nervous system disorders | None | View |
| Weight Gain | None | Nervous system disorders | None | View |
| Insomnia | None | Nervous system disorders | None | View |
| Dry Mouth | None | Immune system disorders | None | View |
| Decreased Libido | None | Nervous system disorders | None | View |
| Malaise | None | Immune system disorders | None | View |
| Impaired Mentation | None | Nervous system disorders | None | View |
| Hyperventilation | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Dizziness/Faintness | None | Ear and labyrinth disorders | None | View |
| Sexual Dysfunction | None | Nervous system disorders | None | View |
| Diarrhea | None | Gastrointestinal disorders | None | View |
| Nasal Congestion | None | Immune system disorders | None | View |
| Excessive Sweating | None | Nervous system disorders | None | View |
| Back Pain | None | Musculoskeletal and connective tissue disorders | None | View |
| Chest Pain | None | Vascular disorders | None | View |
| Panic | None | Psychiatric disorders | None | View |
| Slurred Speech | None | Nervous system disorders | None | View |
| Difficulty Hearing/Tinnitus | None | Ear and labyrinth disorders | None | View |
| Increased Libido | None | Vascular disorders | None | View |
| Syncope | None | Vascular disorders | None | View |
| Blurred Vision | None | Eye disorders | None | View |
| Increased Salivation | None | General disorders | None | View |
| Tachycardia/Palpitations | None | Cardiac disorders | None | View |
| Menstrual Irregularity | None | Reproductive system and breast disorders | None | View |
| Weight Loss | None | General disorders | None | View |
| Excitement/Weakness | None | Nervous system disorders | None | View |
| Abnormal Muscle Tone/Movements | None | Musculoskeletal and connective tissue disorders | None | View |