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 @ 9:40 PM
Ignite Modification Date:
2025-12-25 @ 7:22 PM
NCT ID:
NCT01325532
Description:
All subjects filled out the PRISE adverse effect instrument at each visit. Emergence of each side effect was assessed during the course of the study.
Frequency Threshold:
5
Time Frame:
3 weeks
Study:
NCT01325532
Study Brief:
Efficacy and Safety of Cranial Electrical Stimulation (CES) for Major Depressive Disorder (MDD)
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Active CES | Active CES: The FW-100 Cranial Stimulator headset was placed on the scalp over the two dorsolateral prefrontal cortex areas. The power knob was turned to maximum setting. The waveform contains a 15000Hz square wave carrier from 0-4 mAmp. The first 15Hz modulating signal provides 50msec of "on" and 16.7msec of "off" time (total 66.7msec, 50% duty cycle). A second 500Hz modulating signal changes the "on" time series of 15000Hz pulses (750 pulses/50msec) into 25 smaller bursts of 15 pulses of the 15000Hz carrier signal, for 375 pulses in 50msec. The consecutive positive burst and "off" time is followed by an opposite negative burst and "off" time, balancing the current component to zero. Output voltage ranges from 0-40V, positive and negative. CES automatically shut off after 20 mins. Active CES: CES current | None | None | 0 | 17 | 11 | 17 | View |
| Sham CES | Shame CES: The sham devices were modified to not deliver current to the headset. The current from the active device departs from the posts at the top of the device into the headsets, creating a loop when the headset is worn by the subject with the wet electrode sponges. This loop is eliminated in the sham devices by wrapping wire around the posts, thus containing the loop within the device, with no electricity leaving the headsets. This approach allows the loop to be maintained, and therefore all of the device's green and yellow amperage lights still light up, protecting the blind. Sham CES: Sham CES (device off) for 20-minutes each day 5 days/week for 3 weeks. | None | None | 0 | 13 | 8 | 13 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | PRISE | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | PRISE | View |
| Nausea/vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | PRISE | View |
| Palpitations | SYSTEMATIC_ASSESSMENT | Cardiac disorders | PRISE | View |
| Orthostatic hypotension | SYSTEMATIC_ASSESSMENT | Cardiac disorders | PRISE | View |
| Increased perspiration | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | PRISE | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | PRISE | View |
| Tremors | SYSTEMATIC_ASSESSMENT | Nervous system disorders | PRISE | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | PRISE | View |
| Blurred vision | SYSTEMATIC_ASSESSMENT | Eye disorders | PRISE | View |
| Ringing in ears | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | PRISE | View |
| Difficulty urinating | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | PRISE | View |
| Frequent urination | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | PRISE | View |
| Menstrual irregularity | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | PRISE | View |
| Difficulty sleeping | SYSTEMATIC_ASSESSMENT | General disorders | PRISE | View |
| Sleeping too much | SYSTEMATIC_ASSESSMENT | General disorders | PRISE | View |
| Loss of sexual desire | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | PRISE | View |
| Trouble achieving orgasm | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | PRISE | View |
| Trouble with erections | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | PRISE | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | PRISE | View |
| Poor concentration | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | PRISE | View |
| General malaise | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | PRISE | View |
| Restlessness | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | PRISE | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | PRISE | View |
| Flashing light and tingling sensation | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | Spontaneous report | View |
| Decreased energy | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | PRISE | View |