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 @ 5:05 AM
Ignite Modification Date:
2025-12-26 @ 4:09 AM
NCT ID:
NCT02461927
Description:
Adverse events were collected using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) method.
Frequency Threshold:
4
Time Frame:
During the study period (8 weeks)
Study:
NCT02461927
Study Brief:
Ketamine for the Rapid Treatment of Major Depressive Disorder and Alcohol Use Disorder
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Ketamine + Naltrexone | Subjects in this arm will receive (1) intravenous ketamine treatment once a week for 4 weeks (a total of 4 infusions) with a follow-up of 4 weeks and (2) intramuscular naltrexone once a month (a total of 2 injections). Ketamine + Naltrexone: Subjects in this arm will receive (1) intravenous ketamine (0.5 mg/kg) once a week for 4 weeks (a total of 4 infusions) and (2) intramuscular naltrexone (380 mg) once a month (a total of 2 injections). | 0 | None | 0 | 20 | 14 | 20 | View |
| Ketamine + Placebo | Subjects in this arm will receive (1) intravenous ketamine treatment once a week for 4 weeks (a total of 4 infusions) with a follow-up of 4 weeks and (2) intramuscular placebo once a month (a total of 2 injections). Ketamine + Placebo: Subjects in this arm will receive (1) intravenous ketamine (0.5 mg/kg) once a week for 4 weeks (a total of 4 infusions) and (2) intramuscular placebo once a month (a total of 2 injections). | 0 | None | 0 | 19 | 11 | 19 | View |
| Placebo (Psychoactive Placebo Midazolam) + Placebo | Subjects in this arm will receive (1) intravenous placebo treatment (psychoactive placebo midazolam) once a week for 4 weeks (a total of 4 infusions) with a follow-up of 4 weeks and (2) intramuscular placebo once a month (a total of 2 injections). Placebo (psychoactive placebo midazolam) + Placebo: Subjects in this arm will receive (1) intravenous psychoactive placebo midazolam (0.045 mg/kg) once a week for 4 weeks (a total of 4 infusions) and (2) intramuscular placebo once a month (a total of 2 injections). | 0 | None | 0 | 19 | 14 | 19 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Blurred or double vision | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Chest pain, tightness, or discomfort | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| General confusion | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Confusion as to time, place, person | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Cough | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Difficult, troubled breath or shortness of breath | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Difficult, burning, pain, frequent urge to urinate | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Difficulty with swallowing | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| General dizziness | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Dizziness, faintness, lightheadedness upon rising | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Dream-like state | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Fast, slow, irregular heartbeat | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Flushing or redness of skin | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Irregular, fast, slow, or shallow breathing | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Itching | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Loss of appetite | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Nausea | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Pain at IV site | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Pale or blue lips, fingernails, skin | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Puffiness or swelling of eyelids or eyes | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Puffiness or swelling around eyes, face, lips, tongue | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Seeing, hearing, feeling things that are not there | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Skin rash | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Sweating | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Unusually warm skin | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Unusual excitement, nervousness, restlessness | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Unusual tiredness or weakness | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Weight loss | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Headache | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Drowsiness | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Tiredness | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Breast Pain | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Painful menstrual periods | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Missed menstrual periods | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Excessive menstrual bleeding | SYSTEMATIC_ASSESSMENT | General disorders | None | View |