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 @ 1:34 AM
Ignite Modification Date:
2025-12-25 @ 11:48 PM
NCT ID:
NCT01943994
Description:
After TQD participants were asked at each study visit about any adverse events (AEs) since their last visit, which were documented, including duration, severity, and relatedness. Participants in the Nicotine Replacement Therapy (NRT) arm were eligible to receive a 30mg/70kg psilocybin session after completing the primary 6-month follow-up. Those who completed this cross-over psilocybin session received 2 interventions (NRT and psilocybin), so their AEs are reported separately.
Frequency Threshold:
5
Time Frame:
Up to 12 months
Study:
NCT01943994
Study Brief:
Psilocybin-facilitated Smoking Cessation Treatment: A Pilot Study
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Psilocybin-assisted Treatment | Participants will receive a 13-week cognitive behavioral intervention for smoking cessation, with a high dose of psilocybin (30mg / 70kg) to be administered on the Target Quit Date in week 5. Psilocybin-assisted treatment: Participants will be administered 30 mg/70 kg psilocybin. Preliminary evidence from our ongoing psilocybin dose-effects study suggests that this dose is associated with mystical-type experiences. | 0 | None | 0 | 42 | 37 | 42 | View |
| Nicotine Replacement Therapy (NRT) | Participants will receive a 13-week cognitive behavioral intervention for smoking cessation, with a standard 8 to 10-week regimen of NRT to be administered beginning on the Target Quit Date in week 5. NRT for this study will be a transdermal nicotine patch administered according to recommended label usage (For individuals who smoke more than 10 cigarettes per day: 21mg daily weeks 1-6, 14mg daily weeks 7-8, 7mg daily weeks 9-10. For individuals who smoke 10 or less cigarettes per day: 14mg daily for weeks 1-6, 7mg daily for weeks 7-8). | 0 | None | 1 | 40 | 31 | 40 | View |
| Cross-over to Psilocybin-assisted Treatment | Participants in the Nicotine Replacement Therapy (NRT) arm were also eligible to receive a single high-dose (30mg/70kg) psilocybin administration after completing the primary study endpoint at 6-month follow-up. Thus, individuals in this category opted to complete this cross-over psilocybin session after completing a course of NRT. | 0 | None | 1 | 26 | 25 | 26 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Elevated Blood Pressure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Respiratory Infection | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| GI Illness / Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Irritability | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Back Pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Visual Disturbance | SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |
| Vivid Dreams | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Joint Pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Migraine | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Elevated Heart Rate | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Concentration Impairment | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Fever | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Ear Infection | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | None | View |
| Panic | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Hernia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Emotional Lability | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |