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 @ 5:12 PM
Ignite Modification Date:
2025-12-25 @ 2:50 PM
NCT ID:
NCT01747850
Description:
ADVERSE EVENT COLLECTION BY QUESTIONNAIRE DURING STUDY VISITS (SAFTEE)
Frequency Threshold:
5
Time Frame:
1 year, 10 months
Study:
NCT01747850
Study Brief:
Sativex and Behavioral-relapse Prevention Strategy in Cannabis Dependence
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Sativex | Intervention consist on Sativex Spray (Δ9-tetrahydrocannabinol/cannabidiol). There will be a gradual increase of the maximal allowed dose starting at five sprays per day for the first two days and increasing of five sprays per day until reaching the max number of 42 sprays per day at the end of week 2. There will be a total of 12 weeks of drug exposure. All participants will receive a combination of pharmacotherapy (Sativex ) associated with a weekly intervention of combined Motivational Enhancement Therapy and Cognitive Behavioral Therapy. | None | None | 0 | 20 | 16 | 20 | View |
| Placebo Spray | Placebo spray: Study subjects will gradually increase the maximal allowed dose of Placebo starting at five sprays per day for the first two days and increasing of five sprays per day until reaching the max number of 42 sprays maximal per day at end of week 2 (Day 11). There will be a total of 12 weeks Placebo treatment exposure. Participants will receive a combination of Placebo spray associated with a weekly intervention of combined Motivational Enhancement Therapy and Cognitive Behavioral Therapy | None | None | 0 | 20 | 18 | 20 | View |
| Pilot Study | The first five subjects will be treatment-seekers that will be treated open-label. Study subjects will gradually increase the maximal allowed dose of Sativex starting at five sprays per day for the first two days and increasing of five sprays per day until reaching the max number of 42 sprays maximal per day at end of week 2 (Day 11). There will be a total of 12 weeks medication treatment exposure). Motivational Enhancement/Cognitive Behavioral Therapy: All participants will receive a combination of pharmacotherapy (Sativex) associated with a weekly intervention of combined Motivational Enhancement Therapy and Cognitive Behavioral Therapy. | None | None | 0 | 5 | 4 | 5 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Insomnia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Oro Mucal | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Cardiovascular | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Nightmare | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Diarrhea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Decrease in Libido | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Decreased appetite | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Urinary Problems | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Skin rashes | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Indigestion | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Light Headedness | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| excessive sweating | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Ringing in ears | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Walking up in the middle of night | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Tiredness | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Cold/Influenza | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Mood Disturbance | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |