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 @ 3:48 PM
Ignite Modification Date:
2025-12-25 @ 1:56 PM
NCT ID:
NCT02460692
Description:
None
Frequency Threshold:
0
Time Frame:
10 weeks
Study:
NCT02460692
Study Brief:
Trial of Dronabinol and Vaporized Cannabis in Chronic Low Back Pain
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Placebos | The present study is designed to evaluate whether or not a medium dose of cannabis (3.7% delta-9-THC/5.6% CBD) can maintain an analgesic response over an eight week period compared to placebo. Placebos: Administration of vaporized cannabis plus either dronabinol or placebo pill | 0 | None | 0 | 44 | 30 | 44 | View |
| Dronabinol | A direct comparison of cannabis and dronabinol has not been performed in a clinical population. The present study will fill this void by performing a randomized, controlled 8 week trial comparing the effectiveness of oral versus vaporized cannabis in patients with neuropathic low back pain. dronabinol: Administration of vaporized cannabis plus either dronabinol or placebo pill | 0 | None | 0 | 43 | 31 | 43 | View |
| Vaporized Cannabis 3.7% THC/5.6% CBD | The eight week outpatient study will compare the efficacy and side effect profile of cannabis (3.7%THC/5.6%CBD) and dronabinol. We will also perform a human laboratory experiment evaluating driving using the same study medications that subjects received during their 8 week outpatient treatment. Vaporized Cannabis 3.7% THC/5.6% CBD: Administration of vaporized cannabis plus either dronabinol or placebo pill | 0 | None | 0 | 44 | 30 | 44 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Confusion | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Lethargy | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Dry Mouth | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Abnormal cognition | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Depression | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Dizzy | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Emotional Changes | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Sleeping Problems | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Paranoia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Stomach Pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Abnormal Coordination | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Anxiety | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Back/Flank Paresthesia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Abnormal Dreams | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Back/Flank Numbness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Abnormal Balance | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Orthostatic Hypotension | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Abnormal heart rate | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Vision Alteration | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Blood pressure decreased | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Abdomen/Groin/Pelvis Pain | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Blood pressure increased | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Face/Jaw/Lips dry | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Generalized/Multiple site numbness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Behavior changes | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Bronchial washing nausea | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Cronic bronchitis | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Sexual drive alteration | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |