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 @ 6:27 PM
Ignite Modification Date:
2025-12-25 @ 3:57 PM
NCT ID:
NCT04036968
Description:
Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).
Frequency Threshold:
1
Time Frame:
Up to 40 hours
Study:
NCT04036968
Study Brief:
Enhancing Medication-based Analgesia in Humans- STUDY 2
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Placebo+Placebo | Within-subject double-blind, double-dummy administration of placebo + placebo. Order of dose randomized session days 2-5. Within-subject test of blinded study medications: Within-subject double-blind, double-dummy, study design wherein all participants received all doses in 8-hour outpatient sessions. Primary outcomes assessed during 8-hour outpatient sessions and included laboratory pain testing, subjective reports of drug effects, and cognitive performance, evaluated as a function of study medication condition. | 0 | None | 0 | 31 | 8 | 31 | View |
| Hydromorphone+Placebo | Within-subject double-blind, double-dummy administration of hydromorphone (oral) 4mg + placebo. Always administered during session 1. Within-subject test of blinded study medications: Within-subject double-blind, double-dummy, study design wherein all participants received all doses in 8-hour outpatient sessions. Primary outcomes assessed during 8-hour outpatient sessions and included laboratory pain testing, subjective reports of drug effects, and cognitive performance, evaluated as a function of study medication condition. | 0 | None | 0 | 31 | 20 | 31 | View |
| Hydromorphone (Oral) 4mg + Cannabidiol 50mg | Within-subject double-blind, double-dummy administration of hydromorphone (oral) 4mg + cannabidiol (oral) 50mg. Order of dose randomized session days 2-5. Within-subject test of blinded study medications: Within-subject double-blind, double-dummy, study design wherein all participants received all doses in 8-hour outpatient sessions. Primary outcomes assessed during 8-hour outpatient sessions and included laboratory pain testing, subjective reports of drug effects, and cognitive performance, evaluated as a function of study medication condition. | 0 | None | 0 | 31 | 15 | 31 | View |
| Hydromorphone (Oral) 4mg + Cannabidiol 100mg | Within-subject double-blind, double-dummy administration of hydromorphone (oral) 4mg + cannabidiol (oral) 100mg. Order of dose randomized session days 2-5. Within-subject test of blinded study medications: Within-subject double-blind, double-dummy, study design wherein all participants received all doses in 8-hour outpatient sessions. Primary outcomes assessed during 8-hour outpatient sessions and included laboratory pain testing, subjective reports of drug effects, and cognitive performance, evaluated as a function of study medication condition. | 0 | None | 0 | 31 | 22 | 31 | View |
| Hydromorphone (Oral) 4mg + Cannabidiol 200mg | Within-subject double-blind, double-dummy administration of hydromorphone (oral) 4mg + cannabidiol (oral) 200mg. Order of dose randomized session days 2-5. Within-subject test of blinded study medications: Within-subject double-blind, double-dummy, study design wherein all participants received all doses in 8-hour outpatient sessions. Primary outcomes assessed during 8-hour outpatient sessions and included laboratory pain testing, subjective reports of drug effects, and cognitive performance, evaluated as a function of study medication condition. | 0 | None | 0 | 31 | 20 | 31 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Chills | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Headache | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Abdominal Cramp | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Appetite Decrease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Appetite Increase | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Dry Mouth | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Clumsy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Confusion | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Depression | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Drowsiness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Euphoria | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Impaired | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Irritability | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Light Headed | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Nervousness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Tingling | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Restlessness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Shaky | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Tremor | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Yawning | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Photosensitivity | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Piloerection | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Pruitus | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Dry Eyes | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Frequent Urination | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |