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 @ 3:21 AM
Ignite Modification Date:
2025-12-26 @ 1:59 AM
NCT ID:
NCT04711005
Description:
None
Frequency Threshold:
0
Time Frame:
Data were collected for the SAD arms through Day 8, MAD through Day 19, CSF through Day 8, and Placebo up to Day 19.
Study:
NCT04711005
Study Brief:
Phase 1 Evaluation of (2R,6R)-Hydroxynorketamine
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| SAD Cohort 1 | (2R,6R)-Hydroxynorketamine @ 0.1 mg/kg via slow IV infusion (40 minutes) (2R,6R)-Hydroxynorketamine hydrochloride: (2R,6R)-Hydroxynorketamine is a metabolite of the drug ketamine. (2R,6R)-Hydroxynorketamine hydrochloride will be administered intravenously over a 40-minute period as a solution in a 25 mM sodium phosphate 0.9% w/v saline solution. The investigational drug product will be diluted into a 53 mL total volume of formulant. | 0 | None | 0 | 6 | 1 | 6 | View |
| SAD Cohort 2 | (2R,6R)-Hydroxynorketamine @ 0.25 mg/kg via slow IV infusion (40 minutes) (2R,6R)-Hydroxynorketamine hydrochloride: (2R,6R)-Hydroxynorketamine is a metabolite of the drug ketamine. (2R,6R)-Hydroxynorketamine hydrochloride will be administered intravenously over a 40-minute period as a solution in a 25 mM sodium phosphate 0.9% w/v saline solution. The investigational drug product will be diluted into a 53 mL total volume of formulant. | 0 | None | 0 | 6 | 0 | 6 | View |
| SAD Cohort 3 | (2R,6R)-Hydroxynorketamine @ 0.5 mg/kg via slow IV infusion (40 minutes) (2R,6R)-Hydroxynorketamine hydrochloride: (2R,6R)-Hydroxynorketamine is a metabolite of the drug ketamine. (2R,6R)-Hydroxynorketamine hydrochloride will be administered intravenously over a 40-minute period as a solution in a 25 mM sodium phosphate 0.9% w/v saline solution. The investigational drug product will be diluted into a 53 mL total volume of formulant. | 0 | None | 0 | 6 | 1 | 6 | View |
| SAD Cohort 4 | (2R,6R)-Hydroxynorketamine @ 1.0 mg/kg via slow IV infusion (40 minutes) (2R,6R)-Hydroxynorketamine hydrochloride: (2R,6R)-Hydroxynorketamine is a metabolite of the drug ketamine. (2R,6R)-Hydroxynorketamine hydrochloride will be administered intravenously over a 40-minute period as a solution in a 25 mM sodium phosphate 0.9% w/v saline solution. The investigational drug product will be diluted into a 53 mL total volume of formulant. | 0 | None | 0 | 6 | 1 | 6 | View |
| SAD Cohort 5 | (2R,6R)-Hydroxynorketamine @ 2.0 mg/kg via slow IV infusion (40 minutes) (2R,6R)-Hydroxynorketamine hydrochloride: (2R,6R)-Hydroxynorketamine is a metabolite of the drug ketamine. (2R,6R)-Hydroxynorketamine hydrochloride will be administered intravenously over a 40-minute period as a solution in a 25 mM sodium phosphate 0.9% w/v saline solution. The investigational drug product will be diluted into a 53 mL total volume of formulant. | 0 | None | 0 | 6 | 1 | 6 | View |
| SAD Cohort 6 | (2R,6R)-Hydroxynorketamine @ 4.0 mg/kg via slow IV infusion (40 minutes) (2R,6R)-Hydroxynorketamine hydrochloride: (2R,6R)-Hydroxynorketamine is a metabolite of the drug ketamine. (2R,6R)-Hydroxynorketamine hydrochloride will be administered intravenously over a 40-minute period as a solution in a 25 mM sodium phosphate 0.9% w/v saline solution. The investigational drug product will be diluted into a 53 mL total volume of formulant. | 0 | None | 0 | 6 | 2 | 6 | View |
| MAD Cohort 1 | (2R,6R)-Hydroxynorketamine @ 1.0 mg/kg via slow IV infusion (40 minutes) on days 1, 4, 7, 10 (2R,6R)-Hydroxynorketamine hydrochloride: (2R,6R)-Hydroxynorketamine is a metabolite of the drug ketamine. (2R,6R)-Hydroxynorketamine hydrochloride will be administered intravenously over a 40-minute period as a solution in a 25 mM sodium phosphate 0.9% w/v saline solution. The investigational drug product will be diluted into a 53 mL total volume of formulant. | 0 | None | 0 | 6 | 1 | 6 | View |
| MAD Cohort 2 | (2R,6R)-Hydroxynorketamine @ 2.0 mg/kg via slow IV infusion (40 minutes) on days 1, 4, 7, 10 (2R,6R)-Hydroxynorketamine hydrochloride: (2R,6R)-Hydroxynorketamine is a metabolite of the drug ketamine. (2R,6R)-Hydroxynorketamine hydrochloride will be administered intravenously over a 40-minute period as a solution in a 25 mM sodium phosphate 0.9% w/v saline solution. The investigational drug product will be diluted into a 53 mL total volume of formulant. | 0 | None | 0 | 9 | 2 | 9 | View |
| Placebo | Control product (placebo) will be sterile saline also administered via slow IV infusion (40 minutes). Placebo: Placebo will be made up of a 0.9% w/v saline solution (53 mL total volume) administered via slow IV infusion over a 40-minute period. | 0 | None | 0 | 19 | 5 | 19 | View |
| CSF Capture Cohort 1 | (2R,6R)-Hydroxynorketamine @ 0.25 mg/kg via slow IV infusion (40 minutes) (2R,6R)-Hydroxynorketamine hydrochloride: (2R,6R)-Hydroxynorketamine is a metabolite of the drug ketamine. (2R,6R)-Hydroxynorketamine hydrochloride will be administered intravenously over a 40-minute period as a solution in a 25 mM sodium phosphate 0.9% w/v saline solution. The investigational drug product will be diluted into a 53 mL total volume of formulant. | 0 | None | 0 | 4 | 4 | 4 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedRA v21.0 | View |
| Tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedRA v21.0 | View |
| Diastolic blood pressure increase | SYSTEMATIC_ASSESSMENT | Investigations | MedRA v21.0 | View |
| Dehydratiuon | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedRA v21.0 | View |
| Procedure site pain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedRA v21.0 | View |
| Puncture site pain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedRA v21.0 | View |
| Catheter site pain | SYSTEMATIC_ASSESSMENT | General disorders | MedRA v21.0 | View |
| Neck pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedRA v21.0 | View |
| Pain in fingers | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedRA v21.0 | View |
| Blood Pressure Systolic increased | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MEDRA v21.0 | View |
| Rash over arms | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MEDRA v21.0 | View |
| Visual Disturbance | SYSTEMATIC_ASSESSMENT | Eye disorders | MEDRA v21.0 | View |