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 @ 4:56 AM
Ignite Modification Date:
2025-12-26 @ 3:56 AM
NCT ID:
NCT02918318
Description:
There was 1 participant who was randomized to the Esk 84 mg group but was dosed Esk 56 mg on Days 1 and 4, and Esk 28 mg on Day 8, then withdrew due to an adverse event on Day 11. This participant was summarized under the Esk 56 mg group for safety analyses.
Frequency Threshold:
5
Time Frame:
Up to 42 weeks
Study:
NCT02918318
Study Brief:
A Study to Evaluate the Efficacy, Safety and Tolerability of Fixed Doses of Intranasal Esketamine in Japanese Participants With Treatment Resistant Depression
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| DB: Esketamine 56 mg | Participants received intranasal esketamine 56 mg twice a week add-on to an oral AD for 4 weeks. Analysis was performed on safety analysis set- all randomized participants who received at least 1 dose of Esk DB induction phase. | 0 | None | 0 | 41 | 39 | 41 | View |
| DB FU: Esketamine 84 mg | Participants who were non responders at the end of DB induction phase and entered the DB follow-up phase received only oral AD in the DB FU phase. Analysis was performed on follow-up analysis set- all participants who entered the follow-up phase and were evaluated for the safety. | 0 | None | 1 | 23 | 3 | 23 | View |
| PT Phase: Placebo | Participants who were responders at the end of DB induction phase and entered in the PT phase received only oral AD in the PT phase. Analysis was performed on safety analysis set- All participants who received at least 1 dose of oral AD during PT phase. | 0 | None | 0 | 27 | 7 | 27 | View |
| Open-Label (OL): Flexible Esketamine | Participants received flexible esketamine add-on to an oral AD during OL induction phase for 4 weeks. Analysis was performed on safety analysis set- All participants who received at least 1 dose of flexible Esk during OL induction phase. | 0 | None | 1 | 48 | 47 | 48 | View |
| OL FU: Flexible Esketamine | Participants who received flexible esketamine add-on to an oral AD during OL induction phase were followed for 4 weeks in OL FU phase. Analysis was performed on follow-up analysis set- all participants who entered the OL follow-up phase and were evaluated for the safety. | 0 | None | 2 | 48 | 3 | 48 | View |
| Double Blind (DB): Esketamine 28 mg | Participants received intranasal esketamine 28 mg twice a week add-on to an oral antidepressant (AD) for 4 weeks. Analysis was performed on safety analysis set- all randomized participants who received at least 1 dose of Esk during DB induction phase. | 0 | None | 1 | 41 | 33 | 41 | View |
| DB: Esketamine 84 mg | Participants received intranasal esketamine 84 mg twice a week add-on to an oral AD for 4 weeks. Analysis was performed on safety analysis set- all randomized participants who received at least 1 dose of Esk during DB induction phase. | 0 | None | 1 | 40 | 39 | 40 | View |
| DB: Placebo | Participants received intranasal placebo twice a week add-on to an oral AD for 4 weeks. Analysis was performed on safety analysis set- all randomized participants who received dose of internasal placebo during DB induction phase. | 0 | None | 1 | 80 | 34 | 80 | View |
| DB Follow Up (FU): Esketamine 28 mg | Participants who were non responders at the end of DB induction phase and entered the DB follow-up phase received only oral AD for 4 weeks. Analysis was performed on follow-up analysis set- all participants who entered the follow-up phase and were evaluated for the safety. | 0 | None | 0 | 27 | 3 | 27 | View |
| DB FU: Esketamine 56 mg | Participants who were non responders at the end of DB induction phase and entered the DB follow-up phase received only oral AD in the DB FU phase. Analysis was performed on follow-up analysis set- all participants who entered the follow-up phase and were evaluated for the safety. | 0 | None | 0 | 29 | 3 | 29 | View |
| DB FU: Placebo | Participants who were non responders at the end of DB induction phase and entered the DB follow-up phase received only oral AD in the DB FU phase. Analysis was performed on follow-up analysis set- all participants who entered the follow-up phase and were evaluated for the safety. | 0 | None | 2 | 53 | 7 | 53 | View |
| Post-Treatment (PT) Phase: Esketamine 28 mg | Participants who were responders at the end of DB induction phase and entered in the PT phase received only oral AD in the PT phase. Analysis was performed on safety analysis set- All participants who received at least 1 dose of oral AD during PT phase. | 0 | None | 0 | 13 | 6 | 13 | View |
| PT Phase: Esketamine 56 mg | Participants who were responders at the end of DB induction phase and entered in the PT phase received only oral AD in the PT phase. Analysis was performed on safety analysis set- All participants who received at least 1 dose of oral AD during PT phase. | 0 | None | 0 | 11 | 4 | 11 | View |
| PT Phase: Esketamine 84 mg | Participants who were responders at the end of DB induction phase and entered in the PT phase received only an oral AD in the PT phase. Analysis was performed on safety analysis set- All participants who received at least 1 dose of oral AD during PT phase. | 0 | None | 0 | 17 | 6 | 17 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Ankle Fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 22.0 | View |
| Fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 22.0 | View |
| Muscular Weakness | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 22.0 | View |
| Uterine Leiomyoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 22.0 | View |
| Cerebral Disorder | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 22.0 | View |
| Suicidal Ideation | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 22.0 | View |
| Suicide Attempt | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 22.0 | View |
| Atrioventricular Block Second Degree | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 22.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Palpitations | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 22.0 | View |
| Hyperacusis | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA Version 22.0 | View |
| Tinnitus | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA Version 22.0 | View |
| Vertigo | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA Version 22.0 | View |
| Conjunctivitis Allergic | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA Version 22.0 | View |
| Diplopia | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA Version 22.0 | View |
| Dry Eye | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA Version 22.0 | View |
| Visual Impairment | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA Version 22.0 | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 22.0 | View |
| Hypoaesthesia Oral | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 22.0 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 22.0 | View |
| Stomatitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 22.0 | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 22.0 | View |
| Asthenia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 22.0 | View |
| Feeling Drunk | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 22.0 | View |
| Malaise | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 22.0 | View |
| Thirst | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 22.0 | View |
| Nasopharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 22.0 | View |
| Muscle Strain | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 22.0 | View |
| Blood Pressure Diastolic Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 22.0 | View |
| Blood Pressure Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 22.0 | View |
| Respiratory Rate Decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 22.0 | View |
| Weight Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 22.0 | View |
| Muscular Weakness | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 22.0 | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 22.0 | View |
| Dizziness Postural | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 22.0 | View |
| Dysarthria | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 22.0 | View |
| Dyslalia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 22.0 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 22.0 | View |
| Hypoaesthesia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 22.0 | View |
| Hypotonia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 22.0 | View |
| Mental Impairment | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 22.0 | View |
| Sedation | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 22.0 | View |
| Somnolence | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 22.0 | View |
| Agitation | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 22.0 | View |
| Anxiety | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 22.0 | View |
| Depersonalisation/Derealisation Disorder | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 22.0 | View |
| Dissociation | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 22.0 | View |
| Euphoric Mood | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 22.0 | View |
| Hallucination | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 22.0 | View |
| Albuminuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA Version 22.0 | View |
| Dysmenorrhoea | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA Version 22.0 | View |
| Dyspnoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.0 | View |
| Oropharyngeal Pain | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.0 | View |
| Rhinitis Allergic | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.0 | View |
| Night Sweats | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 22.0 | View |