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 @ 5:25 PM
Ignite Modification Date:
2025-12-25 @ 3:00 PM
NCT ID:
NCT03565068
Description:
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
Frequency Threshold:
0
Time Frame:
Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Study:
NCT03565068
Study Brief:
A Safety, Tolerability, and Pharmacokinetics Study of MK-8189 in Participants With Schizophrenia and in Healthy Participants (MK-8189-007)
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Panel A (Healthy Participants): MK-8189 Monotherapy 4 mg | Healthy participants received MK-8189 monotherapy orally QD at a dose of 4 mg starting on Day 1 and continuing up to Day 3, based on participant tolerability | 0 | None | 0 | 12 | 5 | 12 | View |
| Panel A (Healthy Participants): MK-8189 Monotherapy 8 mg | Healthy participants received MK-8189 monotherapy orally QD at a dose of 8 mg starting on Day 4 and continuing up to Day 6, based on participant tolerability | 0 | None | 0 | 12 | 3 | 12 | View |
| Panel A (Healthy Participants): MK-8189 Monotherapy 12 mg | Healthy participants received MK-8189 monotherapy orally QD at a dose of 12 mg starting on Day 7 and continuing up to Day 9, based on participant tolerability | 0 | None | 0 | 11 | 4 | 11 | View |
| Panel A (Healthy Participants): MK-8189 Monotherapy 16 mg | Healthy participants received MK-8189 monotherapy orally QD at a dose of 16 mg starting on Day 10 and continuing up to Day 12, based on participant tolerability | 0 | None | 0 | 11 | 5 | 11 | View |
| Panel A (Healthy Participants): MK-8189 Monotherapy 20 mg | Healthy participants received MK-8189 monotherapy orally QD at a dose of 20 mg starting on Day 13 and continuing up to Day 15, based on participant tolerability | 0 | None | 0 | 10 | 2 | 10 | View |
| Panel A (Healthy Participants): MK-8189 Monotherapy 24 mg | Healthy participants received MK-8189 monotherapy orally QD at a dose of 24 mg starting on Day 16 and continuing up to Day 18, based on participant tolerability | 0 | None | 0 | 10 | 5 | 10 | View |
| Panel A (Healthy Participants): Placebo Monotherapy | Healthy participants received MK-8189 monotherapy matching placebo orally QD on Days 1-18 | 0 | None | 0 | 4 | 3 | 4 | View |
| Panel B (Schizophrenia Participants): MK-8189 Monotherapy 4 mg | Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 4 mg starting on Day 1 and continuing up to Day 3, based on participant tolerability | 0 | None | 0 | 12 | 4 | 12 | View |
| Panel B (Schizophrenia Participants): MK-8189 Monotherapy 8 mg | Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 8 mg starting on Day 4 and continuing up to Day 6, based on participant tolerability | 0 | None | 0 | 11 | 3 | 11 | View |
| Panel B (Schizophrenia Participants): MK-8189 Monotherapy 12 mg | Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 12 mg starting on Day 7 and continuing up to Day 9, based on participant tolerability | 0 | None | 0 | 11 | 4 | 11 | View |
| Panel B (Schizophrenia Participants): MK-8189 Monotherapy 16 mg | Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 16 mg starting on Day 10 and continuing up to Day 12, based on participant tolerability | 0 | None | 0 | 11 | 8 | 11 | View |
| Panel B (Schizophrenia Participants): MK-8189 Monotherapy 20 mg | Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 20 mg starting on Day 13 and continuing up to Day 15, based on participant tolerability | 0 | None | 0 | 10 | 5 | 10 | View |
| Panel B (Schizophrenia Participants): MK-8189 Monotherapy 24 mg | Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 24 mg starting on Day 16 and continuing up to Day 18, based on participant tolerability | 0 | None | 0 | 10 | 7 | 10 | View |
| Panel B (Schizophrenia Participants): Placebo Monotherapy | Participants with Schizophrenia received MK-8189 monotherapy matching placebo orally QD on Days 1-18 | 0 | None | 0 | 4 | 4 | 4 | View |
| Panel C (Schizophrenia Participants): MK-8189 Add-on Therapy 4 mg | In addition to background AAP treatment, participants with Schizophrenia received MK-8189 add-on therapy orally QD at a dose of 4 mg starting on Day 1 and continuing up to Day 3, based on participant tolerability | 0 | None | 0 | 13 | 6 | 13 | View |
| Panel C (Schizophrenia Participants): MK-8189 Add-on Therapy 8 mg | In addition to background AAP treatment, participants with Schizophrenia received MK-8189 add-on therapy orally QD at a dose of 8 mg starting on Day 4 and continuing up to Day 11, based on participant tolerability | 0 | None | 0 | 11 | 8 | 11 | View |
| Panel C (Schizophrenia Participants): MK-8189 Add-on Therapy 12 mg | In addition to background AAP treatment, participants with Schizophrenia received MK-8189 add-on therapy orally QD at a dose of 12 mg starting on Day 7 and continuing up to Day 9, based on participant tolerability | 0 | None | 0 | 10 | 5 | 10 | View |
| Panel C (Schizophrenia Participants): MK-8189 Add-on Therapy 16 mg | In addition to background AAP treatment, participants with Schizophrenia received MK-8189 add-on therapy orally QD at a dose of 16 mg starting on Day 10 and continuing up to Day 12, based on participant tolerability | 0 | None | 0 | 8 | 5 | 8 | View |
| Panel C (Schizophrenia Participants): MK-8189 Add-on Therapy 20 mg | In addition to background AAP treatment, participants with Schizophrenia received MK-8189 add-on therapy orally QD at a dose of 20 mg starting on Day 13 and continuing up to Day 15, based on participant tolerability | 0 | None | 0 | 7 | 4 | 7 | View |
| Panel C (Schizophrenia Participants): MK-8189 Add-on Therapy 24 mg | In addition to background AAP treatment, participants with Schizophrenia received MK-8189 add-on therapy orally QD at a dose of 24 mg starting on Day 16 and continuing up to Day 18, based on participant tolerability | 0 | None | 0 | 7 | 4 | 7 | View |
| Panel C (Schizophrenia Participants): Placebo Add-on Therapy | In addition to background AAP treatment, participants with Schizophrenia received MK-8189 add-on therapy matching placebo orally QD on Days 1-18 | 0 | None | 0 | 4 | 1 | 4 | View |
| Panel D (Schizophrenia Participants): MK-8189 Monotherapy 8 mg | Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 8 mg starting on Day 1 and continuing up to Day 3, based on participant tolerability | 0 | None | 0 | 17 | 8 | 17 | View |
| Panel D (Schizophrenia Participants): MK-8189 Monotherapy 16 mg | Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 16 mg starting on Day 4 and continuing up to Day 6, based on participant tolerability | 0 | None | 0 | 16 | 8 | 16 | View |
| Panel D (Schizophrenia Participants): MK-8189 Monotherapy 24 mg | Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 24 mg starting on Day 7 and continuing up to Day 9, based on participant tolerability | 0 | None | 0 | 15 | 5 | 15 | View |
| Panel D (Schizophrenia Participants): MK-8189 Monotherapy 36 mg | Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 36 mg starting on Day 10 and continuing up to Day 12, based on participant tolerability | 0 | None | 1 | 13 | 4 | 13 | View |
| Panel D (Schizophrenia Participants): MK-8189 Monotherapy 48 mg | Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 48 mg starting on Day 13 and continuing up to Day 15, based on participant tolerability | 0 | None | 0 | 11 | 8 | 11 | View |
| Panel D (Schizophrenia Participants): Placebo Monotherapy | Participants with Schizophrenia received MK-8189 monotherapy matching placebo orally QD on Days 1-15 | 0 | None | 0 | 9 | 9 | 9 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Psychotic disorder | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 23.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Extrapyramidal disorder | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 23.0 | View |
| Head discomfort | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 23.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 23.0 | View |
| Hypoaesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 23.0 | View |
| Paraesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 23.0 | View |
| Parosmia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 23.0 | View |
| Somnolence | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 23.0 | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 23.0 | View |
| Tremor | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 23.0 | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 23.0 | View |
| Dissociation | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 23.0 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 23.0 | View |
| Nightmare | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 23.0 | View |
| Panic attack | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 23.0 | View |
| Paranoia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 23.0 | View |
| Psychotic disorder | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 23.0 | View |
| Restlessness | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 23.0 | View |
| Tic | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 23.0 | View |
| Breast tenderness | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 23.0 | View |
| Dysmenorrhoea | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 23.0 | View |
| Vulvovaginal pruritus | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 23.0 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | View |
| Epistaxis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | View |
| Hyperventilation | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | View |
| Oropharyngeal pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | View |
| Throat irritation | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | View |
| Dermatitis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 23.0 | View |
| Dermatitis contact | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 23.0 | View |
| Dry skin | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 23.0 | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 23.0 | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 23.0 | View |
| Skin lesion | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 23.0 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 23.0 | View |
| Orthostatic hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 23.0 | View |
| Asthenopia | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 23.0 | View |
| Eye irritation | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 23.0 | View |
| Abdominal discomfort | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.0 | View |
| Abdominal pain lower | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.0 | View |
| Abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.0 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.0 | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.0 | View |
| Gastrooesophageal reflux disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.0 | View |
| Gingival pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.0 | View |
| Glossodynia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.0 | View |
| Paraesthesia oral | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.0 | View |
| Neck pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | View |
| Akathisia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 23.0 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 23.0 | View |
| Dyskinesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 23.0 | View |
| Dystonia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 23.0 | View |
| Feeling of body temperature change | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 23.0 | View |
| Non-cardiac chest pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 23.0 | View |
| Vessel puncture site pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 23.0 | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.0 | View |
| Skin abrasion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 23.0 | View |
| Skin laceration | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 23.0 | View |
| Blood pressure increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 23.0 | View |
| Orthostatic heart rate response increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 23.0 | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 23.0 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | View |
| Flank pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | View |
| Muscle spasms | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | View |
| Muscle tightness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | View |
| Muscle twitching | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | View |
| Musculoskeletal pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | View |
| Atrial fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 23.0 | View |
| Palpitations | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 23.0 | View |
| Postural orthostatic tachycardia syndrome | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 23.0 | View |
| Abdominal distension | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.0 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.0 | View |
| Dry mouth | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.0 | View |
| Salivary hypersecretion | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.0 | View |
| Tongue dry | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.0 | View |
| Toothache | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.0 | View |
| Chest discomfort | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 23.0 | View |
| Chest pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 23.0 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 23.0 | View |
| Feeling hot | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 23.0 | View |