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 @ 1:24 AM
Ignite Modification Date:
2025-12-25 @ 11:35 PM
NCT ID:
NCT05567393
Description:
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Frequency Threshold:
5
Time Frame:
From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
Study:
NCT05567393
Study Brief:
A Study of TAK-951 in Healthy Adults
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Part 1 (SRD): Cohort 6: TAK-951 Dose 6 | TAK-951 Dose 6, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period. | 0 | None | 0 | 6 | 3 | 6 | View |
| Part 1 (SRD): Cohort 13: TAK-951 Dose 7 | TAK-951 Dose 7, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period. | 0 | None | 0 | 6 | 3 | 6 | View |
| Part 1 (SRD): Cohort 17: TAK-951 Dose 10 | TAK-951 Dose 10, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period. | 0 | None | 0 | 6 | 5 | 6 | View |
| Part 1 (SRD): Cohort 18: TAK-951 Dose 11 | TAK-951 Dose 11, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period. | 0 | None | 0 | 6 | 2 | 6 | View |
| Part 3 (MRD): Pooled Placebo | TAK-951 placebo-matching, SC injection, for 5 days from Days 1 to 5 in fasted healthy participants in the MRD period. | 0 | None | 0 | 8 | 3 | 8 | View |
| Part 3 (MRD): Cohort 10: TAK-951 Dose 1A | TAK-951 Dose 1A, SC injection, for 5 days from Days 1 to 5 in fasted healthy participants in the MRD period. | 0 | None | 0 | 6 | 1 | 6 | View |
| Part 3 (MRD): Cohort 11: TAK-951 Dose 2A | TAK-951 Dose 2A, SC injection, for 5 days from Days 1 to 5 in fasted healthy participants in the MRD period. | 0 | None | 1 | 6 | 5 | 6 | View |
| Part 1 (SRD): Cohort 14: TAK-951 Dose 8 | TAK-951 Dose 8, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period. | 0 | None | 0 | 6 | 5 | 6 | View |
| Part 1 (SRD): Cohort 16: TAK-951 Dose 9 | TAK-951 Dose 9, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period. | 0 | None | 0 | 6 | 4 | 6 | View |
| Part 3 (MRD): Cohort 12: TAK-951 Dose 3A | TAK-951 Dose 3A, SC injection, for 5 days from Days 1 to 5 in fasted healthy participants in the MRD period. | 0 | None | 0 | 6 | 4 | 6 | View |
| Part 3 (MRD): Cohort 20: TAK-951 Dose 4A | TAK-951 Dose 4A, SC injection, for 5 days from Days 1 to 5 in fasted healthy participants in the MRD period. | 0 | None | 0 | 6 | 5 | 6 | View |
| Part 1 (SRD): Cohort 1: TAK-951 Dose 2 | TAK-951 Dose 2, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period. | 0 | None | 0 | 6 | 1 | 6 | View |
| Part 1 (SRD): Cohort 15: TAK-951 Dose 2 | TAK-951 Dose 2, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period. | 0 | None | 0 | 6 | 1 | 6 | View |
| Part 1 (SRD): Cohort 3: TAK-951 Dose 3 | TAK-951 Dose 3, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period. | 0 | None | 0 | 6 | 1 | 6 | View |
| Part 1 (SRD): Cohort 5: TAK-951 Dose 5 | TAK-951 Dose 5, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period. | 0 | None | 0 | 6 | 2 | 6 | View |
| Part 1 (SRD): Pooled Placebo | TAK-951 placebo-matching, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period. | 0 | None | 0 | 24 | 0 | 24 | View |
| Part 1 (SRD): Cohort 2: TAK-951 Dose 1 | TAK-951 Dose 1, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period. | 0 | None | 0 | 6 | 1 | 6 | View |
| Part 1 (SRD): Cohort 4: TAK-951 Dose 4 | TAK-951 Dose 4, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period. | 0 | None | 0 | 6 | 1 | 6 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Ventricular tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 23 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23 | View |
| Abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23 | View |
| Accelerated idioventricular rhythm | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 23 | View |
| Amnesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 23 | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 23 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 23 | View |
| Bradyphrenia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 23 | View |
| Chills | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 23 | View |
| Contusion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 23 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 23 | View |
| Dermatitis contact | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 23 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 23 | View |
| Dizziness postural | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 23 | View |
| Dry mouth | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 23 | View |
| Faeces discoloured | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 23 | View |
| Feeling hot | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 23 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 23 | View |
| Hot flush | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 23 | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 23 | View |
| Injection site bruising | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 23 | View |
| Injection site induration | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 23 | View |
| Injection site pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 23 | View |
| Injection site reaction | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 23 | View |
| Muscle spasms | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 23 | View |
| Musculoskeletal discomfort | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 23 | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 23 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23 | View |
| Non-cardiac chest pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 23 | View |
| Orthostatic hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 23 | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 23 | View |
| Palpitations | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 23 | View |
| Papule | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 23 | View |
| Paraesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 23 | View |
| Peripheral swelling | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 23 | View |
| Postural orthostatic tachycardia syndrome | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 23 | View |
| Presyncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 23 | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 23 | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 23 | View |
| Sinus tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 23 | View |
| Somnolence | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 23 | View |
| Toothache | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23 | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23 | View |
| Upper-airway cough syndrome | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 23 | View |
| Vessel puncture site bruise | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 23 | View |
| Visual impairment | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 23 | View |