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 @ 2:38 PM
Ignite Modification Date:
2025-12-25 @ 1:10 PM
NCT ID:
NCT02566759
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:
0
Time Frame:
Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (Part 1 Day 31, Part 2 Day 46, Part 3 Day 44 and Part 4 Day 43)
Study:
NCT02566759
Study Brief:
A TAK-831-1001, Single and Multiple Rising Dose Study in Healthy Participants
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: Placebo Pooled | TAK-831 placebo-matching suspension, orally, once on Day 1. | None | None | 0 | 12 | 6 | 12 | View |
| Part 1: TAK-831 30 mg | TAK-831 30 mg, suspension, orally, once on Day 1. | None | None | 0 | 6 | 2 | 6 | View |
| Part 1: TAK-831 100 mg | TAK-831 100 mg, suspension, orally, once on Day 1. | None | None | 0 | 6 | 2 | 6 | View |
| Part 1: TAK-831 250 mg | TAK-831 250 mg, suspension, orally, once on Day 1. | None | None | 0 | 6 | 1 | 6 | View |
| Part 1: TAK-831 500 mg | TAK-831 500 mg, suspension, orally, once on Day 1. | None | None | 0 | 6 | 3 | 6 | View |
| Part 1: TAK-831 750 mg | TAK-831 750 mg, suspension, orally, once on Day 1. | None | None | 0 | 6 | 4 | 6 | View |
| Part 2: Placebo Pooled | TAK-831 placebo-matching suspension, orally, once on Day 1 and Days 4-16. | None | None | 0 | 8 | 6 | 8 | View |
| Part 2: TAK-831 30 mg | TAK-831 30 mg, suspension, orally, once on Day 1 and Days 4-16. | None | None | 0 | 6 | 5 | 6 | View |
| Part 2: TAK-831 100 mg | TAK-831 100 mg, suspension, orally, once on Day 1 and Days 4-16. | None | None | 0 | 6 | 6 | 6 | View |
| Part 2: TAK-831 200 mg | TAK-831 200 mg, suspension, orally, once on Day 1 and Days 4-16. | None | None | 0 | 6 | 2 | 6 | View |
| Part 2: TAK-831 400 mg | TAK-831 400 mg, suspension, orally, once on Day 1 and Days 4-16. | None | None | 0 | 6 | 5 | 6 | View |
| Part 3: Placebo | TAK-831 placebo-matching suspension, orally, once daily on Days 1-14. | None | None | 0 | 1 | 1 | 1 | View |
| Part 3: TAK-831 400 mg | TAK-831 400 mg, suspension, orally, once daily from Days 1-14. | None | None | 0 | 5 | 5 | 5 | View |
| Part 4: TAK-831 100 mg Tablet Fasted | TAK-831 100 mg, tablet, orally, once in fasted state on Day 1 of either Period 1, 2 or 3. | None | None | 0 | 23 | 5 | 23 | View |
| Part 4: TAK-831 100 mg Tablet Fed | TAK-831 100 mg, tablet, orally, once in fed state on Day 1 of either Period 1, 2 or 3. | None | None | 0 | 23 | 3 | 23 | View |
| Part 4: TAK-831 100 mg Suspension Fasted | TAK-831 100 mg, suspension, orally, once in fasted state on Day 1 of either Period 1, 2 or 3. | None | None | 0 | 24 | 4 | 24 | View |
| Part 1: TAK-831 10 mg | TAK-831 10 milligram (mg), suspension, orally, once on Day 1. | None | None | 0 | 6 | 2 | 6 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.0) | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.0) | View |
| Dry mouth | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.0) | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.0) | View |
| Oral pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.0) | View |
| Swollen tongue | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.0) | View |
| Abdominal discomfort | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.0) | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.0) | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.0) | View |
| Eructation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.0) | View |
| Abdominal distension | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.0) | View |
| Catheter site bruise | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.0) | View |
| Catheter site related reaction | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.0) | View |
| Chills | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.0) | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.0) | View |
| Feeling cold | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.0) | View |
| Feeling abnormal | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.0) | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.0) | View |
| Influenza like illness | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.0) | View |
| Fungal skin infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.0) | View |
| Ligament sprain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (19.0) | View |
| Nail injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (19.0) | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (19.0) | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (19.0) | View |
| Dizziness postural | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (19.0) | View |
| Dysgeusia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (19.0) | View |
| Presyncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (19.0) | View |
| Somnolence | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (19.0) | View |
| Paraesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (19.0) | View |
| Tremor | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (19.0) | View |
| Disturbance in attention | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (19.0) | View |
| Lethargy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (19.0) | View |
| Memory impairment | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (19.0) | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (19.0) | View |
| Disorientation | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (19.0) | View |
| Tearfulness | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (19.0) | View |
| Throat irritation | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | View |
| Epistaxis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | View |
| Oropharyngeal pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | View |
| Nasal congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | View |
| Dermatitis contact | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (19.0) | View |
| Dry skin | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (19.0) | View |
| Erythema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (19.0) | View |
| Palpitations | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (19.0) | View |
| Eye irritation | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (19.0) | View |
| Muscle twitching | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | View |
| Musculoskeletal stiffness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | View |
| Flatulence | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.0) | View |
| Catheter site pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.0) | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | View |
| Neck pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | View |
| Musculoskeletal pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | View |
| Trismus | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | View |
| Hypoaesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (19.0) | View |
| Hyperhidrosis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (19.0) | View |
| Hypoacusis | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (19.0) | View |
| Tinnitus | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (19.0) | View |