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 @ 2:19 AM
Ignite Modification Date:
2025-12-26 @ 12:49 AM
NCT ID:
NCT02706834
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 Day 1 up to 30 days after last dose of study drug (up to 85 days).
Study:
NCT02706834
Study Brief:
Safety, Tolerability and Pharmacokinetics of Escalating Single Doses of TAK-828 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 |
|---|---|---|---|---|---|---|---|---|
| Cohort 1: Placebo | Non-Japanese participants in Cohort 1 who received placebo-matching TAK-828 oral solution, fasted (after an 8 hour fast), on Day 1 of Periods 1, 2, 3 or 4. | None | None | 0 | 10 | 3 | 10 | View |
| Cohort 1: TAK-828 0.1 mg/ Fasted | Non-Japanese participants in Cohort 1 who received TAK-828 0.1 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 1. | None | None | 1 | 9 | 5 | 9 | View |
| Cohort 1: TAK-828 0.5 mg/ Fasted | Non-Japanese participants in Cohort 1 who received TAK-828 0.5 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 2. | None | None | 0 | 8 | 3 | 8 | View |
| Cohort 1: TAK-828 15 mg/ Fasted | Non-Japanese participants in Cohort 1 who received TAK-828 15 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 3. | None | None | 0 | 7 | 1 | 7 | View |
| Cohort 1: TAK-828 100 mg/ Fasted | Non-Japanese participants in Cohort 1 who received TAK-828 100 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 4. | None | None | 0 | 7 | 0 | 7 | View |
| Cohort 1: TAK-828 100 mg/ Fed | Non-Japanese participants in Cohort 1 who received TAK-828 100 mg oral solution, fed (high-fat, high-calorie meal 30 minutes prior to administration of study drug), on Day 1 of Period 5. | None | None | 0 | 8 | 1 | 8 | View |
| Cohort 2: Placebo | Non-Japanese participants in Cohort 2 who received placebo-matching TAK-828 oral solution, fasted (after an 8 hour fast), on Day 1 of Periods 1, 2, 3 or 4. | None | None | 0 | 9 | 0 | 9 | View |
| Cohort 2: TAK-828 3 mg/ Fasted | Non-Japanese participants in Cohort 2 who received TAK-828 3 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 1. | None | None | 0 | 9 | 1 | 9 | View |
| Cohort 2: TAK-828 50 mg/ Fasted | Non-Japanese participants in Cohort 2 who received TAK-828 50 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 2. | None | None | 0 | 9 | 1 | 9 | View |
| Cohort 2: TAK-828 200 mg/ Fasted | Cohort 2: TAK-828 200 mg/ Fasted Non-Japanese participants in Cohort 2 who received TAK-828 200 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 3. | None | None | 0 | 9 | 1 | 9 | View |
| Cohort 2: TAK-828 100 mg/ Fasted | Non-Japanese participants in Cohort 2 who received TAK-828 100 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 4. | None | None | 0 | 9 | 2 | 9 | View |
| Cohort 2: TAK-828 100 mg/ Fed | Non-Japanese participants in Cohort 2 who received TAK-828 100 mg oral solution, fed (high-fat, high-calorie meal 30 minutes prior to administration of study drug), on Day 1 of Period 5. | None | None | 0 | 4 | 0 | 4 | View |
| Cohort 3: Placebo | Japanese participants in Cohort 3 who received placebo-matching TAK-828 oral solution, fasted (after an 8 hour fast), on Day 1 of Periods 1, 2 or 3. | None | None | 0 | 12 | 0 | 12 | View |
| Cohort 3: TAK-828 15 mg/ Fasted | Japanese participants in Cohort 3 who received TAK-828 15 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 1. | None | None | 0 | 8 | 2 | 8 | View |
| Cohort 3: TAK-828 100 mg/ Fasted | Japanese participants in Cohort 3 who received TAK-828 100 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 2. | None | None | 0 | 8 | 6 | 8 | View |
| Cohort 3: TAK-828 150 mg/ Fasted | Japanese participants in Cohort 3 who received TAK-828 150 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 3. | None | None | 0 | 6 | 4 | 6 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Ventricular tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 19.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Abdominal discomfort | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.0 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.0 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.0 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.0 | View |
| Feeling abnormal | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 19.0 | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 19.0 | View |
| Musculoskeletal discomfort | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | View |
| Temporomandibular joint syndrome | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 19.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 19.0 | View |
| Presyncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 19.0 | View |
| Chromaturia | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 19.0 | View |
| Oropharyngeal pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | View |
| Dermatitis contact | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 19.0 | View |
| Orthostatic hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 19.0 | View |
| Foreign body reaction | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 19.0 | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | View |
| Abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.0 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 19.0 | View |
| Arthropod bite | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 19.0 | View |
| Sleep disorder | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 19.0 | View |
| Erythema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 19.0 | View |
| Hyperhidrosis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 19.0 | View |