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 @ 2:04 AM
Ignite Modification Date:
2025-12-26 @ 12:30 AM
NCT ID:
NCT02461160
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. Adverse events were summarized as per the regimen received by the participants.
Frequency Threshold:
0
Time Frame:
Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28)
Study:
NCT02461160
Study Brief:
Phase 1, TAK-915-1001, Single-Rising Dose, Multiple-Rising Dose, Drug-Drug Interaction, Relative Bioavailability, Food Effect, and Effect on Elderly Participants Study
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| SRD Cohorts Pooled Placebo | TAK-915 placebo-matching suspension, orally, once on Day 1. | None | None | 0 | 8 | 0 | 8 | View |
| SRD Cohort 1 TAK-915 30 mg | TAK-915 30 mg suspension, orally, once on Day 1. | None | None | 0 | 6 | 1 | 6 | View |
| SRD Cohort 2: TAK-915 100 mg | TAK-915 100 mg suspension, orally, once on Day 1. | None | None | 0 | 6 | 2 | 6 | View |
| SRD Cohort 3: TAK-915 200 mg | TAK-915 200 mg suspension, orally, once on Day 1. | None | None | 0 | 12 | 2 | 12 | View |
| MRD Cohorts Pooled Placebo | TAK-915 placebo-matching suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 placebo-matching suspension, orally, once on Days 8 to 14. | None | None | 0 | 6 | 1 | 6 | View |
| MRD Cohort 5: TAK-915 30 mg | TAK-915 30 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 30 mg suspension, orally, once on Days 8 to 14. | None | None | 0 | 6 | 2 | 6 | View |
| MRD Cohort 6: TAK-915 100 mg | TAK-915 100 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 100 mg suspension, orally, once on Days 8 to 14. | None | None | 0 | 6 | 1 | 6 | View |
| MRD Cohort 7: TAK-915 200 mg | TAK-915 200 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 200 mg suspension, orally, once on Days 8 to 14. | None | None | 1 | 6 | 1 | 6 | View |
| DDI Cohort 8: Midazolam 2 mg | Midazolam 2 mg suspension, orally, once on Days 1 and 16 (within 15 minutes after last dose of TAK-915). | None | None | 0 | 12 | 0 | 12 | View |
| DDI Cohort 8: TAK-915 100 mg | TAK-915 100 mg, suspension, orally, once on Day 3, followed by a 7-day washout period, followed by TAK-915 100 mg, suspension, orally, once, daily on Days 10 to 16. | None | None | 0 | 12 | 5 | 12 | View |
| DDI Cohort 8: TAK-915 + Midazolam 2 mg | Midazolam 2 mg suspension, orally, once on Day 1, followed by TAK-915 100 mg, suspension, orally, once on Day 3, followed by a 7-day washout period, followed by TAK-915 100 mg, suspension, orally, once, daily on Days 10 to 16 and Midazolam 2 mg solution, orally, once, on Day 16 (within 15 minutes after last dose of TAK-915) | None | None | 0 | 12 | 1 | 12 | View |
| BA/FE Cohort Regimen A | TAK-915 50 mg, suspension, orally, under fasted conditions once on Day 1 of ant period. | None | None | 0 | 12 | 2 | 12 | View |
| BA/FE Cohort Regimen B | TAK-915 50 mg, tablet, orally, under fasted conditions once on Day 1 of any Period. | None | None | 0 | 12 | 0 | 12 | View |
| BA/FE Cohort Regimen C | TAK-915 50 mg, tablet, orally under fed conditions once on Day 1 of any period. | None | None | 0 | 12 | 3 | 12 | View |
| ESSD Cohort 12: TAK-915 50 mg | TAK-915 50 mg, suspension, orally, under fasted conditions, once on Day 1 in participants aged 65 to 75 years. | None | None | 0 | 8 | 2 | 8 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anxiety | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version: 19.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version: 19.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version: 19.0 | View |
| Chest discomfort | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version: 19.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version: 19.0 | View |
| Pollakiuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA version: 19.0 | View |
| Application site irritation | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version: 19.0 | View |
| Faeces hard | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version: 19.0 | View |
| Infrequent bowel movements | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version: 19.0 | View |
| Hyperhidrosis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA version: 19.0 | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version: 19.0 | View |
| Rhinitis allergic | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version: 19.0 | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version: 19.0 | View |
| Injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version: 19.0 | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA version: 19.0 | View |
| Ear pain | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA version: 19.0 | View |
| Influenza like illness | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version: 19.0 | View |
| Chromaturia | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA version: 19.0 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version: 19.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version: 19.0 | View |
| Rhinorrhoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version: 19.0 | View |