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 @ 3:06 PM
Ignite Modification Date:
2025-12-25 @ 1:27 PM
NCT ID:
NCT02625259
Description:
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
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 (Day 46) after the last dose of study drug
Study:
NCT02625259
Study Brief:
A Study to Evaluate the Relative Bioavailability, Effect of Food, and Gastric Potential Hydrogen (pH) Modification on the Pharmacokinetics of TAK-117 (MLN1117) 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: TAK-117 900 mg Capsules | TAK-117 9\*100 mg, capsules (CTM), orally, once on Day 1 or 15 of intervention period. | None | None | 0 | 19 | 3 | 19 | View |
| Part-1: TAK-117 900 mg Tablets | TAK-117 3\*300 mg, tablets (NTM), orally, once on Day 1 or 15 of intervention period. | None | None | 0 | 18 | 5 | 18 | View |
| Part-2: TAK-117 600 mg Fasted | TAK-117 2\*300 mg, tablets (NTM), orally, once in a fasted state on Day 1 or 15 of intervention period. | None | None | 0 | 17 | 8 | 17 | View |
| Part-2: TAK-117 600 mg Fed | TAK-117 2\*300 mg, tablets (NTM), orally, with a standard high-fat breakfast, once on Day 1 or 15 of intervention period. | None | None | 0 | 17 | 4 | 17 | View |
| Part-3: TAK-117 900 mg | TAK-117 3\*300 mg, tablets (NTM), orally, once on Day 1. | None | None | 0 | 16 | 6 | 16 | View |
| Part-3: Lansoprazole 30 mg | Lansoprazole 30 mg, capsule, orally, once daily from Day 10 to Day 14. | None | None | 0 | 16 | 1 | 16 | View |
| Part 3: Lansoprazole 30 mg + TAK-117 900 mg | Lansoprazole 30 mg, capsule, orally, once daily on Day 15 along with TAK-117 3\*300 mg, tablets (NTM), orally, once on Day 15. | None | None | 0 | 16 | 1 | 16 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.0) | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.0) | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (18.0) | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (18.0) | View |
| Paraesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (18.0) | View |
| Menstruation delayed | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (18.0) | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | View |
| Vision blurred | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (18.0) | View |
| Oropharyngeal pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | View |
| Dry throat | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | View |
| Rash macular | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (18.0) | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (18.0) | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.0) | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.0) | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (18.0) | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (18.0) | View |
| Somnolence | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (18.0) | View |
| Vessel puncture site pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (18.0) | View |