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 @ 1:45 AM
Ignite Modification Date:
2025-12-26 @ 12:02 AM
NCT ID:
NCT02748694
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:
From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks)
Study:
NCT02748694
Study Brief:
Phase 1 TAK-041 First-in-Human Safety, Tolerability, and Pharmacokinetics 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 |
|---|---|---|---|---|---|---|---|---|
| Part 1 (SRD): Placebo Cohorts 1-5 | TAK-041 placebo-matching suspension, orally, once on Day 1 in fasted healthy participants in the SRD period. | 0 | None | 0 | 10 | 4 | 10 | View |
| Part 1 (SRD): Cohort 1: TAK-041 5 mg | TAK-041 5 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period. | 0 | None | 0 | 6 | 0 | 6 | View |
| Part 1 (SRD): Cohort 2: TAK-041 10 mg | TAK-041 10 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period. | 0 | None | 0 | 6 | 0 | 6 | View |
| Part 1 (SRD): Cohort 1: TAK-041 20 mg | TAK-041 20 mg, suspension, orally, once on Day 8 in the SRD period. | 0 | None | 0 | 6 | 0 | 6 | View |
| Part 1 (SRD): Cohort 2: TAK-041 40 mg | TAK-041 40 mg, suspension, orally, once on Day 8 in the SRD period. | 0 | None | 0 | 6 | 0 | 6 | View |
| Part 1 (SRD): Cohort 3: TAK-041 80 mg | TAK-041 80 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period. | 0 | None | 0 | 6 | 2 | 6 | View |
| Part 1 (SRD): Cohort 4: TAK-041 120 mg | TAK-041 120 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period. | 0 | None | 0 | 6 | 2 | 6 | View |
| Part 1 (SRD): Cohort 5: TAK-041 160 mg | TAK-041 160 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period. | 0 | None | 0 | 8 | 2 | 6 | View |
| Part 2 (MRD): Placebo Cohorts 1-4 | TAK-041 placebo-matching suspension, orally, once on Day 1 in fasted healthy participants in the MRD period. | 0 | None | 0 | 6 | 3 | 8 | View |
| Part 2 (MRD): Cohort 1: TAK-041 40/20 mg | TAK-041 40 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 20 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period. | 0 | None | 0 | 6 | 4 | 6 | View |
| Part 2 (MRD): Cohort 2: TAK-041 80/40 mg | TAK-041 80 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 40 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period. | 0 | None | 0 | 6 | 4 | 6 | View |
| Part 2 (MRD): Cohort 3: TAK-041 120/60 mg | TAK-041 120 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 60 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period. | 0 | None | 0 | 6 | 3 | 6 | View |
| Part 2 (MRD): Cohort 4: TAK-041 160/80 mg | TAK-041 160 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 80 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period. | 0 | None | 0 | 6 | 5 | 6 | View |
| Part 3: Relative Bioavailability (RBA)/Food Effect: Regimen A | TAK-041 40 mg, tablet, orally, once on Day 1 in fasted state (Regimen A) in Cohort 1. | 0 | None | 0 | 9 | 1 | 9 | View |
| Part 3: RBA/Food Effect: Regimen B | TAK-041 40 mg, tablet, orally, once on Day 1 in fed state (Regimen B) in Cohort 2. | 0 | None | 0 | 9 | 2 | 9 | View |
| Part 4: MRD: Placebo | TAK-041 placebo-matching, suspension, orally, on Days 1, 8, 15 and 22 in participants with schizophrenia | 0 | None | 0 | 8 | 6 | 8 | View |
| Part 4: MRD: TAK-041 160/80 mg | TAK-041 160 mg as loading dose, suspension, orally, once on Day 1 followed by 80 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in participants with schizophrenia. | 0 | None | 0 | 16 | 9 | 16 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Application site dermatitis | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 21.0 | View |
| Catheter site phlebitis | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 21.0 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 21.0 | View |
| Feeling abnormal | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 21.0 | View |
| Energy increased | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 21.0 | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.0 | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.0 | View |
| Conjunctivitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.0 | View |
| Thermal burn | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 21.0 | View |
| Contusion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 21.0 | View |
| Limb fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 21.0 | View |
| Skin abrasion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 21.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 21.0 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 21.0 | View |
| Paraesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 21.0 | View |
| Somnolence | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 21.0 | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 21.0 | View |
| Speech disorder | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 21.0 | View |
| Oropharyngeal pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | View |
| Throat irritation | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | View |
| Nasal congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | View |
| Rhinorrhoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | View |
| Palpitations | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 21.0 | View |
| Eyelid oedema | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 21.0 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 21.0 | View |
| Abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 21.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 21.0 | View |
| Abdominal discomfort | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 21.0 | View |
| Aphthous ulcer | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 21.0 | View |
| Blood creatine phosphokinase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 21.0 | View |
| Application site irritation | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 21.0 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | View |
| Agitation | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 21.0 | View |
| Abnormal dreams | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 21.0 | View |
| Change in sustained attention | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 21.0 | View |
| Euphoric mood | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 21.0 | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 21.0 | View |
| Dermatitis contact | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 21.0 | View |
| Orthostatic hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 21.0 | View |
| Toothache | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 21.0 | View |
| Arthropod bite | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 21.0 | View |
| Road traffic accident | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 21.0 | View |