Adverse Events Module

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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 @ 12:07 AM
Ignite Modification Date: 2025-12-25 @ 10:06 PM
NCT ID: NCT04964258
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: Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
Study: NCT04964258
Study Brief: A Study of TAK-105 in Healthy Adults
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 TAK-105-a matching-placebo, injection, subcutaneously, once on Day 1. 0 None 0 14 6 14 View
Part 1: TAK-105 Dose 1 TAK-105-a Dose 1, injection, subcutaneously, once on Day 1. 0 None 0 6 3 6 View
Part 1: TAK-105 Dose 2 TAK-105-a Dose 2, injection, subcutaneously, once on Day 1. 0 None 1 6 4 6 View
Part 1: TAK-105 Dose 3 TAK-105-a Dose 3, injection, subcutaneously, once on Day 1. 0 None 0 6 3 6 View
Part 1: TAK-105 Dose 4 TAK-105-a Dose 4, injection, subcutaneously, once on Day 1. 0 None 0 6 4 6 View
Part 1: TAK-105 Dose 5 TAK-105-a Dose 5, injection, subcutaneously, once on Day 1. 0 None 0 6 3 6 View
Part 1: TAK-105 Dose 6 TAK-105-a Dose 6, injection, subcutaneously, once on Day 1. 0 None 1 6 4 6 View
Part 1: TAK-105 Dose 7 TAK-105-a Dose 7, injection, subcutaneously, once on Day 1. 0 None 1 6 4 6 View
Part 2: Placebo TAK-105-a matching-placebo, injection, subcutaneously, once weekly for 4 weeks. 0 None 1 6 5 6 View
Part 2: TAK-105 Dose 1A TAK-105-a Dose 1A, injection, subcutaneously, once weekly for 2 and 4 weeks. 0 None 1 12 9 12 View
Part 2: TAK-105 Dose 2A TAK-105-a Dose 2A, injection, subcutaneously, once weekly for 1 week. 0 None 1 6 6 6 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 26 View
Ventricular tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 26 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Medical device site vesicles SYSTEMATIC_ASSESSMENT General disorders MedDRA 26 View
Muscle strain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 26 View
Muscle twitching SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 26 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 26 View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 26 View
Orthostatic hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 26 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 26 View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 26 View
Restlessness SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 26 View
Rhinorrhoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 26 View
Salivary hypersecretion SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 26 View
Sinus arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 26 View
Supraventricular extrasystoles SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 26 View
Supraventricular tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 26 View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 26 View
Temporomandibular joint syndrome SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 26 View
Ventricular extrasystoles SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 26 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 26 View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 26 View
Dizziness postural SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 26 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 26 View
Dysuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 26 View
Electrocardiogram T wave inversion SYSTEMATIC_ASSESSMENT Investigations MedDRA 26 View
Extrasystoles SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 26 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 26 View
Foot fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 26 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 26 View
Hunger SYSTEMATIC_ASSESSMENT General disorders MedDRA 26 View
Hyperhidrosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 26 View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 26 View
Lymphadenopathy SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 26 View
Medical device site dermatitis SYSTEMATIC_ASSESSMENT General disorders MedDRA 26 View
Medical device site erythema SYSTEMATIC_ASSESSMENT General disorders MedDRA 26 View
Medical device site irritation SYSTEMATIC_ASSESSMENT General disorders MedDRA 26 View
Medical device site papule SYSTEMATIC_ASSESSMENT General disorders MedDRA 26 View
Medical device site pruritus SYSTEMATIC_ASSESSMENT General disorders MedDRA 26 View
Medical device site reaction SYSTEMATIC_ASSESSMENT General disorders MedDRA 26 View
Chromaturia SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 26 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 26 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 26 View
Abdominal tenderness SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 26 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 26 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 26 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 26 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 26 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 26 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 26 View
Abdominal discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 26 View