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: 2025-12-24 @ 4:32 PM
Ignite Modification Date: 2025-12-25 @ 2:24 PM
NCT ID: NCT02302066
Description: Safety Analysis Set included all participants who received at least 1 dose of trial vaccine. Data for other (non-serious) adverse events is reported for participants from Immunogenicity Subset with available data for analyses.
Frequency Threshold: 2
Time Frame: All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 540); Other adverse events: From any vaccination (Day 1, Day 91, and Day 365) up to 28 days post vaccination.
Study: NCT02302066
Study Brief: Safety and Immunogenicity of Different Schedules of Takeda's Tetravalent Dengue Vaccine Candidate (TDV) 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
Group 1 (TDV 2-Dose) Takeda's tetravalent dengue vaccine candidate (TDV), 0.5 mL, subcutaneous injection on Days 1 and 91. Placebo-matching, 0.5 mL, subcutaneous injection on Day 365. 0 None 10 200 17 91 View
Group 2 (TDV 1-Dose) Takeda's TDV, 0.5 mL, subcutaneous injection on Day 1. Placebo-matching, 0.5 mL, subcutaneous injection on Days 91 and 365. 1 None 18 398 43 187 View
Group 3 (TDV 1-Dose + Booster) Takeda's TDV, 0.5 mL, subcutaneous injection on Days 1 and 365. Placebo-matching, 0.5 mL, subcutaneous injection on Day 91. 1 None 65 998 41 191 View
Group 4 (Placebo Control) Placebo-matching, 0.5 mL, subcutaneous injection on Days 1, 91 and 365. 0 None 10 198 22 93 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Tonsillitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Tooth Abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Viral Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.0 View
Head Injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.0 View
Multiple Injuries SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.0 View
Abdominal Injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.0 View
Ankle Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.0 View
Arthropod Bite SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.0 View
Arthropod Sting SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.0 View
Burns Second Degree SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.0 View
Facial Bones Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.0 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.0 View
Aneurysmal Bone Cyst SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.0 View
Teratoma Benign SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 21.0 View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Epilepsy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Generalised Tonic-Clonic SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Migraine SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Relapsing-Remitting Multiple Sclerosis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Abortion Spontaneous SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA 21.0 View
Premature Baby SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA 21.0 View
Glomerulonephritis Acute SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 21.0 View
Nephritic Syndrome SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 21.0 View
Ovarian Cyst SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 21.0 View
Ovarian Cyst Torsion SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 21.0 View
Asthmatic Crisis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Bronchospasm SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Homicide SYSTEMATIC_ASSESSMENT Social circumstances MedDRA 21.0 View
Finger Amputation SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 21.0 View
Infectious Colitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Nasal Abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Osteomyelitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Peritonitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Peritonsillar Abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Pharyngotonsillitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Pulmonary Tuberculosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Pyelonephritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Septic Shock SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Ileus Paralytic SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Inguinal Hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Intestinal Obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Volvulus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Dehiscence SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Food Allergy SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 21.0 View
Hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 21.0 View
Amoebic Dysentery SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Appendicitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Abscess Limb SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Ascariasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Dengue Fever SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Scarlet Fever SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Amoebiasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Appendicitis Perforated SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Burkholderia Cepacia Complex Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Encephalomyelitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Endometritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Gastroenteritis Rotavirus SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Hepatitis A SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Immune Thrombocytopenic Purpura SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 21.0 View
Ocular Myasthenia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 21.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 21.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Viral Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Tonsillitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Parasitic Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Nasal Congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View