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 @ 5:02 PM
Ignite Modification Date: 2025-12-25 @ 2:42 PM
NCT ID: NCT05507450
Description: All-cause Mortality: randomized participants; Adverse Events: randomized participants who received at least 1 dose of study intervention according to the study intervention they received
Frequency Threshold: 5
Time Frame: All-cause Mortality: Randomization up to 12 months post-vaccination; Serious Adverse Events: Vaccination up to 12 months post-vaccination; Non-Serious Adverse Events: Vaccination up to 28 Days post-vaccination
Study: NCT05507450
Study Brief: Safety and Immunogenicity of Three V181 Dengue Vaccine Potencies in Adults (V181-003)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
V181 High-Potency Level Participants received a single 0.5 mL SC dose of V181 High-Potency vaccine. 0 None 8 231 200 231 View
V181 Mid-Potency Level Participants received a single 0.5 mL SC dose of V181 Mid-Potency vaccine. 0 None 9 461 402 461 View
V181 Low-Potency Level Participants received a single 0.5 mL SC dose of V181 Low-Potency vaccine. 1 None 12 459 406 459 View
Placebo Participants received a single 0.5 mL SC dose of placebo 0 None 6 115 79 115 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hypertensive heart disease SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 27.0 View
Inguinal hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Tooth impacted SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.0 View
Cholecystitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 27.0 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Diverticulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Herpes simplex encephalitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Osteomyelitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Perineal abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Scrotal abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Vestibular neuronitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Buttock injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27.0 View
Concussion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27.0 View
Fibula fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27.0 View
Ligament injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27.0 View
Post procedural bile leak SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27.0 View
Radius fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27.0 View
Tendon rupture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27.0 View
Hypocalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.0 View
Chondromalacia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 27.0 View
Intervertebral disc protrusion SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 27.0 View
Rhabdomyolysis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 27.0 View
Spinal osteoarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 27.0 View
Cancer pain SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 27.0 View
Neuroendocrine tumour SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 27.0 View
Thyroid cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 27.0 View
Epilepsy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.0 View
Abortion spontaneous SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA 27.0 View
Biochemical pregnancy SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA 27.0 View
Ectopic pregnancy SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA 27.0 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 27.0 View
Post-traumatic stress disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 27.0 View
Psychotic disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 27.0 View
Self-destructive behaviour SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 27.0 View
Suicidal ideation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 27.0 View
Suicide attempt SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 27.0 View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 27.0 View
Ligament rupture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27.0 View
Meniscus injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27.0 View
Overdose SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27.0 View
Post lumbar puncture syndrome SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27.0 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 27.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Lymphadenopathy SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 27.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.0 View
Injection site erythema SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.0 View
Injection site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.0 View
Injection site swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 27.0 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 27.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.0 View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.0 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 27.0 View