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 @ 2:35 AM
Ignite Modification Date: 2025-12-26 @ 1:11 AM
NCT ID: NCT03486834
Description: The analysis population for the serious and non-serious adverse events included all randomized participants who received at least 1 injection of V160 or placebo, had safety follow-up data, and had been assigned to the treatment arm corresponding to the actual clinical material received. The all-cause mortality analysis population included all randomized participants.
Frequency Threshold: 5
Time Frame: All-cause mortality and serious adverse events: Up to ~Month 24; Non-serious adverse events: Up to 14 days following any vaccination.
Study: NCT03486834
Study Brief: V160 2-Dose and 3-Dose Regimens in Healthy Cytomegalovirus (CMV) Seronegative Females (V160-002)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
V160 3-Dose Group Participants received V160 vaccination by intramuscular (IM) injection on Day 1, Month 2, and Month 6. 0 None 22 728 697 728 View
Placebo Group Participants received placebo by IM injection on Day 1, Month 2, and Month 6. 0 None 26 732 557 732 View
V160 2-Dose Group Participants received V160 vaccination by IM injection on Day 1 and Month 6 and placebo at Month 2. 0 None 29 729 700 729 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cardiac arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.0 View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Abdominal pain lower SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Oesophageal ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Salivary gland calculus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Cholelithiasis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 24.0 View
Appendicitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Breast abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
COVID-19 pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Epstein-Barr virus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Pharyngotonsillitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Pyelonephritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Pyelonephritis acute SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Ankle fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
Chest injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
Concussion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
Intentional overdose SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
Pelvic bone injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
Procedural haemorrhage SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
Radius fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
Rib fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
Splenic rupture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
Tendon rupture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
Tibia fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
Traumatic arthropathy SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
Intervertebral disc protrusion SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
Cervix carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.0 View
Enchondromatosis SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.0 View
Ovarian germ cell teratoma benign SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.0 View
Epilepsy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
Idiopathic intracranial hypertension SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
Abortion missed SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA 24.0 View
Abortion spontaneous SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA 24.0 View
Anembryonic gestation SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA 24.0 View
Eclampsia SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA 24.0 View
Ectopic pregnancy SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA 24.0 View
Postpartum haemorrhage SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA 24.0 View
Pre-eclampsia SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA 24.0 View
Ruptured ectopic pregnancy SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA 24.0 View
Threatened labour SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA 24.0 View
Alcohol abuse SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24.0 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24.0 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24.0 View
Suicidal ideation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24.0 View
Suicide attempt SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24.0 View
Renal colic SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24.0 View
Renal impairment SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24.0 View
Ureterolithiasis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24.0 View
Adnexal torsion SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 24.0 View
Intermenstrual bleeding SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 24.0 View
Ovarian cyst SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 24.0 View
Ovarian cyst ruptured SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 24.0 View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Haemorrhage SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 24.0 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 24.0 View
Appendicitis perforated SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Injection site erythema SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Injection site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Injection site pruritus SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Injection site swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View