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 @ 11:20 PM
Ignite Modification Date: 2025-12-25 @ 9:02 PM
NCT ID: NCT04138056
Description: As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).
Frequency Threshold: 0
Time Frame: Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study).
Study: NCT04138056
Study Brief: A Study of a Vaccine Against Respiratory Syncytial Virus (RSV) When Given Alone and Together With a Vaccine Against Diphtheria, Pertussis and Tetanus (Tdap) Viruses Followed by a 2nd Dose of the RSV Vaccine to Healthy Non-Pregnant Women
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
RSV120_dTpa_RSV120(Pooled) Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and either one dose of 300 μg or 500 μg dTpa (Boostrix) vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end. 0 None 1 101 92 101 View
RSV120_Placebo_RSV120(Pooled) Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end. 0 None 0 101 90 101 View
RSV60_dTpa_RSV120(Pooled) Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and either one dose of 300 μg or 500 μg dTpa vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end. 0 None 0 103 91 103 View
RSV60_Placebo_RSV120(Pooled) Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end. 0 None 1 102 82 102 View
dTpa_Placebo_RSV120(Pooled) Subjects received one dose of Placebo and either one dose of 300 μg or 500 μg dTpa vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end. 0 None 0 102 89 102 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Radius fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Ulna fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Wrist fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Pyelonephritis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Inflammation - Extension Study SYSTEMATIC_ASSESSMENT General disorders None View
Injection site haematoma - Primary Study SYSTEMATIC_ASSESSMENT General disorders None View
Injection site pain - Primary Study SYSTEMATIC_ASSESSMENT General disorders None View
Fatigue - Primary Study SYSTEMATIC_ASSESSMENT General disorders None View
Injection site erythema - Primary Study SYSTEMATIC_ASSESSMENT General disorders None View
Injection site swelling - Primary Study SYSTEMATIC_ASSESSMENT General disorders None View
Pyrexia - Primary Study SYSTEMATIC_ASSESSMENT General disorders None View
Injection site bruising - Primary Study SYSTEMATIC_ASSESSMENT General disorders None View
Administration site pain - Primary Study SYSTEMATIC_ASSESSMENT General disorders None View
Administration site erythema - Primary Study SYSTEMATIC_ASSESSMENT General disorders None View
Injection site pruritus - Primary Study SYSTEMATIC_ASSESSMENT General disorders None View
Administration site swelling - Primary Study SYSTEMATIC_ASSESSMENT General disorders None View
Injection site haemorrhage - Primary Study SYSTEMATIC_ASSESSMENT General disorders None View
Vaccination site nodule - Primary Study SYSTEMATIC_ASSESSMENT General disorders None View
Malaise - Primary Study SYSTEMATIC_ASSESSMENT General disorders None View
Pain - Primary Study SYSTEMATIC_ASSESSMENT General disorders None View
Injection site warmth - Primary Study SYSTEMATIC_ASSESSMENT General disorders None View
Axillary pain - Primary Study SYSTEMATIC_ASSESSMENT General disorders None View
Chills - Primary Study SYSTEMATIC_ASSESSMENT General disorders None View
Injection site induration - Primary Study SYSTEMATIC_ASSESSMENT General disorders None View
Influenza like illness - Primary Study SYSTEMATIC_ASSESSMENT General disorders None View
Feeling cold - Primary Study SYSTEMATIC_ASSESSMENT General disorders None View
Hangover - Primary Study SYSTEMATIC_ASSESSMENT General disorders None View
Injection site discomfort - Primary Study SYSTEMATIC_ASSESSMENT General disorders None View
Injection site discolouration - Primary Study SYSTEMATIC_ASSESSMENT General disorders None View
Injection site rash - Primary Study SYSTEMATIC_ASSESSMENT General disorders None View
Headache - Primary Study SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dizziness - Primary Study SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Disturbance in attention - Primary Study SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Migraine - Primary Study SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Sciatica - Primary Study SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Head discomfort - Primary Study SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Neuralgia - Primary Study SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Sleep deficit - Primary Study SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Post-traumatic headache - Primary Study SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Gastrointestinal disorder - Primary Study SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea - Primary Study SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dyspepsia - Primary Study SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Toothache - Primary Study SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal distension - Primary Study SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhoea - Primary Study SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hyperchlorhydria - Primary Study SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal pain - Primary Study SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Upper respiratory tract infection - Primary Study SYSTEMATIC_ASSESSMENT Infections and infestations None View
Nasopharyngitis - Primary Study SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urinary tract infection - Primary Study SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sinusitis - Primary Study SYSTEMATIC_ASSESSMENT Infections and infestations None View
Rhinitis - Primary Study SYSTEMATIC_ASSESSMENT Infections and infestations None View
Gastroenteritis - Primary Study SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pharyngitis - Primary Study SYSTEMATIC_ASSESSMENT Infections and infestations None View
Tooth infection - Primary Study SYSTEMATIC_ASSESSMENT Infections and infestations None View
Conjunctivitis - Primary Study SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pharyngitis bacterial - Primary Study SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pharyngitis streptococcal - Primary Study SYSTEMATIC_ASSESSMENT Infections and infestations None View
Viral infection - Primary Study SYSTEMATIC_ASSESSMENT Infections and infestations None View
Bacterial vaginosis - Primary Study SYSTEMATIC_ASSESSMENT Infections and infestations None View
Chlamydial infection - Primary Study SYSTEMATIC_ASSESSMENT Infections and infestations None View
Cystitis - Primary Study SYSTEMATIC_ASSESSMENT Infections and infestations None View
Ear infection - Primary Study SYSTEMATIC_ASSESSMENT Infections and infestations None View
Gingivitis - Primary Study SYSTEMATIC_ASSESSMENT Infections and infestations None View
Oral herpes - Primary Study SYSTEMATIC_ASSESSMENT Infections and infestations None View
Otitis media - Primary Study SYSTEMATIC_ASSESSMENT Infections and infestations None View
Otitis media acute - Primary Study SYSTEMATIC_ASSESSMENT Infections and infestations None View
Vaginitis chlamydial - Primary Study SYSTEMATIC_ASSESSMENT Infections and infestations None View
Vulvovaginal mycotic infection - Primary Study SYSTEMATIC_ASSESSMENT Infections and infestations None View
Myalgia - Primary Study SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Back pain - Primary Study SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Neck pain - Primary Study SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Arthralgia - Primary Study SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Muscle tightness - Primary Study SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pain in extremity - Primary Study SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Musculoskeletal pain - Primary Study SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Musculoskeletal stiffness - Primary Study SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pain in jaw - Primary Study SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Oropharyngeal pain - Primary Study SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Cough - Primary Study SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Rhinorrhoea - Primary Study SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Nasal congestion - Primary Study SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Rash - Primary Study SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Dermatitis - Primary Study SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Dermatitis allergic - Primary Study SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Night sweats - Primary Study SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Lymphadenopathy - Primary Study SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Lymphadenitis - Primary Study SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Procedural pain - Primary Study SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Thermal burn - Primary Study SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Dysmenorrhoea - Primary Study SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Intermenstrual bleeding - Primary Study SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Vaginal discharge - Primary Study SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Insomnia - Primary Study SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Drug hypersensitivity - Primary Study SYSTEMATIC_ASSESSMENT Immune system disorders None View
Palpitations - Primary Study SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Injection site pain - Extension Study SYSTEMATIC_ASSESSMENT General disorders None View
Fatigue - Extension Study SYSTEMATIC_ASSESSMENT General disorders None View
Injection site erythema - Extension Study SYSTEMATIC_ASSESSMENT General disorders None View
Injection site swelling - Extension Study SYSTEMATIC_ASSESSMENT General disorders None View
Pyrexia - Extension Study SYSTEMATIC_ASSESSMENT General disorders None View
Injection site pruritus - Extension Study SYSTEMATIC_ASSESSMENT General disorders None View
Malaise - Extension Study SYSTEMATIC_ASSESSMENT General disorders None View
Administration site pain - Extension Study SYSTEMATIC_ASSESSMENT General disorders None View
Injection site induration - Extension Study SYSTEMATIC_ASSESSMENT General disorders None View
Influenza like illness - Extension Study SYSTEMATIC_ASSESSMENT General disorders None View
Injection site haemorrhage - Extension Study SYSTEMATIC_ASSESSMENT General disorders None View
Pain - Extension Study SYSTEMATIC_ASSESSMENT General disorders None View
Administration site swelling - Extension Study SYSTEMATIC_ASSESSMENT General disorders None View
Injection site lymphadenopathy - Extension Study SYSTEMATIC_ASSESSMENT General disorders None View
Headache - Extension Study SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Migraine with aura - Extension Study SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Gastrointestinal disorder - Extension Study SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Oesophageal spasm - Extension Study SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal pain - Extension Study SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhoea - Extension Study SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting - Extension Study SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pharyngitis - Extension Study SYSTEMATIC_ASSESSMENT Infections and infestations None View
Nasopharyngitis - Extension Study SYSTEMATIC_ASSESSMENT Infections and infestations None View
Bronchitis - Extension Study SYSTEMATIC_ASSESSMENT Infections and infestations None View
Ear infection - Extension Study SYSTEMATIC_ASSESSMENT Infections and infestations None View
Gastroenteritis - Extension Study SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pyelonephritis - Extension Study SYSTEMATIC_ASSESSMENT Infections and infestations None View
Tonsillitis - Extension Study SYSTEMATIC_ASSESSMENT Infections and infestations None View
Respiratory tract infection - Extension Study SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sinusitis - Extension Study SYSTEMATIC_ASSESSMENT Infections and infestations None View
Upper respiratory tract infection - Extension Study SYSTEMATIC_ASSESSMENT Infections and infestations None View
Oropharyngeal pain - Extension Study SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Nasal congestion - Extension Study SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Rhinorrhoea - Extension Study SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Limb discomfort - Extension Study SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Myalgia - Extension Study SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Arthralgia - Extension Study SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Muscle strain - Extension Study SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Contusion - Extension Study SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Affect lability - Extension Study SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Poor quality sleep - Extension Study SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Night sweats - Extension Study SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rash - Extension Study SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Ear pain - Extension Study SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Dysmenorrhoea - Extension Study SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Vision blurred - Extension Study SYSTEMATIC_ASSESSMENT Eye disorders None View
Seasonal allergy - Extension Study SYSTEMATIC_ASSESSMENT Immune system disorders None View
Hypertension - Extension Study SYSTEMATIC_ASSESSMENT Vascular disorders None View