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 @ 2:39 AM
Ignite Modification Date:
2025-12-26 @ 1:17 AM
NCT ID:
NCT05596734
Description:
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
Frequency Threshold:
1
Time Frame:
Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Study:
NCT05596734
Study Brief:
A Study to Evaluate the Safety, Tolerability, and Immunogenicity of Combined Modified RNA Vaccine Candidates Against COVID-19 and Influenza
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1) | Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 1- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1. | 0 | None | 0 | 30 | 26 | 30 | View |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg | Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 60 mcg (original/OMI BA.4/BA.5) intramuscularly on Day 1. | 0 | None | 1 | 28 | 27 | 28 | View |
| Substudy A, 18-64 Years: qIRV 60 mcg | Participants aged 18-64 years were administered qIRV 60 mcg intramuscularly on Day 1. | 0 | None | 0 | 30 | 24 | 30 | View |
| Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV | Participants aged 18-64 years were administered Bivalent BNT162b2 30 mcg (Original/OMI BA.4/BA.5) and concurrent administration of licensed QIV in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations. | 0 | None | 1 | 32 | 27 | 32 | View |
| Substudy A, >=65 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1) | Participants aged greater than or equal to (\>=) 65 years were administered qIRV and Bivalent BNT162b2 (Combination 1- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1. | 0 | None | 0 | 33 | 31 | 33 | View |
| Substudy A, >=65 Years: qIRV /Bivalent BNT162b2 (60 mcg) | Participants aged \>=65 years were administered qIRV and Bivalent BNT162b2 60 mcg (original/OMI BA.4/BA.5) intramuscularly on Day 1. | 0 | None | 0 | 32 | 22 | 32 | View |
| Substudy A, >=65 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2) | Participants aged \>=65 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1. | 0 | None | 0 | 33 | 29 | 33 | View |
| Substudy A, >=65 Years: qIRV 30 mcg | Participants aged \>=65 years were administered qIRV 30 mcg intramuscularly on Day 1. | 0 | None | 2 | 33 | 25 | 33 | View |
| Substudy A, >=65 Years: qIRV 60 mcg | Participants aged \>=65 years were administered qIRV 60 mcg intramuscularly on Day 1. | 0 | None | 0 | 33 | 27 | 33 | View |
| Substudy A, >=65 Years: Bivalent BNT162b2 (30 mcg) /QIV | Participants aged \>=65 years were administered Bivalent BNT162b2 30 mcg (Original/OMI BA.4/BA.5) and concurrent administration of licensed QIV in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations. | 0 | None | 0 | 33 | 20 | 33 | View |
| Substudy B, 18-64 Years: QIV and Bivalent BNT162b2 (30 mcg) | Participants aged 18-64 years were administered bivalent BNT162b2 30 mcg (Original/OMI BA.4/BA.5) and licensed QIV concurrently in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations. | 0 | None | 0 | 29 | 19 | 29 | View |
| Substudy B, 18-64 Years: QIV and bIRV /Bivalent BNT162b2 (45mcg) | Participants aged 18-64 years were administered bIRV and Bivalent BNT162b2 45 mcg (OMI BA.4/BA.5) and licensed QIV concurrently in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations. | 0 | None | 0 | 32 | 23 | 32 | View |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1) | Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 1- 90 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1. | 0 | None | 0 | 124 | 107 | 124 | View |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2) | Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 90 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1. | 0 | None | 0 | 122 | 104 | 122 | View |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 1) | Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 1- 60 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1. | 0 | None | 0 | 114 | 95 | 114 | View |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (75 mcg) | Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 75 mcg (OMI BA.4/BA.5) intramuscularly on Day 1. | 0 | None | 1 | 31 | 26 | 31 | View |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 3) | Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 3- 90 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1. | 0 | None | 0 | 30 | 27 | 30 | View |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 2) | Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 60 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1. | 0 | None | 0 | 33 | 29 | 33 | View |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2) | Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1. | 0 | None | 0 | 30 | 24 | 30 | View |
| Substudy A, 18-64 Years: qIRV 30 mcg | Participants aged 18-64 years were administered qIRV 30 mcg intramuscularly on Day 1. | 0 | None | 0 | 30 | 22 | 30 | View |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 4) | Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 4- 90 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1. | 0 | None | 0 | 30 | 23 | 30 | View |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 3) | Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 3- 60 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1. | 0 | None | 0 | 26 | 20 | 26 | View |
| Substudy B, 18-64 Years: tIRV /Bivalent BNT162b2 (75 mcg) | Participants aged 18-64 years were administered tIRV and Bivalent BNT162b2 75 mcg (OMI BA.4/BA.5) intramuscularly on Day 1. | 0 | None | 0 | 32 | 24 | 32 | View |
| Substudy B, 18-64 Years: qIRV (30 mcg) | Participants aged 18-64 years were administered qIRV 30 mcg intramuscularly on Day 1. | 0 | None | 0 | 29 | 20 | 29 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Appendicitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v26.1 | View |
| Gastric ulcer | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v26.1 | View |
| Cervical spinal stenosis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v26.1 | View |
| Cholecystitis infective | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v26.1 | View |
| Cervical vertebral fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v26.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Lymphadenopathy | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v26.1 | View |
| Palpitations | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v26.1 | View |
| Chest pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v26.1 | View |
| Fatigue (FATIGUE) | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v26.1 | View |
| Injection site erythema | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v26.1 | View |
| Injection site pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v26.1 | View |
| Diarrhoea (DIARRHEA) | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v26.1 | View |
| Conjunctivitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v26.1 | View |
| Upper respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v26.1 | View |
| Viral infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v26.1 | View |
| Animal bite | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v26.1 | View |
| Muscle strain | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v26.1 | View |
| SARS-CoV-2 test positive | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v26.1 | View |
| Arthralgia (JOINT PAIN) | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v26.1 | View |
| Myalgia (MUSCLE PAIN) | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v26.1 | View |
| Pain in extremity | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v26.1 | View |
| Headache (HEADACHE) | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v26.1 | View |
| Menstruation irregular | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA v26.1 | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v26.1 | View |
| Productive cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v26.1 | View |
| Wheezing | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v26.1 | View |
| Dermatitis contact | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v26.1 | View |
| INFLUENZA LIKE ILLNESS | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v26.1 | View |
| Pharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v26.1 | View |
| Tooth abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v26.1 | View |
| Viral upper respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v26.1 | View |
| Back pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v26.1 | View |
| Tachycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v26.1 | View |
| Hypothyroidism | NON_SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA v26.1 | View |
| Acute sinusitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v26.1 | View |
| Rhinovirus infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v26.1 | View |
| Urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v26.1 | View |
| Corneal abrasion | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v26.1 | View |
| Blood pressure systolic increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v26.1 | View |
| Spinal osteoarthritis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v26.1 | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v26.1 | View |
| Syncope | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v26.1 | View |
| Tension headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v26.1 | View |
| Oropharyngeal pain | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v26.1 | View |
| Sinus congestion | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v26.1 | View |
| Chills (CHILLS) | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v26.1 | View |
| Injection site erythema (REDNESS) | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v26.1 | View |
| Injection site pain (PAIN) | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v26.1 | View |
| Injection site swelling (SWELLING) | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v26.1 | View |
| Pyrexia (FEVER) | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v26.1 | View |
| Vomiting (VOMITING) | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v26.1 | View |
| COVID-19 | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v26.1 | View |