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 @ 2:23 AM
Ignite Modification Date: 2025-12-26 @ 12:55 AM
NCT ID: NCT05178134
Description: Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
Frequency Threshold: 0
Time Frame: Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Study: NCT05178134
Study Brief: A Phase 2 Bridging Study to Assess the New Formulation of ETVAX
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
The Wet Formulation of ETVAX. The wet formulation consists of a liquid suspension of inactivated bacteria (ETEX 21-24) and LCTBA in one vial, freeze-dried dmLT adjuvant in a second vial, and effervescent buffer granules in a separate sachet. Prior to administration, the buffer is dissolved in 150 ml tap water, followed by the addition of the content of the vaccine vial (inactivated bacteria mixed with LCTBA) and reconstituted and diluted adjuvant dmLT from the second vial. Etvax: Preparation of complete Wet formulation. The vaccine supplied as a liquid, is mixed with the 150 ml of sodium bicarbonate buffer solution on the day of preparation for use on dosing day. Just prior to administration 10 µg of dmLT is added by pipette (50 µl). 0 None 0 140 107 140 View
The Partially Dried Formulation of Selected Components of ETVAX. The partially dried formulation, dmLT and LCTBA are spray-dried and mixed with the buffer granules and stabilizing excipients in a sachet. Prior to administration, the content of the buffer sachet (buffer, dmLT, and LCTBA) is dissolved in 150 ml tap water, followed by the addition of a liquid suspension of inactivated bacteria (ETEX 21-24). Etvax: Preparation of partially dry formulation. The partially dry formulation of vaccine is prepared by adding the effervescent powder containing the dmLT and LCTBA to 150 ml of water. After mixing, the content of the vaccine vial is added to the mixture and the vaccine is administered to the volunteer within 30 minutes after adding the buffer powder to the water. 0 None 0 140 102 140 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Cerumen impaction NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Ear pain NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Excessive cerumen production NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Inner ear inflammation NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Visual impairment NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Abdominal discomfort NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal distension NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal pain upper NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dyspepsia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Eructation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Faeces hard NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastrointestinal hypermotility NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastrooesophageal reflux disease NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gingival swelling NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Mouth ulceration NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Reflux gastritis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Toothache NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Asthenia NON_SYSTEMATIC_ASSESSMENT General disorders None View
Chest discomfort NON_SYSTEMATIC_ASSESSMENT General disorders None View
Chest pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Chills NON_SYSTEMATIC_ASSESSMENT General disorders None View
Feeling cold NON_SYSTEMATIC_ASSESSMENT General disorders None View
Hunger NON_SYSTEMATIC_ASSESSMENT General disorders None View
Malaise NON_SYSTEMATIC_ASSESSMENT General disorders None View
Pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Sensation of foreign body NON_SYSTEMATIC_ASSESSMENT General disorders None View
Thirst NON_SYSTEMATIC_ASSESSMENT General disorders None View
Hypersensitivity NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View
Seasonal allergy NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View
COVID-19 NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Candida infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Herpes Simplex NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Otosalpingitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Limb injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Appetite disorder NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Vitamin B12 deficiency NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Musculoskeletal pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Myalgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Spondylolisthesis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Papilloma conjunctival NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Burning sensation NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Exertional headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Migraine NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Tremor NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Anxiety NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Disorientation NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Dysuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Cervical polyp NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Dysmenorrhoea NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Premenstrual dysphoric disorder NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dry throat NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Nasal congestion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Oropharyngeal pain NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Cold sweat NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Dermatitis atopic NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Eczema NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Sinus tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Vertigo NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Eye inflammation NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Flatulence NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastric dilatation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders None View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders None View
Gastroenteritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Ophthalmic herpes simplex NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Ligament sprain NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Decreased appetite NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Neck pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Lymphadenopathy NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View