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 @ 2:58 AM
Ignite Modification Date: 2025-12-26 @ 1:39 AM
NCT ID: NCT05067933
Description: Safety Population: Included all randomized participants who received at least one dose of the study drug and were analyzed in the treatment group corresponding to actual study drug received. During the safety follow-up period, only SAEs and MAAEs were collected.
Frequency Threshold: 4
Time Frame: Active Study Period: Day 1 to Day 57; Safety Follow-up Period: Last-dose to up to 12 months post-last dose
Study: NCT05067933
Study Brief: A Ph 2 Trial With an Oral Tableted COVID-19 Vaccine
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Safety Follow-up Period: VXA-CoV2-1.1-S: 1 x 10^10 IU ± 0.5 Log Healthy participants who received VXA-CoV2-1.1-S at a dose of 1 x 10\^10 IU ± 0.5 log and entered the safety follow-up period until Month 13. 1 None 3 44 1 44 View
Active Study Period: VXA-CoV2-1.1-S: 1 x 10^10 IU ± 0.5 Log Healthy participants received VXA-CoV2-1.1-S at a dose of 1 x 10\^10 IU ± 0.5 log as an oral tablet on Day 1 and Day 29 of the 57-day active study period. 0 None 1 45 25 45 View
Active Study Period: VXA-CoV2-1.1-S: 1 x 10^11 IU ± 0.5 Log Healthy participants received VXA-CoV2-1.1-S at a dose of 1 x 10\^11 IU ± 0.5 log as an oral tablet on Day 1 and Day 29 of the 57-day active study period. 0 None 0 21 14 21 View
Safety Follow-up Period: VXA-CoV2-1.1-S: 1 x 10^11 IU ± 0.5 Log Healthy participants who received VXA-CoV2-1.1-S at a dose of 1 x 10\^11 IU ± 0.5 log and entered the safety follow-up period until Month 13. 0 None 0 21 3 21 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hospitalization SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA (24.0) View
Iron deficiency anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA (24.0) View
Cardiac arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (24.0) View
Appendicitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (24.0) View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (24.0) View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (24.0) View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (24.0) View
Deep vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (24.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (24.0) View
Amylase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA (24.0) View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (24.0) View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (24.0) View
Thirst SYSTEMATIC_ASSESSMENT General disorders MedDRA (24.0) View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (24.0) View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (24.0) View
Abdominal Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (24.0) View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (24.0) View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (24.0) View
Malaise SYSTEMATIC_ASSESSMENT General disorders MedDRA (24.0) View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA (24.0) View
Limb injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (24.0) View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (24.0) View