Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 9:56 PM
Ignite Modification Date: 2025-12-25 @ 7:34 PM
NCT ID: NCT03120832
Description: None
Frequency Threshold: 0
Time Frame: Adverse events were collected up to 6 months after last dose/visit, a total of about 640 days since the start of the study.
Study: NCT03120832
Study Brief: Phase 1 Trial of PAN-301-1 (SNS-301) in Cancer Patients
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Cohort 1 PAN-301-1 vaccine is administered intradermally in 3 cohorts of patients in a dose escalation schema every 21 days In this cohort it is administered as SNS-301 2.0 x 10\^10 particles/administration intradermally once every 21 days. Then from 6th treatment visit escalated within same patient to dose 10\^11 particles/administration intradermally once every 21 days. Then from 11th treatment visit escalated within same patient to dose 3 X 10\^11 particles/administration intradermally once every 21 days. 0 None 1 3 3 3 View
Cohort 2 PAN-301-1 vaccine is administered intradermally in 3 cohorts of patients in a dose escalation schema every 21 days In this cohort it is administered as SNS-301 1.0 x 10\^11 particles/administration intradermally once every 21 days. Then from 6th treatment visit escalated within same patient to dose 3 X 10\^11 particles/administration intradermally once every 21 days. 0 None 0 3 2 3 View
Cohort 3 PAN-301-1 vaccine is administered intradermally in 3 cohorts of patients in a dose escalation schema every 21 days In this cohort it is administered as SNS-301 3.0 x 10\^11 particles/administration intradermally once every 21 days. 0 None 1 6 5 6 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Vertigo positional NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Demyelination NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hypertension NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Dyspnea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders None View
Injection site erythema NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View
Arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Alanine aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Herpes Zoster NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Decreased appetite NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Tinea cruris NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Tooth abscess NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Actinic keratosis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Infarction NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Bronchitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Chest pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Generalized Oedema NON_SYSTEMATIC_ASSESSMENT General disorders None View
Oedema peripheral NON_SYSTEMATIC_ASSESSMENT General disorders None View
Peripheral Swelling NON_SYSTEMATIC_ASSESSMENT General disorders None View
Rash Erythematous NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Palpitations NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cataract NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dyspepsia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastroesophageal reflux disease NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hypochloremia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Back Pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Depression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Cystitis hemorrhagic NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Hematuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Lymphoedema NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View