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: 2025-12-25 @ 1:33 AM
Ignite Modification Date: 2025-12-25 @ 11:47 PM
NCT ID: NCT04826094
Description: ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
Frequency Threshold: 5
Time Frame: AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
Study: NCT04826094
Study Brief: A Study to Assess the Safety and Immune Response to Env-C DNA and Protein Vaccines in Kenya
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Group 1: Vaccine 3 doses of prime vaccination at weeks 0, 4, 12 followed by 3 doses of boost vaccination at weeks 20, 32, 56 0 None 1 17 15 17 View
Group 2: Vaccine 3 doses of prime vaccination at weeks 0, 4, 12 followed by 3 doses of boost vaccination at weeks 20, 32, 56 0 None 0 16 15 16 View
Group 5: Vaccine 3 doses of prime vaccination at weeks 0, 4, 12 followed by 3 doses of boost vaccination at weeks 20, 32, 56 0 None 0 16 13 16 View
Group 6: Vaccine 3 doses of prime vaccination at weeks 0, 4, 12 followed by 3 doses of boost vaccination at weeks 20, 32, 56 0 None 0 17 13 17 View
Group 7: Vaccine 3 doses of prime vaccination at weeks 0, 4, 12 followed by 3 doses of boost vaccination at weeks 20, 32, 56 0 None 0 16 13 16 View
Pooled Placebo Pooled placebo arm. 0 None 0 23 17 23 View
Group 3: Vaccine 3 doses of prime vaccination at weeks 0, 4, 12 followed by 3 doses of boost vaccination at weeks 20, 32, 56 0 None 0 16 14 16 View
Group 4: Vaccine 3 doses of prime vaccination at weeks 0, 4, 12 followed by 3 doses of boost vaccination at weeks 20, 32, 56 0 None 0 16 13 16 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Type 1 diabetes mellitus NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (25.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders Medra View
Leukopenias NEC NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders Medra View
Neutropenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders Medra View
Thrombocytopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders Medra View
Excessive cerumen production NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders Medra View
Graves' disease NON_SYSTEMATIC_ASSESSMENT Endocrine disorders Medra View
Abdominal discomfort NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Medra View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Medra View
Abdominal pain lower NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Medra View
Abdominal pain upper NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Medra View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Medra View
Dental caries NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Medra View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Medra View
Dyspepsia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Medra View
Enteritis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Medra View
Gastritis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Medra View
Gastrooesophageal reflux disease NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Medra View
Haematochezia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Medra View
Haemorrhoids NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Medra View
Hyperchlorhydria NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Medra View
Odynophagia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Medra View
Proctalgia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Medra View
Stomatitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Medra View
Toothache NON_SYSTEMATIC_ASSESSMENT General disorders Medra View
Chest pain NON_SYSTEMATIC_ASSESSMENT General disorders Medra View
Chills NON_SYSTEMATIC_ASSESSMENT General disorders Medra View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders Medra View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders Medra View
Swelling NON_SYSTEMATIC_ASSESSMENT General disorders Medra View
Tenderness NON_SYSTEMATIC_ASSESSMENT General disorders Medra View
Amoebiasis NON_SYSTEMATIC_ASSESSMENT Infections and infestations Medra View
Bacterial vaginosis NON_SYSTEMATIC_ASSESSMENT Infections and infestations Medra View
Bronchitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations Medra View
Conjunctivitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations Medra View
Extrapulmonary tuberculosis NON_SYSTEMATIC_ASSESSMENT Infections and infestations Medra View
Gastroenteritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations Medra View
Helicobacter infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations Medra View
Malaria NON_SYSTEMATIC_ASSESSMENT Infections and infestations Medra View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations Medra View
Pelvic inflammatory disease NON_SYSTEMATIC_ASSESSMENT Infections and infestations Medra View
Pharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations Medra View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations Medra View
Respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations Medra View
Rhinitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations Medra View
Septic rash NON_SYSTEMATIC_ASSESSMENT Infections and infestations Medra View
Sinusitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations Medra View
Tonsillitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations Medra View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations Medra View
Urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations Medra View
Vaginal infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations Medra View
Vulvovaginal candidiasis NON_SYSTEMATIC_ASSESSMENT Infections and infestations Medra View
Wound infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations Medra View
Wound infection bacterial NON_SYSTEMATIC_ASSESSMENT Infections and infestations Medra View
Eye injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications Medra View
Incision site pain NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications Medra View
Limb injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications Medra View
Road traffic accident NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications Medra View
Soft tissue injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications Medra View
Wound NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications Medra View
Alanine aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations Medra View
Aspartate aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations Medra View
Blood creatinine increased NON_SYSTEMATIC_ASSESSMENT Investigations Medra View
International normalised ratio increased NON_SYSTEMATIC_ASSESSMENT Investigations Medra View
Lymphocyte count decreased NON_SYSTEMATIC_ASSESSMENT Investigations Medra View
Prothrombin time prolonged NON_SYSTEMATIC_ASSESSMENT Investigations Medra View
White blood cell count decreased NON_SYSTEMATIC_ASSESSMENT Investigations Medra View
Arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders Medra View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders Medra View
Groin pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders Medra View
Muscle spasms NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders Medra View
Myalgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders Medra View
Pain in extremity NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders Medra View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders Medra View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders Medra View
Neuropathy peripheral NON_SYSTEMATIC_ASSESSMENT Nervous system disorders Medra View
Abnormal uterine bleeding NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders Medra View
Heavy menstrual bleeding NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders Medra View
Intermenstrual bleeding NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders Medra View
Ovarian disorder NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders Medra View
Vaginal haemorrhage NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders Medra View
Allergic cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders Medra View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders Medra View
Epistaxis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders Medra View
Oropharyngeal pain NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders Medra View
Rhinitis allergic NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders Medra View
Rhinorrhoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders Medra View
Dermatitis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Medra View
Dermatitis allergic NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Medra View
Hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders Medra View