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 @ 1:25 AM
Ignite Modification Date: 2025-12-25 @ 11:35 PM
NCT ID: NCT02761993
Description: None
Frequency Threshold: 0
Time Frame: Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
Study: NCT02761993
Study Brief: Safety, Efficacy and Treatment Regimen Study of ST266 in Subjects With Moderate to Severe Periodontitis
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 Group 1: 1XST266 dosed as per regimen 1. ST266: 1X ST266 applied in a dose of 20 microliters per tooth. Total daily dose will be less than 1 milliliter. ST266 will be applied directly to the marginal gingiva around each tooth (buccal and lingual). 0 None 2 52 29 52 View
Group 2 Group 2: 1XST266 as per regimen 2. ST266: 1X ST266 applied in a dose of 20 microliters per tooth. Total daily dose will be less than 1 milliliter. ST266 will be applied directly to the marginal gingiva around each tooth (buccal and lingual). 0 None 2 49 27 49 View
Group 3 Group 3: Placebo dosed as per regimen 1. Saline (0.9% NaCl): Saline applied in a dose of 20 microliters per tooth. Total daily dose will be less than 1 milliliter. Saline will be applied directly to the marginal gingiva around each tooth (buccal and lingual). 0 None 2 50 24 50 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Colon Cancer NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Endometrial cancer NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Pancreatic carcinoma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Cholecystitis NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Anaphylactic shock NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View
Arthritis bacterial NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Sensitivity of teeth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Toothache SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gingival erythema SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Leukoplakia oral SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dental fistula SYSTEMATIC_ASSESSMENT Infections and infestations None View
Mouth injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Lip injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Tooth fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Burn oral cavity SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Tongue injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Blood pressure increased SYSTEMATIC_ASSESSMENT Investigations None View
Blood pressure systolic increased SYSTEMATIC_ASSESSMENT Investigations None View
Blood pressure diastolic decreased SYSTEMATIC_ASSESSMENT Investigations None View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Device failure SYSTEMATIC_ASSESSMENT Product Issues None View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Oral disorder SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Oral mucosal erythema SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Palatal disorder SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dental discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dyspepsia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gingival oedema SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hypoaesthesia oral SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Lip haematoma SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Lip swelling SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Oral mucosal discolouration SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Oral mucosal exfoliation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Oral pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Palatal swelling SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Paraesthesia oral SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Tongue discolouration SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Tongue disorder SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Tongue geographic SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Tongue ulceration SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Tooth loss SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Tooth resorption SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Traumatic occlusion SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastroenteritis viral NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Gingivitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Influenza NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Tooth abscess SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Angular cheilitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Arthritis bacterial NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Eye infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Gastroenteritis norovirus NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Kidney infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Lyme disease NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Oral herpes SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Tooth infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Vulvovaginal mycotic infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Arthropod sting NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Thermal burn SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Arthropod bite NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Back injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Concussion NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Contusion NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Fall NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Gingival injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Laceration NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Muscle strain NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Post procedural swelling NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Procedural complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Procedural pain NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations None View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations None View
Blood pressure decreased SYSTEMATIC_ASSESSMENT Investigations None View
Blood urine present SYSTEMATIC_ASSESSMENT Investigations None View
C-reactive protein increased SYSTEMATIC_ASSESSMENT Investigations None View
Haemoglobin decreased SYSTEMATIC_ASSESSMENT Investigations None View
Haemoglobin urine SYSTEMATIC_ASSESSMENT Investigations None View
Lymphocyte count increased SYSTEMATIC_ASSESSMENT Investigations None View
Mean cell volume increased SYSTEMATIC_ASSESSMENT Investigations None View
Monocyte count decreased SYSTEMATIC_ASSESSMENT Investigations None View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations None View
Protein urine present SYSTEMATIC_ASSESSMENT Investigations None View
Red blood cell count decreased SYSTEMATIC_ASSESSMENT Investigations None View
Urine leukocyte esterase positive SYSTEMATIC_ASSESSMENT Investigations None View
White blood cell count decreased SYSTEMATIC_ASSESSMENT Investigations None View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Muscle spasms NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pain in jaw SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Arthritis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Musculoskeletal pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Seasonal allergy NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View
Anaphylactic shock NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View
Hypersensitivity NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View
Device damage SYSTEMATIC_ASSESSMENT Product Issues None View
Dermatitis allergic NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Hyperkeratosis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rash pruritic NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Swelling face SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Adverse drug reaction NON_SYSTEMATIC_ASSESSMENT General disorders None View
Chills NON_SYSTEMATIC_ASSESSMENT General disorders None View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders None View
Complication associated with device SYSTEMATIC_ASSESSMENT General disorders None View
Colon cancer NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Endometrial cancer NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Pancreatic carcinoma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Lower respiratory tract congestion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Eye swelling NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Ocular hyperaemia NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Cholecystitis NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Hypercholesterolaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Anxiety NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Vaginal haemorrhage NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Aphthous ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Gingival pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View