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: 2025-12-26 @ 12:16 PM
Ignite Modification Date: 2025-12-26 @ 12:16 PM
NCT ID: NCT02207400
Description: None
Frequency Threshold: 0
Time Frame: Adverse events were collected throughout the study from the start of the washout period, until five days following last treatment.
Study: NCT02207400
Study Brief: To Evaluate Efficacy and Tolerability of Sodium Bicarbonate Toothpaste and Its Effect on Opportunistic or Resistant Organisms
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Sodium Bicarbonate and Sodium Fluoride Dentifrice Experimental toothpaste containing sodium bicarbonate experimental dentifrice plus 1150 ppm fluoride as sodium fluoride None None 0 123 17 123 View
Sodium Fluoride Dentifrice Toothpaste containing 1100 ppm fluoride as sodium fluoride None None 0 123 14 123 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Cellulitis Orbital SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Lower Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Acute sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
GASTROENTERITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
PHARYNGITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
PHARYNGITIS STREPTOCOCCAL SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
PULPITIS DENTAL SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
SINUSITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
STAPHYLOCOCCAL INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
TOOTH ABSCESS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
MOUTH INJURY SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 10.0 View
TRAUMATIC ULCER SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 10.0 View
ARTHROPOD BITE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 10.0 View
THERMAL BURN SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 10.0 View
CHEILITIS SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
SENSITIVITY OF TEETH SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
APHTHOUS STOMATITIS SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
DIARRHOEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
GINGIVAL ULCERATION SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
MOUTH ULCERATION SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
TONGUE ULCERATION SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
HYPOTHYROIDISM SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 10.0 View
BURNING SENSATION SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
PULMONARY CONGESTION SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.0 View
INGROWING NAIL SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 10.0 View
GASTROENTERITIS VIRAL SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View