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: 2025-12-24 @ 4:32 PM
Ignite Modification Date: 2025-12-25 @ 2:24 PM
NCT ID: NCT02005666
Description: None
Frequency Threshold: 0
Time Frame: Day 1 to Day 78
Study: NCT02005666
Study Brief: To Compare the Efficacy and Safety of Clindamycin Phosphate 1.2% / Benzoyl Peroxide 5% Gel of CHL Versus DUAC® Gel
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Test-Cadila Healthcare Limited 1.2% Clindamycin Phosphate/ 5% Benzoyl Peroxide Gel of Cadila healthcare limited Dosage Form:-Gel Dosage:-Thin Layer/Pea sized Frequency:-Once a day ,every evening Duration:-77 consecutive days Other Name: 1.2% Clindamycin Phosphate/ 5% 0 None 0 338 59 338 View
Reference-DUAC® Gel DUAC® Gel Dosage Form:-Gel Dosage:-Thin Layer/Pea sized Frequency:-Once a day ,every evening Duration:-77 consecutive days 0 None 0 343 61 343 View
Placebo Placebo, Dosage Form:-Gel Dosage:-Thin Layer/Pea sized Frequency:-Once a day ,every evening Duration:-77 consecutive days 0 None 0 169 29 169 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Toothache SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.1 View
Application site dryness SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.1 View
Application site erythema SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.1 View
Application site oedema SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.1 View
Application site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.1 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.1 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Chapped lips SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Hyperchlorhydria SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Application site pruritus SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.1 View
Facial pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.1 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.1 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.1 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.1 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Conjunctivitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Cystitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Ear infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Gastroenteritis viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Gastrointestinal viral infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Otitis media SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Pharyngitis streptococcal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Tonsillitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.1 View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.1 View
Rhinorrhoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.1 View
Sinus congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.1 View
Throat irritation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.1 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.1 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.1 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.1 View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.1 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.1 View
Pain in Jaw SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.1 View
Dermatitis contact SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.1 View
Eczema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.1 View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.1 View
Mechanical urticaria SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.1 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.1 View
Animal bite SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.1 View
Concussion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.1 View
Heat stroke SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.1 View
Muscle strain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.1 View
Road traffic accident SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.1 View
Breast tenderness SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 19.1 View
Dysmenorrhoea SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 19.1 View
Pelvic pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 19.1 View
Vaginal discharge SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 19.1 View
Conjunctival haemorrhage SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 19.1 View
Scleral cyst SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 19.1 View
Hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 19.1 View
Seasonal allergy SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 19.1 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.1 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.1 View
Eosinophil count increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.1 View
Lymphadenopathy SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 19.1 View
Ear deformity acquired SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 19.1 View
Device dislocation SYSTEMATIC_ASSESSMENT Product Issues MedDRA 19.1 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 19.1 View
Haematoma SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 19.1 View
Staphylococcal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View