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 @ 5:07 PM
Ignite Modification Date:
2025-12-25 @ 2:45 PM
NCT ID:
NCT01922050
Description:
The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.
Frequency Threshold:
0
Time Frame:
From Day 1 to Week 8
Study:
NCT01922050
Study Brief:
A Study of Increasing Strengths, Safety and Efficacy of Two Formulas of LEO 43204 on the Face or the Chest in Patients With Actinic Keratosis
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Part 2: LEO 43204 Gel 0.012 | Part 2: Double-Blind, Once-Daily, 2-Day Treatment | None | None | 2 | 60 | 40 | 60 | View |
| Part 2: LEO 43204 Gel 0.018 | Part 2: Double-Blind, Once-Daily, 2-Day Treatment | None | None | 0 | 62 | 47 | 62 | View |
| Part 1: LEO 43204 Gel 0.0015 | Part 1: Open-Label, Dose-Escalation, Once-Daily, 2-Day Treatment | None | None | 0 | 3 | 3 | 3 | View |
| Part 1: LEO 43204 Gel 0.003 | Part 1: Open-Label, Dose-Escalation, Once-Daily, 2-Day Treatment | None | None | 0 | 3 | 1 | 3 | View |
| Part 1: LEO 43204 Gel 0.006 | Part 1: Open-Label, Dose-Escalation, Once-Daily, 2-Day Treatment | None | None | 1 | 6 | 5 | 6 | View |
| Part 1: LEO 43204 Gel 0.012 | Part 1: Open-Label, Dose-Escalation, Once-Daily, 2-Day Treatment | None | None | 0 | 6 | 5 | 6 | View |
| Part 1: LEO 43204 Gel 0.025 | Part 1: Open-Label, Dose-Escalation, Once-Daily, 2-Day Treatment | None | None | 0 | 18 | 11 | 18 | View |
| Part 1: LEO 43204 Cream 0.0015 | Part 1: Open-Label phase, Dose-Escalation, Once-Daily, 2-Day Treatment | None | None | 0 | 3 | 1 | 3 | View |
| Part 1: LEO 43204 Cream 0.003 | Part 1: Open-Label phase, Dose-Escalation, Once-Daily, 2-Day Treatment | None | None | 0 | 3 | 1 | 3 | View |
| Part 1: LEO 43204 Cream 0.006 | Part 1: Open-Label phase, Dose-Escalation, Once-Daily, 2-Day Treatment | None | None | 0 | 6 | 2 | 6 | View |
| Part 1: LEO 43204 Cream 0.012 | Part 1: Open-Label phase, Dose-Escalation, Once-Daily, 2-Day Treatment | None | None | 0 | 12 | 8 | 12 | View |
| Part 2: LEO 43204 Gel Vehicle | Part 2: Double-Blind, Once-Daily, 2-Day Treatment | None | None | 0 | 58 | 11 | 58 | View |
| Part 1: LEO 43204 Gel 0.018 | Part 1: Open-Label, Dose-Escalation, Once-Daily, 2-Day Treatment | None | None | 1 | 17 | 10 | 17 | View |
| Part 2: LEO 43204 Gel 0.006 | Part 2: Double-Blind, Once-Daily, 2-Day Treatment | None | None | 5 | 62 | 38 | 62 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Myocardial infarction | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (15.1) | View |
| Ventricular fibrillation | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (15.1) | View |
| Hip fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (15.1) | View |
| Squamous cell carcinoma of skin | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.1) | View |
| Convulsion | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (15.1) | View |
| Breast Cancer | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.1) | View |
| Chest pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.1) | View |
| Bradycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (15.1) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Eyelid oedema | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (15.1) | View |
| Periorbital oedema | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (15.1) | View |
| Scintillating scotoma | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (15.1) | View |
| Herpes simplex | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.1) | View |
| Nasopharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.1) | View |
| Upper respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.1) | View |
| Viral infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.1) | View |
| Viral upper respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.1) | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (15.1) | View |
| Sciatica | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (15.1) | View |
| Cheilitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.1) | View |
| Glossodynia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.1) | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.1) | View |
| Basal cell carcinoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.1) | View |
| Haematuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (15.1) | View |
| Polyuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (15.1) | View |
| Lymphadenopathy | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (15.1) | View |
| Hepatic enzyme increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (15.1) | View |
| Sinus congestion | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) | View |
| Rash | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (15.1) | View |
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (15.1) | View |
| Application site warmth | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.1) | View |
| Conjunctival hyperaemia | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (15.1) | View |
| Urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.1) | View |
| Pain in extremity | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (15.1) | View |
| Spinal column stenosis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (15.1) | View |
| Renal colic | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (15.1) | View |
| Flushing | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (15.1) | View |
| Application site paraesthesia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.1) | View |
| Application site dermatitis | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.1) | View |
| Application site irritation | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.1) | View |
| Application site swelling | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.1) | View |
| Chills | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.1) | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.1) | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (15.1) | View |
| Neuralgia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (15.1) | View |
| Presyncope | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (15.1) | View |
| Tension headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (15.1) | View |
| Gastroenteritis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.1) | View |
| Herpes zoster | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.1) | View |
| Hordeolum | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.1) | View |
| Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.1) | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.1) | View |
| Oral herpes | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.1) | View |
| Pruritus | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (15.1) | View |
| Acne | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (15.1) | View |
| Actinic keratosis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (15.1) | View |
| Dermatitis contact | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (15.1) | View |
| Dry skin | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (15.1) | View |
| Ecchymosis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (15.1) | View |
| Granuloma skin | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (15.1) | View |
| Skin lesion | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (15.1) | View |
| Abdominal discomfort | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.1) | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.1) | View |
| Abdominal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.1) | View |
| Abdominal pain upper | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.1) | View |
| Dental caries | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.1) | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.1) | View |
| Gastrooesophageal reflux disease | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.1) | View |
| Toothache | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.1) | View |
| Arthropod bite | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (15.1) | View |
| Contusion | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (15.1) | View |
| Excoriation | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (15.1) | View |
| Fall | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (15.1) | View |
| Hand fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (15.1) | View |
| Ligament injury | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (15.1) | View |
| Lip injury | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (15.1) | View |
| Muscle strain | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (15.1) | View |
| Periorbital haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (15.1) | View |
| Eye pain | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (15.1) | View |
| Back pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (15.1) | View |
| Arthralgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (15.1) | View |
| Bursitis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (15.1) | View |
| Joint hyperextension | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (15.1) | View |
| Muscle spasms | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (15.1) | View |
| Musculoskeletal chest pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (15.1) | View |
| Musculoskeletal pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (15.1) | View |
| Neck pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (15.1) | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) | View |
| Nasal congestion | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) | View |
| Oropharyngeal pain | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) | View |
| Productive cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) | View |
| Pulmonary congestion | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) | View |
| Angina pectoris | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (15.1) | View |
| Atrioventricular block first degree | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (15.1) | View |
| Insomnia | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (15.1) | View |
| Anxiety | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (15.1) | View |
| Depression | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (15.1) | View |
| Electrocardiogram abnormal | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (15.1) | View |
| White blood cell count increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (15.1) | View |
| Skin papilloma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.1) | View |
| Haematoma | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (15.1) | View |
| Ear pain | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (15.1) | View |
| Hepatic steatosis | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (15.1) | View |
| Diabetes mellitus | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (15.1) | View |
| Renal failure chronic | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (15.1) | View |
| Benign prostatic hyperplasia | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (15.1) | View |
| Application site pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.1) | View |
| Application site pruritus | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.1) | View |
| Application site erythema | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.1) | View |
| Application site discolouration | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.1) | View |
| Application site discomfort | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.1) | View |
| Application site exfoliation | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.1) | View |
| Application site oedema | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.1) | View |
| Application site photosensitivity reaction | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.1) | View |
| Eye irritation | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (15.1) | View |
| Dry eye | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (15.1) | View |