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 @ 11:35 PM
Ignite Modification Date:
2025-12-25 @ 9:25 PM
NCT ID:
NCT02120456
Description:
None
Frequency Threshold:
0
Time Frame:
Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8
Study:
NCT02120456
Study Brief:
Safety and Efficacy of Escalating Doses of LEO 43204 Applied Once Daily for Two Consecutive Days on Approximately 250 cm2 on Trunk and Extremities in Subjects 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 1: LEO 43204 Gel 0.1% | Once daily treatment for two consecutive days with LEO 43204 gel 0.1% | None | None | 0 | 9 | 7 | 9 | View |
| Part 2: LEO 43204 Vehicle Gel | Once daily treatment for two consecutive days LEO 43204 vehicle gel | None | None | 0 | 32 | 6 | 32 | View |
| Part 2: LEO 43204 Gel 0.075% | Once daily treatment for two consecutive days LEO 43204 gel 0.075% | None | None | 1 | 60 | 36 | 60 | View |
| Part 2: LEO 43204 Gel 0.1% | Once daily treatment for two consecutive days LEO 43204 gel 0.1% | None | None | 2 | 63 | 39 | 63 | View |
| Part 1: LEO 43204 Gel 0.018% | Once daily treatment for two consecutive days with LEO 43204 gel 0.018% | None | None | 0 | 12 | 3 | 12 | View |
| Part 1: LEO 43204 Gel 0.025% | Once daily treatment for two consecutive days with LEO 43204 gel 0.025% | None | None | 0 | 12 | 3 | 12 | View |
| Part 1: LEO 43204 Gel 0.037% | Once daily treatment for two consecutive days with LEO 43204 gel 0.037% | None | None | 0 | 12 | 5 | 12 | View |
| Part 1: LEO 43204 Gel 0.05% | Once daily treatment for two consecutive days with LEO 43204 gel 0.05% | None | None | 0 | 12 | 9 | 12 | View |
| Part 1: LEO 43204 Gel 0.075% | Once daily treatment for two consecutive days with LEO 43204 gel 0.075% | None | None | 0 | 12 | 10 | 12 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Keratoacanthoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.1) | View |
| Urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | 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 |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Application site pruritus | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.1) | View |
| Application site pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.1) | View |
| Application site paraesthesia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.1) | View |
| Application site vesicles | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.1) | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.1) | View |
| Foreign body reaction | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.1) | View |
| Administration site reaction | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.1) | View |
| Application site discomfort | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.1) | View |
| Application site inflammation | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.1) | View |
| Oedema peripheral | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.1) | View |
| Upper respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.1) | View |
| Nasopharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.1) | View |
| Bronchitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.1) | View |
| Helicobacter gastritis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.1) | View |
| Sinusitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.1) | View |
| Viral infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.1) | View |
| Viral pharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.1) | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (15.1) | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (15.1) | View |
| Hypoaesthesia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (15.1) | View |
| Nerve compression | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (15.1) | View |
| Restless legs syndrome | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (15.1) | View |
| Tension headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (15.1) | View |
| Tremor | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (15.1) | View |
| Rash | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (15.1) | View |
| Erythema | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (15.1) | View |
| Dermatitis | 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 |
| Eczema asteatotic | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (15.1) | View |
| Pain of skin | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (15.1) | View |
| Skin burning sensation | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue 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 |
| Muscle strain | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (15.1) | View |
| Basal cell carcinoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.1) | View |
| Melanocytic naevus | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.1) | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) | View |
| Bronchitis chronic | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) | View |
| Sinus congestion | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) | View |
| Conjunctivitis | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (15.1) | View |
| Dry eye | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (15.1) | View |
| Eye irritation | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (15.1) | View |
| Alanine aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (15.1) | View |
| Electrocardiogram qt prolonged | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (15.1) | View |
| Platelet count increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (15.1) | View |
| Blood lactate dehydrogenase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (15.1) | View |
| Muscle spasms | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (15.1) | View |
| Muscle twitching | 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 |
| Osteoarthritis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (15.1) | View |
| Cheilitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.1) | View |
| Dental caries | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.1) | View |
| Supraventricular tachycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (15.1) | View |
| Nephrolithiasis | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (15.1) | View |
| Prostatomegaly | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (15.1) | View |
| Haematoma | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (15.1) | View |
| Vertigo | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (15.1) | View |
| Depression | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (15.1) | View |
| Urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | 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 |