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 @ 1:28 PM
Ignite Modification Date:
2025-12-25 @ 12:32 PM
NCT ID:
NCT01116895
Description:
None
Frequency Threshold:
0
Time Frame:
From Day 0 to Follow-up (Day 122 + 28±2 days)
Study:
NCT01116895
Study Brief:
A Proof of Concept Study Comparing Three Doses of an Oral Solution of LEO 22811 With a Placebo Oral Solution for the Treatment of Psoriasis Vulgaris
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Placebo | Placebo: Oral solution | 0 | None | 0 | 14 | 10 | 14 | View |
| LEO 22811 0.5 mg | LEO 22811 0.5 mg: Oral solution | 0 | None | 1 | 16 | 11 | 16 | View |
| LEO 22811 1.5 mg | LEO 22811 1.5 mg: Oral solution | 0 | None | 1 | 15 | 11 | 15 | View |
| LEO 22811 3.0 mg | LEO 22811 3.0 mg: Oral solution | 0 | None | 0 | 18 | 15 | 18 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Myocardial ischaemia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (6.1) | View |
| Sinus tachycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (6.1) | View |
| Keratoconjunctivitis sicca | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (6.1) | View |
| Visual disturbance | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (6.1) | View |
| Abdominal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (6.1) | View |
| Abdominal pain upper | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (6.1) | View |
| Aphthous stomatitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (6.1) | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (6.1) | View |
| Duodenal ulcer | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (6.1) | View |
| Dyspepsia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (6.1) | View |
| Gastrooesophageal reflux disease | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (6.1) | View |
| Chest pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (6.1) | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (6.1) | View |
| Influenza like illness | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (6.1) | View |
| Bacillary angiomatosis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (6.1) | View |
| Bronchitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (6.1) | View |
| Ear infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (6.1) | View |
| Folliculitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (6.1) | View |
| Furuncle | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (6.1) | View |
| Gastrointestinal fungal infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (6.1) | View |
| Gingival infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (6.1) | View |
| Herpes simplex | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (6.1) | View |
| Herpes zoster | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (6.1) | View |
| Nasopharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (6.1) | View |
| Otitis externa | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (6.1) | View |
| Pharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (6.1) | View |
| Tooth abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (6.1) | View |
| Upper respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (6.1) | View |
| Vaginal mycosis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (6.1) | View |
| Alanine aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (6.1) | View |
| Aspartate aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (6.1) | View |
| Blood alkaline phosphatase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (6.1) | View |
| Blood testosterone decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (6.1) | View |
| Blood triglycerides increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (6.1) | View |
| C-reactive protein increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (6.1) | View |
| Electrocardiogram normal | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (6.1) | View |
| Gamma-glutamyltransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (6.1) | View |
| Low density lipoprotein increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (6.1) | View |
| Lymphocyte count decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (6.1) | View |
| Lymphocyte count increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (6.1) | View |
| Mean cell volume increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (6.1) | View |
| Neutrophil count increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (6.1) | View |
| Platelet count increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (6.1) | View |
| White blood cell count increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (6.1) | View |
| Decreased appetite | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (6.1) | View |
| Hypercholesterolaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (6.1) | View |
| Arthralgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (6.1) | View |
| Back pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (6.1) | View |
| Ganglion | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (6.1) | View |
| Musculoskeletal chest pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (6.1) | View |
| Psoriatic arthropathy | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (6.1) | View |
| Amnesia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (6.1) | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (6.1) | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (6.1) | View |
| Migraine | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (6.1) | View |
| Tremor | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (6.1) | View |
| Affective disorder | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (6.1) | View |
| Anxiety | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (6.1) | View |
| Insomnia | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (6.1) | View |
| Libido decreased | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (6.1) | View |
| Stress symptoms | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (6.1) | View |
| Glycosuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (6.1) | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (6.1) | View |
| Nasal congestion | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (6.1) | View |
| Pharyngolaryngeal pain | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (6.1) | View |
| Acne | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (6.1) | View |
| Dermatitis acneiform | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (6.1) | View |
| Eczema | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (6.1) | View |
| Hyperhidrosis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (6.1) | View |
| Ingrowing nail | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (6.1) | View |
| Pain of skin | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (6.1) | View |
| Pruritus | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (6.1) | View |
| Psoriasis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (6.1) | View |
| Rash | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (6.1) | View |
| Rash maculo-papular | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (6.1) | View |
| Rash papular | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (6.1) | View |
| Skin fissures | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (6.1) | View |
| Asthenia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (6.1) | View |