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 @ 11:38 PM
Ignite Modification Date:
2025-12-25 @ 9:28 PM
NCT ID:
NCT00317356
Description:
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
Frequency Threshold:
5
Time Frame:
Treatment period (8 weeks)
Study:
NCT00317356
Study Brief:
A Dose-finding Study of OPC-6535 in Patients With Active Ulcerative Colitis
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| OPC-6535 12.5 mg | 12.5 mg OPC-6535 orally administered once daily in the morning for 8 weeks. | 0 | None | 0 | 11 | 6 | 11 | View |
| OPC-6535 25 mg | 25 mg OPC-6535 orally administered once daily in the morning for 8 weeks. | 0 | None | 2 | 11 | 7 | 11 | View |
| OPC-6535 50 mg | 25 mg OPC-6535 orally administered for the first week and then the dose was increased to 50 mg for the following 7 weeks. | 0 | None | 2 | 10 | 7 | 10 | View |
| Placebo | 0 mg OPC-6535 orally administered once daily in the morning for 8 weeks. | 0 | None | 1 | 11 | 8 | 11 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Colitis ulcerative | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Ver. 10.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Ver. 10.1 | View |
| Ear discomfort | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA Ver. 10.1 | View |
| Conjunctivitis allergic | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA Ver. 10.1 | View |
| Eye pruritus | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA Ver. 10.1 | View |
| Abdominal distension | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Ver. 10.1 | View |
| Abdominal pain upper | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Ver. 10.1 | View |
| Abdominal tenderness | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Ver. 10.1 | View |
| Colitis ulcerative | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Ver. 10.1 | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Ver. 10.1 | View |
| Faeces hard | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Ver. 10.1 | View |
| Haemorrhoids | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Ver. 10.1 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Ver. 10.1 | View |
| Proctalgia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Ver. 10.1 | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Ver. 10.1 | View |
| Asthenia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Ver. 10.1 | View |
| Feeling abnormal | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Ver. 10.1 | View |
| Malaise | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Ver. 10.1 | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Ver. 10.1 | View |
| Hepatic function abnormal | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA Ver. 10.1 | View |
| Influenza | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Ver. 10.1 | View |
| Nasopharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Ver. 10.1 | View |
| Pharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Ver. 10.1 | View |
| Alanine aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Ver. 10.1 | View |
| Blood creatine phosphokinase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Ver. 10.1 | View |
| Blood potassium decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Ver. 10.1 | View |
| Blood triglycerides increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Ver. 10.1 | View |
| Electrocardiogram QT prolonged | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Ver. 10.1 | View |
| Blood urine present | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Ver. 10.1 | View |
| Red blood cell count decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Ver. 10.1 | View |
| White blood cell count decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Ver. 10.1 | View |
| White blood cell count increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Ver. 10.1 | View |
| Protein urine present | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Ver. 10.1 | View |
| Decreased appetite | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Ver. 10.1 | View |
| Back pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Ver. 10.1 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Ver. 10.1 | View |
| Hypoaesthesia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Ver. 10.1 | View |
| Somnolence | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Ver. 10.1 | View |
| Asthma | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Ver. 10.1 | View |
| Pharyngolaryngeal pain | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Ver. 10.1 | View |
| Upper respiratory tract inflammation | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Ver. 10.1 | View |
| Eczema | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Ver. 10.1 | View |