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 @ 11:44 PM
Ignite Modification Date:
2025-12-25 @ 9:37 PM
NCT ID:
NCT00463151
Description:
Safety Set comprised subjects who received the study drug at least once.
Frequency Threshold:
0
Time Frame:
Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks
Study:
NCT00463151
Study Brief:
An Exploratory Study of Rebamipide 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 |
|---|---|---|---|---|---|---|---|---|
| Rebamipide 60 mg | Once daily intracolonial administration at a dose of 60 mg for 6 weeks | 0 | None | 0 | 35 | 22 | 35 | View |
| Rebamipide 150 mg | Once daily intracolonial administration at a dose of 150 mg for 6 weeks | 0 | None | 2 | 29 | 20 | 29 | View |
| Rebamipide 300 mg | Once daily intracolonial administration at a dose of 300 mg for 6 weeks | 0 | None | 0 | 29 | 18 | 29 | View |
| Placebo | Once daily intracolonial administration of placebo for 6 weeks | 0 | None | 1 | 31 | 22 | 31 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Colitis ulcerative | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Ver.11.0 | View |
| Necrotising fasciitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Ver.11.0 | View |
| Vertigo positional | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA Ver.11.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Pancreatitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Ver.11.0 | View |
| Rectal haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Ver.11.0 | View |
| Hepatic function abnormal | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA Ver.11.0 | View |
| Blood urine present | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Ver.11.0 | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Ver.11.0 | View |
| Iron deficiency anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Ver.11.0 | View |
| Thrombocytopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Ver.11.0 | View |
| Tachycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Ver.11.0 | View |
| Asthenopia | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA Ver.11.0 | View |
| Abdominal distension | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Ver.11.0 | View |
| Abdominal pain upper | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Ver.11.0 | View |
| Cheilitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Ver.11.0 | View |
| Colitis ulcerative | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Ver.11.0 | View |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Ver.11.0 | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Ver.11.0 | View |
| Gastritis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Ver.11.0 | View |
| Stomach discomfort | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Ver.11.0 | View |
| Anal haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Ver.11.0 | View |
| Haemorrhoidal haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Ver.11.0 | View |
| Rectal tenesmus | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Ver.11.0 | View |
| Gastrointestinal motility disorder | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Ver.11.0 | View |
| Gastrointestinal inflammation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Ver.11.0 | View |
| Feeling hot | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Ver.11.0 | View |
| Malaise | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Ver.11.0 | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Ver.11.0 | View |
| Food allergy | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA Ver.11.0 | View |
| Seasonal allergy | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA Ver.11.0 | View |
| Furuncle | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Ver.11.0 | View |
| Herpes simplex | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Ver.11.0 | View |
| Hordeolum | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Ver.11.0 | View |
| Nasopharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Ver.11.0 | View |
| Upper respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Ver.11.0 | View |
| Urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Ver.11.0 | View |
| Enteritis infectious | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Ver.11.0 | View |
| Contusion | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Ver.11.0 | View |
| Alanine aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Ver.11.0 | View |
| Aspartate aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Ver.11.0 | View |
| Basophil count increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Ver.11.0 | View |
| Blood albumin decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Ver.11.0 | View |
| Blood cholesterol increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Ver.11.0 | View |
| Blood lactate dehydrogenase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Ver.11.0 | View |
| Blood potassium decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Ver.11.0 | View |
| Blood potassium increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Ver.11.0 | View |
| Blood pressure increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Ver.11.0 | View |
| Blood triglycerides increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Ver.11.0 | View |
| Blood urea decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Ver.11.0 | View |
| Blood uric acid increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Ver.11.0 | View |
| Eosinophil count decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Ver.11.0 | View |
| Eosinophil count increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Ver.11.0 | View |
| Gamma-glutamyltransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Ver.11.0 | View |
| Glucose urine present | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Ver.11.0 | View |
| Haematocrit decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Ver.11.0 | View |
| Haemoglobin decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Ver.11.0 | View |
| Liver function test abnormal | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Ver.11.0 | View |
| Lymphocyte count abnormal | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Ver.11.0 | View |
| Lymphocyte count decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Ver.11.0 | View |
| Monocyte count increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Ver.11.0 | View |
| Neutrophil count decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Ver.11.0 | View |
| Neutrophil count increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Ver.11.0 | View |
| Red blood cell count decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Ver.11.0 | View |
| Red blood cell count increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Ver.11.0 | View |
| White blood cell count decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Ver.11.0 | View |
| White blood cell count increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Ver.11.0 | View |
| White blood cells urine positive | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Ver.11.0 | View |
| Platelet count increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Ver.11.0 | View |
| Protein urine present | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Ver.11.0 | View |
| Urine ketone body present | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Ver.11.0 | View |
| Blood alkaline phosphatase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Ver.11.0 | View |
| Diabetes mellitus | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Ver.11.0 | View |
| Decreased appetite | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Ver.11.0 | View |
| Sacroiliitis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Ver.11.0 | View |
| Muscle tightness | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Ver.11.0 | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Ver.11.0 | View |
| Dysgeusia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Ver.11.0 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Ver.11.0 | View |
| Migraine | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Ver.11.0 | View |
| Somnolence | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Ver.11.0 | View |
| Depression | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Ver.11.0 | View |
| Insomnia | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Ver.11.0 | View |
| Pharyngeal erythema | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Ver.11.0 | View |
| Acne | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Ver.11.0 | View |
| Eczema asteatotic | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Ver.11.0 | View |
| Night sweats | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Ver.11.0 | View |
| Urticaria | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Ver.11.0 | View |