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 @ 4:24 PM
Ignite Modification Date:
2025-12-25 @ 2:18 PM
NCT ID:
NCT00805766
Description:
None
Frequency Threshold:
0
Time Frame:
None
Study:
NCT00805766
Study Brief:
Efficacy and Safety of Increased Dose of TA-650 (Infliximab) in Patients With Crohn's Disease (CD)
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Entire Evaluation Period | Screening Period + Increased Dose Period | None | None | 9 | 45 | 37 | 45 | View |
| Screening Period | None | None | None | 2 | 45 | 25 | 45 | View |
| Increased Dose Period | None | None | None | 8 | 39 | 29 | 39 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Crohn's disease | None | Gastrointestinal disorders | MedDRA/J ver. 13.0 | View |
| Melaena | None | Gastrointestinal disorders | MedDRA/J ver. 13.0 | View |
| Peritonitis | None | Gastrointestinal disorders | MedDRA/J ver. 13.0 | View |
| Bronchitis | None | Infections and infestations | MedDRA/J ver. 13.0 | View |
| Cytomegalovirus infection | None | Infections and infestations | MedDRA/J ver. 13.0 | View |
| Upper limb fracture | None | Injury, poisoning and procedural complications | MedDRA/J ver. 13.0 | View |
| Chronic inflammatory demyelinating polyradiculoneuropathy | None | Nervous system disorders | MedDRA/J ver. 13.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Upper respiratory tract inflammation | None | Respiratory, thoracic and mediastinal disorders | MedDRA/J ver. 13.0 | View |
| Nasopharyngitis | None | Infections and infestations | MedDRA/J ver. 13.0 | View |
| Influenza | None | Infections and infestations | MedDRA/J ver. 13.0 | View |
| Gastroenteritis | None | Infections and infestations | MedDRA/J ver. 13.0 | View |
| Pharyngitis | None | Infections and infestations | MedDRA/J ver. 13.0 | View |
| Bronchitis | None | Infections and infestations | MedDRA/J ver. 13.0 | View |
| Folliculitis | None | Infections and infestations | MedDRA/J ver. 13.0 | View |
| Otitis externa | None | Infections and infestations | MedDRA/J ver. 13.0 | View |
| Otitis media | None | Infections and infestations | MedDRA/J ver. 13.0 | View |
| Vulvovaginal candidiasis | None | Infections and infestations | MedDRA/J ver. 13.0 | View |
| Anal fistula infection | None | Infections and infestations | MedDRA/J ver. 13.0 | View |
| DNA antibody positive | None | Investigations | MedDRA/J ver. 13.0 | View |
| Blood urine present | None | Investigations | MedDRA/J ver. 13.0 | View |
| Liver function test abnormal | None | Investigations | MedDRA/J ver. 13.0 | View |
| Protein urine present | None | Investigations | MedDRA/J ver. 13.0 | View |
| Blood alkaline phosphatase increased | None | Investigations | MedDRA/J ver. 13.0 | View |
| Chest X-ray abnormal | None | Investigations | MedDRA/J ver. 13.0 | View |
| Oropharyngeal pain | None | Respiratory, thoracic and mediastinal disorders | MedDRA/J ver. 13.0 | View |
| Dyspnoea | None | Respiratory, thoracic and mediastinal disorders | MedDRA/J ver. 13.0 | View |
| Cough | None | Respiratory, thoracic and mediastinal disorders | MedDRA/J ver. 13.0 | View |
| Epistaxis | None | Respiratory, thoracic and mediastinal disorders | MedDRA/J ver. 13.0 | View |
| Rhinitis allergic | None | Respiratory, thoracic and mediastinal disorders | MedDRA/J ver. 13.0 | View |
| Arthralgia | None | Musculoskeletal and connective tissue disorders | MedDRA/J ver. 13.0 | View |
| Musculoskeletal stiffness | None | Musculoskeletal and connective tissue disorders | MedDRA/J ver. 13.0 | View |
| Musculoskeletal pain | None | Musculoskeletal and connective tissue disorders | MedDRA/J ver. 13.0 | View |
| Headache | None | Nervous system disorders | MedDRA/J ver. 13.0 | View |
| Dizziness | None | Nervous system disorders | MedDRA/J ver. 13.0 | View |
| Somnolence | None | Nervous system disorders | MedDRA/J ver. 13.0 | View |
| Eczema | None | Skin and subcutaneous tissue disorders | MedDRA/J ver. 13.0 | View |
| Acne | None | Skin and subcutaneous tissue disorders | MedDRA/J ver. 13.0 | View |
| Alopecia | None | Skin and subcutaneous tissue disorders | MedDRA/J ver. 13.0 | View |
| Polymorphic light eruption | None | Skin and subcutaneous tissue disorders | MedDRA/J ver. 13.0 | View |
| Pruritus | None | Skin and subcutaneous tissue disorders | MedDRA/J ver. 13.0 | View |
| Pyrexia | None | General disorders | MedDRA/J ver. 13.0 | View |
| Oedema peripheral | None | General disorders | MedDRA/J ver. 13.0 | View |
| Hot flush | None | Vascular disorders | MedDRA/J ver. 13.0 | View |
| Anaemia | None | Blood and lymphatic system disorders | MedDRA/J ver. 13.0 | View |
| Iron deficiency anaemia | None | Blood and lymphatic system disorders | MedDRA/J ver. 13.0 | View |
| Injury | None | Injury, poisoning and procedural complications | MedDRA/J ver. 13.0 | View |
| Contusion | None | Injury, poisoning and procedural complications | MedDRA/J ver. 13.0 | View |
| Periodontitis | None | Gastrointestinal disorders | MedDRA/J ver. 13.0 | View |
| Renal mass | None | Renal and urinary disorders | MedDRA/J ver. 13.0 | View |
| Haematospermia | None | Reproductive system and breast disorders | MedDRA/J ver. 13.0 | View |