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 @ 4:01 PM
Ignite Modification Date:
2025-12-25 @ 2:04 PM
NCT ID:
NCT02647866
Description:
None
Frequency Threshold:
5
Time Frame:
52 Weeks
Study:
NCT02647866
Study Brief:
Study of a Monoclonal Antibody KHK4083 in Moderate 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 |
|---|---|---|---|---|---|---|---|---|
| KHK4083 Cohort 1 | Subjects who qualify will receive 1.0 mg/kg IV infusion treatments of KHK4083 from Baseline to Week 48. | 0 | None | 1 | 9 | 5 | 9 | View |
| KHK4083 Cohort 2 | Subjects who qualify will receive 3.0 mg/kg IV infusion treatments of KHK4083 from Baseline to Week 48. | 1 | None | 1 | 10 | 7 | 10 | View |
| KHK4083 Cohort 3 | Subjects who qualify will receive 10.0 mg/kg IV infusion treatments of KHK4083 from Baseline to Week 48. | 0 | None | 1 | 9 | 7 | 9 | View |
| KHK4083 Cohort 4 | Subjects who qualify will receive maximum tolerated dose (10.0 mg/kg) IV infusion treatments of KHK4083 from Baseline to Week 48. | 0 | None | 3 | 21 | 13 | 21 | View |
| KHK4083 Combined | The total number of participants analyzed who were randomized to KHK4083 during Treatment parts A \& B. | 1 | None | 6 | 49 | 32 | 49 | View |
| Placebo | Subjects received placebo IV infusion treatments from Baseline to Week 12. Subjects who completed double-blind Induction Therapy (i.e., at least five of six treatments) were eligible to enter OLE Therapy and receive 10 treatments of open-label KHK4083 (at the same dose administered to that subject during Induction Therapy) as maintenance therapy. Each subject was to receive one IV infusion every 4 weeks from Week 12 to Week 48. | 0 | None | 3 | 17 | 13 | 17 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (18.1) | View |
| Myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (18.1) | View |
| Colitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.1) | View |
| Colitis ulcerative | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.1) | View |
| Hepatotoxicity | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (18.1) | View |
| Clostridium difficile infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (18.1) | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (18.1) | View |
| Post procedural infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (18.1) | View |
| Pyelonephritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (18.1) | View |
| Blood albumin decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (18.1) | View |
| Abscess drainage | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (18.1) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (18.1) | View |
| Lymphopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (18.1) | View |
| Thrombocytosis | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (18.1) | View |
| Sinus bradycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (18.1) | View |
| Renal aplasia | SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA (18.1) | View |
| Abdominal distension | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.1) | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.1) | View |
| Abdominal pain lower | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.1) | View |
| Abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.1) | View |
| Abdominal tenderness | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.1) | View |
| Colitis ulcerative | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.1) | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.1) | View |
| Flatulence | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.1) | View |
| Gastrooesophageal reflux disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.1) | View |
| Haemorrhoidal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.1) | View |
| Haemorrhoids | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.1) | View |
| Mouth ulceration | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.1) | View |
| Mucous stools | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.1) | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.1) | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.1) | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (18.1) | View |
| Chest discomfort | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (18.1) | View |
| Chills | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (18.1) | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (18.1) | View |
| Hepatic steatosis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (18.1) | View |
| Influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (18.1) | View |
| Oral candidiasis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (18.1) | View |
| Oral herpes | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (18.1) | View |
| Pharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (18.1) | View |
| Sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (18.1) | View |
| Tonsillitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (18.1) | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (18.1) | View |
| Viral upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (18.1) | View |
| Arthropod bite | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (18.1) | View |
| Scar | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (18.1) | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (18.1) | View |
| Amylase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (18.1) | View |
| Aspartate aminotransferase abnormal | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (18.1) | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (18.1) | View |
| Blood creatine phosphokinase abnormal | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (18.1) | View |
| Blood creatine phosphokinase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (18.1) | View |
| Blood folate decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (18.1) | View |
| C-reactive protein increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (18.1) | View |
| Lipase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (18.1) | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | View |
| Joint swelling | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | View |
| Muscular weakness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (18.1) | View |
| Paraesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (18.1) | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (18.1) | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | View |
| Oropharyageal pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | View |
| Sneezing | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | View |
| Pruritis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (18.1) | View |