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 @ 9:45 PM
Ignite Modification Date:
2025-12-25 @ 7:25 PM
NCT ID:
NCT03532932
Description:
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
Frequency Threshold:
0
Time Frame:
Up to 12 months after enrollment into the study
Study:
NCT03532932
Study Brief:
A Study to Evaluate Disease Control and Treatment Pattern in Participants With Moderate to Severe Inflammatory Bowel Disease (IBD) in Real Life Practice
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| UC Participants | Participants diagnosed with moderate to severe UC were observed retrospectively for previous 2 years before enrollment until Baseline Visit 1 (Day 1) and further observed prospectively for 1 year after participants were enrolled into the study during Observational Visit 2 at 6 months and Final Visit 3 at 12 months to assess treatment patterns and treatment outcomes. | 3 | None | 146 | 1214 | 48 | 1214 | View |
| CD Participants | Participants diagnosed with moderate to severe CD were observed retrospectively for previous 2 years before enrollment until Baseline Visit 1 (Day 1) and further observed prospectively for 1 year after participants were enrolled into the study during Observational Visit 2 at 6 months and Final Visit 3 at 12 months to assess treatment patterns and treatment outcomes. | 5 | None | 84 | 687 | 31 | 687 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anal fistula | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.0 | View |
| Colitis ulcerative | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.0 | View |
| Haematochezia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.0 | View |
| Intestinal fistula | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.0 | View |
| Intestinal perforation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.0 | View |
| Peritonitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.0 | View |
| Proctitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.0 | View |
| Rectal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.0 | View |
| Large intestinal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.0 | View |
| Intestinal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.0 | View |
| Bile duct stone | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 25.0 | View |
| Cholecystitis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 25.0 | View |
| Drug-induced liver injury | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 25.0 | View |
| Abscess intestinal | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.0 | View |
| Appendicitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.0 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.0 | View |
| Anal abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.0 | View |
| Acute hepatitis C | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.0 | View |
| COVID-19 | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.0 | View |
| Arthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | View |
| Rectal cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.0 | View |
| Colorectal cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.0 | View |
| Speech disorder | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 25.0 | View |
| Cervical leukoplakia | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 25.0 | View |
| Bronchospasm | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | View |
| Pulmonary embolism | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | View |
| Colitis ulcerative | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 25.0 | View |
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 25.0 | View |
| Crohn's disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.0 | View |
| Ileal stenosis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.0 | View |
| Intestinal obstruction | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.0 | View |
| Intestinal stenosis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.0 | View |
| Pancreatitis acute | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.0 | View |
| Enterocolonic fistula | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.0 | View |
| Large intestinal stenosis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.0 | View |
| Pulmonary tuberculosis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.0 | View |
| Pyelonephritis chronic | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.0 | View |
| Subcutaneous abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.0 | View |
| Abdominal abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.0 | View |
| Colon cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.0 | View |
| Ureterolithiasis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 25.0 | View |
| Angioedema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 25.0 | View |
| Small intestinal resection | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 25.0 | View |
| Ileectomy | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 25.0 | View |
| Thyroidectomy | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 25.0 | View |
| Takayasu's arteritis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 25.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Hepatocellular injury | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA | View |
| Urticaria | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA | View |
| Pruritus allergic | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA | View |
| Leukopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA | View |
| Bicytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA | View |
| Gilbert's syndrome | SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA | View |
| Colitis ulcerative | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA | View |
| Duodenal ulcer | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA | View |
| Gastric polyps | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA | View |
| Pancreatitis chronic | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA | View |
| Gait disturbance | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA | View |
| Drug resistance | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA | View |
| Drug intolerance | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA | View |
| Loss of therapeutic response | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA | View |
| Bartholin's abscess | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |
| Tuberculosis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |
| Injection related reaction | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA | View |
| Transaminases increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA | View |
| Cell death | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA | View |
| Arthropathy | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA | View |
| Sacroiliitis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA | View |
| Cervical leukoplakia | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA | View |
| Dermatitis allergic | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA | View |
| Drug eruption | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA | View |
| Psoriasis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA | View |
| Abscess drainage | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA | View |
| Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA | View |
| Drug ineffective | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA | View |
| Loss of therapeutic response | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA | View |
| Drug induced liver injury | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA | View |
| Drug hypersensitivity | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA | View |
| Herpes zoster | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |
| Pulmonary tuberculosis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |
| Blood pressure decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA | View |
| Alopecia totalis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA | View |
| Angioedema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA | View |
| Erythema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA | View |
| Yellow skin | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA | View |