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 @ 9:59 PM
Ignite Modification Date:
2025-12-25 @ 7:36 PM
NCT ID:
NCT00988832
Description:
None
Frequency Threshold:
5
Time Frame:
None
Study:
NCT00988832
Study Brief:
An Audit of Patients With Crohn's Disease Treated With Infliximab (P06066)
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| INFLIXIMAB, RECOMBINANT | Infliximab as prescribed by a physician in normal practice for Crohn's disease: 5 mg/kg or 10 mg/kg infusion as either maintenance or episodic therapy. | None | None | 36 | 380 | 0 | 380 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| LIVER ABSCESS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 14.0 | View |
| CERVICAL DYSPLASIA | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 14.0 | View |
| CHRONIC OBSTRUCTIVE PULMONARY DISEASE | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | View |
| HAEMOLYTIC URAEMIC SYNDROME | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 14.0 | View |
| PALPITATIONS | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 14.0 | View |
| TACHYCARDIA | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 14.0 | View |
| ABDOMINAL PAIN | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.0 | View |
| ANAL FISTULA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.0 | View |
| CROHN'S DISEASE | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.0 | View |
| INTESTINAL OBSTRUCTION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.0 | View |
| INTESTINAL PERFORATION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.0 | View |
| CHEST DISCOMFORT | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 14.0 | View |
| FEELING HOT | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 14.0 | View |
| MALAISE | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 14.0 | View |
| ANAPHYLACTIC REACTION | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 14.0 | View |
| DRUG HYPERSENSITIVITY | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 14.0 | View |
| HYPERSENSITIVITY | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 14.0 | View |
| ANAL ABSCESS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 14.0 | View |
| CELLULITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 14.0 | View |
| MENINGITIS HERPES | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 14.0 | View |
| PULMONARY TUBERCULOSIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 14.0 | View |
| SEPSIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 14.0 | View |
| TRACHEOBRONCHITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 14.0 | View |
| DRUG EXPOSURE DURING PREGNANCY | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 14.0 | View |
| DRUG EXPOSURE VIA BREAST MILK | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 14.0 | View |
| INFUSION RELATED REACTION | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 14.0 | View |
| INTENTIONAL OVERDOSE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 14.0 | View |
| ANTINUCLEAR ANTIBODY POSITIVE | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 14.0 | View |
| HEART RATE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 14.0 | View |
| ARTHRALGIA | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | View |
| SYSTEMIC LUPUS ERYTHEMATOSUS | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | View |
| BASAL CELL CARCINOMA | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | View |
| METASTASES TO LIVER | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | View |
| PROSTATE CANCER METASTATIC | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | View |
| RECTAL CANCER | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | View |
| RENAL CANCER | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | View |
| HEADACHE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 14.0 | View |
| LOSS OF CONSCIOUSNESS | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 14.0 | View |
| MYELITIS TRANSVERSE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 14.0 | View |
| ABORTION SPONTANEOUS | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA 14.0 | View |
| MAJOR DEPRESSION | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 14.0 | View |
| RENAL FAILURE ACUTE | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 14.0 | View |
| COUGH | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | View |
| DYSPNOEA | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | View |
| CUTANEOUS LUPUS ERYTHEMATOSUS | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 14.0 | View |
| ABORTION INDUCED | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 14.0 | View |
Other Events(If Any):