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:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2025-12-25 @ 10:37 PM
NCT ID:
NCT00771667
Description:
None
Frequency Threshold:
5
Time Frame:
None
Study:
NCT00771667
Study Brief:
A Study of Safety and Effectiveness of Ustekinumab in Patients With Moderate to Severe Active Crohn's Disease Who Have Been Previously Treated With Anti-TNF Therapy
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Ustekinumab 6 mg/kg (IP) | Induction phase (Week 0-8) (IP) - Ustekinumab 6mg/kg IV group | None | None | 9 | 131 | 47 | 131 | View |
| Placebo (IP) | Induction phase (Week 0-8) (IP) - Placebo IV group | None | None | 11 | 132 | 53 | 132 | View |
| Ustekinumab 1 mg/kg (IP) | Induction phase (Week 0-8) (IP) - Ustekinumab 1mg/kg IV group | None | None | 6 | 130 | 51 | 130 | View |
| Ustekinumab 3 mg/kg (IP) | Induction phase (Week 0-8) (IP) - Ustekinumab 3mg/kg IV group | None | None | 8 | 133 | 50 | 133 | View |
| Placebo IV -> Responder -> Placebo SC (MP) | Maintenance phase (Week 8-36) (MP) - Receiving Placebo IV at Week 0 -\> Responder at week 6 -\> Receiving Placebo SC at Week 8 and Week 16 | None | None | 8 | 28 | 18 | 28 | View |
| Placebo IV -> Nonresponder -> Ustekinumab 270/90 mg SC (MP) | Maintenance phase (Week 8-36) (MP) - Receiving Placebo IV at Week 0 -\> Nonresponder at week 6 -\> Receiving Ustekinumab 270 mg SC at Week 8 and 90 mg at Week 16 | None | None | 16 | 85 | 47 | 85 | View |
| Ustekinumab IV -> Responder -> Placebo SC (MP) | Maintenance phase (Week 8-36) (MP) - Receiving Ustekinumab IV at Week 0 -\> Responder at week 6 -\> Receiving Placebo SC at Week 8 and Week 16 | None | None | 12 | 73 | 39 | 73 | View |
| Ustekinumab IV -> Responder -> Ustekinumab 90mg SC (MP) | Maintenance phase (Week 8-36) (MP) - Receiving Ustekinumab IV at Week 0 -\> Responder at week 6 -\> Receiving Ustekinumab 90 mg SC at Week 8 and Week 16 | None | None | 9 | 72 | 39 | 72 | View |
| Ustekinumab IV -> Nonresponder -> Placebo SC (MP) | Maintenance phase (Week 8-36) (MP) - Receiving Ustekinumab IV at Week 0 -\> Nonresponder at week 6 -\> Receiving Placebo SC at Week 8 and Week 16 | None | None | 21 | 110 | 64 | 110 | View |
| Ustekinumab IV -> Nonresponder -> Ustekinumab 90mg SC (MP) | Maintenance phase (Week 8-36) (MP) - Receiving Ustekinumab IV at Week 0 -\> Nonresponder at week 6 -\> Receiving Ustekinumab 90 mg SC at Week 8 and Week 16 | None | None | 22 | 109 | 52 | 109 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 13.1 | View |
| Abdominal hernia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 13.1 | View |
| Abdominal hernia obstructive | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 13.1 | View |
| Abdominal mass | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 13.1 | View |
| Abdominal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 13.1 | View |
| Anal stenosis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 13.1 | View |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 13.1 | View |
| Crohn's disease | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 13.1 | View |
| Enterocutaneous fistula | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 13.1 | View |
| Enterovesical fistula | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 13.1 | View |
| Gastritis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 13.1 | View |
| Gastrointestinal haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 13.1 | View |
| Ileal stenosis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 13.1 | View |
| Intestinal obstruction | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 13.1 | View |
| Intestinal stenosis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 13.1 | View |
| Oesophageal stenosis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 13.1 | View |
| Pancreatitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 13.1 | View |
| Pancreatitis acute | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 13.1 | View |
| Proctalgia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 13.1 | View |
| Rectal discharge | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 13.1 | View |
| Rectal haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 13.1 | View |
| Small intestinal obstruction | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 13.1 | View |
| Asthenia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 13.1 | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 13.1 | View |
| Hernia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 13.1 | View |
| Impaired healing | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 13.1 | View |
| Malaise | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 13.1 | View |
| Oedema peripheral | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 13.1 | View |
| Biliary colic | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 13.1 | View |
| Cholecystitis acute | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 13.1 | View |
| Cholelithiasis | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 13.1 | View |
| Hepatic cirrhosis | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 13.1 | View |
| Serum sickness-like reaction | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 13.1 | View |
| Abdominal abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 13.1 | View |
| Anal abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 13.1 | View |
| Beta haemolytic streptococcal infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 13.1 | View |
| Campylobacter infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 13.1 | View |
| Clostridial infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 13.1 | View |
| Gastroenteritis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 13.1 | View |
| Gastroenteritis viral | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 13.1 | View |
| Gastrointestinal infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 13.1 | View |
| Perirectal abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 13.1 | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 13.1 | View |
| Postoperative abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 13.1 | View |
| Rectal abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 13.1 | View |
| Respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 13.1 | View |
| Staphylococcal infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 13.1 | View |
| Upper respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 13.1 | View |
| Urinary tract infection bacterial | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 13.1 | View |
| Vaginal abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 13.1 | View |
| Drug toxicity | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 13.1 | View |
| Fractured sacrum | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 13.1 | View |
| Gastrointestinal stoma complication | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 13.1 | View |
| Hand fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 13.1 | View |
| Intestinal anastomosis complication | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 13.1 | View |
| Multiple fractures | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 13.1 | View |
| Seroma | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 13.1 | View |
| Tibia fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 13.1 | View |
| International normalised ratio increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 13.1 | View |
| Decreased appetite | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 13.1 | View |
| Dehydration | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 13.1 | View |
| Hyponatraemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 13.1 | View |
| Iron deficiency | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 13.1 | View |
| Arthralgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | View |
| Intervertebral disc disorder | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 13.1 | View |
| Syncope | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 13.1 | View |
| VIIth nerve paralysis | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 13.1 | View |
| Conversion disorder | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 13.1 | View |
| Psychiatric decompensation | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 13.1 | View |
| Somatoform disorder | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 13.1 | View |
| Suicidal ideation | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 13.1 | View |
| Acute prerenal failure | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 13.1 | View |
| Nephrolithiasis | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 13.1 | View |
| Renal colic | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 13.1 | View |
| Ovarian cyst | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 13.1 | View |
| Pulmonary embolism | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | View |
| Acute febrile neutrophilic dermatosis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 13.1 | View |
| Deep vein thrombosis | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 13.1 | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 13.1 | View |
| Bile duct stone | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 13.1 | View |
| Fistula | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | View |
| Intervertebral disc degeneration | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Abdominal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 13.1 | View |
| Crohn's disease | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 13.1 | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 13.1 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 13.1 | View |
| Rectal haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 13.1 | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 13.1 | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 13.1 | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 13.1 | View |
| Nasopharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 13.1 | View |
| Sinusitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 13.1 | View |
| Upper respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 13.1 | View |
| Urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 13.1 | View |
| Arthralgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | View |
| Back pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 13.1 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 13.1 | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | View |
| Rash | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 13.1 | View |