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 @ 2:47 PM
Ignite Modification Date:
2025-12-25 @ 1:15 PM
NCT ID:
NCT02513459
Description:
TEAEs and SAEs are defined as any adverse event (AE) with an onset date that is on or after the first dose of study drug until 140 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Frequency Threshold:
5
Time Frame:
Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 140 days after the last dose of study drug in the current study or until the first dose of study drug in NCT03105102 (AbbVie M16-000 Sub-study 3), up to 4 years for participants who rolled-over.
Study:
NCT02513459
Study Brief:
A Long Term Extension Trial of BI 655066/ABBV-066 (Risankizumab), in Patients With Moderately to Severely Active Crohn's Disease
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Risankizumab 600 mg IV | Re-induction treatment; 3 infusions every 4 weeks, after which eligibility was assessed if clinical response was re-gained | 0 | None | 0 | 4 | 2 | 4 | View |
| Risankizumab 180 mg SC | Maintenance treatment every 8 weeks (q8w) from Visit 2 through the end of trial (EOT) visit. Participants who re-gained their clinical response following the re-induction treatment could continue with maintenance treatment beginning at Visit 5. | 0 | None | 23 | 65 | 52 | 65 | View |
| All Risankizumab | Participants who received at least one dose of risankizumab in the current study | 0 | None | 23 | 65 | 52 | 65 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Iron deficiency anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 21.1 | View |
| Tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 21.1 | View |
| Adrenal insufficiency | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA 21.1 | View |
| Abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 21.1 | View |
| Crohn's disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 21.1 | View |
| Dumping syndrome | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 21.1 | View |
| Haemorrhoids | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 21.1 | View |
| Ileal stenosis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 21.1 | View |
| Ileus | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 21.1 | View |
| Impaired gastric emptying | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 21.1 | View |
| Intestinal obstruction | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 21.1 | View |
| Intestinal stenosis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 21.1 | View |
| Umbilical hernia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 21.1 | View |
| Chest pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 21.1 | View |
| Anaphylactic reaction | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 21.1 | View |
| Anal abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Campylobacter infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Gastroenteritis viral | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Peritonitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Subcutaneous abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Anastomotic leak | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 21.1 | View |
| Ankle fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 21.1 | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 21.1 | View |
| Hip fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 21.1 | View |
| Post procedural complication | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 21.1 | View |
| Procedural pain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 21.1 | View |
| Thermal burn | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 21.1 | View |
| Carotid sinus syndrome | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 21.1 | View |
| Cluster headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 21.1 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 21.1 | View |
| Menorrhagia | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 21.1 | View |
| Ovarian cyst | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 21.1 | View |
| Nasal obstruction | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | View |
| Selective abortion | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 21.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Ear pain | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 21.1 | View |
| Abdominal distension | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 21.1 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 21.1 | View |
| Abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 21.1 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 21.1 | View |
| Crohn's disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 21.1 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 21.1 | View |
| Gastrooesophageal reflux disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 21.1 | View |
| Haematochezia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 21.1 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 21.1 | View |
| Odynophagia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 21.1 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 21.1 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 21.1 | View |
| Ear infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Oral herpes | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Pharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Rhinitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Tooth abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Tracheitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Contusion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 21.1 | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 21.1 | View |
| Weight increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 21.1 | View |
| Vitamin B12 deficiency | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 21.1 | View |
| Vitamin D deficiency | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 21.1 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 21.1 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 21.1 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 21.1 | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 21.1 | View |