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 @ 11:38 PM
Ignite Modification Date:
2025-12-25 @ 9:28 PM
NCT ID:
NCT03478956
Description:
After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were reported. After initiation of study drug, all AEs were reported until the last study visit or 12 weeks after the last dose of study drug. After this period, only serious AEs related to prior study drug were reported. Safety population included all treated participants in the study.
Frequency Threshold:
5
Time Frame:
From Baseline up to the last dose of drug in the Randomized Treatment phase (up to 24 weeks); OLE Period: From end of Week 24 up to end of 12-week safety follow-up (up to 195 weeks); PML Period: After completion of safety follow up in the Randomized Treatment phase or after completion of safety follow up after OLE treatment, up to approximately 92 weeks
Study:
NCT03478956
Study Brief:
A Phase I Study of Etrolizumab Followed by Open-Label Extension and Safety Monitoring in Pediatric Patients With Moderate to Severe Ulcerative Colitis or Moderate to Severe 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 |
|---|---|---|---|---|---|---|---|---|
| Etrolizumab Q4W | Etrolizumab 1.5 mg/kg was administered by SC injection Q4W for a total of 4 doses over the course of the 24-week randomized treatment phase (16-week treatment plus 8-week safety follow-up). | 0 | None | 2 | 12 | 8 | 12 | View |
| Etrolizumab Q8W | Etrolizumab 3.0 mg/kg was administered by SC injection Q8W for a total of 2 doses over the course of the 24-week randomized treatment phase (16-week treatment plus 8-week safety follow-up). | 0 | None | 2 | 12 | 9 | 12 | View |
| OLE: Etrolizumab 1.5 mg/kg Q4W | Participants from Etrolizumab Q4W and Etrolizumab Q8W who completed the randomized treatment period, were given the option to participate in the OLE period. All participants who chose to enter the OLE period were administered etrolizumab 1.5 mg/kg SC Q4W for a maximum of 183 weeks. Post treatment discontinuation patients entered a 12-week safety follow up. | 0 | None | 6 | 21 | 20 | 21 | View |
| PML Safety Monitoring | After the randomized treatment period (if participants did not enter the OLE period) or after the OLE period, participants who chose to continue in PML safety surveillance phase were monitored for PML for approximately 92 weeks. Participants who chose to enter PML surveillance phase were only followed up for PML and did not receive any study treatment. | 0 | None | 0 | 13 | 4 | 13 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA version 26.0 | View |
| Colitis ulcerative | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 26.0 | View |
| Crohn's disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 26.0 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 26.0 | View |
| Gastritis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 26.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 26.0 | View |
| Anxiety disorder | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA version 26.0 | View |
| Sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 26.0 | View |
| Drug abuse | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA version 26.0 | View |
| Intentional self-injury | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA version 26.0 | View |
| Idiopathic intracranial hypertension | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 26.0 | View |
| Balanoposthitis | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA version 26.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA version 26.0 | View |
| Lymphopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA version 26.0 | View |
| Tinnitus | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA version 26.0 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 26.0 | View |
| Abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 26.0 | View |
| Aphthous ulcer | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 26.0 | View |
| Colitis ulcerative | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 26.0 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 26.0 | View |
| Crohn's disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 26.0 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 26.0 | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 26.0 | View |
| Haematochezia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 26.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 26.0 | View |
| Odynophagia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 26.0 | View |
| Toothache | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 26.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 26.0 | View |
| Peripheral swelling | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 26.0 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 26.0 | View |
| Conjunctivitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 26.0 | View |
| Folliculitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 26.0 | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 26.0 | View |
| Respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 26.0 | View |
| Respiratory tract infection viral | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 26.0 | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 26.0 | View |
| Varicella | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 26.0 | View |
| Viral upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 26.0 | View |
| Arthropod bite | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 26.0 | View |
| Weight decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 26.0 | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA version 26.0 | View |
| Iron deficiency | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA version 26.0 | View |
| Vitamin B12 deficiency | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA version 26.0 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA version 26.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 26.0 | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 26.0 | View |
| Leukocyturia | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA version 26.0 | View |
| Amenorrhoea | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA version 26.0 | View |
| Polymenorrhoea | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA version 26.0 | View |
| Catarrh | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.0 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.0 | View |
| Epistaxis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.0 | View |
| Nasal congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.0 | View |
| Oropharyngeal pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.0 | View |
| Rhinorrhoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.0 | View |
| Erythema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA version 26.0 | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA version 26.0 | View |
| Rash papular | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA version 26.0 | View |
| Chest pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 26.0 | View |
| COVID-19 | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 26.0 | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 26.0 | View |
| Gastrointestinal infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 26.0 | View |
| Herpes zoster | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 26.0 | View |
| Oral herpes | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 26.0 | View |
| Pharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 26.0 | View |
| Rhinitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 26.0 | View |
| Head injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 26.0 | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA version 26.0 | View |
| Dysmenorrhoea | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA version 26.0 | View |
| Vaccination site reaction | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 26.0 | View |
| Ligament sprain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 26.0 | View |