Adverse Events Module

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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 @ 4:18 AM
Ignite Modification Date: 2025-12-26 @ 3:19 AM
NCT ID: NCT02633020
Description: Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Frequency Threshold: 0
Time Frame: From first dose of study drug until week 16.
Study: NCT02633020
Study Brief: Study to Evaluate the Efficacy and Safety of AMG 714 in Adult Patients With Type II Refractory Celiac 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
AMG 714 Participants were administered 8 mg/kg AMG 714 via intravenous infusion on day 0, day 7 and every 2 weeks thereafter through week 10. 0 None 5 19 16 19 View
Placebo Participants were administered placebo via intravenous infusion on day 0, day 7 and every 2 weeks thereafter through week 10. 0 None 1 9 8 9 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hepatitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 18.1 View
Pneumococcal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Tuberculosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Balance disorder SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Cerebellar syndrome SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Peroneal nerve palsy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Dyspnoea exertional SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Rosacea SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.1 View
Lip dry SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Lip exfoliation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Blood albumin decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Blood urine present SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Chronic obstructive pulmonary disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Eye swelling SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 18.1 View
Visual impairment SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 18.1 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Duodenal ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Gastric ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Mouth ulceration SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Bronchitis viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Conjunctivitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Oral herpes SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Infusion related reaction SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.1 View
Alanine aminotransferase abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Bacterial test SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Blood alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Blood lactate dehydrogenase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Eosinophil count abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Eosinophil count increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Helicobacter test positive SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Prostatic specific antigen increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Protein total decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Iron deficiency SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.1 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Dizziness postural SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Depressed mood SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 18.1 View
Disorientation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 18.1 View
Sleep disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 18.1 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Actinic keratosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.1 View
Eczema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.1 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.1 View
Skin plaque SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.1 View
Deep vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 18.1 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 18.1 View
Eosinophilia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 18.1 View
Erythema of eyelid SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 18.1 View