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 @ 1:25 AM
Ignite Modification Date: 2025-12-25 @ 11:36 PM
NCT ID: NCT02370693
Description: Adverse event information collected by study team at each study visit.
Frequency Threshold: 0
Time Frame: First dosing day to last study visit day: Mean duration 8 months.
Study: NCT02370693
Study Brief: Comparing and Combining Bortezomib and Mycophenolate in SSc Pulmonary Fibrosis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Bortezomib Plus Mycophenolate Mofetil Bortezomib 1.3 mg/m² subcutaneously (or IV push if unable to tolerate subcutaneous injection) once per week for the first two weeks per month and mycophenolate mofetil 1.5 g orally twice daily for 24 weeks Bortezomib: Bortezomib 1.3 mg/m² subcutaneously (or IV push if unable to tolerate subcutaneous injection) once per week for the first two weeks per month for 24 weeks Mycophenolate mofetil: Mycophenolate mofetil 1.5 g twice a day orally for 24 weeks 0 None 1 3 3 3 View
Placebo Plus Mycophenolate Mofetil Placebo (normal saline) 1.3 mg/m² subcutaneously (or IV push if unable to tolerate subcutaneous injection) once per week for the first two weeks per month and mycophenolate mofetil 1.5 g orally twice daily for 24 weeks Placebo: Placebo (normal saline) 1.3 mg/m² subcutaneously (or IV push if unable to tolerate subcutaneous injection) once per week for the first two weeks per month for 24 weeks Mycophenolate mofetil: Mycophenolate mofetil 1.5 g twice a day orally for 24 weeks 0 None 1 4 4 4 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Herpes Zoster Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Respiratory Syncytial Virus Bilaterial Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Ache on forehead and eyelids SYSTEMATIC_ASSESSMENT General disorders None View
Acid reflux SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Bach ache SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Bloating SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Body aches SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Bruising at injection site SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Burning sensation at injection site SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Chills SYSTEMATIC_ASSESSMENT General disorders None View
Cold SYSTEMATIC_ASSESSMENT Infections and infestations None View
Cold sweats SYSTEMATIC_ASSESSMENT General disorders None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Cough with increased mucus SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dry cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dry eyes SYSTEMATIC_ASSESSMENT Eye disorders None View
Dry Skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Dry throat SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Gastroparesis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Headache SYSTEMATIC_ASSESSMENT General disorders None View
High cholesterol SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Left ankle pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pain at injection site SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Pain in right shoulder SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pre-diabetes SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Productive cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Prolonged coughing episode SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Redness at injection site SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Right side back muscle spasm SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Runny nose SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Shaking SYSTEMATIC_ASSESSMENT General disorders None View
Skin peeling at injection site SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Tingling at injection site SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Sore throat SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Soreness at injection site SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Tingling sensation on face SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Tooth extraction SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Upset stomach SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Urinary tract infection SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Vomiting due to coughing SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Warmth at injection site SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Weight loss of ~10 lbs SYSTEMATIC_ASSESSMENT General disorders None View
Worsened body aches SYSTEMATIC_ASSESSMENT General disorders None View
Worsened cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Worsened fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Worsening diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Worsening shortness of breath SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View