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: 2025-12-26 @ 10:46 PM
Ignite Modification Date: 2025-12-26 @ 10:46 PM
NCT ID: NCT05330312
Description: In this study, selective AE collection was conducted. All ADE, SAE, or SADE are reported, regardless of treatment-relation. For non-serious, non-treatment-related AEs, only events that were associated with a psychological disorder or with a procedure of the clinical investigation were collected in accordance with the clinical investigation plan and are reported.1 subject in the dCBT-PF arm of Part 2 was randomised but unable to start treatment. AE information was not collected for this subject.
Frequency Threshold: 0
Time Frame: Part 1 - Adverse events/adverse device effects were collected from week 2 until week 4. Subjects were asked at week 2 and 4 if any AE or ADE had been experienced since last visit. AE information was not collected for the subject who did not initiate treatment. Part 2 - Adverse events/adverse device effects were collected from week 3 until week 12. Subjects were asked at week 3, 6, 9 and 12 if any AE or ADE had been experienced since last visit.
Study: NCT05330312
Study Brief: Controlled Investigation to Evaluate Impact of dCBT on Psychological Symptom Burden in Adult Subjects With PF
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Part 2 - Digital Cognitive Behavioral Therapy 9 weeks digital cognitive behavioral therapy. Digital cognitive behavioral therapy: Therapy for patients with pulmonary fibrosis 1 None 5 53 3 53 View
Part 2 - Control Group No intervention 4 None 9 54 4 54 View
Part 1 - Digital Cognitive Behavioral Therapy 4 weeks digital cognitive behavioral therapy. Digital cognitive behavioral therapy: Therapy for patients with pulmonary fibrosis 0 None 0 10 1 10 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Atrioventricular block complete SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (26.1) View
Chest Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA (26.1) View
Death SYSTEMATIC_ASSESSMENT General disorders MedDRA (26.1) View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (26.1) View
Oxygen saturation decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA (26.1) View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (26.1) View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (26.1) View
Urosepsis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (26.1) View
Aspiration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (26.1) View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (26.1) View
Idiopathic pulmonary fibrosis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (26.1) View
Pneumomediastinum SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (26.1) View
Pulmonary Hypertension SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (26.1) View
Hip arthroplasty SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA (26.1) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA (26.1) View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (26.1) View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (26.1) View
Arthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (26.1) View