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 @ 3:06 PM
Ignite Modification Date:
2025-12-25 @ 1:27 PM
NCT ID:
NCT03242759
Description:
All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.
Frequency Threshold:
5
Time Frame:
From baseline until end of follow-up, up to 899 days.
Study:
NCT03242759
Study Brief:
Non-Interventional Study (NIS) Collecting Experiences For IPF in Taiwan
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug | Eligible patients with idiopathic pulmonary fibrosis (IPF) who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria, recruiting from 10 hospitals in Taiwan, and used anti-fibrotic drug were included in this group. | 28 | None | 29 | 88 | 36 | 88 | View |
| Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug | Eligible patients with idiopathic pulmonary fibrosis (IPF) who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria, recruiting from 10 hospitals in Taiwan, and did not use anti-fibrotic drug were included in this group. | 1 | None | 2 | 13 | 2 | 13 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia of chronic disease | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 23.1 | View |
| Acute myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 23.1 | View |
| Atrioventricular block complete | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 23.1 | View |
| Bradycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 23.1 | View |
| Cardiac arrest | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 23.1 | View |
| Myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 23.1 | View |
| Death | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 23.1 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 23.1 | View |
| Hepatitis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 23.1 | View |
| Bacteraemia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.1 | View |
| Oral candidiasis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.1 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.1 | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.1 | View |
| Septic shock | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.1 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.1 | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 23.1 | View |
| Alanine aminotransferase abnormal | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 23.1 | View |
| Aspartate aminotransferase abnormal | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 23.1 | View |
| Intraventricular haemorrhage | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 23.1 | View |
| Acute kidney injury | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 23.1 | View |
| Chronic obstructive pulmonary disease | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | View |
| Idiopathic pulmonary fibrosis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | View |
| Pneumonia aspiration | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | View |
| Respiratory failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.1 | View |
| Alanine aminotransferase abnormal | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 23.1 | View |
| Aspartate aminotransferase abnormal | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 23.1 | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 23.1 | View |
| Pulmonary mass | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | View |