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 @ 7:34 PM
Ignite Modification Date:
2025-12-25 @ 5:15 PM
NCT ID:
NCT01560403
Description:
Date of Study Initiation (first subject, first visit) 21 May 2012 Date of Study Completion (last subject, last visit) 23 July 2013. Due to the different start dates of each subject in this study, not all subjects completed the 12 month visits by the study completion date as the study was terminated on this date by the sponsor.
Frequency Threshold:
5
Time Frame:
1 year, 2 months
Study:
NCT01560403
Study Brief:
A One-Year, Open-Label Study With Teduglutide for Subjects Who Completed Study CL0600-021
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| TED/TED | This group represents those subjects exposed to active treatment with teduglutide for 24 weeks in Study CL0600-020 (NCT00798967) and an additional 24 months in Study CL0600-021 (NCT00930644) | None | None | 5 | 5 | 4 | 5 | View |
| NT/PBO,TED | This group represents those subjects who either participated in Study CL0600-020 and received placebo, or who were eligible for randomization in Study CL0600-020 (NCT00798967), but qualified after the enrollment number was already satisfied and therefore entered the open-label extension Study CL0600-021 (NCT00930644) directly | None | None | 1 | 9 | 4 | 9 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Ischaemic cardiomyopathy | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (12.0) | View |
| Atrial fibrillation | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (12.0) | View |
| Atrial tachycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (12.0) | View |
| Cardiac failure acute | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (12.0) | View |
| Cardiac failure congestive | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (12.0) | View |
| Cardiomyopathy | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (12.0) | View |
| Central line infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (12.0) | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (12.0) | View |
| Urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (12.0) | View |
| In-stent arterial restenosis | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (12.0) | View |
| Upper limb fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (12.0) | View |
| Lactic acidosis | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (12.0) | View |
| Dyspnoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (12.0) | View |
| Abdominal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (12.0) | View |
| Anxiety symptoms | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (12.0) | View |
| Benign neoplasms gastrointestinal | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | View |
| Catheter sepsis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (12.0) | View |
| Catheter site related reaction | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (12.0) | View |
| Cognition and attention disorders and disturbances | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (12.0) | View |
| Dyspnoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | View |
| Fluid overload | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (12.0) | View |
| Hepatic enzyme increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (12.0) | View |
| Hypersensitivity | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (12.0) | View |
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (12.0) | View |
| Lower respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (12.0) | View |
| Musculoskeletal pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | View |
| Seasonal allergy | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (12.0) | View |
| Upper respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (12.0) | View |
| Viral infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (12.0) | View |
| Weight decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (12.0) | View |
| Asthenic conditions | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (12.0) | View |