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: 2025-12-24 @ 2:28 PM
Ignite Modification Date: 2025-12-25 @ 1:03 PM
NCT ID: NCT01706159
Description: Safety analysis set was identical to the FAS which included all randomised and treated subjects.
Frequency Threshold: 5
Time Frame: Adverse events reported by the investigator from the first trial-related activity after the subject is exposed to the trial drug until the end of trial visit (Week 10).
Study: NCT01706159
Study Brief: A Placebo-controlled Trial With rFXIII Administered to Subjects With Mild to Moderate Active Ulcerative Colitis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
rFXIII Recombinant factor XIII (rFXIII) was administered as intravenous (i.v.) injections (at an approximate rate of 1-2 mL/min) at a dose of 35 IU/kg. The doses were administered once every second week for a total of 4 doses. None None 1 13 2 13 View
Placebo Placebo formulation was administered as intravenous (i.v.) injections (at an approximate rate of 1-2 mL/min) once every second week. The doses were administered for a total of 4 doses. None None 0 5 2 5 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Colitis ulcerative SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (16.1) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA (16.1) View
Colitis ulcerative SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (16.1) View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA (16.1) View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA (16.1) View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA (16.1) View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (16.1) View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (16.1) View
Blood creatinine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA (16.1) View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (16.1) View
Bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (16.1) View