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 @ 1:28 PM
Ignite Modification Date: 2025-12-25 @ 12:32 PM
NCT ID: NCT02717195
Description: None
Frequency Threshold: 5
Time Frame: 22 weeks
Study: NCT02717195
Study Brief: Effect of Lu AF35700 in Patients With Treatment-resistant Schizophrenia
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Prospective Confirmation (PC) Period, Risperidone Patients not randomized to double-blind treatment 0 None 14 708 60 708 View
PC Period, Olanzapine Patients not randomized to double-blind treatment 0 None 7 384 45 384 View
Double Blind Treatment (DBT) Period, Lu AF35700 10 mg Lu AF35700: 10 mg/day, encapsulated tablets, orally for 10 weeks 0 None 6 234 20 235 View
DBT Period, Lu AF35700 20 mg Lu AF35700: 20 mg/day, encapsulated tablets, orally for 10 weeks 0 None 5 232 40 232 View
DBT Period, Continued Treatment From PC Period Patients in this arm continued with the same treatment and dose as at the last visit of the PC Period. This arm is analyzed as one single treatment arm independent on which treatment was administered (olanzapine or risperidone). 1 None 5 230 25 230 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Myocardial infarction NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA - 21.0 View
Sinus tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA - 21.0 View
Intestinal haemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA - 21.0 View
Vascular stent thrombosis NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA - 21.0 View
Intentional overdose NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA - 21.0 View
Electrocardiogram abnormal NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA - 21.0 View
Presyncope NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA - 21.0 View
Type 2 diabetes mellitus NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA - 21.0 View
Multiple sclerosis NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA - 21.0 View
Acute psychosis NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA - 21.0 View
Hallucination NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA - 21.0 View
Paranoia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA - 21.0 View
Psychotic disorder NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA - 21.0 View
Schizophrenia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA - 21.0 View
Suicidal ideation NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA - 21.0 View
Suicide attempt NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA - 21.0 View
Asthma NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA - 21.0 View
Pulmonary embolism NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA - 21.0 View
Pulmonary thrombosis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA - 21.0 View
Social stay hospitalisation NON_SYSTEMATIC_ASSESSMENT Social circumstances MedDRA - 21.0 View
Psychosocial support NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA - 21.0 View
Hypertensive emergency NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA - 21.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Weight increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA - 21.0 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA - 21.0 View
Somnolence NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA - 21.0 View
Akathisia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View