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: 2025-12-25 @ 2:41 AM
Ignite Modification Date: 2025-12-26 @ 1:19 AM
NCT ID: NCT01663233
Description: None
Frequency Threshold: 2
Time Frame: None
Study: NCT01663233
Study Brief: Efficacy and Safety of LCZ696 200 mg + Amlodipine 5 mg in Comparison With Amlodipine 5 mg in Hypertensive Patients Not Responding to Amlodipine
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
LCZ696 and Amlodipine Participants, first treated with 5 mg of amlodipine for 4 weeks to determine if they were not adequately responding to amlodipine (an office msSBP ≥145 mmHg and \<180 mmHg) and who met all inclusion and exclusion criteria), were randomized to receive 200mg of LCZ696 in combination with 5 mg of amlodipine for 8 weeks. None None 0 130 13 130 View
Amlodipine Participants, first treated with 5 mg of amlodipine for 4 weeks to determine if they were not adequately responding to amlodipine (an office msSBP ≥145 mmHg and \<180 mmHg) and who met all inclusion and exclusion criteria), were randomized to receive 5 mg of amlodipine and placebo to LCZ696 for 8 weeks. None None 0 136 19 136 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
NASOPHARYNGITIS SYSTEMATIC_ASSESSMENT Infections and infestations 16.0 View
UPPER RESPIRATORY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations 16.0 View
DYSLIPIDAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders 16.0 View
HYPOKALAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders 16.0 View
DIZZINESS SYSTEMATIC_ASSESSMENT Nervous system disorders 16.0 View