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 @ 10:44 PM
Ignite Modification Date: 2025-12-25 @ 8:14 PM
NCT ID: NCT03364335
Description: Treatment-Emergent Adverse Event (TEAE) is defined as an adverse event occuring on (or) after the first dose of randomized Study medication, (or) existing prior to the time of and worsening after the time of the first dose of randomized study medication. N:number of subjects in the Intent-to-Treat population; n:number of subjects in the category; %:percentage calculated using the N as the denominator.
Frequency Threshold: 5
Time Frame: 6 months
Study: NCT03364335
Study Brief: The Effect Of NS-0200 and NS-0300 Versus Placebo on Weight In Obesity
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo Placebo: Placebo 0 None 0 52 14 52 View
Leu Sil 1.0mg 3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 1.0 mg of sildenafil Leucine: 1100 mg BID Sildenafil Citrate 1.0 mg: Sildenafil 1.0 mg BID 0 None 2 51 19 51 View
Leu Sil 4.0mg 3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 4.0 mg of sildenafil Leucine: 1100 mg BID Sildenafil Citrate 4.0 mg: Sildenafil 4.0 mg BID 0 None 0 53 12 53 View
Leu Met Sil 1.0mg 3 capsules BID consisting of 2 capsules containing 550 mg L-leucine and 250 mg metformin and 1 capsule containing 1.0 mg of sildenafil Leucine: 1100 mg BID Sildenafil Citrate 1.0 mg: Sildenafil 1.0 mg BID Metformin: Metformin 500 mg BID 0 None 1 50 21 50 View
Leu Met Sil 4.0mg 3 capsules BID consisting of 2 capsules containing 550 mg L-leucine and 250 mg metformin and 1 capsule containing 4.0 mg of sildenafil Leucine: 1100 mg BID Sildenafil Citrate 4.0 mg: Sildenafil 4.0 mg BID Metformin: Metformin 500 mg BID 0 None 0 52 19 52 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Tooth abscess SYSTEMATIC_ASSESSMENT Infections and infestations None View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Anal Cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Metastatic malignant melanoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Sinusitis SYSTEMATIC_ASSESSMENT General disorders None View
Back Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Nasopharyngitis SYSTEMATIC_ASSESSMENT General disorders None View
Pharyngitis SYSTEMATIC_ASSESSMENT General disorders None View
Headache SYSTEMATIC_ASSESSMENT General disorders None View
Nausea SYSTEMATIC_ASSESSMENT General disorders None View
Abdominal Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
C-reactive protein increased SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Constipation SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Diarrhoea SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Hypertension SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Increased Appetite SYSTEMATIC_ASSESSMENT General disorders None View
Influenza SYSTEMATIC_ASSESSMENT General disorders None View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Viral infection SYSTEMATIC_ASSESSMENT General disorders None View