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 @ 1:46 AM
Ignite Modification Date: 2025-12-26 @ 12:04 AM
NCT ID: NCT02335294
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT02335294
Study Brief: A Study of TRV130 for the Treatment of Pain After Abdominoplasty
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Protocol v1-4 Morphine Morphine loading doses totaling 4 mg. Morphine 1 mg PCA with 6-min lockout. 0 None 0 42 39 42 View
Protocol v1-4 Placebo Placebo (5% D5W) loading doses totaling 4 ml. Placebo 1 ml PCA with 6-min lockout. 0 None 0 19 8 19 View
Protocol v5 TRV130 0.35 mg TRV130 loading doses totaling 1.5 mg. TRV130 0.35 mg PCA with 6-min lockout. 0 None 0 39 32 39 View
Protocol v5 Morphine Morphine loading doses totaling 4 mg. Morphine 1 mg PCA with 6-min lockout. 0 None 1 41 39 41 View
Protocol v5 Placebo Placebo (5% D5W) loading doses totaling 4 ml. Placebo 1 ml PCA with 6-min lockout. 0 None 0 20 16 20 View
Protocol v1-4 TRV130 0.1 mg TRV130 loading doses totaling 1.5 mg. TRV130 0.1 mg PCA with 6-min lockout. 0 None 0 39 26 39 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anemia None Blood and lymphatic system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Upper Respiratory Tract Infection None Infections and infestations None View
Back Pain None Musculoskeletal and connective tissue disorders None View
Headache None Nervous system disorders None View
Presyncope None Nervous system disorders None View
Sedation None Nervous system disorders None View
Somnolence None Nervous system disorders None View
Tension Headache None Nervous system disorders None View
Hypoventilation None Respiratory, thoracic and mediastinal disorders None View
Hypoxia None Respiratory, thoracic and mediastinal disorders None View
Respiratory Depression None Respiratory, thoracic and mediastinal disorders None View
Dermatitis Contact None Skin and subcutaneous tissue disorders None View
Pruritus None Skin and subcutaneous tissue disorders None View
Pruritus Generalized None Skin and subcutaneous tissue disorders None View
Hypotension None Vascular disorders None View
Regurgitation None Gastrointestinal disorders None View
Infusion Site Discomfort None General disorders None View
Infusion Site Extravasation None General disorders None View
Infusion Site Inflammation None General disorders None View
Infusion Site Pain None General disorders None View
Postoperative Fever None Injury, poisoning and procedural complications None View
Electrocardiogram T-Wave Abnormal None Investigations None View
Pain in Extremity None Musculoskeletal and connective tissue disorders None View
Syncope None Nervous system disorders None View
Insomina None Psychiatric disorders None View
Sinus Congestion None Respiratory, thoracic and mediastinal disorders None View
Phlebitis None Vascular disorders None View
Tachycardia None Cardiac disorders None View
Nausea None Gastrointestinal disorders None View
Vomiting None Gastrointestinal disorders None View
Local Swelling None General disorders None View