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 @ 5:40 PM
Ignite Modification Date: 2025-12-25 @ 3:09 PM
NCT ID: NCT01361568
Description: None
Frequency Threshold: 5
Time Frame: Treatment-emergent adverse events were collected from the time the patient received her first dose of study drug through the Follow-up Visit.
Study: NCT01361568
Study Brief: Study to Evaluate Analgesic Effect of IV Administration of Kappa Agonist CR845 For Hysterectomy Surgery
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 administered both preoperatively and postoperatively None None 0 71 59 71 View
Placebo-CR845 Placebo administered preoperatively and CR845 administered postoperatively None None 6 71 62 71 View
CR845-CR845 CR845 administered both preoperatively and postoperatively None None 3 20 19 20 View
CR845-Placebo CR845 administered preoperatively and placebo administered postoperatively None None 0 21 15 21 View
CR845-No Postoperative Treatment CR845 administered preoperatively and no study drug administered postoperatively None None 3 7 7 7 View
Placebo-No Postoperative Treatment Placebo administered preoperatively and no study drug administered postoperatively None None 1 13 10 13 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Post procedural haemorrhage NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.1 View
Anaemia Postoperative NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.1 View
Sedation NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Somnolence NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Mental Status Changes NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.1 View
Pulmonary Embolism NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
Respiratory Depression NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
Deep Vein Thrombosis NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 13.1 View
Hypovolaemic Shock NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 13.1 View
Tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.1 View
Blood Sodium Increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.1 View
Muscular Weakness NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.1 View
Endometriosis NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 13.1 View
Pelvic Adhesions NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 13.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Flatulence NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Abdominal Pain Lower NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Intestinal Dilatation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Hypotension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 13.1 View
Hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 13.1 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Paraesthesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Hypoaesthesia NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 13.1 View
Somnolence NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Sedation NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Dysstasia NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 13.1 View
Blood Sodium Increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.1 View
Blood Chloride Increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.1 View
Oxygen Saturation Decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.1 View
Airway Peak Pressure Increase NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.1 View
Gamma-Glutamyltransferase Increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.1 View
Urine Output Decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.1 View
Urinary Retension NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 13.1 View
Bladder Spasm NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 13.1 View
Haematuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 13.1 View
Polyuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 13.1 View
Micturition Urgency NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 13.1 View
Renal Failure Acute NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 13.1 View
Tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.1 View
Procedural Pain NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.1 View
Incisional Site Pain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.1 View
Post Procedural Haemorrhage NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.1 View
Hypoxia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
Asthma NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
Atelectasis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
Respiratory Depression NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.1 View
Mental Status Change NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.1 View
Pruritus NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.1 View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Chest Pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Sensation of Pressure NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Hypomagnesaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.1 View
Hypokalaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.1 View
Hypophosphataemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.1 View
Urinary tract Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Cellulitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Back Pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.1 View
Limb Discomfort NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.1 View
Muscule Spasm NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.1 View
Anaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 13.1 View
Diploplia NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 13.1 View
Vulvovaginal Pruritus NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 13.1 View
Breast Tenderness NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 13.1 View
Hypersensitivity NON_SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 13.1 View