Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 10:30 PM
Ignite Modification Date: 2025-12-25 @ 8:03 PM
NCT ID: NCT01388335
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT01388335
Study Brief: A Drug Interaction Study to Assess the Effect of LY317615 on the Metabolic Pathway of Warfarin
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Period 1 Period 1 Day 1 (of an 8-day period): 5 milligrams (mg) warfarin administered as a single oral dose. Period included at least a 7-day washout. None None 0 13 5 13 View
Period 2, Prior to Warfarin Dose Period 2 (19 up to 30 days): 500 mg enzastaurin administered orally once daily up to Day 14. None None 0 12 8 12 View
Period 2, Post Warfarin Dose Period 2 (19 up to 30 days): 500 mg enzastaurin administered orally once daily for at least 19 consecutive days and 5 mg warfarin administered as a single oral dose on Day 15. Enzastaurin administered up to 30 days total. None None 0 10 7 10 View
Safety Extension Safety Extension: Participants were allowed to continue receiving 500 mg enzastaurin orally once daily alone until disease progression or other discontinuation criteria are met. Participants were on study for up to a total 8 months (Period 1, Period 2 and Safety Extension). None None 0 7 5 7 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 14.0 View
Ocular icterus SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 14.0 View
Vision blurred SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 14.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Haemorrhoids SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Rectal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.0 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.0 View
Hepatic function abnormal SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 14.0 View
Iodine allergy SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 14.0 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Eye infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Postoperative wound infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Vaginal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Tooth avulsion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 14.0 View
Blood albumin decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 14.0 View
Electrocardiogram qt prolonged SYSTEMATIC_ASSESSMENT Investigations MedDRA 14.0 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 14.0 View
Hypoalbuminaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 14.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 14.0 View
Muscle spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 14.0 View
Tumour pain SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 14.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.0 View
Sciatica SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.0 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 14.0 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 14.0 View
Mood altered SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 14.0 View
Chromaturia SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 14.0 View
Hydronephrosis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 14.0 View
Renal failure acute SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 14.0 View
Metrorrhagia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 14.0 View
Pelvic pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 14.0 View
Vulvovaginal pruritus SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 14.0 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 14.0 View
Hyperhidrosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 14.0 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 14.0 View