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 @ 2:32 AM
Ignite Modification Date: 2025-12-26 @ 1:08 AM
NCT ID: NCT01149434
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT01149434
Study Brief: Study of JI-101 in Patients With Advanced Low Grade Endocrine Tumors, Ovarian Cancers or K-RAS Mutant Colon Cancers
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Pharmacokinetic Arm Patients going on Pharmacokinetic arm will receive JI-101 \& Everolimus (4 patients only) JI-101: JI-101 inhibits angiogenesis, and subsequently tumor growth, by inhibiting three receptor tyrosine kinases: VEGF Receptor Type 2 (VEGFR 2), platelet derived growth factor receptor beta (PDGFR β and Ephrin B4 (EphB4). JI-101 selectively inhibits kinases critical for all three stages of tumor angiogenesis. Everolimus: Everolimus is a signal transduction inhibitor that selectively inhibits mTOR (mammalian target of rapamycin), a key and highly conserved serine-threonine kinase, that is present in all cells and is a central regulator of protein synthesis and ultimately cell growth, cell proliferation, angiogenesis, and cell survival. mTOR is the only currently known target of everolimus (1). None None 1 4 4 4 View
Pharmacodynamic Arm Patients going on the Pharmacodynamic study will receive JI-101 only. JI-101: JI-101 inhibits angiogenesis, and subsequently tumor growth, by inhibiting three receptor tyrosine kinases: VEGF Receptor Type 2 (VEGFR 2), platelet derived growth factor receptor beta (PDGFR β and Ephrin B4 (EphB4). JI-101 selectively inhibits kinases critical for all three stages of tumor angiogenesis. None None 4 15 12 15 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hypertension None Vascular disorders None View
Small bowel obstruction None Gastrointestinal disorders None View
Constipation None Gastrointestinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
abdominal pain None Gastrointestinal disorders None View
anemia None Vascular disorders None View
Anorexia None Gastrointestinal disorders None View
consitpation None Gastrointestinal disorders None View
dehydration None Gastrointestinal disorders None View
depression None Nervous system disorders None View
diarrhea None Gastrointestinal disorders None View
deep vein thrombosis None Blood and lymphatic system disorders None View
Elevated ALT None Metabolism and nutrition disorders None View
Elevated AST None Metabolism and nutrition disorders None View
fatigue None Investigations None View
headache None Nervous system disorders None View
Elevated Alk Phos None Metabolism and nutrition disorders None View
Hyperglycemia None Metabolism and nutrition disorders None View
Hypertension None Vascular disorders None View
Hyperthyroidism None Endocrine disorders None View
Hypoalbuminemia None Metabolism and nutrition disorders None View
Hypotension None Vascular disorders None View
left toe infection None Infections and infestations None View
lymphopenia None Blood and lymphatic system disorders None View
Mouth Soreness None Investigations None View
nausea None Gastrointestinal disorders None View
right upper quadrant pain None Musculoskeletal and connective tissue disorders None View
small bowel obstruction None Gastrointestinal disorders None View
Urinary Tract Infection None Infections and infestations None View
vomiting None Gastrointestinal disorders None View
Weakness None Musculoskeletal and connective tissue disorders None View
weight loss None Investigations None View