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 @ 9:13 PM
Ignite Modification Date: 2025-12-25 @ 7:03 PM
NCT ID: NCT01335204
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT01335204
Study Brief: Ph Ib/IIa Study of Cabazitaxel Plus Bavituximab in Castration-resistant Prostate Cancer
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Cabazitaxel Plus Bavituximab Cabazitaxel (25 mg/m2) will be administered IV on Day 1 of each 21-day treatment cycle. Bavituximab (3 mg/kg) will be administered as an IV infusion on a weekly basis (Cycle 1 Day 2, all other cycles Day 1; day 8; day 15) for 8 cycles. Cabazitaxel plus bavituximab: Cabazitaxel (25 mg/m2) will be administered IV on Day 1 of each 21-day treatment cycle, and bavituximab (3 mg/kg) will be administered as an IV infusion on a weekly basis (Cycle 1 Day 2, all other cycles Day 1; day 8; day 15) for 8 cycles. 0 None 0 4 4 4 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
chest wall pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
memory impairment SYSTEMATIC_ASSESSMENT Nervous system disorders None View
peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
stomach pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
hematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
urinary urgency SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
hypertension SYSTEMATIC_ASSESSMENT Vascular disorders None View
anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
fatigue SYSTEMATIC_ASSESSMENT General disorders None View
oral pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
neutrophil count decrease SYSTEMATIC_ASSESSMENT Investigations None View