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 @ 3:04 PM
Ignite Modification Date: 2025-12-25 @ 1:26 PM
NCT ID: NCT00081159
Description: Three of the 40 participants in the Non-Strontium arm (Arm 2) did not receive treatment and are therefore excluded from Adverse Event reporting.
Frequency Threshold: 3
Time Frame: Adverse event collection from beginning of treatment through week 21, and up to week 24 post treatment.
Study: NCT00081159
Study Brief: Hormone Ablation Therapy, Doxorubicin, and Zoledronate With or Without Strontium 89 in Treating Patients With Androgen-Dependent Prostate Cancer and Bone Metastases
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
HAT, Doxorubicin, Zoledronate + Strontium Chloride Arm I: Hormonal ablative therapy (HAT) comprising luteinizing hormone-releasing hormone agonist (e.g., leuprolide or goserelin) continuously during study treatment OR bilateral orchiectomy; doxorubicin IV on days 1, 8, and 15 every 28 days for 2 courses; zoledronate IV over 15 minutes on day 1 every 28 days for 6 courses; and a single dose of strontium chloride Sr 89 IV over 1-2 minutes on day 1. None None 0 39 24 39 View
HAT, Doxorubicin + Zoledronate Arm II: HAT, doxorubicin, and zoledronate as in arm I. HAT comprising luteinizing hormone-releasing hormone agonist (e.g., leuprolide or goserelin) continuously during study treatment OR bilateral orchiectomy; doxorubicin IV on days 1, 8, and 15 every 28 days for 2 courses; zoledronate IV over 15 minutes on day 1 every 28 days for 6 courses. None None 0 37 29 37 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Hemoglobin Increased SYSTEMATIC_ASSESSMENT Investigations CTCAE (3.0) View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (3.0) View
Alanine aminotransferase increased (Alt, Sgpt) SYSTEMATIC_ASSESSMENT Investigations CTCAE (3.0) View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
Aspartate aminotransferase increased (Ast, Sgot) SYSTEMATIC_ASSESSMENT Investigations CTCAE (3.0) View
Bilirubin Increased SYSTEMATIC_ASSESSMENT Investigations CTCAE (3.0) View
Cytokine release syndrome SYSTEMATIC_ASSESSMENT Immune system disorders CTCAE (3.0) View
Fatigue SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Fever Without Neutropenia SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Flu-Like Syndrome SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Gynecomastia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTCAE (3.0) View
Leukocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
Mood Alteration SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE (3.0) View
Mucositis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (3.0) View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE (3.0) View
Pain (Back) SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (3.0) View
Pain (Extremity-Limbs) SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (3.0) View
Pain (Face) SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Pain (Joint) SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (3.0) View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View