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 @ 1:36 PM
Ignite Modification Date: 2025-12-25 @ 12:35 PM
NCT ID: NCT02598895
Description: The investigator was responsible for ensuring that all non-serious grade 3 and above non-serious adverse events (as defined in Section 6.7.1 and as further specified below) observed by the investigator or reported by subjects were collected and recorded in the CRF. Source documents may have included the subjects' medical records, patient diaries or study-specific worksheets. Recording for all events were done in a concise manner using standard, acceptable medical terms.
Frequency Threshold: 5
Time Frame: Adverse events data were collected up to 2.5 years after the last dose of study treatment for each participant.
Study: NCT02598895
Study Brief: Docetaxel and Carboplatin in Treating Patients With Metastatic, Castration Resistant Prostate Cancer Containing Inactivated Genes in the BRCA 1/2 Pathway
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Treatment (Docetaxel, Carboplatin) Patients receive docetaxel IV over 30-60 minutes and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 10 courses in the absence of disease progression or unacceptable toxicity. Carboplatin: Given IV Docetaxel: Given IV Laboratory Biomarker Analysis: Correlative studies 10 None 0 14 5 14 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Platelet Count Decreased SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (4.0) View
Neutrophil Count Decreased SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (4.0) View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (4.0) View
Maculopapular rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (4.0) View
Anaphylaxis SYSTEMATIC_ASSESSMENT Immune system disorders CTCAE (4.0) View
Leukocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (4.0) View
Disseminated Intravascular Coagulation SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (4.0) View