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 @ 11:37 PM
Ignite Modification Date: 2025-12-25 @ 9:27 PM
NCT ID: NCT00617656
Description: The drugs used in this trial have been on the market for several years and the profile of safety is known. No unusual AEs has occurred in this trial. Since the objective of the interim analysis for which the trial was closed was not the analysis of AEs, these have not been analyzed for this trial. During the study were reported 68 cases of SAEs related to medication and 106 cases of SAEs not related to medication. The only SUSAR was: Severe afebrile neutropenia and renal failure.
Frequency Threshold: 5
Time Frame: 60 Months
Study: NCT00617656
Study Brief: Study to Evaluate Treatment Customized According to RAP80 and BRCA1 in Patients With Advanced Lung Carcinoma
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Control Group Docetaxel 75 mg/m2 and cisplatin 75 mg/m2, both on day 1, every 21 days. Total number of cycles: 6 Cisplatin, Docetaxel: Docetaxel 75 mg/m2 and cisplatin 75 mg/m2, both on day 1, every 21 days. Total number of cycles: 6 2 None 9 142 0 142 View
B1: Experimental Group 1 Low RAP expression and any levels of BRCA1 expression: Gemcitabine 1250 mg/m2, days 1 and 8, and Cisplatin 75 mg/m2, day 1. 21-day cycles. Total number of cycles: 6 Gemcitabine, Cisplatin: Gemcitabine 1250 mg/m2, days 1 and 8, and Cisplatin 75 mg/m2, day 1. 21-day cycles. Total number of cycles: 6 7 None 29 45 0 45 View
B2 Experimental Group 2 Intermediate or high RAP expression and low or intermediate BRCA1 expression: Docetaxel 75 mg/m2 and Cisplatin 75 mg/m2, both administered on day 1, every 21 days. Total number of cycles: 6 Docetaxel, Cisplatin: Docetaxel 75 mg/m2 and Cisplatin 75 mg/m2, both administered on day 1, every 21 days. Total number of cycles: 6 19 None 49 49 0 49 View
B3 Experimental Group 3 Intermediate or high RAP expression and high BRCA1 expression: Docetaxel 75 mg/m2, day 1. 21-day cycles. Total number of cycles: 6 Docetaxel: Docetaxel 75 mg/m2, day 1. 21-day cycles. Total number of cycles: 6 3 None 6 43 0 43 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Neutropenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 10.0 View
Tromboembolismo pulmonar NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10.0 View
Pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
Dyspnoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.0 View
Renal failure NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 10.0 View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
Mucositis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
Fever NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
Asthenia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
Respiratory infection NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.0 View
Gastrointestinal bleeding NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
Confusional syndrome NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10.0 View
Pneumoniae NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.0 View
Anemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 10.0 View
Sepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Other Events(If Any):