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 @ 2:31 AM
Ignite Modification Date: 2025-12-26 @ 1:06 AM
NCT ID: NCT00201734
Description: Adverse Events were graded using the National Cancer Institute Common Toxicity Criteria version 3.0.
Frequency Threshold: 5
Time Frame: None
Study: NCT00201734
Study Brief: Capecitabine, Carboplatin and Weekly Paclitaxel for Patients With Solid Tumors and Adenocarcinoma of Unknown Primary
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Phase I Cycles will be of 4-week duration. Carboplatin was administered on day 1 intravenously for 3 weeks (days 1, 8, 15) and paclitaxel weekly intravenously for 3 weeks on days 1, 8 and 15. Capecitabine was given orally twice daily days 18-21 followed by 1 week rest. None None 0 29 29 29 View
Phase II Phase II trial combination at the recommended doses from the Phase I portion in patients with adenocarcinoma of unknown primary site. None None 0 25 25 25 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE version 3.0 View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE version 3.0 View
Lymphopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE version 3.0 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE version 3.0 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE version 3.0 View
Anorexia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE version 3.0 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE version 3.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders CTCAE version 3.0 View
Fever without Neutropenia SYSTEMATIC_ASSESSMENT General disorders CTCAE version 3.0 View
Mucositis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE version 3.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE version 3.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE version 3.0 View
Neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE version 3.0 View
Hand Foot Syndrome SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE version 3.0 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE version 3.0 View