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 @ 11:02 PM
Ignite Modification Date: 2025-12-25 @ 8:32 PM
NCT ID: NCT00091169
Description: None
Frequency Threshold: 5
Time Frame: Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Study: NCT00091169
Study Brief: Levocarnitine in Treating Fatigue in Cancer Patients
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Levocarnitine Patients receive oral levocarnitine (L-carnitine) twice daily on weeks 1-4. levocarnitine: Given orally None None 8 166 10 166 View
Placebo Patients receive oral placebo twice daily on weeks 1-4. placebo: Given orally None None 8 171 9 171 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Platelets decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE 3.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders CTCAE 3.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 3.0 View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE 3.0 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE 3.0 View
Pruritus/itching SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE 3.0 View
Rash/desquamation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE 3.0 View
Death - disease progression NOS SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) CTCAE 3.0 View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 3.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 3.0 View
Diarrhea w/o prior colostomy SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 3.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 3.0 View
Infection w/ unk ANC urinary tract NOS SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE 3.0 View
Abdomen, pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 3.0 View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 3.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE 3.0 View