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 @ 4:50 PM
Ignite Modification Date: 2025-12-25 @ 2:34 PM
NCT ID: NCT01754350
Description: Few minor adverse events are not listed seperately because some of these occured in the same patients.
Frequency Threshold: 0
Time Frame: All, even non-serious adverse events, were monitored at start of treatment until end of intervention at day 12 to assess procedure-specific adverse events. After day 12, the prespecified secondary end point and adverse event "epileptic seizures"), and all serious adverse events were documented until the end of the study of individual patients (until primary end points was reached).
Study: NCT01754350
Study Brief: Calorie-restricted, Ketogenic Diet and Transient Fasting During Reirradiation for Patients With Recurrent Glioblastoma
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Ketogenic Diet and Transient Fasting Calorie-restricted, ketogenic diet and transient fasting during reirradiation calorie-restricted ketogenic diet and transient fasting: On day 1-3 and day 7-9, restriction of carbohydrates to \< 60 g and of calories to 21-23 kcal/kg per day, on day 4-6 fasting. On day 1-3 and 7-9, restriction of carbohydrates can be supported by the use of drinks provided by "Tavarlin". 0 None 0 20 4 20 View
Standard Nutrition nutrition according to recommendations of the German society for nutrition during reirradiation standard nutrition: nutrition as recommended by the german society for nutrition, 30 kcal/kg per day 0 None 0 22 5 22 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
epileptic seizure SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Others SYSTEMATIC_ASSESSMENT Nervous system disorders None View