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 @ 2:13 AM
Ignite Modification Date: 2025-12-26 @ 12:41 AM
NCT ID: NCT01490060
Description: Number of participants for different study groups are: 22 single dose, Arm A (11 from group 1, cycle 1 \& 11 from group 2, cycle 2); 17 two doses, Arm B (9 from group 1, cycle 1 \& 8 from group 2, cycle 2); 37 control cycle \[Arm A: 21(12 from group 1, cycle 2 \& 11 from group 2,cycle 1); Arm B: 16(8 from group 1, cycle 2 \& 8 from group 2,cycle 1)\].
Frequency Threshold: 0
Time Frame: Adverse events (AEs) and Serious Adverse Events (SAEs) were assessed in two 21-days cycles (Cycle 1 and Cycle 2). Collection period: May 23, 2012 to June 11, 2014.
Study: NCT01490060
Study Brief: Fosaprepitant in Patients Receiving Ifosfamide-based Regimen
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 Cycle (Arm A/Arm B) Control cycle without fosaprepitant. None None 4 37 35 37 View
Arm A: Single Dose, Day 1 Fosaprepitant 150 mg intravenous (IV) Day 1 of Cycle 1 (Group 1) or Day 1 of Cycle 2 (Group 2). Participants Randomized to Group 1 (Fosaprepitant Cycle 1 + No Fosaprepitant Cycle 2) or Group 2 (No Fosaprepitant Cycle 1 + Fosaprepitant Cycle 2). None None 1 22 22 22 View
Arm B: Two Doses, Day 1 + Day 4 Fosaprepitant 150 mg IV Day 1 + Day 4 of Cycle 1 (Group 1) or Day 1 + Day 4 of Cycle 2 (Group 2). Participants Randomized to Group 1 (Fosaprepitant Cycle 1 + No Fosaprepitant Cycle 2) or Group 2 (No Fosaprepitant Cycle 1 + Fosaprepitant Cycle 2). None None 1 17 16 17 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Neutropenic Fever SYSTEMATIC_ASSESSMENT General disorders CTCAE v4.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v4.0 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE v4.0 View
Paresthesia SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE v4.0 View
Pain SYSTEMATIC_ASSESSMENT General disorders CTCAE v4.0 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v4.0 View
Anorexia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v4.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders CTCAE v4.0 View
Chills SYSTEMATIC_ASSESSMENT General disorders CTCAE v4.0 View
Headache SYSTEMATIC_ASSESSMENT General disorders CTCAE v4.0 View
Memory Impairment SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE v4.0 View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE v4.0 View
Alopecia SYSTEMATIC_ASSESSMENT General disorders CTCAE v4.0 View
Eye Disorders SYSTEMATIC_ASSESSMENT Eye disorders CTCAE v4.0 View