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 @ 2:53 AM
Ignite Modification Date: 2025-12-26 @ 1:34 AM
NCT ID: NCT01841333
Description: None
Frequency Threshold: 0
Time Frame: AE's were collected over the 1 year subjects were on glasdegib
Study: NCT01841333
Study Brief: PF-04449913 For Patients With Acute Myeloid Leukemia at High Risk of Relapse After Donor Stem Cell Transplant
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
PF-04449913 Beginning 80 days after allogeneic stem cell transplant, patients receive PF-04449913 (100mg) orally once daily on days 1-28. Treatment repeats every 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity. PF-04449913: 100mg given orally 19 None 2 31 26 31 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Worsening nausea, appetite changes NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Cramping/Myalgias NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Dysgeusia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Anorexia/Weight Loss NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Thrombocytopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Alopecia NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
lymphopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
neutropenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
hypophosphatemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
hypocalcemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
hypoalbuminemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
hyperbilirubinemia NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
hypertriglyceridemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
LFT Increase NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
hyponatremia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View