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 @ 3:00 AM
Ignite Modification Date: 2025-12-26 @ 1:41 AM
NCT ID: NCT03349333
Description: None
Frequency Threshold: 5
Time Frame: AEs were recorded in the eCRF from the point at which the ICF was signed until 30 (± 5) days after the last dose of pralatrexate. This included new AEs that were reported in the 30 (± 5) days after the last dose of pralatrexate.
Study: NCT03349333
Study Brief: A Single Arm Study Evaluating the Efficacy and Safety of Pralatrexate in Subjects With Relapsed or Refractory PTCL
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Pralatrexate Vitamin B12 and folic acid will be taken concurrently with pralatrexate pralatrexate: Pralatrexate will be administered at a dose of 30 mg/m2/week for 6 weeks followed by 1 week of rest in a 7-week cycle. Pralatrexate administration occurs once a week during week 1 through week 6 of each cycle. Vitamin B12 and folic acid: The eligible subjects will receive vitamin supplementation at screening phase, at least 10 days prior to pralatrexate administration on cycle 1, dose 1. Vitamin supplementation will consist of vitamin B12 1 mg intramuscular (IM) q 8-10 weeks and folic acid 1.2mg by mouth (PO) once a day (QD). Once pralatrexate is permanently discontinued, vitamin supplementation should continue at least 1 month after the last pralatrexate dose, or longer at the discretion of the investigator. 29 None 35 71 70 71 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Lung infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Platelet count decreased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Thrombocytopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Stomatitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Febrile neutropenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Pancytopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hepatic function abnormal NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Liver injury NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Stomatitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Neutropenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View