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 @ 10:35 PM
Ignite Modification Date: 2025-12-25 @ 8:07 PM
NCT ID: NCT00595335
Description: None
Frequency Threshold: 0
Time Frame: Participants were followed for adverse events for one year after the first infusion.
Study: NCT00595335
Study Brief: Trial of Rituximab for Graves' Ophthalmopathy
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Rituximab Rituximab 1000 mg IV twice at 2-week intervals, each preceded by Methylprednisolone 100 mg IV as premedication to the rituximab infusion. All subjects will be treated with an acetaminophen tablet and a diphenhydramine hydrochloride tablet before the infusion. Rituximab: Subjects will receive 2 infusions of rituximab (1000 mg IV), two weeks apart. Methylprednisolone: Subjects will receive methylprednisolone 100 mg IV as premedication to the rituximab infusion. None None 2 13 6 13 View
Placebo Subjects will receive 2 infusions of saline IV, 2 weeks apart, each preceded by a premedication saline IV. All subjects will be treated with an acetaminophen tablet and a diphenhydramine hydrochloride tablet before the infusion. Saline: Subjects will receive 2 infusions of saline IV, 2 weeks apart, each preceded by a premedication saline IV. None None 0 12 3 12 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Dysthroid optic neuropathy SYSTEMATIC_ASSESSMENT Eye disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Rash on face SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Vasculitis legs SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Significant eye tearing SYSTEMATIC_ASSESSMENT Eye disorders None View
Indigestion SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Itching of face and scalp SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Arthralgia both knees SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Abdominal Discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Left eye conjunctivitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Acute Bronchitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Tongue pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Arthritis of left hip SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View