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 @ 3:43 PM
Ignite Modification Date: 2025-12-25 @ 1:51 PM
NCT ID: NCT00943592
Description: None
Frequency Threshold: 1
Time Frame: None
Study: NCT00943592
Study Brief: Clofarabine-Melphalan-Alemtuzumab Conditioning in Patients With Advanced Hematologic Malignancies
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Clofarabine, Melphalan, and Alemtuzumab Clofarabine was initially administered IV infusion over 1 hour on days -7 through -3 (4 dose levels from 10 to 40 mg/m2); subsequently, the protocol was amended to infuse clofarabine over 3 hours. Melphalan (doses ranging from 100 to 140 mg/m2) was infused over 30 minutes on day -2. Alemtuzumab was administered at 20 mg IV infusion on day -7 through day -3 over 1 hour. None None 44 82 62 82 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anaphylactic reaction None Immune system disorders None View
Atrial fibrillation None Cardiac disorders None View
Cardiovascular disease, unspecified None Cardiac disorders None View
Confusion None Psychiatric disorders None View
Hypotension None Vascular disorders None View
Mental status changes None Psychiatric disorders None View
Mucositis None General disorders None View
Pulmonary embolism None Respiratory, thoracic and mediastinal disorders None View
Pulmonary hemorrhage None Respiratory, thoracic and mediastinal disorders None View
Palmar-plantar erythrodysesthesia syndrome None Skin and subcutaneous tissue disorders None View
Renal disorder NOS None Renal and urinary disorders None View
Hepatobiliary disease NOS None Hepatobiliary disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Confusion None Psychiatric disorders None View
Hepatobiliary disease NOS None Hepatobiliary disorders None View
Mucositis None General disorders None View
Palmar-plantar erythrodysesthesia syndrome None Skin and subcutaneous tissue disorders None View
Pancreatitis None Gastrointestinal disorders None View
Renal disorder NOS None Renal and urinary disorders None View
Diarrhea None Gastrointestinal disorders None View
Pseudotumor cerebri None Nervous system disorders None View
Anxiety None Psychiatric disorders None View
Atrial flutter None Cardiac disorders None View