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 @ 7:24 PM
Ignite Modification Date: 2025-12-25 @ 5:04 PM
NCT ID: NCT01413503
Description: All study records, including participant charts, IND files, and staff computers, were destroyed in a flood. Partial Adverse Event information was derived from publication-PubMed ID: 19636009
Frequency Threshold: 0
Time Frame: None
Study: NCT01413503
Study Brief: A Phase II Study of 131I- Metaiodobenzylguanidine (MIBG) for Treatment of Metastatic or Unresectable Pheochromocytoma and Related Tumors
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
131I-MIBG Patients received 131I-MIBG 8-12 mCi/kg (maximum 500 mCi ± 10% at investigator's discretion) diluted in 25 ml of normal saline. Patients were infused intravenously through a patient's peripheral or central line over 120 minutes 4 None 6 49 43 49 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Bronchiolitis obliterans organizing pneumonia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 3.0 View
Myelodysplastic syndrome SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE 3.0 View
Acute respiratory distress syndrome SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 3.0 View
Pulmonary Embolism NON_SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE 3.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Neutropenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE 3.0 View
Thrombocytopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE 3.0 View
Pulmonary embolism NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 3.0 View
Febrile neutropenia NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE 3.0 View
Acute hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE 3.0 View
Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE 3.0 View
Hyperthyroidism NON_SYSTEMATIC_ASSESSMENT Endocrine disorders CTCAE 3.0 View
Hypogonadism NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTCAE 3.0 View