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 @ 4:36 PM
Ignite Modification Date: 2025-12-25 @ 2:27 PM
NCT ID: NCT00914966
Description: None
Frequency Threshold: 5
Time Frame: 12 to 24 weeks at each dose level. Events reported during the 3 month follow-up period are counted with the dose level at which they occurred.
Study: NCT00914966
Study Brief: A Study to Evaluate the Safety and Effect of Escalating Doses of CINRYZE
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Step 1: 1500 Units 1500 Units of CINRYZE (C1 inhibitor \[human\]) administered by IV infusion twice per week for 12 weeks None None 1 20 12 20 View
Step 2: 2000 Units 2000 Units of CINRYZE (C1 inhibitor \[human\]) administered by IV infusion twice per week for 12 weeks None None 1 13 5 13 View
Step 3: 2500 Units 2500 Units of CINRYZE (C1 inhibitor \[human\]) administered by IV infusion twice per week for 12 weeks None None 1 12 6 12 View
All Subjects None None None 2 20 13 20 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anemia None Blood and lymphatic system disorders MedDRA 15.0 View
Hereditary angioedema None Congenital, familial and genetic disorders MedDRA 15.0 View
Bile duct stone None Hepatobiliary disorders MedDRA 15.0 View
Cerebral hygroma None Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 15.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Upper respiratory tract infection None Infections and infestations MedDRA 15.0 View
Nasopharyngitis None Infections and infestations MedDRA 15.0 View
Abdominal discomfort None Gastrointestinal disorders MedDRA 15.0 View
Arthralgia None Musculoskeletal and connective tissue disorders MedDRA 15.0 View
Diarrhea None Gastrointestinal disorders MedDRA 15.0 View
Ligament sprain None Injury, poisoning and procedural complications MedDRA 15.0 View
Medical device complication None General disorders MedDRA 15.0 View
Peripheral edema None General disorders MedDRA 15.0 View
Pain in extremity None Musculoskeletal and connective tissue disorders MedDRA 15.0 View
Rhinitis None Infections and infestations MedDRA 15.0 View
Sinusitis None Infections and infestations MedDRA 15.0 View
Urinary tract infection None Infections and infestations MedDRA 15.0 View