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 @ 4:04 AM
Ignite Modification Date: 2025-12-26 @ 2:59 AM
NCT ID: NCT01309802
Description: None
Frequency Threshold: 0
Time Frame: For adverse events were followed to resolution.
Study: NCT01309802
Study Brief: A Two-Part Study of BOTOX® Therapy for Ischemic Digits
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo no intervention 0 None 5 25 25 25 View
Onabotulinum Toxin Type-A up to 4 injections per hand dosage per injection: 100 units diluted in 2.0 mL normal saline; dosing will not exceed 360 units in a 3 month interval frequency: no less than 28 days between injections duration: during Study Year 1 onabotulinum toxin type-A: up to 4 injections per hand dosage per injection: 100 units diluted in 2.0 mL normal saline; dosing will not exceed 360 units in a 3 month interval frequency: no less than 28 days between injections duration: during Study Year 1 0 None 2 23 22 23 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Broken bone NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Collapsed Lung NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dizziness NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Throat Swelling NON_SYSTEMATIC_ASSESSMENT General disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Pain, Redness, Bleeding NON_SYSTEMATIC_ASSESSMENT General disorders None View
Swelling, Tenderness, Bruising NON_SYSTEMATIC_ASSESSMENT General disorders None View
Temporary Weakness or numbness of muscle NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Dizziness, Drowsiness NON_SYSTEMATIC_ASSESSMENT General disorders None View
Dry Eyes, Dry Mouth NON_SYSTEMATIC_ASSESSMENT General disorders None View
Vision Changes NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Increased Cough, Runny nose NON_SYSTEMATIC_ASSESSMENT General disorders None View
Allergic Reaction or Itching NON_SYSTEMATIC_ASSESSMENT General disorders None View
Tingling NON_SYSTEMATIC_ASSESSMENT General disorders None View
Shortness of breath NON_SYSTEMATIC_ASSESSMENT General disorders None View
Difficulty Swallowing NON_SYSTEMATIC_ASSESSMENT General disorders None View