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 @ 3:28 AM
Ignite Modification Date: 2025-12-26 @ 2:09 AM
NCT ID: NCT01399905
Description: None
Frequency Threshold: 1
Time Frame: None
Study: NCT01399905
Study Brief: High and Low Dose Carbidopa Treatment of Parkinson's Disease
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Low-dose Carbidopa (75 mg/Day) Due to the cross-over study design all 12 participants who completed the study are included in both the high-dose and low-dose treatment arms. 0 None 0 12 11 12 View
High-dose Carbidopa (450 mg/Day) Due to the cross-over study design all 12 participants who completed the study are included in both the high-dose and low-dose treatment arms. In addition, the subject who initiated treatment but did not complete the study is included in this arm for the purpose of reporting adverse events. 0 None 0 13 9 13 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Body aches NON_SYSTEMATIC_ASSESSMENT General disorders None View
Difficulty swallowing study drug NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Dyspnea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
GERD NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Increased dyskinesia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Mania/anxiety NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
More off time/tremor SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Sciatica NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Upper Respiratory Infection NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Falls NON_SYSTEMATIC_ASSESSMENT General disorders None View
Orthostasis SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Voice fading NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View