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 @ 9:16 PM
Ignite Modification Date: 2025-12-25 @ 7:04 PM
NCT ID: NCT01704404
Description: The Participant Flow shows the # of subjs in each of the 6 treatment sequences (each sequence has 4 treatments; 4/6 study drug doses and placebo) as instructed by CTgov for complex crossover designs. The Number of Participants at Risk, instead, shows the # of subjs exposed to each of the 6 doses of study drug and placebo. Also, some subjs did not complete all of the doses in their treatment sequence. The # of subjs in each sequence is not related to the # of subjs in each dose level therefore.
Frequency Threshold: 4
Time Frame: 13 weeks
Study: NCT01704404
Study Brief: 7 Days of TD-4208 in Subjects With Chronic Obstructive Pulmonary 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
Dose 1 TD-4208 22 µg TD-4208 None None 2 42 14 41 View
Dose 2 TD-4208 44 µg TD-4208 None None 0 42 12 39 View
Dose 3 TD-4208 88 µg TD-4208 None None 0 40 12 40 View
Dose 4 TD-4208 175 µg TD-4208 None None 0 41 13 37 View
Dose 5 TD-4208 350 µg TD-4208 None None 0 41 8 41 View
Dose 6 TD-4208 700 µg TD-4208 None None 0 42 9 37 View
Placebo Placebo Placebo None None 1 62 16 61 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Chest Pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
Transient Ischaemic Attack NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.0 View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.0 View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.0 View
Dyspnoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.0 View
Back Pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.0 View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.0 View
COPD NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.0 View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Contusion NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.0 View
Haematoma NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 15.0 View
Rhinorrhoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.0 View