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 @ 9:13 PM
Ignite Modification Date: 2025-12-25 @ 7:03 PM
NCT ID: NCT01916304
Description: At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Frequency Threshold: 5
Time Frame: 5 months from inclusion (all patients) or up to recovery/final status is known for AE's.
Study: NCT01916304
Study Brief: Study of Dose Adjustment From Levothyroxine to a New Levothyroxine Sodium Test Formulation
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Levothyroxine Sodium New Formulation Levothyroxine (25-225 μg), tablets, orally, once daily for up to 12 to 20 weeks. Dose administered depends on the thyroid stimulating hormone level. None None 7 101 7 101 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Post procedural haematoma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 17.0 View
Catheterisation cardiac SYSTEMATIC_ASSESSMENT Investigations MedDRA 17.0 View
Skin lesion SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 17.0 View
Bladder catheterisation SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 17.0 View
Hysterectomy SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 17.0 View
Mastectomy SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 17.0 View
Salivary gland resection SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 17.0 View
Haemorrhage SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 17.0 View
Cardiac failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 17.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 17.0 View