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 @ 1:26 AM
Ignite Modification Date: 2025-12-25 @ 11:36 PM
NCT ID: NCT01216293
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: First dose of study drug and within 30 days of the last dose of study drug (Up to 30 Weeks)
Study: NCT01216293
Study Brief: Effect of Dexlansoprazole on Bone Homeostasis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Esomeprazole 40mg Esomeprazole 40 mg, capsules, orally, once daily for up to 26 weeks. 0 None 0 35 9 35 View
Calcium Absorption Sub Study: Placebo Following the main study participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 calcium (42 Ca) 3 milligram (mg), intravenously and 44 calcium (44 Ca) 8 mg, orally, once on Day-1 and Week 26. 0 None 0 14 3 14 View
Calcium Absorption Sub Study: Dexlansoprazole 60 mg Following the main study Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 Ca 3 mg, intravenously and 44 Ca 8 mg, orally, once on Day-1 and Week 26. 0 None 0 10 4 10 View
Calcium Absorption Sub Study: Esomeprazole 40 mg Following the main study participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 Ca 3 mg, intravenously and 44 Ca 8 mg, orally, once on Day-1 and Week 26. 0 None 0 10 5 10 View
Placebo Placebo-matching capsules, orally, once daily for up to 26 weeks. 0 None 0 41 6 41 View
Dexlansoprazole 60 mg Dexlansoprazole 60 mg, capsules, orally, once daily for up to 26 weeks. 0 None 1 38 8 38 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Nephrolithiasis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA version 17.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 17.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 17.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 17.0 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 17.0 View