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 @ 11:37 PM
NCT ID: NCT02053493
Description: Per protocol, non-serious AEs were not collected; all SAEs were collected except for anticipated, disease-related events in patients with HF with preserved EF. 3 time points summarized: Informed Consent to start of Phase 1 study drug, Phase 1 study drug start to start of Phase 2 study drug, Phase 2 study drug start to Week 15 phone call.
Frequency Threshold: 0
Time Frame: Informed Consent through Week 15 phone visit
Study: NCT02053493
Study Brief: Nitrate's Effect on Activity Tolerance in Heart Failure With Preserved Ejection Fraction
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Isosorbide Mononitrate Crossover to Placebo Isosorbide Mononitrate with dose up-titration (30 to 120 mg/day over 4 weeks) Isosorbide Mononitrate: Dispense phase 1 study drug: Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg ISMN Week 4: 60 mg ISMN Weeks 5 and 6: 120 mg ISMN Dispense phase-2 study drug: Weeks 7 and 8: No study drug (washout) Week 9: 30 mg ISMN Week 10: 60 mg ISMN Weeks 11 and 12: 120 mg ISMN None None 2 51 0 0 View
Placebo Crossover to Isosorbide Mononitrate Isosorbide Mononitrate placebo with dose up-titration (30 to 120 mg/day over 4 weeks) Placebo: Dispense phase 1 study drug: Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg Placebo Week 4: 60 mg Placebo Weeks 5 and 6: 120 mg Placebo Dispense phase-2 study drug: Weeks 7 and 8: No study drug (washout) Week 9: 30 mg Placebo Week 10: 60 mg Placebo Weeks 11 and 12: 120 mg Placebo None None 1 59 0 0 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (Unspecified) View
chronic obstructive pulmonary disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (Unspecified) View
Herpes Zoster SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (Unspecified) View
Faecaloma SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (Unspecified) View
Urinary retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (Unspecified) View
Other Events(If Any):