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 @ 11:53 AM
Ignite Modification Date: 2025-12-25 @ 11:53 AM
NCT ID: NCT03340961
Description: Adverse events were collected by spontaneous reports from subjects, either verbal or recorded in the subject's diary, by directed question of subjects, and by observation. All AEs from the time of signing of the ICF up to the EOS visit were recorded. AEs occurring from the time of first study drug administration up to the End-of-Study were defined as treatment emergent AEs.
Frequency Threshold: 5
Time Frame: AEs were collected from subjects from the time of signing of the ICF up to Week 16/End of Study Visit.
Study: NCT03340961
Study Brief: A Controlled Study to Assess the Efficacy, Safety and Tolerability of Oral DFD-29 Extended Release Capsules
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
DFD-29 Extended Release Capsules (40 mg) DFD-29 (minocycline HCl) Extended Release Capsules (40 mg) once per day for 16 weeks. DFD-29 Extended Release Capsules (40 mg): Oral Treatment 0 None 1 52 37 52 View
Oraycea® (Doxycycline) Capsules Oraycea® (doxycycline) Modified Release Hard Capsules (40 mg) once per day for 16 weeks. Oraycea® (doxycycline) Capsules: Oral Treatment 0 None 2 48 27 48 View
DFD-29 Extended Release Capsules (20 mg) DFD-29 (minocycline HCl) Extended Release Capsules (20 mg) once per day for 16 weeks. DFD-29 Extended Release Capsules (20 mg): Oral Treatment 0 None 2 48 33 48 View
Placebo Capsules Placebo Capsules once per day for 16 weeks. Placebo Capsules: Oral Treatment 0 None 0 53 35 53 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Coronary artery disease SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (18.0) View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (18.0) View
Lymphoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (18.0) View
Papilloma SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (18.0) View
Retinal detachment SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (18.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal Pain Upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (18.0) View
Back Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (18.0) View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (18.0) View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Investigations MedDRA (18.0) View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (18.0) View
Rosacea SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (18.0) View