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 @ 2:28 AM
Ignite Modification Date: 2025-12-26 @ 1:02 AM
NCT ID: NCT03334734
Description: None
Frequency Threshold: 0
Time Frame: Collection and evaluation of safety data started at the Screening Visit (Day -10 to -1) after signing the informed consent form and was continued till the last visit of the patient within the study (Day 21+1)
Study: NCT03334734
Study Brief: Phase 2a Study of PBTZ169
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
PBTZ169, 320 mg 4 capsules 80 mg of PBTZ169 once a day for 14 days PBTZ169: Once a day for 14 days 0 None 0 4 3 4 View
Isoniazid, 600 mg 2 tablets 300 mg of Isoniazid once a day for 14 days Isoniazid: Once a day for 14 days 0 None 0 1 0 1 View
PBTZ169, 160 mg 2 capsules 80 mg of PBTZ169 once a day for 14 days PBTZ169: Once a day for 14 days 0 None 0 4 3 4 View
PBTZ169, 640 mg 8 capsules 80 mg of PBTZ169 once a day for 14 days PBTZ169: Once a day for 14 days 0 None 1 7 2 7 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Spontaneously opened tuberculous paraproctitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (10.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Sinus tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (10.0) View
Wandering atrial pacemaker SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (Unspecified) View
Hyperthermia SYSTEMATIC_ASSESSMENT General disorders MedDRA (Unspecified) View
Fever SYSTEMATIC_ASSESSMENT Investigations MedDRA (Unspecified) View
Metabolic disorders found in ECG SYSTEMATIC_ASSESSMENT Investigations MedDRA (Unspecified) View
QTc elongation SYSTEMATIC_ASSESSMENT Investigations MedDRA (Unspecified) View
QTc(F) shortening SYSTEMATIC_ASSESSMENT Investigations MedDRA (Unspecified) View
Repolarization disturbances in the V1 lead in ECG SYSTEMATIC_ASSESSMENT Investigations MedDRA (Unspecified) View
Reduced (+)T amplitude in standard leads SYSTEMATIC_ASSESSMENT Investigations MedDRA (Unspecified) View
ESR over 2.5 x normal SYSTEMATIC_ASSESSMENT Investigations MedDRA (Unspecified) View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (Unspecified) View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (Unspecified) View
Sinus arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (10.0) View