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: 2025-12-26 @ 10:46 PM
Ignite Modification Date: 2025-12-26 @ 10:46 PM
NCT ID: NCT01504412
Description: Adverse events that appeared for the first time during treatment, or that worsened relative to the pre-treatment state, were analyzed. Additionally, 3 participants who had major violations of GCP were excluded from the Safety Analysis Set (1 participant each in the placebo, pregabalin, and in the 20-mg/day group).
Frequency Threshold: 5
Time Frame: Adverse event data were collected from the time the Informed Consent Form was signed to 7 days after the last dose of study medication, approximately 18 months.
Study: NCT01504412
Study Brief: Asian Phase 2 Study for Treatment of Pain Associated With Diabetic Peripheral Neuropathy
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo DS-5565 placebo oral tablets and pregabalin placebo oral capsules administered 2 times per day. 0 None 3 88 13 88 View
Pregabalin Pregabalin capsules 300 mg/day administered in 2 doses 0 None 2 86 28 86 View
DS-5565 10 mg/Day DS-5565 10 mg/day, administered in 2 doses (5 mg twice daily). Treatment period: 1 week titration and 6 weeks of fixed dose. 0 None 1 90 18 90 View
DS-5565 20 mg/Day DS-5565 20 mg/day, administered in 2 doses (10 mg twice daily). Treatment period: 1 week titration and 6 weeks of fixed dose. 1 None 4 93 38 93 View
DS-5565 30 mg/Day DS-5565 30mg/day, administered in 2 doses (15 mg twice daily). Treatment period: 1 week titration and 6 weeks of fixed dose. 0 None 2 90 42 90 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (16.0) View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (16.0) View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (16.0) View
Osteomyelitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (16.0) View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (16.0) View
Metastases to lymph node SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (16.0) View
Completed suicide SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (16.0) View
Brain stem infarction SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (16.0) View
Cognitive disorder SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (16.0) View
Diabetic retinopathy SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (16.0) View
Vitreous haemorrhage SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (16.0) View
Thermal burn SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (16.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (16.0) View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (16.0) View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (16.0) View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (16.0) View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (16.0) View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA (16.0) View
Gait disturbance SYSTEMATIC_ASSESSMENT General disorders MedDRA (16.0) View
Weight increased SYSTEMATIC_ASSESSMENT Investigations MedDRA (16.0) View