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 @ 4:26 AM
Ignite Modification Date: 2025-12-26 @ 3:29 AM
NCT ID: NCT00313820
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00313820
Study Brief: Efficacy Of Pregabalin In Subjects With Post-Stroke Central Neuropathic Pain
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Pregabalin 75 milligram (mg) capsule by mouth (PO) twice a day (BID) for 7 days. Pregabalin was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID. None None 6 110 59 110 View
Placebo 75 milligram (mg) capsule PO BID for 7 days. Placebo was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID. None None 2 109 25 109 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Acute myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v11.1 View
Local swelling SYSTEMATIC_ASSESSMENT General disorders None View
Edema peripheral SYSTEMATIC_ASSESSMENT General disorders None View
Kidney infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Rib fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Hypoglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Metastases to spine SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Prostate cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Convulsion SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Musculoskeletal stiffness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Hydronephrosis SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v 11.1 View
Oedema SYSTEMATIC_ASSESSMENT General disorders None View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders None View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Weight increased SYSTEMATIC_ASSESSMENT Investigations None View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders None View