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 @ 3:32 AM
Ignite Modification Date: 2025-12-26 @ 2:15 AM
NCT ID: NCT01119105
Description: Adverse events were reported for the ITT population (i.e. all patients who received at least one dose of study medication). Treatment-emergent adverse events, defined as adverse events that started on or after the first dose of study medication, are reported. Adverse events were recorded whether or not they were considered to be study drug related.
Frequency Threshold: 3
Time Frame: Adverse events and serious adverse events were collected from the time of consent through 30 days following the last dose of study medication; approximately 35 to 44 days per participant.
Study: NCT01119105
Study Brief: Study Comparing the Safety and Efficacy of Two Doses of BC-3781 vs Vancomycin in Patients With Acute Bacterial Skin and Skin Structure Infection (ABSSSI)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
BC-3781 Dose 100mg BC-3781: BC-3781 dose 100mg is administered as i.v. infusion every 12 h for 5 to 14 days depending on the clinical response. 0 None 1 70 50 70 View
BC-3781 Dose 150mg BC-3781: BC-3781 dose 150mg is administered as i.v. infusion every 12 h for 5 to 14 days depending on the clinical response. 0 None 2 71 48 71 View
Vancomycin Vancomycin: Vancomycin is administered as i.v. infusion every 12 h for 5 to 14 days depending on the clinical response. 0 None 2 66 49 66 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (13.0) View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (13.0) View
Accidental Overdose SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (13.0) View
Convulsion SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (13.0) View
Respiratory Failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (13.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (13.0) View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (13.0) View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (13.0) View
Infusion Site Phlebitis SYSTEMATIC_ASSESSMENT General disorders MedDRA (13.0) View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA (13.0) View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (13.0) View
Alanine Aminotransferase Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA (13.0) View
Pain in Extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (13.0) View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (13.0) View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (13.0) View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (13.0) View
Pruritus Generalized SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (13.0) View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (13.0) View
Blood Creatine Phosphokinase Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA (13.0) View
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (13.0) View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (13.0) View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (13.0) View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (13.0) View