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 @ 4:54 AM
Ignite Modification Date: 2025-12-26 @ 3:54 AM
NCT ID: NCT01532518
Description: Analysed for the Safety Population (all patients who received the study drug) The analysis is by treatment - Each infant was treated with two out of three ascending dose (0.1, 0.5 or 1.0 mg/kg), therefore counted in more than one dose level.
Frequency Threshold: 5
Time Frame: 4 weeks
Study: NCT01532518
Study Brief: Preliminary Efficacy, Safety and Pharmacokinetics Study of Nepadutant in Infant With Feeding Intolerance
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
High Dose Level (1.0 mg/Kg) Subjects who received at least 1 dose of nepadutant 1.0mg/kg (Subjects who took Nepadutant 1.0 mg/dl for the additional 7 days - coming from Nepadutant 0.1 mg/kg and 0.5 mg/kg) Nepadutant: Nepadutant oral solution None None 1 21 12 21 View
Medium Dose Level (0.5mg/Kg) Subjects who received at least 1 dose of nepadutant 0.5 mg/kg (subjects who took Nepadutant 0.5 mg/dl for the first 7 days AND subjects who took Nepadutant 0.5 mg/dl for the additional 7 days - coming from Neapdutant 0.1 mg/kg) Nepadutant: Nepadutant oral solution None None 0 21 2 21 View
Low Dose Level(0.1mg/Kg) Subjects who received at least 1 dose of nepadutant 0.1 mg/kg (subjects who took Nepadutant 0.1mg/dl for the first 7 days) Nepadutant: Nepadutant oral solution None None 1 12 8 12 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hospitalisation for investigation for suspected seizures SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedRA View
Laryngeal Edema-post intubation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Ear infection SYSTEMATIC_ASSESSMENT Infections and infestations MedRA View
Viral infection SYSTEMATIC_ASSESSMENT Infections and infestations MedRA View
Dermatitis diaper NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedRA View
Candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations MedRA View
Screaming SYSTEMATIC_ASSESSMENT Psychiatric disorders MedRA View
Upper respiratory atract congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedRA View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedRA View
Seborrhoic dermatitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedRA View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedRA View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedRA View
Teething SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedRA View