Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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: 2025-12-24 @ 3:29 PM
Ignite Modification Date: 2025-12-25 @ 1:44 PM
NCT ID: NCT01384292
Description: None
Frequency Threshold: 2
Time Frame: None
Study: NCT01384292
Study Brief: Assessment of Efficacy and Safety in Relieving Opioid-induced Constipation in Patients With Cancer-related 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
NKTR-118 12.5 mg - Part A Part A NKTR-118 12.5 mg, oral treatment None None 0 5 4 5 View
NKTR-118 25 mg - Part A Part A NKTR-118 25 mg, oral treatment None None 0 5 3 5 View
Placebo - Part A Part A Placebo, oral treatment None None 0 4 3 4 View
NKTR-118 12.5 mg - Part B Part B NKTR-118 12.5 mg, oral treatment None None 0 3 1 3 View
NKTR-118 25 mg - Part B Part B NKTR-118 25 mg, oral treatment None None 0 6 5 6 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Blood pressure increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.0 View
Blood creatinine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.0 View
Blood urea increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Blister SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.0 View
Hyperhidrosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.0 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.0 View
Pruritis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.0 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.0 View
Rhinorrhea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.0 View
Lacrimation increased SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 15.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
Musculoskeletal chest pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.0 View
Gastroenteritis viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Hypothyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 15.0 View
Conjunctivitis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 15.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Thermal burn SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.0 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.0 View
Migraine SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.0 View
Skin lesion SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.0 View
Lymphadenopathy SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 15.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 15.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Hematochezia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View