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 @ 3:30 AM
Ignite Modification Date: 2025-12-26 @ 2:12 AM
NCT ID: NCT01336205
Description: None
Frequency Threshold: 2
Time Frame: None
Study: NCT01336205
Study Brief: Assessment of Long-term Safety in Patients With Non-cancer-related Pain and Opioid-induced Constipation
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 25 mg None None None 51 534 365 534 View
Usual Care None None None 30 270 152 270 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
CHOLELITHIASIS OBSTRUCTIVE SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 15.0 View
DRUG HYPERSENSITIVITY SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 15.0 View
CELLULITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
OVERDOSE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.0 View
POST PROCEDURAL COMPLICATION SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.0 View
RADIUS FRACTURE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.0 View
OSTEONECROSIS SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.0 View
PAIN IN EXTREMITY SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.0 View
HYPOGLYCAEMIC COMA SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.0 View
IDIOPATHIC GENERALISED EPILEPSY SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.0 View
ISCHAEMIC CEREBRAL INFARCTION SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.0 View
RADICULITIS CERVICAL SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.0 View
DEEP VEIN THROMBOSIS SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 15.0 View
ANAEMIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 15.0 View
ATRIAL FIBRILLATION SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 15.0 View
CARDIAC FAILURE CONGESTIVE SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 15.0 View
MYOCARDIAL ISCHAEMIA SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 15.0 View
THYROID MASS SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 15.0 View
ABDOMINAL PAIN SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
COLITIS ISCHAEMIC SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
PANCREATITIS ACUTE SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
RECTAL HAEMORRHAGE SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
SMALL INTESTINAL OBSTRUCTION SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
VOMITING SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
ASTHENIA SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
DEATH SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
NON-CARDIAC CHEST PAIN SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
CHOLECYSTITIS SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 15.0 View
CELLULITIS GANGRENOUS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
EXTRADURAL ABSCESS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
GASTROENTERITIS VIRAL SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
LOBAR PNEUMONIA SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
PNEUMONIA SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
PYELONEPHRITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
SEPSIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
SINUSITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
STAPHYLOCOCCAL INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
VULVAL ABSCESS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
ANKLE FRACTURE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.0 View
CONTUSION SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.0 View
FALL SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.0 View
FIBULA FRACTURE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.0 View
INTENTIONAL OVERDOSE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.0 View
LIMB INJURY SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.0 View
RIB FRACTURE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.0 View
THORACIC VERTEBRAL FRACTURE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.0 View
TIBIA FRACTURE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.0 View
ULNA FRACTURE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.0 View
BLOOD PRESSURE DECREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.0 View
BLOOD PRESSURE INCREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.0 View
TRANSAMINASES INCREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.0 View
TROPONIN INCREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.0 View
HYPERKALAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 15.0 View
HYPOGLYCAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 15.0 View
BACK PAIN SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.0 View
FLANK PAIN SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.0 View
LUMBAR SPINAL STENOSIS SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.0 View
MUSCULOSKELETAL CHEST PAIN SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.0 View
MUSCULOSKELETAL PAIN SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.0 View
OSTEOARTHRITIS SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.0 View
RHABDOMYOLYSIS SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.0 View
RHEUMATOID ARTHRITIS SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.0 View
ROTATOR CUFF SYNDROME SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.0 View
BREAST CANCER SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 15.0 View
LUNG ADENOCARCINOMA SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 15.0 View
LYMPHOMA SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 15.0 View
SUPERFICIAL SPREADING MELANOMA STAGE II SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 15.0 View
THYROID CANCER RECURRENT SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 15.0 View
AKATHISIA SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.0 View
ALTERED STATE OF CONSCIOUSNESS SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.0 View
CEREBROVASCULAR ACCIDENT SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.0 View
CERVICAL NEURITIS SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.0 View
CERVICOBRACHIAL SYNDROME SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.0 View
COMPLICATED MIGRAINE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.0 View
SYNCOPE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.0 View
BIPOLAR I DISORDER SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 15.0 View
DEPRESSION SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 15.0 View
HOMICIDAL IDEATION SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 15.0 View
MAJOR DEPRESSION SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 15.0 View
PANIC ATTACK SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 15.0 View
PSYCHOTIC DISORDER SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 15.0 View
SCHIZOPHRENIA SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 15.0 View
SUICIDAL IDEATION SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 15.0 View
SUICIDE ATTEMPT SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 15.0 View
RENAL FAILURE ACUTE SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 15.0 View
RENAL INJURY SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 15.0 View
ENDOMETRIAL HYPERPLASIA SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 15.0 View
ASTHMA SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.0 View
CHRONIC OBSTRUCTIVE PULMONARY DISEASE SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.0 View
PNEUMOTHORAX SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.0 View
PULMONARY CONGESTION SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.0 View
SKIN DISCOLOURATION SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.0 View
HYPOVOLAEMIC SHOCK SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 15.0 View
ORTHOSTATIC HYPOTENSION SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 15.0 View
THROMBOSIS SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 15.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
ABDOMINAL DISCOMFORT SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
ABDOMINAL DISTENSION SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
ABDOMINAL PAIN SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
ABDOMINAL PAIN UPPER SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
DIARRHOEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
FLATULENCE SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
GASTROOESOPHAGEAL REFLUX DISEASE SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
NAUSEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
VOMITING SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
CHILLS SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
FATIGUE SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
OEDEMA PERIPHERAL SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
BRONCHITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
GASTROENTERITIS VIRAL SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
INFLUENZA SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
SINUSITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
UPPER RESPIRATORY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
HYPERCHOLESTEROLAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 15.0 View
ARTHRALGIA SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.0 View
BACK PAIN SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.0 View
PAIN IN EXTREMITY SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.0 View
HEADACHE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.0 View
INSOMNIA SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 15.0 View
COUGH SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.0 View
NASAL CONGESTION SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.0 View
HYPERHIDROSIS SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.0 View
PYREXIA SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
NASOPHARYNGITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
URINARY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
CONTUSION SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.0 View
FALL SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.0 View
DEHYDRATION SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 15.0 View
MUSCLE SPASMS SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.0 View
DIZZINESS SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.0 View
ANXIETY SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 15.0 View
DEPRESSION SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 15.0 View
HYPERTENSION SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 15.0 View