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 @ 4:10 AM
Ignite Modification Date:
2025-12-26 @ 3:08 AM
NCT ID:
NCT02367820
Description:
Adverse events were collected after the subject provided written informed consent through the end of study. Adverse event data were obtained via spontaneous reports or per direct questioning or observation during protocol-mandated study assessments. All ongoing AEs were followed until resolution or for 14 days after the subject's last visit, whichever came first. All SAEs were followed until resolution, stabilization of condition, return to baseline, or until follow-up was no longer possible.
Frequency Threshold:
5
Time Frame:
Adverse events were reported starting immediately after the subject provided written informed consent through the end of study, which was approximately 57-weeks in length for each subject.
Study:
NCT02367820
Study Brief:
Long-Term Safety and Tolerability Study of NKTR-181 in Subjects With Chronic Low Back Pain or Chronic Non-Cancer 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 |
|---|---|---|---|---|---|---|---|---|
| Rollover NKTR-181 | Subjects administered NKTR-181 in preceding phase 3 efficacy/safety study | 0 | None | 10 | 214 | 136 | 214 | View |
| Rollover PBO | Subjects administered placebo in preceding phase 3 efficacy/safety study | 0 | None | 8 | 217 | 151 | 217 | View |
| De Novo Opioid Experienced | Newly enrolled opioid experienced subjects | 0 | None | 8 | 134 | 110 | 134 | View |
| De Novo Naive | Newly enrolled opioid naïve subjects | 0 | None | 4 | 73 | 62 | 73 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 17.1 | View |
| Duodenal ulcer | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 17.1 | View |
| Duodenitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 17.1 | View |
| Gastric ulcer | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 17.1 | View |
| Follicular thyroid cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | View |
| Lung adenocarcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | View |
| Cerebral Infarction | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 17.1 | View |
| Cerebrovascular accident | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 17.1 | View |
| Convulsion | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 17.1 | View |
| Myocardial Infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 17.1 | View |
| Goitre | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA 17.1 | View |
| abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 17.1 | View |
| Pancreatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 17.1 | View |
| Rectal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 17.1 | View |
| Generalized Oedema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 17.1 | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 17.1 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 17.1 | View |
| Cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 17.1 | View |
| Diverticulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 17.1 | View |
| Hisoplasmosis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 17.1 | View |
| Urinary Tract Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 17.1 | View |
| Head injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 17.1 | View |
| Road traffic accident | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 17.1 | View |
| Subdural haematoma | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 17.1 | View |
| Back Pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | View |
| Osteoarthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 17.1 | View |
| Renal Mass | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 17.1 | View |
| Uterine Cyst | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 17.1 | View |
| Chronic Obstructive Pulmonary Disease | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | View |
| Pulmonary fibrosis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | View |
| Decubitus Ulcer | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 17.1 | View |
| Deep Vein Thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 17.1 | View |
| Malignant hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 17.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 17.1 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 17.1 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 17.1 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 17.1 | View |
| Drug withdrawal | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 17.1 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 17.1 | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 17.1 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 17.1 | View |
| Influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 17.1 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 17.1 | View |
| Somnolence | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 17.1 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 17.1 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 17.1 | View |
| Pruritis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 17.1 | View |