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 @ 3:15 PM
Ignite Modification Date:
2025-12-25 @ 1:37 PM
NCT ID:
NCT02549092
Description:
None
Frequency Threshold:
5
Time Frame:
All adverse events are reported from the time of randomization until 30 days following last OMT dose, last study visit, discontinuation of study drug administration, removal of the PEG-J tube or Last LCIG Commercial Transition Visit have elapsed. Median duration of follow-up was 191 days for OMT and 565 days for LCIG in the Treatment Period, and was 1366 days for OMT -> LCIG and 1003.5 days for LCIG -> LCIG in the Extension/Transition period.
Study:
NCT02549092
Study Brief:
A Study to Examine the Effect of Levodopa-Carbidopa Intestinal Gel (LCIG) Therapy Relative to That of Optimized Medical Treatment (OMT) on Non-motor Symptoms (NMS) Associated With Advanced Parkinson's Disease (PD)
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Optimized Medical Treatment (OMT) | Participants randomized to continue OMT remained on their current optimized regimen during the 26-week treatment phase. Changes to anti-PD and NMS medications are to remain stable and can only be made if medically indicated. | 0 | None | 4 | 44 | 13 | 44 | View |
| Extension/Transition OMT->LCIG | Participants randomized to continue OMT in the United States or South Korea who elected to enter an Extension/Transition follow-up period to receive an individually optimized LCIG dose (after NJ and/or PEG-J placement), in order to transition to commercially available LCIG. | 1 | None | 2 | 10 | 6 | 10 | View |
| Extension/Transition LCIG->LCIG | Participants randomized to LCIG in the United States or South Korea who elected to enter an Extension/Transition follow-up period to receive an individually optimized LCIG dose, in order to transition to commercially available LCIG. | 0 | None | 1 | 14 | 4 | 14 | View |
| LCIG | Participants randomized to LCIG at an individually optimized dose, in accordance with the LCIG approved product label for countries participating in the study during the 26-week treatment phase. Changes to anti-PD and NMS medications were to remain stable and were only made if medically indicated. The total daily dose of LCIG was composed of 3 components: (i) the morning dose, (ii) continuous maintenance infusion dose and (iii) extra doses. The continuous infusion was expected to run over a period of 16 consecutive hours each day. | 0 | None | 9 | 43 | 33 | 43 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| ILEUS PARALYTIC | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.0 | View |
| INGUINAL HERNIA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.0 | View |
| PNEUMOPERITONEUM | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.0 | View |
| BACTERAEMIA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.0 | View |
| PERITONITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.0 | View |
| PNEUMONIA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.0 | View |
| FALL | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 23.0 | View |
| KETOACIDOSIS | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 23.0 | View |
| NEURALGIA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 23.0 | View |
| PARKINSON'S DISEASE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 23.0 | View |
| SYNCOPE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 23.0 | View |
| DEPRESSION | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 23.0 | View |
| DYSPNOEA | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | View |
| PNEUMONIA ASPIRATION | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | View |
| AORTIC VALVE STENOSIS | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 23.0 | View |
| ASTHENIA | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 23.0 | View |
| DEATH | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 23.0 | View |
| PYELONEPHRITIS ACUTE | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.0 | View |
| STOMA SITE INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.0 | View |
| URINARY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.0 | View |
| FEMUR FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 23.0 | View |
| HUMERUS FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 23.0 | View |
| LOWER LIMB FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 23.0 | View |
| PATELLA FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 23.0 | View |
| SUBDURAL HAEMATOMA | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 23.0 | View |
| ROTATOR CUFF SYNDROME | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| CATARACT NUCLEAR | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 23.0 | View |
| NORMAL TENSION GLAUCOMA | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 23.0 | View |
| ABDOMINAL DISCOMFORT | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.0 | View |
| ABDOMINAL DISTENSION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.0 | View |
| ABDOMINAL PAIN | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.0 | View |
| CONSTIPATION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.0 | View |
| DIARRHOEA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.0 | View |
| DUODENAL ULCER | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.0 | View |
| DYSPEPSIA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.0 | View |
| DYSPHAGIA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.0 | View |
| GASTRIC MUCOSAL LESION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.0 | View |
| GASTRIC ULCER | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.0 | View |
| GASTROOESOPHAGEAL REFLUX DISEASE | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.0 | View |
| CHEST PAIN | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 23.0 | View |
| PYREXIA | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 23.0 | View |
| ASYMPTOMATIC COVID-19 | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.0 | View |
| STOMA SITE CELLULITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.0 | View |
| STOMA SITE INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.0 | View |
| FALL | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 23.0 | View |
| PROCEDURAL PAIN | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 23.0 | View |
| STOMA SITE DERMATITIS | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 23.0 | View |
| STOMA SITE DISCHARGE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 23.0 | View |
| STOMA SITE HYPERGRANULATION | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 23.0 | View |
| STOMA SITE PAIN | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 23.0 | View |
| VITAMIN B6 DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 23.0 | View |
| WEIGHT DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 23.0 | View |
| DYSKINESIA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 23.0 | View |
| FREEZING PHENOMENON | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 23.0 | View |
| PARKINSON'S DISEASE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 23.0 | View |
| PERIPHERAL SENSORY NEUROPATHY | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 23.0 | View |
| DEVICE DISLOCATION | SYSTEMATIC_ASSESSMENT | Product Issues | MedDRA 23.0 | View |
| DEVICE MALFUNCTION | SYSTEMATIC_ASSESSMENT | Product Issues | MedDRA 23.0 | View |
| AGITATION | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 23.0 | View |
| ANXIETY | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 23.0 | View |
| DEPRESSED MOOD | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 23.0 | View |
| DEPRESSION | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 23.0 | View |
| HALLUCINATION | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 23.0 | View |
| IMPULSE-CONTROL DISORDER | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 23.0 | View |
| IMPULSIVE BEHAVIOUR | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 23.0 | View |
| INSOMNIA | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 23.0 | View |
| PSYCHOTIC DISORDER | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 23.0 | View |
| SLEEP ATTACKS | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 23.0 | View |
| COUGH | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | View |
| HYPOXIA | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | View |
| PRODUCTIVE COUGH | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | View |
| SOCIAL PROBLEM | SYSTEMATIC_ASSESSMENT | Social circumstances | MedDRA 23.0 | View |