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 @ 1:33 AM
Ignite Modification Date:
2025-12-25 @ 11:47 PM
NCT ID:
NCT00357994
Description:
Serious adverse events (AEs) and treatment-emergent AEs are presented. Treatment-emergent adverse events were defined as AEs that began or worsened from date of the study device implantation to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
Frequency Threshold:
5
Time Frame:
From Screening to the end of study or early termination of treatment, including the removal of PEG-J (up to 12 weeks), plus 30 days.
Study:
NCT00357994
Study Brief:
Study of Efficacy, Safety and Tolerability of Levodopa-Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson's Subjects
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| LCIG + Placebo Capsules | Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG. | None | None | 5 | 37 | 35 | 37 | View |
| Placebo Gel + Levodopa-Carbidopa Capsules | Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo. | None | None | 7 | 34 | 34 | 34 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| HALLUCINATION | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 14.0 | View |
| NEUTROPENIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 14.0 | View |
| ATRIAL FIBRILLATION | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 14.0 | View |
| ATRIAL FLUTTER | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 14.0 | View |
| ABDOMINAL PAIN | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.0 | View |
| PERITONITIS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.0 | View |
| PNEUMOPERITONEUM | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.0 | View |
| COMPLICATION OF DEVICE INSERTION | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 14.0 | View |
| CATHETER SITE CELLULITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 14.0 | View |
| PNEUMONIA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 14.0 | View |
| FEMUR FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 14.0 | View |
| POST PROCEDURAL COMPLICATION | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 14.0 | View |
| BODY TEMPERATURE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 14.0 | View |
| SPINAL HAEMANGIOMA | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | View |
| DEPRESSED LEVEL OF CONSCIOUSNESS | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 14.0 | View |
| DYSKINESIA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 14.0 | View |
| HYPERSOMNIA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 14.0 | View |
| PARKINSON'S DISEASE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 14.0 | View |
| CONFUSIONAL STATE | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 14.0 | View |
| DELUSION | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 14.0 | View |
| MENTAL STATUS CHANGES | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 14.0 | View |
| MUTISM | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 14.0 | View |
| PSYCHOTIC DISORDER | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 14.0 | View |
| RENAL CYST | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 14.0 | View |
| ORTHOSTATIC HYPOTENSION | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 14.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| ABDOMINAL DISCOMFORT | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.0 | View |
| ABDOMINAL DISTENSION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.0 | View |
| ABDOMINAL PAIN | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.0 | View |
| ABDOMINAL PAIN UPPER | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.0 | View |
| CONSTIPATION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.0 | View |
| DIARRHOEA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.0 | View |
| DYSPEPSIA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.0 | View |
| FLATULENCE | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.0 | View |
| GASTRITIS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.0 | View |
| HIATUS HERNIA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.0 | View |
| NAUSEA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.0 | View |
| PNEUMOPERITONEUM | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.0 | View |
| REFLUX OESOPHAGITIS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.0 | View |
| VOMITING | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.0 | View |
| COMPLICATION OF DEVICE INSERTION | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 14.0 | View |
| FATIGUE | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 14.0 | View |
| NON-CARDIAC CHEST PAIN | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 14.0 | View |
| OEDEMA PERIPHERAL | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 14.0 | View |
| PYREXIA | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 14.0 | View |
| POSTOPERATIVE WOUND INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 14.0 | View |
| UPPER RESPIRATORY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 14.0 | View |
| URINARY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 14.0 | View |
| FALL | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 14.0 | View |
| INCISION SITE ERYTHEMA | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 14.0 | View |
| POST PROCEDURAL DISCHARGE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 14.0 | View |
| POSTOPERATIVE ILEUS | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 14.0 | View |
| PROCEDURAL PAIN | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 14.0 | View |
| PROCEDURAL SITE REACTION | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 14.0 | View |
| BACTERIAL TEST POSITIVE | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 14.0 | View |
| VITAMIN B6 DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 14.0 | View |
| WEIGHT DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 14.0 | View |
| WHITE BLOOD CELLS URINE POSITIVE | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 14.0 | View |
| DECREASED APPETITE | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 14.0 | View |
| ARTHRALGIA | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | View |
| MUSCULOSKELETAL PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | View |
| PAIN IN EXTREMITY | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | View |
| DIZZINESS | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 14.0 | View |
| DYSKINESIA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 14.0 | View |
| FREEZING PHENOMENON | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 14.0 | View |
| HEADACHE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 14.0 | View |
| ANXIETY | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 14.0 | View |
| DEPRESSION | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 14.0 | View |
| INSOMNIA | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 14.0 | View |
| SLEEP DISORDER | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 14.0 | View |
| ATELECTASIS | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | View |
| OROPHARYNGEAL PAIN | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | View |
| EXCESSIVE GRANULATION TISSUE | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 14.0 | View |
| RASH | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 14.0 | View |
| HYPERTENSION | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 14.0 | View |
| ORTHOSTATIC HYPOTENSION | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 14.0 | View |