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 @ 12:56 AM
Ignite Modification Date:
2025-12-25 @ 11:11 PM
NCT ID:
NCT03781167
Description:
None
Frequency Threshold:
5
Time Frame:
All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
Study:
NCT03781167
Study Brief:
A Study to Evaluate the Safety and Tolerability of ABBV-951 in Subjects With 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 |
|---|---|---|---|---|---|---|---|---|
| ABBV-951 Low Dose Subgroup | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was \< 2530 mg of Foslevodopa/day were analyzed as the Low Dose Subgroup. | 0 | None | 32 | 131 | 111 | 131 | View |
| ABBV-951 High Dose Subgroup | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was ≥ 2530 mg of Foslevodopa/day were analyzed as the High Dose Subgroup. | 5 | None | 31 | 113 | 107 | 113 | View |
| ABBV-951 All Participants | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. | 5 | None | 63 | 244 | 218 | 244 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| ACUTE MYOCARDIAL INFARCTION | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 24.0 | View |
| ATRIAL FIBRILLATION | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 24.0 | View |
| CARDIAC ARREST | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 24.0 | View |
| CARDIO-RESPIRATORY ARREST | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 24.0 | View |
| CORONARY ARTERY DISEASE | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 24.0 | View |
| PERIORBITAL PAIN | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 24.0 | View |
| PERIORBITAL SWELLING | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 24.0 | View |
| COLITIS ISCHAEMIC | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 24.0 | View |
| INTESTINAL HAEMORRHAGE | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 24.0 | View |
| ASTHENIA | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 24.0 | View |
| CHEST DISCOMFORT | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 24.0 | View |
| CHEST PAIN | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 24.0 | View |
| HYPOTHERMIA | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 24.0 | View |
| INFUSION SITE HAEMATOMA | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 24.0 | View |
| INFUSION SITE INJURY | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 24.0 | View |
| ABSCESS LIMB | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 24.0 | View |
| COVID-19 | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 24.0 | View |
| CELLULITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 24.0 | View |
| INFUSION SITE ABSCESS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 24.0 | View |
| INFUSION SITE CELLULITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 24.0 | View |
| INFUSION SITE INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 24.0 | View |
| PAROTID ABSCESS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 24.0 | View |
| PNEUMONIA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 24.0 | View |
| SEPSIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 24.0 | View |
| SEPTIC SHOCK | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 24.0 | View |
| URINARY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 24.0 | View |
| FACE INJURY | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 24.0 | View |
| FALL | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 24.0 | View |
| SUBDURAL HAEMATOMA | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 24.0 | View |
| BLOOD SODIUM DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 24.0 | View |
| DEHYDRATION | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 24.0 | View |
| HYPOKALAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 24.0 | View |
| HYPONATRAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 24.0 | View |
| ARTHRITIS REACTIVE | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | View |
| OSTEOARTHRITIS | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | View |
| RHABDOMYOLYSIS | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | View |
| SACROILIAC JOINT DYSFUNCTION | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | View |
| RECTAL ADENOCARCINOMA | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | View |
| CEREBRAL MASS EFFECT | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 24.0 | View |
| CEREBROVASCULAR ACCIDENT | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 24.0 | View |
| COGNITIVE DISORDER | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 24.0 | View |
| DIZZINESS | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 24.0 | View |
| DYSARTHRIA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 24.0 | View |
| DYSTONIA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 24.0 | View |
| GENERALISED TONIC-CLONIC SEIZURE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 24.0 | View |
| HEMIANAESTHESIA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 24.0 | View |
| HEMIPARESIS | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 24.0 | View |
| LOSS OF CONSCIOUSNESS | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 24.0 | View |
| LUMBOSACRAL RADICULOPATHY | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 24.0 | View |
| ON AND OFF PHENOMENON | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 24.0 | View |
| PARAESTHESIA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 24.0 | View |
| PARKINSON'S DISEASE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 24.0 | View |
| PARKINSONISM | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 24.0 | View |
| PSYCHOGENIC SEIZURE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 24.0 | View |
| ANXIETY | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 24.0 | View |
| CONFUSIONAL STATE | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 24.0 | View |
| DELIRIUM | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 24.0 | View |
| DELUSION | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 24.0 | View |
| DELUSIONAL DISORDER, UNSPECIFIED TYPE | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 24.0 | View |
| DOPAMINE DYSREGULATION SYNDROME | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 24.0 | View |
| HALLUCINATION | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 24.0 | View |
| PSYCHOTIC DISORDER | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 24.0 | View |
| SUICIDE ATTEMPT | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 24.0 | View |
| BRONCHIECTASIS | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | View |
| DYSPNOEA | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | View |
| HYPERVENTILATION | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | View |
| PULMONARY EMBOLISM | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | View |
| HAEMATOMA | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 24.0 | View |
| HAEMORRHAGE | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 24.0 | View |
| ORTHOSTATIC HYPOTENSION | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 24.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| CONSTIPATION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 24.0 | View |
| NAUSEA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 24.0 | View |
| INFUSION SITE BRUISING | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 24.0 | View |
| INFUSION SITE ERYTHEMA | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 24.0 | View |
| INFUSION SITE EXTRAVASATION | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 24.0 | View |
| INFUSION SITE HAEMATOMA | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 24.0 | View |
| INFUSION SITE INFLAMMATION | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 24.0 | View |
| INFUSION SITE NODULE | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 24.0 | View |
| INFUSION SITE OEDEMA | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 24.0 | View |
| INFUSION SITE PAIN | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 24.0 | View |
| INFUSION SITE PAPULE | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 24.0 | View |
| INFUSION SITE REACTION | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 24.0 | View |
| INJECTION SITE ERYTHEMA | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 24.0 | View |
| INJECTION SITE NODULE | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 24.0 | View |
| INJECTION SITE PAIN | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 24.0 | View |
| INFUSION SITE ABSCESS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 24.0 | View |
| INFUSION SITE CELLULITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 24.0 | View |
| INFUSION SITE INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 24.0 | View |
| URINARY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 24.0 | View |
| CONTUSION | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 24.0 | View |
| FALL | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 24.0 | View |
| SKIN LACERATION | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 24.0 | View |
| VITAMIN B6 DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 24.0 | View |
| WEIGHT DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 24.0 | View |
| BACK PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | View |
| DIZZINESS | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 24.0 | View |
| DYSKINESIA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 24.0 | View |
| HEADACHE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 24.0 | View |
| PARKINSON'S DISEASE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 24.0 | View |
| SOMNOLENCE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 24.0 | View |
| ANXIETY | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 24.0 | View |
| DELUSION | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 24.0 | View |
| HALLUCINATION | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 24.0 | View |
| HALLUCINATION, VISUAL | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 24.0 | View |
| INSOMNIA | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 24.0 | View |
| ORTHOSTATIC HYPOTENSION | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 24.0 | View |