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 @ 12:38 AM
Ignite Modification Date:
2025-12-25 @ 10:48 PM
NCT ID:
NCT00466167
Description:
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
Frequency Threshold:
5
Time Frame:
From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
Study:
NCT00466167
Study Brief:
Pivotal Study in Advanced Parkinsons Disease Patients
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Placebo | Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day Matching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning | None | None | 15 | 178 | 74 | 178 | View |
| Pramipexole ER | Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning | None | None | 8 | 164 | 73 | 164 | View |
| Pramipexole IR | Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day" | None | None | 11 | 175 | 90 | 175 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Delusion | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MEDDRA 11.1 | View |
| Femoral neck fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MEDDRA 11.1 | View |
| Peripheral nerve injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MEDDRA 11.1 | View |
| Tendon injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MEDDRA 11.1 | View |
| Tibia fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MEDDRA 11.1 | View |
| Medical device change | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MEDDRA 11.1 | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MEDDRA 11.1 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MEDDRA 11.1 | View |
| Post viral fatigue syndrome | SYSTEMATIC_ASSESSMENT | Infections and infestations | MEDDRA 11.1 | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MEDDRA 11.1 | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MEDDRA 11.1 | View |
| Hypokalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MEDDRA 11.1 | View |
| Hallucination, visual | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MEDDRA 11.1 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MEDDRA 11.1 | View |
| Agitation | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MEDDRA 11.1 | View |
| Delirium | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MEDDRA 11.1 | View |
| Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MEDDRA 11.1 | View |
| Hallucination | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MEDDRA 11.1 | View |
| Psychotic disorder | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MEDDRA 11.1 | View |
| Suicide attempt | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MEDDRA 11.1 | View |
| Dementia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MEDDRA 11.1 | View |
| Depressed level of consciousness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MEDDRA 11.1 | View |
| Disturbance in attention | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MEDDRA 11.1 | View |
| On and off phenomenon | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MEDDRA 11.1 | View |
| Peripheral sensory neuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MEDDRA 11.1 | View |
| Presyncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MEDDRA 11.1 | View |
| Radiculpathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MEDDRA 11.1 | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MEDDRA 11.1 | View |
| Arrhythmia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MEDDRA 11.1 | View |
| Atrial fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MEDDRA 11.1 | View |
| Cardiopulmonary failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MEDDRA 11.1 | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MEDDRA 11.1 | View |
| Orthostatic hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MEDDRA 11.1 | View |
| Bronchospasm | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MEDDRA 11.1 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MEDDRA 11.1 | View |
| Pneumonia aspiration | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MEDDRA 11.1 | View |
| Respiratory failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MEDDRA 11.1 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEDDRA 11.1 | View |
| Dysphagia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEDDRA 11.1 | View |
| Renal failure chronic | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MEDDRA 11.1 | View |
| Uterine prolapse | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MEDDRA 11.1 | View |
| Chest pain | SYSTEMATIC_ASSESSMENT | General disorders | MEDDRA 11.1 | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MEDDRA 11.1 | View |
| Femur fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MEDDRA 11.1 | View |
| Fibula fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MEDDRA 11.1 | View |
| Forearm fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MEDDRA 11.1 | View |
| Hip fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MEDDRA 11.1 | View |
| Ligament injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MEDDRA 11.1 | View |
| Overdose | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MEDDRA 11.1 | View |
| Pelvic fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MEDDRA 11.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MEDDRA 11.1 | View |
| Anorexia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MEDDRA 11.1 | View |
| Hallucination | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MEDDRA 11.1 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MEDDRA 11.1 | View |
| Dyskinesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MEDDRA 11.1 | View |
| Somnolence | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MEDDRA 11.1 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MEDDRA 11.1 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MEDDRA 11.1 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEDDRA 11.1 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEDDRA 11.1 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEDDRA 11.1 | View |