Adverse Events Module

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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 @ 4:09 PM
Ignite Modification Date: 2025-12-25 @ 2:09 PM
NCT ID: NCT01154166
Description: SAEs and non-serious AEs were collected in the Safety Population, consisting of all participants who received at least one dose of randomized study medication (placebo or active drug). This does not include placebo given during the Placebo Run-in Period.
Frequency Threshold: 0
Time Frame: Adverse event (AE) and serious adverse event (SAE) data are presented for the On-treatment Phase (Week 1 to Week 24) plus the 7-day Down-titration Period.
Study: NCT01154166
Study Brief: A Phase III, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of Six Months Treatment With Ropinirole PR as Adjunctive Therapy in Patients With Parkinson's Disease Who Are Not Optimally Controlled on L-Dopa
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 Participants received placebo tablets identical to ropinirole prolonged release (Ro-PR) tablets once daily (OD) in the 24-week Treatment Phase (TP). The L-dopa dose was reduced after a dose of 8 milligrams (mg) or 12 mg of study medication had been achieved. If a loss of symptom control occurred and persisted after study medication had been up-titrated once, participants were to be "rescued" with open-label L-dopa, which was not to exceed the dose being taken at baseline. After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of medication. None None 8 170 105 170 View
Ropinirole PR Participants initially received Ro-PR 2 mg tablets OD in the 24-week TP. The Ro-PR dose was up-titrated weekly by 2 mg for the first 3 weeks of treatment. Later, the daily dose was increased by 4 mg every 2 weeks, up to a maximum dose of 24 mg per day. The L-dopa dose was reduced after a dose of 8 mg or 12 mg of study medication had been achieved. Participants who did not experience symptom improvement after up-titration of Ro-PR by 2 dose levels were allowed to take L-dopa (maximum up to their baseline dose). After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of Ro-PR. None None 9 175 129 175 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Coronary artery disease SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Femoral neck fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Gastric ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Inguinal hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Electrolyte imbalance SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hypoglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Urinary retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Cataract SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Cholecystitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA View
Akinesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Lung infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Muscle strain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Neurogenic bladder SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Hernia SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Hallucination SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Lacrimation increased SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Night blindness SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Oculogyric crisis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Head titubation SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Migraine SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Narcolepsy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Parkinsonian gait SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Trigeminal neuralgia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Vascular headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Abdominal discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Toothache SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Salivary hypersecretion SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Sleep disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Abnormal dreams SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Illusion SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Nightmare SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Dependence SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Urinary retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Spermatorrhea SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Gambling SYSTEMATIC_ASSESSMENT Social circumstances MedDRA View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Change of bowel habit SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Faecaloma SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Gastric ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Inguinal hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Edema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Chest discomfort SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Disease progression SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Gait disturbance SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Hernia SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Discomfort SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Face edema SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Hallucination SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Hallucination, visual SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Hypersexuality SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Orthostatic hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Angiopathy SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Hot flush SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Orthostatic hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Herpes virus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Impetigo SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA View
Lung infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA View
Tinnitus SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA View
Vertigo positional SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Hyperhidrosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Night sweats SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Subcutaneous nodule SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Livedo reticularis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Neurodermatitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Pigmentation disorder SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Swelling face SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Muscular weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Intervertebral disc protrusion SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Limb discomfort SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Muscle spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Muscle twitching SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Musculoskeletal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Spinal osteoarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Coronary artery disease SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Cardiac discomfort SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Supraventricular extrasystoles SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Blood pressure increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Blood pressure decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Neutrophil count abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Vision blurred SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Cataract SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Conjunctival hyperemia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Diplopia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Exophthalmos SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Animal bite SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Femoral neck fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Muscle strain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Rib fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Electrolyte imbalance SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hypoglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Dysuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Chromaturia SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Incontinence SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Nephrolithiasis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Neurogenic bladder SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Nocturia SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Renal cyst SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Choking sensation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Throat irritation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Hepatic function abnormal SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA View
Cholecystitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA View
Erectile dysfunction SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Dyskinesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Akinesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Hypoaesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Parkinson's disease SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Sciatica SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Dyspraxia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Lethargy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Cerebral artery embolism SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Cerebrovascular accident SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Dystonia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View