Ignite Creation Date:
2025-12-26 @ 10:43 PM
Ignite Modification Date:
2025-12-26 @ 10:43 PM
Study NCT ID:
NCT01313312
Status:
COMPLETED
Last Update Posted:
2022-09-28
First Post:
2011-03-10
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Dysport® Adult Upper Limb Spasticity Extension Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019274', 'term': 'Botulinum Toxins, Type A'}, {'id': 'C542869', 'term': 'abobotulinumtoxinA'}], 'ancestors': [{'id': 'D001905', 'term': 'Botulinum Toxins'}, {'id': 'D008666', 'term': 'Metalloendopeptidases'}, {'id': 'D010450', 'term': 'Endopeptidases'}, {'id': 'D010447', 'term': 'Peptide Hydrolases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D045726', 'term': 'Metalloproteases'}, {'id': 'D001426', 'term': 'Bacterial Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D001427', 'term': 'Bacterial Toxins'}, {'id': 'D014118', 'term': 'Toxins, Biological'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinical.trials@ipsen.com', 'title': 'Medical Director, Neurology.', 'organization': 'Ipsen Innovation'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Up to Week 52', 'description': 'An AE was reported as emergent if it arose (i.e. started or worsened in severity) in the treatment phase after the subject received study medication.', 'eventGroups': [{'id': 'EG000', 'title': 'Total Dysport®', 'description': "A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.\n\nAll subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject's safety and efficacy response.\n\nFrom Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U.", 'otherNumAtRisk': 254, 'otherNumAffected': 142, 'seriousNumAtRisk': 254, 'seriousNumAffected': 21}], 'otherEvents': [{'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA17.1'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 25, 'numAffected': 20}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA17.1'}, {'term': 'Hand fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA17.1'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA17.1'}, {'term': 'Humerus fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA17.1'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA17.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA17.1'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA17.1'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA17.1'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA17.1'}, {'term': 'Seasonal allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA17.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA17.1'}, {'term': 'Epilepsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 6, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA17.1'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA17.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA17.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA17.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 5, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA17.1'}, {'term': 'Peripheral swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA17.1'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA17.1'}, {'term': 'Injection site bruising', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA17.1'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA17.1'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA17.1'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA17.1'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 18, 'numAffected': 14}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA17.1'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 14, 'numAffected': 13}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA17.1'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA17.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA17.1'}, {'term': 'Joint swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA17.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA17.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA17.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA17.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 10, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA17.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA17.1'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA17.1'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA17.1'}, {'term': 'Gastroenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA17.1'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA17.1'}, {'term': 'Upper respiratory tract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA17.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA17.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA17.1'}], 'seriousEvents': [{'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA17.1'}, {'term': 'Adenocarcinoma pancreas', 'notes': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA17.1'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA17.1'}, {'term': 'Device malfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA17.1'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA17.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA17.1'}, {'term': 'Affect lability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA17.1'}, {'term': 'Affective disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA17.1'}, {'term': 'Mania', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA17.1'}, {'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA17.1'}, {'term': 'Suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA17.1'}, {'term': 'Ulna fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA17.1'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA17.1'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA17.1'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA17.1'}, {'term': 'Cardio-respiratory arrest', 'notes': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA17.1'}, {'term': 'Myocardial infarction', 'notes': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA17.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA17.1'}, {'term': 'Nasal polyps', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA17.1'}, {'term': 'Nephrogenic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA17.1'}, {'term': 'Epilepsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA17.1'}, {'term': 'Brain injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA17.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA17.1'}, {'term': 'Generalised tonic-clonic seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA17.1'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA17.1'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA17.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA17.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA17.1'}, {'term': 'Volvulus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA17.1'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA17.1'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA17.1'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA17.1'}, {'term': 'Diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA17.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA17.1'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Assessment of the Long-term Safety of Dysport® Through the Collection of Treatment Emergent Adverse Events (TEAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Dysport®', 'description': "A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.\n\nAll subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject's safety and efficacy response.\n\nFrom Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."}], 'classes': [{'title': 'TEAEs: Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '102', 'groupId': 'OG000'}]}]}, {'title': 'TEAEs: Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '229', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '62', 'groupId': 'OG000'}]}]}, {'title': 'TEAEs: Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '175', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}]}]}, {'title': 'TEAEs: Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': 'TEAEs: Cycle 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Treatment related TEAE: Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}]}]}, {'title': 'Treatment related TEAE: Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '229', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Treatment related TEAE: Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '175', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Treatment related TEAE: Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Treatment related TEAE: Cycle 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Severe TEAEs: Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}, {'title': 'Severe TEAEs: Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '229', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Severe TEAEs: Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '175', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Severe TEAEs: Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Severe TEAEs: Cycle 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'TEAEs Leading to Withdrawal: Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'TEAEs Leading to Withdrawal: Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '229', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'TEAEs Leading to Withdrawal: Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '175', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'TEAEs Leading to Withdrawal: Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'TEAEs Leading to Withdrawal: Cycle 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'AESIs: Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'AESIs: Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '229', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'AESIs: Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '175', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'AESIs: Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'AESIs: Cycle 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'SAEs: Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': 'SAEs: Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '229', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'SAEs: Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '175', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'SAEs: Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'SAEs: Cycle 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Fatal SAEs: Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Fatal SAEs: Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '229', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Fatal SAEs: Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '175', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Fatal SAEs: Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Fatal SAEs: Cycle 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Week 52', 'description': 'A TEAE was reported as emergent if it arose (i.e. started or worsened in severity) in the treatment phase after the subject received study medication. Adverse events of special interest (AESIs) were identified as those assessed as being due to remote spread of effect of Dysport®, or any adverse event (AE) that was assessed as a hypersensitivity reaction. TEAEs, AESIs, severe TEAEs, serious adverse events (SAEs), treatment related TEAEs, TEAEs leading to withdrawal and fatal SAEs are summarised by treatment cycle.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who entered the study and received at least one open label injection of Dysport® were evaluated for safety analysis. Only subjects with data available for analysis at the point of testing are reported.'}, {'type': 'PRIMARY', 'title': 'Mean Change From Baseline to End of Study/Early Withdrawal in Diastolic and Systolic Blood Pressure (BP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '238', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Dysport®', 'description': "A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.\n\nAll subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject's safety and efficacy response.\n\nFrom Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."}], 'classes': [{'title': 'Diastolic BP', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '-29', 'upperLimit': '34'}]}]}, {'title': 'Systolic BP', 'categories': [{'measurements': [{'value': '-2.8', 'groupId': 'OG000', 'lowerLimit': '-63', 'upperLimit': '41'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to Week 52', 'description': 'Systolic and diastolic BP were recorded at screening, baseline and at each post baseline visit. Vital signs were measured with the subject in a sitting position after resting for 3 minutes. Outcome measure is reported for number of subjects with data available for analysis.', 'unitOfMeasure': 'Millimeters of Mercury (mm Hg)', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who entered the study and received at least one open label injection of Dysport® were evaluated for safety analysis. Only subjects with data available for analysis at the point of testing are reported.'}, {'type': 'PRIMARY', 'title': 'Mean Change From Baseline to End of Study/Early Withdrawal in Heart Rate (HR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '239', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Dysport®', 'description': "A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.\n\nAll subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject's safety and efficacy response.\n\nFrom Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."}], 'classes': [{'categories': [{'measurements': [{'value': '2.5', 'groupId': 'OG000', 'lowerLimit': '-28', 'upperLimit': '30'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to Week 52', 'description': 'HR was recorded at screening, baseline and at each post baseline visit. Vital signs were measured with the subject in a sitting position after resting for 3 minutes. Outcome measure is reported for number of subjects with data available for analysis.', 'unitOfMeasure': 'Beats per minute (bpm)', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who entered the study and received at least one open label injection of Dysport® were evaluated for safety analysis. Only subjects with data available for analysis at the point of testing are reported.'}, {'type': 'PRIMARY', 'title': 'Mean Change From Baseline to End of Study/Early Withdrawal in Red Blood Cell (RBC) Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Dysport®', 'description': "A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.\n\nAll subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject's safety and efficacy response.\n\nFrom Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."}], 'classes': [{'categories': [{'measurements': [{'value': '0.03', 'groupId': 'OG000', 'lowerLimit': '-1.15', 'upperLimit': '1.06'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to Week 52', 'description': 'Blood samples for RBC count were taken at baseline, at post treatment follow up visit Week 4, and at end of study/early withdrawal. Outcome measure is reported for number of subjects with data available for analysis.', 'unitOfMeasure': 'Tera cells/Litre (L)', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who entered the study and received at least one open label injection of Dysport® were evaluated for safety analysis. Only subjects with data available for analysis at the point of testing are reported.'}, {'type': 'PRIMARY', 'title': 'Mean Change From Baseline to End of Study/Early Withdrawal in Haemoglobin and Mean Corpuscular Haemoglobin Concentration (MCHC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Dysport®', 'description': "A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.\n\nAll subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject's safety and efficacy response.\n\nFrom Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."}], 'classes': [{'title': 'Haemoglobin', 'categories': [{'measurements': [{'value': '-0.7', 'groupId': 'OG000', 'lowerLimit': '-33', 'upperLimit': '37'}]}]}, {'title': 'MCHC', 'categories': [{'measurements': [{'value': '-0.8', 'groupId': 'OG000', 'lowerLimit': '-26', 'upperLimit': '34'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to Week 52', 'description': 'Blood samples for haemoglobin and MCHC were taken at baseline, at post treatment follow up visit Week 4, and at the end of study/early withdrawal. Outcome measure is reported for number of subjects with data available for analysis.', 'unitOfMeasure': 'grams(g)/L', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who entered the study and received at least one open label injection of Dysport® were evaluated for safety analysis. Only subjects with data available for analysis at the point of testing are reported.'}, {'type': 'PRIMARY', 'title': 'Mean Change From Baseline to End of Study/Early Withdrawal in Haematocrit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Dysport®', 'description': "A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.\n\nAll subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject's safety and efficacy response.\n\nFrom Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."}], 'classes': [{'categories': [{'measurements': [{'value': '-0.0011', 'groupId': 'OG000', 'lowerLimit': '-0.104', 'upperLimit': '0.087'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to Week 52', 'description': 'Blood samples for haematocrit were taken at baseline, at post treatment follow up visit Week 4, and at end of study/early withdrawal. Outcome measure is reported for number of subjects with data available for analysis.', 'unitOfMeasure': 'percentage of RBC in blood', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who entered the study and received at least one open label injection of Dysport® were evaluated for safety analysis. Only subjects with data available for analysis at the point of testing are reported.'}, {'type': 'PRIMARY', 'title': 'Mean Change From Baseline to End of Study/Early Withdrawal in Mean Corpuscular Haemoglobin (MCH)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Dysport®', 'description': "A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.\n\nAll subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject's safety and efficacy response.\n\nFrom Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."}], 'classes': [{'categories': [{'measurements': [{'value': '-0.33', 'groupId': 'OG000', 'lowerLimit': '-5', 'upperLimit': '4.9'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to Week 52', 'description': 'Blood samples for MCH were taken at baseline, at post treatment follow up visit Week 4, and at end of study/early withdrawal. Outcome measure is reported for number of subjects with data available for analysis.', 'unitOfMeasure': 'picograms (pg)', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who entered the study and received at least one open label injection of Dysport® were evaluated for safety analysis. Only subjects with data available for analysis at the point of testing are reported.'}, {'type': 'PRIMARY', 'title': 'Mean Change From Baseline to End of Study/Early Withdrawal in Mean Corpuscular Volume (MCV)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Dysport®', 'description': "A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.\n\nAll subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject's safety and efficacy response.\n\nFrom Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."}], 'classes': [{'categories': [{'measurements': [{'value': '-0.77', 'groupId': 'OG000', 'lowerLimit': '-9.9', 'upperLimit': '8.2'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to Week 52', 'description': 'Blood samples for MCV were taken at baseline, at post treatment follow up visit Week 4, and at end of study/early withdrawal. Outcome measure is reported for number of subjects with data available for analysis.', 'unitOfMeasure': 'femtoliters (fL)', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who entered the study and received at least one open label injection of Dysport® were evaluated for safety analysis. Only subjects with data available for analysis at the point of testing are reported.'}, {'type': 'PRIMARY', 'title': 'Mean Change From Baseline to End of Study/Early Withdrawal in White Blood Cell (WBC) Count, Neutrophils, Lymphocytes and Platelets', 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Dysport®', 'description': "A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.\n\nAll subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject's safety and efficacy response.\n\nFrom Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."}], 'classes': [{'title': 'WBC count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.04', 'groupId': 'OG000', 'lowerLimit': '-6.5', 'upperLimit': '5.2'}]}]}, {'title': 'Neutrophils', 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '-6.8', 'upperLimit': '5.6'}]}]}, {'title': 'Lymphocytes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.01', 'groupId': 'OG000', 'lowerLimit': '-1.9', 'upperLimit': '1.2'}]}]}, {'title': 'Platelets', 'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.2', 'groupId': 'OG000', 'lowerLimit': '-142', 'upperLimit': '249'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to Week 52', 'description': 'Blood samples for WBC count with differentials (neutrophils, lymphocytes) and platelet count were taken at baseline, at post treatment follow up visit Week 4, and at end of study or early withdrawal.', 'unitOfMeasure': 'Giga cells/L', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who entered the study and received at least one open label injection of Dysport® were evaluated for safety analysis. Only subjects with data available for analysis at the point of testing are reported.'}, {'type': 'PRIMARY', 'title': 'Mean Change From Baseline to End of Study/Early Withdrawal in 12-Lead Electrocardiogram (ECG)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '235', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Dysport®', 'description': "A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.\n\nAll subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject's safety and efficacy response.\n\nFrom Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."}], 'classes': [{'title': 'QT Duration - Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '233', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '403.6', 'spread': '31.9', 'groupId': 'OG000'}]}]}, {'title': 'QT Duration - Change from Baseline to EOS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '210', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-6.3', 'spread': '22.1', 'groupId': 'OG000'}]}]}, {'title': 'QTcF - Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '233', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '417.8', 'spread': '22.9', 'groupId': 'OG000'}]}]}, {'title': 'QTcF - Change from Baseline to EOS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '210', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1', 'spread': '15.5', 'groupId': 'OG000'}]}]}, {'title': 'QTcB - Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '233', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '425.6', 'spread': '25.5', 'groupId': 'OG000'}]}]}, {'title': 'QTcB - Change from Baseline to EOS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '210', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.9', 'spread': '20.2', 'groupId': 'OG000'}]}]}, {'title': 'QRS Duration - Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '235', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '94.9', 'spread': '15.3', 'groupId': 'OG000'}]}]}, {'title': 'QRS Duration - Change from Baseline to EOS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '210', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.4', 'spread': '6.4', 'groupId': 'OG000'}]}]}, {'title': 'PR Duration - Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '233', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '165.6', 'spread': '25.4', 'groupId': 'OG000'}]}]}, {'title': 'PR Duration - Change from Baseline to EOS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '210', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.3', 'spread': '13.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to Week 52', 'description': '12-lead ECG tracing was performed at baseline, post treatment at Week 4 and at the end of study/early withdrawal visit. The 12-lead ECG recordings were performed at a paper speed of 25 mm/s, recorded with the subject in a supine position after 5 minutes rest. The ECG parameters reported were QRS duration, PR duration, QT duration, QTcB (QT interval corrected for HR according to Bazett), and QTcF (QT interval corrected for HR according to Fridericia) at baseline and the change to end of study/early withdrawal visit (EOS).', 'unitOfMeasure': 'milliseconds (ms)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ECG analysis was performed in the safety population among subjects who had at least one ECG measurement before injection and at least one ECG after injection. Only subjects with data available for analysis at the point of testing are reported.'}, {'type': 'PRIMARY', 'title': 'Mean Change From Baseline to End of Study/Early Withdrawal in Alkaline Phosphatase (ALP), Gamma Glutamyl Transferase (GGT), Serum Glutamic Oxaloacetic Transaminase (SGOT) and Serum Glutamic Pyruvic Transaminase (SGPT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '226', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Dysport®', 'description': "A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.\n\nAll subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject's safety and efficacy response.\n\nFrom Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."}], 'classes': [{'title': 'ALP', 'categories': [{'measurements': [{'value': '-0.6', 'groupId': 'OG000', 'lowerLimit': '-39', 'upperLimit': '83'}]}]}, {'title': 'SGOT', 'categories': [{'measurements': [{'value': '1.4', 'groupId': 'OG000', 'lowerLimit': '-32', 'upperLimit': '45'}]}]}, {'title': 'SGPT', 'categories': [{'measurements': [{'value': '1.2', 'groupId': 'OG000', 'lowerLimit': '-81', 'upperLimit': '57'}]}]}, {'title': 'GGT', 'categories': [{'measurements': [{'value': '1.5', 'groupId': 'OG000', 'lowerLimit': '-105', 'upperLimit': '195'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to Week 52', 'description': 'Blood samples for analysis of the following clinical chemistry parameters: ALP, GGT, SGOT and SGPT were taken at baseline, at post treatment follow up visit Week 4, and at end of study/early withdrawal. Outcome measure is reported for number of subjects with data available for analysis.', 'unitOfMeasure': 'International Unit/L (IU/L)', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who entered the study and received at least one open label injection of Dysport® were evaluated for safety analysis. Only subjects with data available for analysis at the point of testing are reported.'}, {'type': 'PRIMARY', 'title': 'Mean Change From Baseline to End of Study/Early Withdrawal in Total Bilirubin and Creatinine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '226', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Dysport®', 'description': "A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.\n\nAll subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject's safety and efficacy response.\n\nFrom Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."}], 'classes': [{'title': 'Total Bilirubin', 'categories': [{'measurements': [{'value': '-0.27', 'groupId': 'OG000', 'lowerLimit': '-18.7', 'upperLimit': '12.2'}]}]}, {'title': 'Creatinine', 'categories': [{'measurements': [{'value': '-3.7', 'groupId': 'OG000', 'lowerLimit': '-115', 'upperLimit': '35'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to Week 52', 'description': 'Blood samples for clinical chemistry analysis of total bilirubin and creatinine were taken at baseline, at post treatment follow up visit Week 4, and at end of study/early withdrawal. Outcome measure is reported for number of subjects with data available for analysis.', 'unitOfMeasure': 'Micromole/L (μmol/L)', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who entered the study and received at least one open label injection of Dysport® were evaluated for safety analysis. Only subjects with data available for analysis at the point of testing are reported.'}, {'type': 'PRIMARY', 'title': 'Mean Change From Baseline to End of Study/Early Withdrawal in Blood Urea Nitrogen (BUN) and Fasting Blood Glucose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '226', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Dysport®', 'description': "A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.\n\nAll subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject's safety and efficacy response.\n\nFrom Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."}], 'classes': [{'title': 'BUN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '226', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.033', 'groupId': 'OG000', 'lowerLimit': '-12.85', 'upperLimit': '8.93'}]}]}, {'title': 'Fasting Blood Glucose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.132', 'groupId': 'OG000', 'lowerLimit': '-3.66', 'upperLimit': '7.94'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to Week 52', 'description': 'Blood samples for analysis of BUN and fasting blood glucose levels were taken at baseline, at post treatment follow up visit Week 4, and at end of study/early withdrawal.', 'unitOfMeasure': 'millimoles(mmol)/L', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who entered the study and received at least one open label injection of Dysport® were evaluated for safety analysis. Only subjects with data available for analysis at the point of testing are reported.'}, {'type': 'PRIMARY', 'title': 'Mean Change From Baseline to End of Study/Early Withdrawal in 12 Lead ECG - HR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '243', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Dysport®', 'description': "A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.\n\nAll subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject's safety and efficacy response.\n\nFrom Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '243', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '68.2', 'spread': '11.3', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline to EOS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '226', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.7', 'spread': '10.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to Week 52', 'description': 'HR was measured by 12-lead ECG tracing, performed at baseline, at post treatment follow up visit Week 4, and at the end of study or early withdrawal visit. The 12-lead ECG recordings were performed at a paper speed of 25 mm/s, recorded with the subject in a supine position after 5 minutes rest.', 'unitOfMeasure': 'bpm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ECG analysis was performed in the safety population among subjects who had at least one ECG measurement before injection and at least one ECG after injection. Only subjects with data available for analysis at the point of testing are reported.'}, {'type': 'PRIMARY', 'title': 'Number of Subjects With Botulinum Toxin A Binding and Neutralising Putative Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '258', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Dysport®', 'description': "A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.\n\nAll subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject's safety and efficacy response.\n\nFrom Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."}], 'classes': [{'title': 'Binding +ve at baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '258', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Binding -ve at baseline & +ve post baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '251', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}]}]}, {'title': 'Neutralising +ve at baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '258', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Neutralising -ve at baseline & +ve post baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '252', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Week 52', 'description': 'Blood samples were collected at baseline, Week 4 of each cycle, and at the end of study/early withdrawal to test for the presence of Botulinum Toxin A Binding antibodies. Samples positive for the presence of binding antibodies were then analysed for the presence of neutralising putative antibodies. The number of subjects who were either positive (+ve) or negative (-ve) at baseline and then positive post baseline for binding or neutralising antibodies were reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Binding and neutralising antibodies were evaluated at baseline for all 258 subjects (rollover and de novo) enrolled in Study 148. Only subjects with data available for analysis at the point of testing are reported.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline Modified Ashworth Scale (MAS) in the Overall Primary Targeted Muscle Group (PTMG) for Upper Limb at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '252', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Dysport®', 'description': "A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.\n\nAll subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject's safety and efficacy response.\n\nFrom Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."}], 'classes': [{'title': 'Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '252', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.4', 'spread': '1.1', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '226', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.6', 'spread': '1.2', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.5', 'spread': '1.1', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.4', 'spread': '1.1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At Week 4', 'description': 'The clinical assessment of muscle tone was performed using the MAS. The MAS consists of 6 grades: 0, 1, 1+, 2, 3, or 4 that can be applied to muscles of both the upper and lower limbs. The MAS was applied by the rater by stretching the joint through its full available range over 1 second. The mean changes from baseline to Week 4 in MAS in the overall PTMG (finger, wrist or elbow flexors) are reported.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Intent-to-Treat (ITT) population was all enrolled subjects who received at least one injection of study medication in this open label extension study. Too few subjects were treated in Cycle 5 to allow direct comparisons with other cycles and are not reported. Only subjects with data available for analysis at the point of testing are reported.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects With at Least 1 or 2 Grade Reduction in MAS for Overall PTMG', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Dysport®', 'description': "A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.\n\nAll subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject's safety and efficacy response.\n\nFrom Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."}], 'classes': [{'title': 'At least 1 grade reduction - Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '77.6', 'groupId': 'OG000'}]}]}, {'title': 'At least 1 grade reduction - Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '229', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '79.5', 'groupId': 'OG000'}]}]}, {'title': 'At least 1 grade reduction - Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '175', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '77.1', 'groupId': 'OG000'}]}]}, {'title': 'At least 1 grade reduction - Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '75.3', 'groupId': 'OG000'}]}]}, {'title': 'At least 2 grades reduction - Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '42.1', 'groupId': 'OG000'}]}]}, {'title': 'At least 2 grades reduction - Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '229', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '48.0', 'groupId': 'OG000'}]}]}, {'title': 'At least 2 grades reduction - Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '175', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '44.6', 'groupId': 'OG000'}]}]}, {'title': 'At least 2 grades reduction - Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '37.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Week 4', 'description': 'The MAS consists of 6 grades: 0, 1, 1+, 2, 3, or 4 that can be applied to muscles of both the upper and lower limbs. The MAS was applied by the rater by stretching the joint through its full available range over 1 second. The percentage of subjects with at least a 1 grade reduction and at least a 2 grades reduction from baseline in mean MAS in the overall PTMG at Week 4 are reported.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population was defined as all enrolled subjects who received at least one injection of study medication in this open label extension study. Too few subjects were treated in Cycle 5 to allow direct comparisons with other cycles and are not reported. Only subjects with data available for analysis at the point of testing are reported.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline MAS in the Extrinsic Finger Flexors at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '220', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Dysport®', 'description': "A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.\n\nAll subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject's safety and efficacy response.\n\nFrom Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."}], 'classes': [{'title': 'Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '220', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.3', 'spread': '1.1', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.5', 'spread': '1.2', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.5', 'spread': '1.3', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.3', 'spread': '1.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At Week 4', 'description': 'The clinical assessment of muscle tone was performed using the MAS. The MAS consists of 6 grades: 0, 1, 1+, 2, 3, or 4 that can be applied to muscles of both the upper and lower limbs. The MAS was applied by the rater by stretching the joint through its full available range over 1 second. The mean changes from baseline to Week 4 in MAS in the extrinsic finger flexors are reported.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population was defined as all enrolled subjects who received at least one injection of study medication in this open label extension study. Too few subjects were treated in Cycle 5 to allow direct comparisons with other cycles and are not reported. Only subjects with data available for analysis at the point of testing are reported.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects With at Least 1 or 2 Grade Reduction in MAS for Extrinsic Finger Flexors at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Dysport®', 'description': "A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.\n\nAll subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject's safety and efficacy response.\n\nFrom Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."}], 'classes': [{'title': 'At least 1 Grade Reduction -Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '78.6', 'groupId': 'OG000'}]}]}, {'title': 'At least 1 Grade Reduction -Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '81.3', 'groupId': 'OG000'}]}]}, {'title': 'At least 1 Grade Reduction -Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000'}]}]}, {'title': 'At least 1 Grade Reduction -Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '80.4', 'groupId': 'OG000'}]}]}, {'title': 'At least 2 Grades Reduction -Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '44.1', 'groupId': 'OG000'}]}]}, {'title': 'At least 2 Grades Reduction -Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '49.3', 'groupId': 'OG000'}]}]}, {'title': 'At least 2 Grades Reduction -Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '49.5', 'groupId': 'OG000'}]}]}, {'title': 'At least 2 Grades Reduction -Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '37.5', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Week 4', 'description': 'The MAS consists of 6 grades: 0, 1, 1+, 2, 3, or 4 that can be applied to muscles of both the upper and lower limbs. The MAS was applied by the rater by stretching the joint through its full available range over 1 second. The percentage of subjects with at least a 1 grade reduction and at least a 2 grades reduction from baseline in mean MAS in the extrinsic finger flexors at Week 4 are reported.', 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population was defined as all enrolled subjects who received at least one injection of study medication in this open label extension study. Too few subjects were treated in Cycle 5 to allow direct comparisons with other cycles and are not reported. Only subjects with data available for analysis at the point of testing are reported.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline MAS in the Wrist Flexors at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '169', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Dysport®', 'description': "A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.\n\nAll subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject's safety and efficacy response.\n\nFrom Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."}], 'classes': [{'title': 'Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '169', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.5', 'spread': '1.2', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.6', 'spread': '1.3', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.6', 'spread': '1.3', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.5', 'spread': '1.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At Week 4', 'description': 'The clinical assessment of muscle tone was performed using the MAS. The MAS consists of 6 grades: 0, 1, 1+, 2, 3, or 4 that can be applied to muscles of both the upper and lower limbs. The MAS was applied by the rater by stretching the joint through its full available range over 1 second. The mean changes from baseline to Week 4 in MAS in the wrist flexors are reported.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population was defined as all enrolled subjects who received at least one injection of study medication in this open label extension study. Too few subjects were treated in Cycle 5 to allow direct comparisons with other cycles and are not reported. Only subjects with data available for analysis at the point of testing are reported.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects With at Least 1 or 2 Grade Reduction in MAS for Wrist Flexors at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Dysport®', 'description': "A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.\n\nAll subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject's safety and efficacy response.\n\nFrom Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."}], 'classes': [{'title': 'At least 1 Grade Reduction -Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '62.5', 'groupId': 'OG000'}]}]}, {'title': 'At least 1 Grade Reduction -Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '74.3', 'groupId': 'OG000'}]}]}, {'title': 'At least 1 Grade Reduction -Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '73.9', 'groupId': 'OG000'}]}]}, {'title': 'At least 1 Grade Reduction -Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}]}]}, {'title': 'At least 2 Grades Reduction -Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '47.5', 'groupId': 'OG000'}]}]}, {'title': 'At least 2 Grades Reduction -Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '54.3', 'groupId': 'OG000'}]}]}, {'title': 'At least 2 Grades Reduction -Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '47.8', 'groupId': 'OG000'}]}]}, {'title': 'At least 2 Grades Reduction -Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '30.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Week 4', 'description': 'The MAS consists of 6 grades: 0, 1, 1+, 2, 3, or 4 that can be applied to muscles of both the upper and lower limbs. The MAS was applied by the rater by stretching the joint through its full available range over 1 second. The percentage of subjects with at least a 1 grade reduction and at least a 2 grades reduction in mean MAS in the wrist flexors at Week 4 are reported.', 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population was defined as all enrolled subjects who received at least one injection of study medication in this open label extension study. Too few subjects were treated in Cycle 5 to allow direct comparisons with other cycles and are not reported. Only subjects with data available for analysis at the point of testing are reported.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline MAS in the Elbow Flexors at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Dysport®', 'description': "A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.\n\nAll subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject's safety and efficacy response.\n\nFrom Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."}], 'classes': [{'title': 'Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.0', 'spread': '1.0', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.1', 'spread': '1.1', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.1', 'spread': '1.1', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.8', 'spread': '1.0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At Week 4', 'description': 'The clinical assessment of muscle tone was performed using the MAS. The MAS consists of 6 grades: 0, 1, 1+, 2, 3, or 4 that can be applied to muscles of both the upper and lower limbs. The MAS was applied by the rater by stretching the joint through its full available range over 1 second. The mean changes from baseline to Week 4 in MAS in the elbow flexors are reported.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population was defined as all enrolled subjects who received at least one injection of study medication in this open label extension study. Too few subjects were treated in Cycle 5 to allow direct comparisons with other cycles and are not reported. Only subjects with data available for analysis at the point of testing are reported.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects With at Least 1 or 2 Grade Reduction in MAS for Elbow Flexors at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Dysport®', 'description': "A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.\n\nAll subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject's safety and efficacy response.\n\nFrom Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."}], 'classes': [{'title': 'At least 1 Grade Reduction -Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '84.1', 'groupId': 'OG000'}]}]}, {'title': 'At least 1 Grade Reduction -Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '78.3', 'groupId': 'OG000'}]}]}, {'title': 'At least 1 Grade Reduction -Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '75.6', 'groupId': 'OG000'}]}]}, {'title': 'At least 1 Grade Reduction -Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '73.3', 'groupId': 'OG000'}]}]}, {'title': 'At least 2 Grades Reduction -Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '34.8', 'groupId': 'OG000'}]}]}, {'title': 'At least 2 Grades Reduction -Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '41.7', 'groupId': 'OG000'}]}]}, {'title': 'At least 2 Grades Reduction -Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000'}]}]}, {'title': 'At least 2 Grades Reduction -Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '40.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Week 4', 'description': 'The MAS consists of 6 grades: 0, 1, 1+, 2, 3, or 4 that can be applied to muscles of both the upper and lower limbs. The MAS was applied by the rater by stretching the joint through its full available range over 1 second. The percentage of subjects at least a 1 grade reduction and at least a 2 grades reduction from baseline in mean MAS in the elbow flexors at Week 4 are reported.', 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population was defined as all enrolled subjects who received at least one injection of study medication in this open label extension study. Too few subjects were treated in Cycle 5 to allow direct comparisons with other cycles and are not reported. Only subjects with data available for analysis at the point of testing are reported.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline MAS in the Shoulder Extensors at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Dysport®', 'description': "A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.\n\nAll subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject's safety and efficacy response.\n\nFrom Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."}], 'classes': [{'title': 'Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.9', 'spread': '1.1', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.7', 'spread': '0.9', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.6', 'spread': '1.0', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.6', 'spread': '0.8', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At Week 4', 'description': 'The clinical assessment of muscle tone was performed using the MAS. The MAS consists of 6 grades: 0, 1, 1+, 2, 3, or 4 that can be applied to muscles of both the upper and lower limbs. The MAS was applied by the rater by stretching the joint through its full available range over 1 second. The mean changes from baseline to Week 4 in MAS in the shoulder extensors are reported.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population was defined as all enrolled subjects who received at least one injection of study medication in this open label extension study. Too few subjects were treated in Cycle 5 to allow direct comparisons with other cycles and are not reported. Only subjects with data available for analysis at the point of testing are reported.'}, {'type': 'SECONDARY', 'title': "Physician's Global Assessment (PGA) of Treatment Response at Week 4", 'denoms': [{'units': 'Participants', 'counts': [{'value': '253', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Dysport®', 'description': "A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.\n\nAll subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject's safety and efficacy response.\n\nFrom Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."}], 'classes': [{'title': 'Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '253', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.7', 'spread': '1', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '227', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.9', 'spread': '1', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '167', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.9', 'spread': '1', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'spread': '0.9', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At Week 4', 'description': 'The PGA is a 9-point rating scale: -4=markedly worse, -3=much worse, -2=worse, -1=slightly worse, 0=no change, +1=slightly improved, +2=improved, +3=much improved, +4=markedly improved. An assessment of overall treatment response was conducted by the investigator and the mean PGA scores during long-term open label treatment with Dysport were reported.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population was defined as all enrolled subjects who received at least one injection of study medication in this open label extension study. Too few subjects were treated in Cycle 5 to allow direct comparisons with other cycles and are not reported. Only subjects with data available for analysis at the point of testing are reported.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Disability Assessment Scale (DAS) Score for the Principal Target of Treatment (PTT) at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '252', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Dysport®', 'description': "A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.\n\nAll subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject's safety and efficacy response.\n\nFrom Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."}], 'classes': [{'title': 'Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '252', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.9', 'spread': '0.8', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '226', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.1', 'spread': '0.8', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '166', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.1', 'spread': '0.8', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.1', 'spread': '0.8', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At Week 4', 'description': 'At baseline the subject and investigator together selected one of the four DAS domains as the PTT. The selected domain was required to have a rating of moderate or severe (≥2) at baseline. The DAS is a 4-point scale, the extent of functional impairment in 4 functional domains (dressing, hygiene, limb position and pain) was rated as follows: 0=no disability, 1=mild disability (noticeable but does not interfere significantly with normal activities), 2=moderate disability (normal activities require increased effort and/or assistance) and 3=severe disability (normal activities limited). The mean changes in DAS at Week 4 are reported.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population was defined as all enrolled subjects who received at least one injection of study medication in this open label extension study. Too few subjects were treated in Cycle 5 to allow direct comparisons with other cycles and are not reported. Only subjects with data available for analysis at the point of testing are reported.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects With at Least 1 Grade Reduction in DAS for PTT at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Dysport®', 'description': "A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.\n\nAll subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject's safety and efficacy response.\n\nFrom Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."}], 'classes': [{'title': 'Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '68.5', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '229', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '75.1', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '175', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '73.7', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '74.1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Week 4', 'description': 'At baseline the subject and investigator together selected one of the four DAS domains as the PTT. The selected domain was required to have a rating of moderate or severe (≥2) at baseline. The DAS is a 4-point scale, the extent of functional impairment in 4 functional domains (dressing, hygiene, limb position and pain) was rated as follows: 0=no disability, 1=mild disability (noticeable but does not interfere significantly with normal activities), 2=moderate disability (normal activities require increased effort and/or assistance) and 3=severe disability (normal activities limited). The percentage of subjects with at least 1 grade reduction from baseline in DAS for PTT at Week 4 are reported.', 'unitOfMeasure': 'Percentage of Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population was defined as all enrolled subjects who received at least one injection of study medication in this open label extension study. Too few subjects were treated in Cycle 5 to allow direct comparisons with other cycles and are not reported. Only subjects with data available for analysis at the point of testing are reported.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects With at Least One Grade Reduction in DAS for Individual Domains at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Dysport®', 'description': "A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.\n\nAll subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject's safety and efficacy response.\n\nFrom Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."}], 'classes': [{'title': 'Hygiene - Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '40.9', 'groupId': 'OG000'}]}]}, {'title': 'Hygiene - Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '229', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '45.4', 'groupId': 'OG000'}]}]}, {'title': 'Hygiene - Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '175', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '44.6', 'groupId': 'OG000'}]}]}, {'title': 'Hygiene - Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '46.9', 'groupId': 'OG000'}]}]}, {'title': 'Dressing - Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '40.9', 'groupId': 'OG000'}]}]}, {'title': 'Dressing - Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '229', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '47.2', 'groupId': 'OG000'}]}]}, {'title': 'Dressing - Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '175', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '46.9', 'groupId': 'OG000'}]}]}, {'title': 'Dressing - Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '53.1', 'groupId': 'OG000'}]}]}, {'title': 'Limb Position - Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '55.5', 'groupId': 'OG000'}]}]}, {'title': 'Limb Position - Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '229', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '59.4', 'groupId': 'OG000'}]}]}, {'title': 'Limb Position - Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '175', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '60.6', 'groupId': 'OG000'}]}]}, {'title': 'Limb Position - Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '53.1', 'groupId': 'OG000'}]}]}, {'title': 'Pain - Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '33.1', 'groupId': 'OG000'}]}]}, {'title': 'Pain - Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '229', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '36.7', 'groupId': 'OG000'}]}]}, {'title': 'Pain - Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '175', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '42.3', 'groupId': 'OG000'}]}]}, {'title': 'Pain - Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '48.1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Week 4', 'description': 'The DAS is a 4-point scale. The extent of functional impairment in 4 functional domains (dressing, hygiene, limb position and pain) was rated as follows: 0=no disability, 1=mild disability (noticeable but does not interfere significantly with normal activities), 2=moderate disability (normal activities require increased effort and/or assistance) and 3=severe disability (normal activities limited). The percentage of subjects with at least one grade reduction in DAS for each of the individual domains at Week 4 is reported.', 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population was defined as all enrolled subjects who received at least one injection of study medication in this open label extension study. Too few subjects were treated in Cycle 5 to allow direct comparisons with other cycles and are not reported. Only subjects with data available for analysis at the point of testing are reported.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline to Week 4 for Angle of Arrest (XV1), Angle of Catch (XV3) and Angle of Spasticity (X) in Extrinsic Finger Flexors as PTMG', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Dysport®', 'description': "A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.\n\nAll subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject's safety and efficacy response.\n\nFrom Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."}], 'classes': [{'title': 'Angle of Spasticity (X) - Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-33.5', 'spread': '54', 'groupId': 'OG000'}]}]}, {'title': 'Angle of Spasticity (X) - Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-33.9', 'spread': '55.9', 'groupId': 'OG000'}]}]}, {'title': 'Angle of Spasticity (X) - Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-43.3', 'spread': '57.8', 'groupId': 'OG000'}]}]}, {'title': 'Angle of Spasticity (X) - Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-35.9', 'spread': '48', 'groupId': 'OG000'}]}]}, {'title': 'Angle of Arrest (XV1) - Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '24.3', 'spread': '36.1', 'groupId': 'OG000'}]}]}, {'title': 'Angle of Arrest (XV1) - Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '25.9', 'spread': '36.5', 'groupId': 'OG000'}]}]}, {'title': 'Angle of Arrest (XV1) - Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '24.9', 'spread': '38.7', 'groupId': 'OG000'}]}]}, {'title': 'Angle of Arrest (XV1) - Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '21.8', 'spread': '39.6', 'groupId': 'OG000'}]}]}, {'title': 'Angle of Catch (XV3) - Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '57.8', 'spread': '55.1', 'groupId': 'OG000'}]}]}, {'title': 'Angle of Catch (XV3) - Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '59.8', 'spread': '57.8', 'groupId': 'OG000'}]}]}, {'title': 'Angle of Catch (XV3) - Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '68.2', 'spread': '55.6', 'groupId': 'OG000'}]}]}, {'title': 'Angle of Catch (XV3) - Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '57.7', 'spread': '52.6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At Week 4', 'description': 'The Tardieu Scale (TS) was used to measure spasticity in extrinsic finger flexors. The TS is administered by applying passive stretch to a muscle group at two velocities. Slow speed of muscle stretch measures the range of passive motion. During a slow stretching movement, the examiner determines the angle of movement arrest, either due to subject discomfort or a mechanical resistance. The same movement is repeated at high velocity (as fast as possible) to determine the angle of catch and release. The angle of movement arrest at slow velocity (XV1) and the angle of catch at fast speed (XV3) were recorded. The spasticity angle (X) was calculated as the difference between XV1 and XV3. Mean changes in Angles XV1, XV3 and X from baseline to Week 4 are reported.', 'unitOfMeasure': 'Degrees', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population was defined as all enrolled subjects who received at least one injection of study medication in this open label extension study. Too few subjects were treated in Cycle 5 to allow direct comparisons with other cycles and are not reported. Only subjects with data available for analysis at the point of testing are reported.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline to Week 4 for Spasticity Grade (Y) in Extrinsic Finger Flexors as PTMG', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Dysport®', 'description': "A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.\n\nAll subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject's safety and efficacy response.\n\nFrom Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."}], 'classes': [{'title': 'Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.6', 'spread': '0.7', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.6', 'spread': '0.8', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.6', 'spread': '0.8', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.5', 'spread': '0.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At Week 4', 'description': 'The TS was used to measure spasticity in extrinsic finger flexors. The TS is administered by applying passive stretch to a muscle group. The spasticity grade (Y) assesses quality of muscle reaction on a 5-point scale (measured at fast speed): 0 =No resistance throughout passive movement, 1=slight resistance throughout passive movement, 2=clear catch at precise angle, interrupting passive movement, followed by release, 3=fatigable clonus (less than 10 seconds when maintaining pressure) occurring at a precise angle, followed by release. 4=unfatigable clonus (more than 10 seconds when maintaining pressure) occurring at precise angle. Mean changes in spasticity grade (Y) from baseline to Week 4 are reported.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population was defined as all enrolled subjects who received at least one injection of study medication in this open label extension study. Too few subjects were treated in Cycle 5 to allow direct comparisons with other cycles and are not reported. Only subjects with data available for analysis at the point of testing are reported.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline to Week 4 for Angle of Arrest (XV1), Angle of Catch (XV3) and Angle of Spasticity (X) in Elbow Flexors as PTMG', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Dysport®', 'description': "A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.\n\nAll subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject's safety and efficacy response.\n\nFrom Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."}], 'classes': [{'title': 'Angle of Spasticity (X) - Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-26.4', 'spread': '24.9', 'groupId': 'OG000'}]}]}, {'title': 'Angle of Spasticity (X) -Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-31', 'spread': '27.7', 'groupId': 'OG000'}]}]}, {'title': 'Angle of Spasticity (X) -Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-33.3', 'spread': '26', 'groupId': 'OG000'}]}]}, {'title': 'Angle of Spasticity (X) -Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-46.4', 'spread': '17.3', 'groupId': 'OG000'}]}]}, {'title': 'Angle of Arrest (XV1) - Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.4', 'spread': '14.9', 'groupId': 'OG000'}]}]}, {'title': 'Angle of Arrest (XV1) - Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.3', 'spread': '13.3', 'groupId': 'OG000'}]}]}, {'title': 'Angle of arrest (XV1) - Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.2', 'spread': '10.6', 'groupId': 'OG000'}]}]}, {'title': 'Angle of Arrest (XV1) - Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.5', 'spread': '9.4', 'groupId': 'OG000'}]}]}, {'title': 'Angle of Catch (XV3) - Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '26.0', 'spread': '26.1', 'groupId': 'OG000'}]}]}, {'title': 'Angle of Catch (XV3) - Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '32.3', 'spread': '28.8', 'groupId': 'OG000'}]}]}, {'title': 'Angle of Catch (XV3) - Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '35.5', 'spread': '27.3', 'groupId': 'OG000'}]}]}, {'title': 'Angle of Catch (XV3) - Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '43.9', 'spread': '23.1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At Week 4', 'description': 'The TS was used to measure spasticity in elbow flexors. The TS is administered by applying passive stretch to a muscle group at two velocities. Slow speed of muscle stretch measures the range of passive motion. During a slow stretching movement, the examiner determines the angle of movement arrest, either due to subject discomfort or a mechanical resistance. The same movement is repeated at high velocity (as fast as possible) to determine the angle of catch and release. The angle of movement arrest at slow velocity (XV1) and the angle of catch at fast speed (XV3) were recorded. The spasticity angle (X) was calculated as the difference between XV1 and XV3. Mean changes in Angles XV1, XV3 and X from baseline to Week 4 are reported.', 'unitOfMeasure': 'Degrees', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population was defined as all enrolled subjects who received at least one injection of study medication in this open label extension study. Too few subjects were treated in Cycle 5 to allow direct comparisons with other cycles and are not reported. Only subjects with data available for analysis at the point of testing are reported.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline to Week 4 for Spasticity Grade (Y) in Elbow Flexors as PTMG', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Dysport®', 'description': "A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.\n\nAll subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject's safety and efficacy response.\n\nFrom Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."}], 'classes': [{'title': 'Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.3', 'spread': '0.5', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.4', 'spread': '0.7', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.5', 'spread': '0.7', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.6', 'spread': '0.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At Week 4', 'description': 'The TS was used to measure spasticity in elbow flexors.The TS is administered by applying passive stretch to a muscle group. The spasticity grade (Y) assesses quality of muscle reaction on a 5-point scale (measured at fast speed): 0 =No resistance throughout passive movement, 1=slight resistance throughout passive movement, 2=clear catch at precise angle, interrupting passive movement, followed by release, 3=fatigable clonus (less than 10 seconds when maintaining pressure) occurring at a precise angle, followed by release. 4=unfatigable clonus (more than 10 seconds when maintaining pressure) occurring at precise angle. Mean changes in spasticity grade (Y) from baseline to Week 4 are reported.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population was defined as all enrolled subjects who received at least one injection of study medication in this open label extension study. Too few subjects were treated in Cycle 5 to allow direct comparisons with other cycles and are not reported. Only subjects with data available for analysis at the point of testing are reported.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline to Week 4 for Angle of Arrest (XV1), Angle of Catch (XV3) and Angle of Spasticity (X) in Wrist Flexors as PTMG', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Dysport®', 'description': "A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.\n\nAll subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject's safety and efficacy response.\n\nFrom Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."}], 'classes': [{'title': 'Angle of Spasticity (X) - Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-23.3', 'spread': '32.5', 'groupId': 'OG000'}]}]}, {'title': 'Angle of Spasticity (X) - Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-28.8', 'spread': '37.1', 'groupId': 'OG000'}]}]}, {'title': 'Angle of Spasticity (X) - Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-21.7', 'spread': '35.2', 'groupId': 'OG000'}]}]}, {'title': 'Angle of Spasticity (X) - Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-13.5', 'spread': '29.3', 'groupId': 'OG000'}]}]}, {'title': 'Angle of Arrest (XV1) - Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '12.6', 'spread': '21.3', 'groupId': 'OG000'}]}]}, {'title': 'Angle of Arrest (XV1) - Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '16.4', 'spread': '23.9', 'groupId': 'OG000'}]}]}, {'title': 'Angle of Arrest (XV1) - Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '18.6', 'spread': '30.6', 'groupId': 'OG000'}]}]}, {'title': 'Angle of Arrest (XV1) - Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '19.0', 'spread': '24.8', 'groupId': 'OG000'}]}]}, {'title': 'Angle of Catch (XV3) - Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '35.9', 'spread': '35.0', 'groupId': 'OG000'}]}]}, {'title': 'Angle of Catch (XV3) - Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '45.2', 'spread': '37.7', 'groupId': 'OG000'}]}]}, {'title': 'Angle of Catch (XV3) - Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '40.3', 'spread': '33.3', 'groupId': 'OG000'}]}]}, {'title': 'Angle of Catch (XV3) - Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '32.5', 'spread': '28.1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At Week 4', 'description': 'The TS was used to measure spasticity in wrist flexors. The TS is administered by applying passive stretch to a muscle group at two velocities. Slow speed of muscle stretch measures the range of passive motion. During a slow stretching movement, the examiner determines the angle of movement arrest, either due to subject discomfort or a mechanical resistance. The same movement is repeated at high velocity (as fast as possible) to determine the angle of catch and release. The angle of movement arrest at slow velocity (XV1) and the angle of catch at fast speed (XV3) were recorded. The spasticity angle (X) was calculated as the difference between XV1 and XV3. Mean changes in Angles XV1, XV3 and X from baseline to Week 4 are reported.', 'unitOfMeasure': 'Degrees', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population was defined as all enrolled subjects who received at least one injection of study medication in this open label extension study. Too few subjects were treated in Cycle 5 to allow direct comparisons with other cycles and are not reported. Only subjects with data available for analysis at the point of testing are reported.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline to Week 4 for Spasticity Grade (Y) in Wrist Flexors as PTMG', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Dysport®', 'description': "A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.\n\nAll subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject's safety and efficacy response.\n\nFrom Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."}], 'classes': [{'title': 'Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.7', 'spread': '1.1', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.9', 'spread': '1.0', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.6', 'spread': '0.9', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.3', 'spread': '0.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At Week 4', 'description': 'The TS was used to measure spasticity in wrist flexors. The TS is administered by applying passive stretch to a muscle group. The spasticity grade (Y) assesses quality of muscle reaction on a 5-point scale (measured at fast speed): 0 =No resistance throughout passive movement, 1=slight resistance throughout passive movement, 2=clear catch at precise angle, interrupting passive movement, followed by release, 3=fatigable clonus (less than 10 seconds when maintaining pressure) occurring at a precise angle, followed by release. 4=unfatigable clonus (more than 10 seconds when maintaining pressure) occurring at precise angle. Mean changes in spasticity grade (Y) from baseline to Week 4 are reported.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population was defined as all enrolled subjects who received at least one injection of study medication in this open label extension study. Too few subjects were treated in Cycle 5 to allow direct comparisons with other cycles and are not reported. Only subjects with data available for analysis at the point of testing are reported.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline to Week 4 for Angle of Arrest (XV1), Angle of Catch (XV3) and Angle of Spasticity (X) in Shoulder Extensors', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Dysport®', 'description': "A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.\n\nAll subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject's safety and efficacy response.\n\nFrom Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."}], 'classes': [{'title': 'Angle of Spasticity (X) - Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-13.3', 'spread': '24.6', 'groupId': 'OG000'}]}]}, {'title': 'Angle of Spasticity (X) - Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-10.8', 'spread': '30.1', 'groupId': 'OG000'}]}]}, {'title': 'Angle of Spasticity (X) - Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-6.4', 'spread': '23.5', 'groupId': 'OG000'}]}]}, {'title': 'Angle of Spasticity (X) - Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-7.2', 'spread': '27.4', 'groupId': 'OG000'}]}]}, {'title': 'Angle of Arrest (XV1) - Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7.2', 'spread': '16.0', 'groupId': 'OG000'}]}]}, {'title': 'Angle of Arrest (XV1) - Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.4', 'spread': '23.0', 'groupId': 'OG000'}]}]}, {'title': 'Angle of Arrest (XV1) - Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '10.7', 'spread': '23.8', 'groupId': 'OG000'}]}]}, {'title': 'Angle of Arrest (XV1) - Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '10.8', 'spread': '26.1', 'groupId': 'OG000'}]}]}, {'title': 'Angle of Catch (XV3) - Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '20.5', 'spread': '22.7', 'groupId': 'OG000'}]}]}, {'title': 'Angle of Catch (XV3) - Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '17.2', 'spread': '26.9', 'groupId': 'OG000'}]}]}, {'title': 'Angle of Catch (XV3) - Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '17.1', 'spread': '24.5', 'groupId': 'OG000'}]}]}, {'title': 'Angle of Catch (XV3) - Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '18.0', 'spread': '19.6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At Week 4', 'description': 'The TS was used to measure spasticity in shoulder extensors. The TS is administered by applying passive stretch to a muscle group at two velocities. Slow speed of muscle stretch measures the range of passive motion. During a slow stretching movement, the examiner determines the angle of movement arrest, either due to subject discomfort or a mechanical resistance. The same movement is repeated at high velocity (as fast as possible) to determine the angle of catch and release. The angle of movement arrest at slow velocity (XV1) and the angle of catch at fast speed (XV3) were recorded. The spasticity angle (X) was calculated as the difference between XV1 and XV3. Mean changes in Angles XV1, XV3 and X from baseline to Week 4 are reported.', 'unitOfMeasure': 'Degrees', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population was defined as all enrolled subjects who received at least one injection of study medication in this open label extension study. Too few subjects were treated in Cycle 5 to allow direct comparisons with other cycles and are not reported. Only subjects with data available for analysis at the point of testing are reported.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline to Week 4 for Spasticity Grade (Y) in Shoulder Extensors', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Dysport®', 'description': "A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.\n\nAll subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject's safety and efficacy response.\n\nFrom Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."}], 'classes': [{'title': 'Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'spread': '0.4', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'spread': '0.6', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.2', 'spread': '0.7', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.2', 'spread': '0.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At Week 4', 'description': 'The TS was used to measure spasticity in shoulder extensors. The TS is administered by applying passive stretch to a muscle group. The spasticity grade (Y) assesses quality of muscle reaction on a 5-point scale (measured at fast speed): 0 =No resistance throughout passive movement, 1=slight resistance throughout passive movement, 2=clear catch at precise angle, interrupting passive movement, followed by release, 3=fatigable clonus (less than 10 seconds when maintaining pressure) occurring at a precise angle, followed by release. 4=unfatigable clonus (more than 10 seconds when maintaining pressure) occurring at precise angle. Mean changes in spasticity grade (Y) from baseline to Week 4 are reported.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population was defined as all enrolled subjects who received at least one injection of study medication in this open label extension study. Too few subjects were treated in Cycle 5 to allow direct comparisons with other cycles and are not reported. Only subjects with data available for analysis at the point of testing are reported.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Active Range of Motion (AROM) at Week 4 in the 3 Possible PTMGs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Dysport®', 'description': "A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.\n\nAll subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject's safety and efficacy response.\n\nFrom Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."}], 'classes': [{'title': 'Extrinsic Finger Flexors: Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '31.3', 'spread': '40.9', 'groupId': 'OG000'}]}]}, {'title': 'Extrinsic Finger Flexors: Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '34.4', 'spread': '45', 'groupId': 'OG000'}]}]}, {'title': 'Extrinsic Finger Flexors: Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '33.5', 'spread': '47.1', 'groupId': 'OG000'}]}]}, {'title': 'Extrinsic Finger Flexors: Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '38', 'spread': '53.4', 'groupId': 'OG000'}]}]}, {'title': 'Elbow Flexors: Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '10.7', 'spread': '25.5', 'groupId': 'OG000'}]}]}, {'title': 'Elbow Flexors: Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '17.6', 'spread': '23.3', 'groupId': 'OG000'}]}]}, {'title': 'Elbow Flexors: Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '14.5', 'spread': '24.1', 'groupId': 'OG000'}]}]}, {'title': 'Elbow Flexors: Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '13.6', 'spread': '20.6', 'groupId': 'OG000'}]}]}, {'title': 'Wrist Flexors: Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '17.3', 'spread': '28.6', 'groupId': 'OG000'}]}]}, {'title': 'Wrist Flexors: Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '23', 'spread': '32.7', 'groupId': 'OG000'}]}]}, {'title': 'Wrist Flexors: Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '22', 'spread': '30.9', 'groupId': 'OG000'}]}]}, {'title': 'Wrist Flexors: Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3', 'spread': '25.1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At Week 4', 'description': 'The AROM was assessed by the range of extension achieved by the subject moving each joint in the PTMGs (extrinsic finger flexors, elbow flexors and wrist flexors) without assistance. A goniometer was used for measurements in the elbow and wrist flexors but not for measurements in the extrinsic finger flexors. Mean changes in AROM in the 3 possible PTMGs from baseline to Week 4 are reported.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population was defined as all enrolled subjects who received at least one injection of study medication in this open label extension study. Too few subjects were treated in Cycle 5 to allow direct comparisons with other cycles and are not reported. Only subjects with data available for analysis at the point of testing are reported.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline at Week 4 in Ease of Applying a Splint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '218', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Dysport®', 'description': "A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.\n\nAll subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject's safety and efficacy response.\n\nFrom Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."}], 'classes': [{'title': 'Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '218', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.4', 'spread': '1.1', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '196', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.4', 'spread': '1.3', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.4', 'spread': '1.4', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.4', 'spread': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At Week 4', 'description': 'The ease of applying a splint was evaluated on a 6-point scale (0= no splint needed, -1= splint needed and applied with no difficulty, -2= splint needed and applied with mild difficulty, -3= splint needed and applied with moderate difficulty, -4= splint needed and applied with severe difficulty, -5= splint needed,but unable to apply). Mean change in ease of applying a splint from baseline to Week 4 was reported.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population was defined as all enrolled subjects who received at least one injection of study medication in this open label extension study. Too few subjects were treated in Cycle 5 to allow direct comparisons with other cycles and are not reported. Only subjects with data available for analysis at the point of testing are reported.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Modified Frenchay Scale (MFS) at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Dysport®', 'description': "A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.\n\nAll subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject's safety and efficacy response.\n\nFrom Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."}], 'classes': [{'title': 'Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.4', 'spread': '0.77', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '190', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.51', 'spread': '0.8', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.44', 'spread': '0.82', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.4', 'spread': '0.75', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At Week 4', 'description': 'The MFS was used to measure upper limb active function. Each subject was video taped while performing specific tasks. The videos were sent to a central provider and were read and scored by two independent readers blinded to the timing of the video and to treatment. These central assessments were used for the analysis of efficacy endpoints. The MFS consists of 10 tasks asking the subject to reach, grasp, carry and release different objects of different sizes which subjects are likely to use in their daily life. Each of these tasks was rated on a 10 point scale ranging from no movement to normal movement; for each task, the score 5 is used to rate a task barely accomplished. Mean change in MFS from baseline to Week 4 was reported.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population was defined as all enrolled subjects who received at least one injection of study medication in this open label extension study. Too few subjects were treated in Cycle 5 to allow direct comparisons with other cycles and are not reported. Only subjects with data available for analysis at the point of testing are reported.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Short Form (36) Health Survey (SF-36) Quality of Life (QoL) at End of Study/Early Withdrawal Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '244', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Dysport®', 'description': "A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.\n\nAll subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject's safety and efficacy response.\n\nFrom Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."}], 'classes': [{'title': 'PCS Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '244', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '37.49', 'spread': '8.94', 'groupId': 'OG000'}]}]}, {'title': 'PCS Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '229', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.07', 'spread': '6.76', 'groupId': 'OG000'}]}]}, {'title': 'MCS Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '244', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '46.88', 'spread': '13.09', 'groupId': 'OG000'}]}]}, {'title': 'MCS Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '229', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.96', 'spread': '11.11', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to Week 52', 'description': 'Subjects were asked to complete the SF-36 questionnaires prior to the study treatment at baseline and at the end of study/early withdrawal visit. The SF-36 is a generic non-preference based health status measure. This instrument assessed subject health across 8 variable dimensions, which are specific health domains such as physical functioning, social functioning and vitality. Each variable item score is coded and turned into a 0-100 scale where 0 indicates the worst and 100 indicates the best possible health state for both the Physical Component Summary (PCS) and Mental Component Summary (MCS) of the questionnaire. Baseline results and the change from baseline to end of study/early withdrawal for the PCS and MCS are reported.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population was defined as all enrolled subjects who received at least one injection of study medication in this open label extension study. Too few subjects were treated in Cycle 5 to allow direct comparisons with other cycles and are not reported. Only subjects with data available for analysis at the point of testing are reported.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in European 5 Dimensions, 5 Level (EQ-5D-5L) QoL at End of Study/Early Withdrawal Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Dysport®', 'description': "A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.\n\nAll subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject's safety and efficacy response.\n\nFrom Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."}], 'classes': [{'title': 'Anxiety/Depression Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.9', 'spread': '0.9', 'groupId': 'OG000'}]}]}, {'title': 'Anxiety/Depression Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '231', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'spread': '0.9', 'groupId': 'OG000'}]}]}, {'title': 'Mobility Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.8', 'spread': '0.9', 'groupId': 'OG000'}]}]}, {'title': 'Mobility Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '231', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'spread': '0.8', 'groupId': 'OG000'}]}]}, {'title': 'Pain/Discomfort Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.1', 'spread': '1', 'groupId': 'OG000'}]}]}, {'title': 'Pain/Discomfort Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '231', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.2', 'spread': '0.9', 'groupId': 'OG000'}]}]}, {'title': 'Self-Care Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.4', 'spread': '1', 'groupId': 'OG000'}]}]}, {'title': 'Self-Care Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '231', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'spread': '0.8', 'groupId': 'OG000'}]}]}, {'title': 'Usual Activities Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.8', 'spread': '1', 'groupId': 'OG000'}]}]}, {'title': 'Usual Activities Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '231', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.2', 'spread': '1', 'groupId': 'OG000'}]}]}, {'title': 'VAS Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '63.6', 'spread': '19.7', 'groupId': 'OG000'}]}]}, {'title': 'VAS Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '231', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.8', 'spread': '19', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to Week 52', 'description': 'Subjects were asked to complete the EQ-5D-5L QoL questionnaires prior to the study treatment at baseline and at the end of study/early withdrawal visit. The EQ-5D-5L index is a generic preference based measure of health related QoL producing utility scores that represent subject preferences for particular health states. This instrument rated subject health state looking at 5 specific dimensions such as mobility, self-care, usual activity, pain/discomfort and anxiety/depression and scored their general health state. Each dimension has 5 levels of severity (no problems, slight problems,moderate problems, severe problems and extreme problems). In addition, a visual analogue scale (VAS) ranging from 0 to 100 was also included for the patients to summarize their overall health status, where 0 is the worst and 100 the best possible health state. The mean values for each dimension and the VAS scores at baseline and at the end of-study /early withdrawal are reported.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population was defined as all enrolled subjects who received at least one injection of study medication in this open label extension study. Too few subjects were treated in Cycle 5 to allow direct comparisons with other cycles and are not reported. Only subjects with data available for analysis at the point of testing are reported.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Total Dysport®', 'description': "A total of 254 subjects in the open label study received between 1 and 5 intramuscular (i.m.) injections of Dysport® according to their individual needs, for a period of up to 12 months.\n\nAll subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject's safety and efficacy response.\n\nFrom Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '258'}]}, {'type': 'Cycle 1', 'achievements': [{'groupId': 'FG000', 'numSubjects': '254'}]}, {'type': 'Cycle 2', 'achievements': [{'groupId': 'FG000', 'numSubjects': '229'}]}, {'type': 'Cycle 3', 'achievements': [{'groupId': 'FG000', 'numSubjects': '175'}]}, {'type': 'Cycle 4', 'achievements': [{'groupId': 'FG000', 'numSubjects': '81'}]}, {'type': 'Cycle 5', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '222'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '18'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Investigator Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Observational Phase', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Subject Withdrawn Early in Error', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Did Not Receive Treatment with Dysport®', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}]}], 'recruitmentDetails': 'The study was designed as a multicentre study and included a total of 34 investigational sites in Belgium, the Czech Republic, France, Hungary, Italy, Poland, Russia, Slovakia and the United States of America (US) that included at least one subject. This study was an open label extension to the double blind Study 145 (Y-52-52120-145).', 'preAssignmentDetails': 'Of 227 subjects who completed Study 145, 4 subjects entered an observational phase and never received treatment with Dysport® in this open label extension study (Study 148). The remaining 223 subjects were eligible for retreatment and progressed to Study 148. In addition, 31 of the 34 de novo subjects screened were included in this study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Total Dysport®', 'description': "A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.\n\nAll subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject's safety and efficacy response.\n\nFrom Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '201', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '53', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '52.4', 'spread': '14', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '91', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '163', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '238', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '27', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '218', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Baseline characteristics are reported for the 254 Subjects who entered this open label study (223 from Study 145 and 31 de novo subjects) and received at least one open label injection of Dysport®.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 258}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'dispFirstSubmitDate': '2015-05-07', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-15', 'studyFirstSubmitDate': '2011-03-10', 'dispFirstSubmitQcDate': '2015-05-07', 'resultsFirstSubmitDate': '2017-03-01', 'studyFirstSubmitQcDate': '2011-03-10', 'dispFirstPostDateStruct': {'date': '2015-05-25', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2022-09-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-05-09', 'studyFirstPostDateStruct': {'date': '2011-03-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-06-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of the Long-term Safety of Dysport® Through the Collection of Treatment Emergent Adverse Events (TEAEs)', 'timeFrame': 'Up to Week 52', 'description': 'A TEAE was reported as emergent if it arose (i.e. started or worsened in severity) in the treatment phase after the subject received study medication. Adverse events of special interest (AESIs) were identified as those assessed as being due to remote spread of effect of Dysport®, or any adverse event (AE) that was assessed as a hypersensitivity reaction. TEAEs, AESIs, severe TEAEs, serious adverse events (SAEs), treatment related TEAEs, TEAEs leading to withdrawal and fatal SAEs are summarised by treatment cycle.'}, {'measure': 'Mean Change From Baseline to End of Study/Early Withdrawal in Diastolic and Systolic Blood Pressure (BP)', 'timeFrame': 'Up to Week 52', 'description': 'Systolic and diastolic BP were recorded at screening, baseline and at each post baseline visit. Vital signs were measured with the subject in a sitting position after resting for 3 minutes. Outcome measure is reported for number of subjects with data available for analysis.'}, {'measure': 'Mean Change From Baseline to End of Study/Early Withdrawal in Heart Rate (HR)', 'timeFrame': 'Up to Week 52', 'description': 'HR was recorded at screening, baseline and at each post baseline visit. Vital signs were measured with the subject in a sitting position after resting for 3 minutes. Outcome measure is reported for number of subjects with data available for analysis.'}, {'measure': 'Mean Change From Baseline to End of Study/Early Withdrawal in Red Blood Cell (RBC) Count', 'timeFrame': 'Up to Week 52', 'description': 'Blood samples for RBC count were taken at baseline, at post treatment follow up visit Week 4, and at end of study/early withdrawal. Outcome measure is reported for number of subjects with data available for analysis.'}, {'measure': 'Mean Change From Baseline to End of Study/Early Withdrawal in Haemoglobin and Mean Corpuscular Haemoglobin Concentration (MCHC)', 'timeFrame': 'Up to Week 52', 'description': 'Blood samples for haemoglobin and MCHC were taken at baseline, at post treatment follow up visit Week 4, and at the end of study/early withdrawal. Outcome measure is reported for number of subjects with data available for analysis.'}, {'measure': 'Mean Change From Baseline to End of Study/Early Withdrawal in Haematocrit', 'timeFrame': 'Up to Week 52', 'description': 'Blood samples for haematocrit were taken at baseline, at post treatment follow up visit Week 4, and at end of study/early withdrawal. Outcome measure is reported for number of subjects with data available for analysis.'}, {'measure': 'Mean Change From Baseline to End of Study/Early Withdrawal in Mean Corpuscular Haemoglobin (MCH)', 'timeFrame': 'Up to Week 52', 'description': 'Blood samples for MCH were taken at baseline, at post treatment follow up visit Week 4, and at end of study/early withdrawal. Outcome measure is reported for number of subjects with data available for analysis.'}, {'measure': 'Mean Change From Baseline to End of Study/Early Withdrawal in Mean Corpuscular Volume (MCV)', 'timeFrame': 'Up to Week 52', 'description': 'Blood samples for MCV were taken at baseline, at post treatment follow up visit Week 4, and at end of study/early withdrawal. Outcome measure is reported for number of subjects with data available for analysis.'}, {'measure': 'Mean Change From Baseline to End of Study/Early Withdrawal in White Blood Cell (WBC) Count, Neutrophils, Lymphocytes and Platelets', 'timeFrame': 'Up to Week 52', 'description': 'Blood samples for WBC count with differentials (neutrophils, lymphocytes) and platelet count were taken at baseline, at post treatment follow up visit Week 4, and at end of study or early withdrawal.'}, {'measure': 'Mean Change From Baseline to End of Study/Early Withdrawal in 12-Lead Electrocardiogram (ECG)', 'timeFrame': 'Up to Week 52', 'description': '12-lead ECG tracing was performed at baseline, post treatment at Week 4 and at the end of study/early withdrawal visit. The 12-lead ECG recordings were performed at a paper speed of 25 mm/s, recorded with the subject in a supine position after 5 minutes rest. The ECG parameters reported were QRS duration, PR duration, QT duration, QTcB (QT interval corrected for HR according to Bazett), and QTcF (QT interval corrected for HR according to Fridericia) at baseline and the change to end of study/early withdrawal visit (EOS).'}, {'measure': 'Mean Change From Baseline to End of Study/Early Withdrawal in Alkaline Phosphatase (ALP), Gamma Glutamyl Transferase (GGT), Serum Glutamic Oxaloacetic Transaminase (SGOT) and Serum Glutamic Pyruvic Transaminase (SGPT)', 'timeFrame': 'Up to Week 52', 'description': 'Blood samples for analysis of the following clinical chemistry parameters: ALP, GGT, SGOT and SGPT were taken at baseline, at post treatment follow up visit Week 4, and at end of study/early withdrawal. Outcome measure is reported for number of subjects with data available for analysis.'}, {'measure': 'Mean Change From Baseline to End of Study/Early Withdrawal in Total Bilirubin and Creatinine', 'timeFrame': 'Up to Week 52', 'description': 'Blood samples for clinical chemistry analysis of total bilirubin and creatinine were taken at baseline, at post treatment follow up visit Week 4, and at end of study/early withdrawal. Outcome measure is reported for number of subjects with data available for analysis.'}, {'measure': 'Mean Change From Baseline to End of Study/Early Withdrawal in Blood Urea Nitrogen (BUN) and Fasting Blood Glucose', 'timeFrame': 'Up to Week 52', 'description': 'Blood samples for analysis of BUN and fasting blood glucose levels were taken at baseline, at post treatment follow up visit Week 4, and at end of study/early withdrawal.'}, {'measure': 'Mean Change From Baseline to End of Study/Early Withdrawal in 12 Lead ECG - HR', 'timeFrame': 'Up to Week 52', 'description': 'HR was measured by 12-lead ECG tracing, performed at baseline, at post treatment follow up visit Week 4, and at the end of study or early withdrawal visit. The 12-lead ECG recordings were performed at a paper speed of 25 mm/s, recorded with the subject in a supine position after 5 minutes rest.'}, {'measure': 'Number of Subjects With Botulinum Toxin A Binding and Neutralising Putative Antibodies', 'timeFrame': 'Up to Week 52', 'description': 'Blood samples were collected at baseline, Week 4 of each cycle, and at the end of study/early withdrawal to test for the presence of Botulinum Toxin A Binding antibodies. Samples positive for the presence of binding antibodies were then analysed for the presence of neutralising putative antibodies. The number of subjects who were either positive (+ve) or negative (-ve) at baseline and then positive post baseline for binding or neutralising antibodies were reported.'}], 'secondaryOutcomes': [{'measure': 'Mean Change From Baseline Modified Ashworth Scale (MAS) in the Overall Primary Targeted Muscle Group (PTMG) for Upper Limb at Week 4', 'timeFrame': 'At Week 4', 'description': 'The clinical assessment of muscle tone was performed using the MAS. The MAS consists of 6 grades: 0, 1, 1+, 2, 3, or 4 that can be applied to muscles of both the upper and lower limbs. The MAS was applied by the rater by stretching the joint through its full available range over 1 second. The mean changes from baseline to Week 4 in MAS in the overall PTMG (finger, wrist or elbow flexors) are reported.'}, {'measure': 'Percentage of Subjects With at Least 1 or 2 Grade Reduction in MAS for Overall PTMG', 'timeFrame': 'At Week 4', 'description': 'The MAS consists of 6 grades: 0, 1, 1+, 2, 3, or 4 that can be applied to muscles of both the upper and lower limbs. The MAS was applied by the rater by stretching the joint through its full available range over 1 second. The percentage of subjects with at least a 1 grade reduction and at least a 2 grades reduction from baseline in mean MAS in the overall PTMG at Week 4 are reported.'}, {'measure': 'Mean Change From Baseline MAS in the Extrinsic Finger Flexors at Week 4', 'timeFrame': 'At Week 4', 'description': 'The clinical assessment of muscle tone was performed using the MAS. The MAS consists of 6 grades: 0, 1, 1+, 2, 3, or 4 that can be applied to muscles of both the upper and lower limbs. The MAS was applied by the rater by stretching the joint through its full available range over 1 second. The mean changes from baseline to Week 4 in MAS in the extrinsic finger flexors are reported.'}, {'measure': 'Percentage of Subjects With at Least 1 or 2 Grade Reduction in MAS for Extrinsic Finger Flexors at Week 4', 'timeFrame': 'At Week 4', 'description': 'The MAS consists of 6 grades: 0, 1, 1+, 2, 3, or 4 that can be applied to muscles of both the upper and lower limbs. The MAS was applied by the rater by stretching the joint through its full available range over 1 second. The percentage of subjects with at least a 1 grade reduction and at least a 2 grades reduction from baseline in mean MAS in the extrinsic finger flexors at Week 4 are reported.'}, {'measure': 'Mean Change From Baseline MAS in the Wrist Flexors at Week 4', 'timeFrame': 'At Week 4', 'description': 'The clinical assessment of muscle tone was performed using the MAS. The MAS consists of 6 grades: 0, 1, 1+, 2, 3, or 4 that can be applied to muscles of both the upper and lower limbs. The MAS was applied by the rater by stretching the joint through its full available range over 1 second. The mean changes from baseline to Week 4 in MAS in the wrist flexors are reported.'}, {'measure': 'Percentage of Subjects With at Least 1 or 2 Grade Reduction in MAS for Wrist Flexors at Week 4', 'timeFrame': 'At Week 4', 'description': 'The MAS consists of 6 grades: 0, 1, 1+, 2, 3, or 4 that can be applied to muscles of both the upper and lower limbs. The MAS was applied by the rater by stretching the joint through its full available range over 1 second. The percentage of subjects with at least a 1 grade reduction and at least a 2 grades reduction in mean MAS in the wrist flexors at Week 4 are reported.'}, {'measure': 'Mean Change From Baseline MAS in the Elbow Flexors at Week 4', 'timeFrame': 'At Week 4', 'description': 'The clinical assessment of muscle tone was performed using the MAS. The MAS consists of 6 grades: 0, 1, 1+, 2, 3, or 4 that can be applied to muscles of both the upper and lower limbs. The MAS was applied by the rater by stretching the joint through its full available range over 1 second. The mean changes from baseline to Week 4 in MAS in the elbow flexors are reported.'}, {'measure': 'Percentage of Subjects With at Least 1 or 2 Grade Reduction in MAS for Elbow Flexors at Week 4', 'timeFrame': 'At Week 4', 'description': 'The MAS consists of 6 grades: 0, 1, 1+, 2, 3, or 4 that can be applied to muscles of both the upper and lower limbs. The MAS was applied by the rater by stretching the joint through its full available range over 1 second. The percentage of subjects at least a 1 grade reduction and at least a 2 grades reduction from baseline in mean MAS in the elbow flexors at Week 4 are reported.'}, {'measure': 'Mean Change From Baseline MAS in the Shoulder Extensors at Week 4', 'timeFrame': 'At Week 4', 'description': 'The clinical assessment of muscle tone was performed using the MAS. The MAS consists of 6 grades: 0, 1, 1+, 2, 3, or 4 that can be applied to muscles of both the upper and lower limbs. The MAS was applied by the rater by stretching the joint through its full available range over 1 second. The mean changes from baseline to Week 4 in MAS in the shoulder extensors are reported.'}, {'measure': "Physician's Global Assessment (PGA) of Treatment Response at Week 4", 'timeFrame': 'At Week 4', 'description': 'The PGA is a 9-point rating scale: -4=markedly worse, -3=much worse, -2=worse, -1=slightly worse, 0=no change, +1=slightly improved, +2=improved, +3=much improved, +4=markedly improved. An assessment of overall treatment response was conducted by the investigator and the mean PGA scores during long-term open label treatment with Dysport were reported.'}, {'measure': 'Mean Change From Baseline in Disability Assessment Scale (DAS) Score for the Principal Target of Treatment (PTT) at Week 4', 'timeFrame': 'At Week 4', 'description': 'At baseline the subject and investigator together selected one of the four DAS domains as the PTT. The selected domain was required to have a rating of moderate or severe (≥2) at baseline. The DAS is a 4-point scale, the extent of functional impairment in 4 functional domains (dressing, hygiene, limb position and pain) was rated as follows: 0=no disability, 1=mild disability (noticeable but does not interfere significantly with normal activities), 2=moderate disability (normal activities require increased effort and/or assistance) and 3=severe disability (normal activities limited). The mean changes in DAS at Week 4 are reported.'}, {'measure': 'Percentage of Subjects With at Least 1 Grade Reduction in DAS for PTT at Week 4', 'timeFrame': 'At Week 4', 'description': 'At baseline the subject and investigator together selected one of the four DAS domains as the PTT. The selected domain was required to have a rating of moderate or severe (≥2) at baseline. The DAS is a 4-point scale, the extent of functional impairment in 4 functional domains (dressing, hygiene, limb position and pain) was rated as follows: 0=no disability, 1=mild disability (noticeable but does not interfere significantly with normal activities), 2=moderate disability (normal activities require increased effort and/or assistance) and 3=severe disability (normal activities limited). The percentage of subjects with at least 1 grade reduction from baseline in DAS for PTT at Week 4 are reported.'}, {'measure': 'Percentage of Subjects With at Least One Grade Reduction in DAS for Individual Domains at Week 4', 'timeFrame': 'At Week 4', 'description': 'The DAS is a 4-point scale. The extent of functional impairment in 4 functional domains (dressing, hygiene, limb position and pain) was rated as follows: 0=no disability, 1=mild disability (noticeable but does not interfere significantly with normal activities), 2=moderate disability (normal activities require increased effort and/or assistance) and 3=severe disability (normal activities limited). The percentage of subjects with at least one grade reduction in DAS for each of the individual domains at Week 4 is reported.'}, {'measure': 'Mean Change From Baseline to Week 4 for Angle of Arrest (XV1), Angle of Catch (XV3) and Angle of Spasticity (X) in Extrinsic Finger Flexors as PTMG', 'timeFrame': 'At Week 4', 'description': 'The Tardieu Scale (TS) was used to measure spasticity in extrinsic finger flexors. The TS is administered by applying passive stretch to a muscle group at two velocities. Slow speed of muscle stretch measures the range of passive motion. During a slow stretching movement, the examiner determines the angle of movement arrest, either due to subject discomfort or a mechanical resistance. The same movement is repeated at high velocity (as fast as possible) to determine the angle of catch and release. The angle of movement arrest at slow velocity (XV1) and the angle of catch at fast speed (XV3) were recorded. The spasticity angle (X) was calculated as the difference between XV1 and XV3. Mean changes in Angles XV1, XV3 and X from baseline to Week 4 are reported.'}, {'measure': 'Mean Change From Baseline to Week 4 for Spasticity Grade (Y) in Extrinsic Finger Flexors as PTMG', 'timeFrame': 'At Week 4', 'description': 'The TS was used to measure spasticity in extrinsic finger flexors. The TS is administered by applying passive stretch to a muscle group. The spasticity grade (Y) assesses quality of muscle reaction on a 5-point scale (measured at fast speed): 0 =No resistance throughout passive movement, 1=slight resistance throughout passive movement, 2=clear catch at precise angle, interrupting passive movement, followed by release, 3=fatigable clonus (less than 10 seconds when maintaining pressure) occurring at a precise angle, followed by release. 4=unfatigable clonus (more than 10 seconds when maintaining pressure) occurring at precise angle. Mean changes in spasticity grade (Y) from baseline to Week 4 are reported.'}, {'measure': 'Mean Change From Baseline to Week 4 for Angle of Arrest (XV1), Angle of Catch (XV3) and Angle of Spasticity (X) in Elbow Flexors as PTMG', 'timeFrame': 'At Week 4', 'description': 'The TS was used to measure spasticity in elbow flexors. The TS is administered by applying passive stretch to a muscle group at two velocities. Slow speed of muscle stretch measures the range of passive motion. During a slow stretching movement, the examiner determines the angle of movement arrest, either due to subject discomfort or a mechanical resistance. The same movement is repeated at high velocity (as fast as possible) to determine the angle of catch and release. The angle of movement arrest at slow velocity (XV1) and the angle of catch at fast speed (XV3) were recorded. The spasticity angle (X) was calculated as the difference between XV1 and XV3. Mean changes in Angles XV1, XV3 and X from baseline to Week 4 are reported.'}, {'measure': 'Mean Change From Baseline to Week 4 for Spasticity Grade (Y) in Elbow Flexors as PTMG', 'timeFrame': 'At Week 4', 'description': 'The TS was used to measure spasticity in elbow flexors.The TS is administered by applying passive stretch to a muscle group. The spasticity grade (Y) assesses quality of muscle reaction on a 5-point scale (measured at fast speed): 0 =No resistance throughout passive movement, 1=slight resistance throughout passive movement, 2=clear catch at precise angle, interrupting passive movement, followed by release, 3=fatigable clonus (less than 10 seconds when maintaining pressure) occurring at a precise angle, followed by release. 4=unfatigable clonus (more than 10 seconds when maintaining pressure) occurring at precise angle. Mean changes in spasticity grade (Y) from baseline to Week 4 are reported.'}, {'measure': 'Mean Change From Baseline to Week 4 for Angle of Arrest (XV1), Angle of Catch (XV3) and Angle of Spasticity (X) in Wrist Flexors as PTMG', 'timeFrame': 'At Week 4', 'description': 'The TS was used to measure spasticity in wrist flexors. The TS is administered by applying passive stretch to a muscle group at two velocities. Slow speed of muscle stretch measures the range of passive motion. During a slow stretching movement, the examiner determines the angle of movement arrest, either due to subject discomfort or a mechanical resistance. The same movement is repeated at high velocity (as fast as possible) to determine the angle of catch and release. The angle of movement arrest at slow velocity (XV1) and the angle of catch at fast speed (XV3) were recorded. The spasticity angle (X) was calculated as the difference between XV1 and XV3. Mean changes in Angles XV1, XV3 and X from baseline to Week 4 are reported.'}, {'measure': 'Mean Change From Baseline to Week 4 for Spasticity Grade (Y) in Wrist Flexors as PTMG', 'timeFrame': 'At Week 4', 'description': 'The TS was used to measure spasticity in wrist flexors. The TS is administered by applying passive stretch to a muscle group. The spasticity grade (Y) assesses quality of muscle reaction on a 5-point scale (measured at fast speed): 0 =No resistance throughout passive movement, 1=slight resistance throughout passive movement, 2=clear catch at precise angle, interrupting passive movement, followed by release, 3=fatigable clonus (less than 10 seconds when maintaining pressure) occurring at a precise angle, followed by release. 4=unfatigable clonus (more than 10 seconds when maintaining pressure) occurring at precise angle. Mean changes in spasticity grade (Y) from baseline to Week 4 are reported.'}, {'measure': 'Mean Change From Baseline to Week 4 for Angle of Arrest (XV1), Angle of Catch (XV3) and Angle of Spasticity (X) in Shoulder Extensors', 'timeFrame': 'At Week 4', 'description': 'The TS was used to measure spasticity in shoulder extensors. The TS is administered by applying passive stretch to a muscle group at two velocities. Slow speed of muscle stretch measures the range of passive motion. During a slow stretching movement, the examiner determines the angle of movement arrest, either due to subject discomfort or a mechanical resistance. The same movement is repeated at high velocity (as fast as possible) to determine the angle of catch and release. The angle of movement arrest at slow velocity (XV1) and the angle of catch at fast speed (XV3) were recorded. The spasticity angle (X) was calculated as the difference between XV1 and XV3. Mean changes in Angles XV1, XV3 and X from baseline to Week 4 are reported.'}, {'measure': 'Mean Change From Baseline to Week 4 for Spasticity Grade (Y) in Shoulder Extensors', 'timeFrame': 'At Week 4', 'description': 'The TS was used to measure spasticity in shoulder extensors. The TS is administered by applying passive stretch to a muscle group. The spasticity grade (Y) assesses quality of muscle reaction on a 5-point scale (measured at fast speed): 0 =No resistance throughout passive movement, 1=slight resistance throughout passive movement, 2=clear catch at precise angle, interrupting passive movement, followed by release, 3=fatigable clonus (less than 10 seconds when maintaining pressure) occurring at a precise angle, followed by release. 4=unfatigable clonus (more than 10 seconds when maintaining pressure) occurring at precise angle. Mean changes in spasticity grade (Y) from baseline to Week 4 are reported.'}, {'measure': 'Mean Change From Baseline in Active Range of Motion (AROM) at Week 4 in the 3 Possible PTMGs', 'timeFrame': 'At Week 4', 'description': 'The AROM was assessed by the range of extension achieved by the subject moving each joint in the PTMGs (extrinsic finger flexors, elbow flexors and wrist flexors) without assistance. A goniometer was used for measurements in the elbow and wrist flexors but not for measurements in the extrinsic finger flexors. Mean changes in AROM in the 3 possible PTMGs from baseline to Week 4 are reported.'}, {'measure': 'Mean Change From Baseline at Week 4 in Ease of Applying a Splint', 'timeFrame': 'At Week 4', 'description': 'The ease of applying a splint was evaluated on a 6-point scale (0= no splint needed, -1= splint needed and applied with no difficulty, -2= splint needed and applied with mild difficulty, -3= splint needed and applied with moderate difficulty, -4= splint needed and applied with severe difficulty, -5= splint needed,but unable to apply). Mean change in ease of applying a splint from baseline to Week 4 was reported.'}, {'measure': 'Mean Change From Baseline in Modified Frenchay Scale (MFS) at Week 4', 'timeFrame': 'At Week 4', 'description': 'The MFS was used to measure upper limb active function. Each subject was video taped while performing specific tasks. The videos were sent to a central provider and were read and scored by two independent readers blinded to the timing of the video and to treatment. These central assessments were used for the analysis of efficacy endpoints. The MFS consists of 10 tasks asking the subject to reach, grasp, carry and release different objects of different sizes which subjects are likely to use in their daily life. Each of these tasks was rated on a 10 point scale ranging from no movement to normal movement; for each task, the score 5 is used to rate a task barely accomplished. Mean change in MFS from baseline to Week 4 was reported.'}, {'measure': 'Mean Change From Baseline in Short Form (36) Health Survey (SF-36) Quality of Life (QoL) at End of Study/Early Withdrawal Visit', 'timeFrame': 'Up to Week 52', 'description': 'Subjects were asked to complete the SF-36 questionnaires prior to the study treatment at baseline and at the end of study/early withdrawal visit. The SF-36 is a generic non-preference based health status measure. This instrument assessed subject health across 8 variable dimensions, which are specific health domains such as physical functioning, social functioning and vitality. Each variable item score is coded and turned into a 0-100 scale where 0 indicates the worst and 100 indicates the best possible health state for both the Physical Component Summary (PCS) and Mental Component Summary (MCS) of the questionnaire. Baseline results and the change from baseline to end of study/early withdrawal for the PCS and MCS are reported.'}, {'measure': 'Mean Change From Baseline in European 5 Dimensions, 5 Level (EQ-5D-5L) QoL at End of Study/Early Withdrawal Visit', 'timeFrame': 'Up to Week 52', 'description': 'Subjects were asked to complete the EQ-5D-5L QoL questionnaires prior to the study treatment at baseline and at the end of study/early withdrawal visit. The EQ-5D-5L index is a generic preference based measure of health related QoL producing utility scores that represent subject preferences for particular health states. This instrument rated subject health state looking at 5 specific dimensions such as mobility, self-care, usual activity, pain/discomfort and anxiety/depression and scored their general health state. Each dimension has 5 levels of severity (no problems, slight problems,moderate problems, severe problems and extreme problems). In addition, a visual analogue scale (VAS) ranging from 0 to 100 was also included for the patients to summarize their overall health status, where 0 is the worst and 100 the best possible health state. The mean values for each dimension and the VAS scores at baseline and at the end of-study /early withdrawal are reported.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Nervous System Disorders']}, 'referencesModule': {'references': [{'pmid': '29781237', 'type': 'DERIVED', 'citation': 'Delafont B, Carroll K, Vilain C, Pham E. Investigation of mixed model repeated measures analyses and non-linear random coefficient models in the context of long-term efficacy data. Pharm Stat. 2018 Sep;17(5):515-526. doi: 10.1002/pst.1868. Epub 2018 May 20.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this research study is to assess the long term safety of Dysport® in hemiparetic subjects with upper limb spasticity due to stroke or traumatic brain injury over repeated treatment cycles.', 'detailedDescription': 'This was a phase III, multicentre, prospective, open label, repeat treatment cycles, extension to the double study Y-52-52120-145 (Study 145) . The study included both rollover subjects from Study 145 and de novo subjects. The primary study objective was to assess the long term safety of Dysport® in hemiparetic subjects with upper limb spasticity due to stroke or traumatic brain injury over repeated treatment cycles. The secondary study objective was to assess the long term efficacy of repeated treatment with Dysport®.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Completion of the double blind study, Y-52-52120-145\n\nExclusion Criteria:\n\n* Major limitation in the passive range of motion in upper limb'}, 'identificationModule': {'nctId': 'NCT01313312', 'briefTitle': 'Dysport® Adult Upper Limb Spasticity Extension Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ipsen'}, 'officialTitle': 'A Phase III, Multicentre, Prospective, Open Label Extension Study to Assess the Long Term Safety and Efficacy of Repeated Treatment of Dysport® Intramuscular Injections Used for the Treatment of Upper Limb Spasticity in Adult Subjects With Spastic Hemiparesis Due to Stroke or Traumatic Brain Injury', 'orgStudyIdInfo': {'id': 'Y-52-52120-148'}, 'secondaryIdInfos': [{'id': '2010-019162-83', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Total Dysport®', 'description': "A total of 254 subjects in the open label study received between 1 and 5 intramuscular (i.m) injections of Dysport® according to their individual needs, for a period of up to 12 months. All subjects were administered an appropriate dosage of Dysport® (1000 Units \\[U\\] or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject's safety and efficacy response. From Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U.", 'interventionNames': ['Biological: Botulinum toxin type A']}], 'interventions': [{'name': 'Botulinum toxin type A', 'type': 'BIOLOGICAL', 'otherNames': ['AbobotulinumtoxinA (Dysport®)'], 'description': 'Dysport® was supplied to the study centres in vials containing 500 U of botulinum toxin type A (BTX-A). Depending on the dose administered up to 3 vials were required for the injection.\n\nEach vial was reconstituted with sodium chloride for injection (0.9%). A total volume of 5.0 mL of the reconstituted product was injected for Dysport® 500 U and 1000 U, and 7.5 mL was injected for Dysport® 1500 U.', 'armGroupLabels': ['Total Dysport®']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90242', 'city': 'Downey', 'state': 'California', 'country': 'United States', 'facility': 'Rancho Los Amigos National Rehabilitation Center', 'geoPoint': {'lat': 33.94001, 'lon': -118.13257}}, {'zip': '06824', 'city': 'Fairfield', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Associated Neurologist of Southern CT, PT', 'geoPoint': {'lat': 41.14121, 'lon': -73.26373}}, {'zip': '33488', 'city': 'Boca Raton', 'state': 'Florida', 'country': 'United States', 'facility': "Parkinson's Disease & Movement Disorders Center of Boca Raton", 'geoPoint': {'lat': 26.35869, 'lon': -80.0831}}, {'zip': '33143', 'city': 'South Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Design Neuroscience Miami', 'geoPoint': {'lat': 25.7076, 'lon': -80.29338}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'The Rehabilitation Institute of Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '10029-6574', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Mount Sinai School of Medicine', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Weill Cornell Medical College', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Univ of North Carolina - Chapel Hill', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest Medical Center', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Southwestern Medical Center at Dallas University of Texas', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '76104', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'facility': 'University of North Texas HSC at Ben Hogan Center', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}, {'zip': '84132', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'University of Utah School of Medicine', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'city': 'Brussels', 'country': 'Belgium', 'facility': 'Université catholique de Louvain av Hippocrate 10', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'city': 'Yvoir', 'country': 'Belgium', 'facility': 'Clinique Universitaire', 'geoPoint': {'lat': 50.3279, 'lon': 4.88059}}, {'city': 'Prague', 'country': 'Czechia', 'facility': 'Charles University in Prague', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'city': 'Brest', 'country': 'France', 'facility': 'CHU Brest', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}, {'city': 'Coubert', 'country': 'France', 'facility': 'Centre de Réadaptation de Coubert', 'geoPoint': {'lat': 48.67186, 'lon': 2.69733}}, {'city': 'Créteil', 'country': 'France', 'facility': 'Centre Hospitalier Albert Chenevier-Hopital Henri Mondor', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}, {'city': 'Garches', 'country': 'France', 'facility': 'Hopital Raymond Poincarré', 'geoPoint': {'lat': 48.84226, 'lon': 2.18232}}, {'city': 'Reims', 'country': 'France', 'facility': 'Hôpital Sébastopol', 'geoPoint': {'lat': 49.26526, 'lon': 4.02853}}, {'city': 'Strasbourg', 'country': 'France', 'facility': 'CHU Strasbourg', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'city': 'Toulouse', 'country': 'France', 'facility': 'Hopital Rangueil', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'city': 'Gyor', 'state': 'Budapest', 'country': 'Hungary', 'facility': 'Petz Aladar County Hospital'}, {'city': 'Budapest', 'country': 'Hungary', 'facility': 'National Institute for Medical Rehabilitation', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'city': 'Catania', 'country': 'Italy', 'facility': 'Azienda Hospedaliero', 'geoPoint': {'lat': 37.49223, 'lon': 15.07041}}, {'city': 'Roma', 'country': 'Italy', 'facility': 'Policlinico Universitario Agostino Gemelli', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'city': 'Krakow', 'country': 'Poland', 'facility': 'Malopolskie Centrum Medyczne', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'city': 'Warsaw', 'country': 'Poland', 'facility': 'Krakowska Akademia Neurologii', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'city': 'Warsaw', 'country': 'Poland', 'facility': 'Samodzielny Publiczny Centralny Szpital Kliniczny', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'city': 'Moscow', 'country': 'Russia', 'facility': 'Medical Rehabilitation Center', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'city': 'Moscow', 'country': 'Russia', 'facility': 'Scientific Center of Neurology of RAMS', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'State University', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'city': 'Bratislava', 'country': 'Slovakia', 'facility': "Derer's Hospital", 'geoPoint': {'lat': 48.14816, 'lon': 17.10674}}], 'overallOfficials': [{'name': 'Ipsen Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ipsen'}]}, 'ipdSharingStatementModule': {'url': 'https://vivli.org/members/ourmembers/', 'timeFrame': 'Where applicable, data from eligible studies are available 6 months after the studied medicine and indication have been approved in the US and EU or after the primary manuscript describing the results has been accepted for publication, whichever is later.', 'ipdSharing': 'YES', 'description': 'Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized, and study documents will be redacted to protect the privacy of study participants.\n\nAny requests should be submitted to www.vivli.org for assessment by an independent scientific review board.', 'accessCriteria': "Further details on Ipsen's sharing criteria, eligible studies and process for sharing are available here (https://vivli.org/members/ourmembers/)."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ipsen', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}