Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2026-04-12 @ 5:55 PM
Study NCT ID:
NCT02229851
Status:
COMPLETED
Last Update Posted:
2020-11-23
First Post:
2014-08-26
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Trial to Compare the Efficacy and Safety of NNC0195-0092 (Somapacitan) With Placebo and Norditropin® FlexPro® (Somatropin) in Adults With Growth Hormone Deficiency.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004393', 'term': 'Dwarfism, Pituitary'}], 'ancestors': [{'id': 'D004392', 'term': 'Dwarfism'}, {'id': 'D001848', 'term': 'Bone Diseases, Developmental'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D001849', 'term': 'Bone Diseases, Endocrine'}, {'id': 'D007018', 'term': 'Hypopituitarism'}, {'id': 'D010900', 'term': 'Pituitary Diseases'}, {'id': 'D007027', 'term': 'Hypothalamic Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000718308', 'term': 'somapacitan'}, {'id': 'C000594654', 'term': 'NNC0195-0092'}, {'id': 'D019382', 'term': 'Human Growth Hormone'}], 'ancestors': [{'id': 'D013006', 'term': 'Growth Hormone'}, {'id': 'D010908', 'term': 'Pituitary Hormones, Anterior'}, {'id': 'D010907', 'term': 'Pituitary Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@novonordisk.com', 'phone': '(+1) 866-867-7178', 'title': 'Clinical Reporting Anchor and Disclosure (1452)', 'organization': 'Novo Nordisk A/S'}, 'certainAgreement': {'otherDetails': 'At the end of the trial, one or more scientific publications may be prepared collaboratively by the investigator(s) and Novo Nordisk. Novo Nordisk reserves the right to postpone publication and/or communication for up to 60 days to protect intellectual property', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Weeks 0-88', 'description': 'All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo - Main Phase', 'description': 'Participants received placebo for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.', 'otherNumAtRisk': 61, 'deathsNumAtRisk': 61, 'otherNumAffected': 29, 'seriousNumAtRisk': 61, 'deathsNumAffected': 1, 'seriousNumAffected': 5}, {'id': 'EG001', 'title': 'Somapacitan - Main Phase', 'description': 'Participants received somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.', 'otherNumAtRisk': 120, 'deathsNumAtRisk': 120, 'otherNumAffected': 53, 'seriousNumAtRisk': 120, 'deathsNumAffected': 0, 'seriousNumAffected': 7}, {'id': 'EG002', 'title': 'Norditropin - Main Phase', 'description': 'Participants received Norditropin® for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.', 'otherNumAtRisk': 119, 'deathsNumAtRisk': 119, 'otherNumAffected': 55, 'seriousNumAtRisk': 119, 'deathsNumAffected': 1, 'seriousNumAffected': 12}, {'id': 'EG003', 'title': 'Somapacitan - Extension Phase', 'description': 'The extension phase treatment period was 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment). This reporting group shows data from the extension phase for the following listed participants: 1) participants who received placebo in the main phase, and switched to receive somapacitan in the extension phase. 2) Participants who received somapacitan in the main phase were continued to receive somapacitan in the extension phase. 3) Participants who received Norditropin® in the main phase and re-randomised at the end of the main phase to receive somapacitan in the extension phase (randomisation was done in a 1:1 manner to receive either somapacitan and Norditropin®).', 'otherNumAtRisk': 220, 'deathsNumAtRisk': 220, 'otherNumAffected': 85, 'seriousNumAtRisk': 220, 'deathsNumAffected': 2, 'seriousNumAffected': 15}, {'id': 'EG004', 'title': 'Norditropin- Extension Phase', 'description': 'The extension phase treatment period was 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment). This reporting group shows data from the extension phase for the participants who received Norditropin® in the main phase and re-randomised at the end of the main phase to receive Norditropin® in the extension phase (randomisation was done in a 1:1 manner to receive either somapacitan and Norditropin®).', 'otherNumAtRisk': 52, 'deathsNumAtRisk': 52, 'otherNumAffected': 27, 'seriousNumAtRisk': 52, 'deathsNumAffected': 1, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 220, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 52, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 220, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 220, 'numEvents': 21, 'numAffected': 14}, {'groupId': 'EG004', 'numAtRisk': 52, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 220, 'numEvents': 11, 'numAffected': 9}, {'groupId': 'EG004', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 15, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 45, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 50, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 220, 'numEvents': 48, 'numAffected': 25}, {'groupId': 'EG004', 'numAtRisk': 52, 'numEvents': 23, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 220, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 52, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Injection site bruising', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 220, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 52, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 12, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 29, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 25, 'numAffected': 20}, {'groupId': 'EG003', 'numAtRisk': 220, 'numEvents': 41, 'numAffected': 33}, {'groupId': 'EG004', 'numAtRisk': 52, 'numEvents': 8, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 220, 'numEvents': 14, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 220, 'numEvents': 17, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 220, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 52, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Tooth abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 220, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 52, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 220, 'numEvents': 18, 'numAffected': 17}, {'groupId': 'EG004', 'numAtRisk': 52, 'numEvents': 6, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Visual impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 52, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}], 'seriousEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Adrenocortical insufficiency acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Arterial stent insertion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Bladder transitional cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Blood testosterone increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Cardiogenic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 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{'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Delirium', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Dental cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Depressed level 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'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Viral upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Truncal Fat Percentage (Week 34)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}, {'value': '116', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}, {'id': 'OG001', 'title': 'Norditropin', 'description': 'Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}, {'id': 'OG002', 'title': 'Somapacitan', 'description': 'Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.49', 'spread': '3.31', 'groupId': 'OG000'}, {'value': '-2.39', 'spread': '4.48', 'groupId': 'OG001'}, {'value': '-1.17', 'spread': '2.89', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '=0.0090', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Treatment difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.53', 'ciLowerLimit': '-2.68', 'ciUpperLimit': '-0.38', 'estimateComment': 'Somapacitan-Placebo', 'groupDescription': "Changes in truncal fat percentage from baseline to the 34 week's measurements was analysed using an analysis of covariance model with treatment, growth hormone deficiency (GHD) onset type, sex, region, diabetes mellitus (DM) and sex by region by DM interaction as factors and baseline as a covariate. The analysis was conducted using a multiple imputation technique where trajectory after a withdrawn subjects last observation was imputed based on data from the placebo arm.", 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Week -3, week 34', 'description': 'Change in Truncal fat percentage was measured from baseline (week -3) until the end of the main treatment period (week 34).', 'unitOfMeasure': 'Percentage of truncal fat', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Truncal Fat Percentage (Week 87)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/Somapacitan', 'description': 'Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG001', 'title': 'Somapacitan/Somapacitan', 'description': 'Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG002', 'title': 'Norditropin/Norditropin', 'description': 'Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG003', 'title': 'Norditropin/Somapacitan', 'description': 'Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.16', 'spread': '3.94', 'groupId': 'OG000'}, {'value': '-1.63', 'spread': '3.65', 'groupId': 'OG001'}, {'value': '-2.63', 'spread': '4.65', 'groupId': 'OG002'}, {'value': '-0.96', 'spread': '4.51', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'week -3, week 87', 'description': 'Change in Truncal fat percentage was measured from baseline (week -3) until the end of the extension treatment period (week 87).', 'unitOfMeasure': 'Percentage of truncal fat', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Truncal Fat Mass (Week 34)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}, {'value': '116', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}, {'id': 'OG001', 'title': 'Norditropin', 'description': 'Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}, {'id': 'OG002', 'title': 'Somapacitan', 'description': 'Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '417.86', 'spread': '1536.36', 'groupId': 'OG000'}, {'value': '-619.67', 'spread': '1887.50', 'groupId': 'OG001'}, {'value': '-180.98', 'spread': '1762.31', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week -3, week 34', 'description': 'Change in Truncal fat mass was measured from baseline (week -3) until the end of the main treatment period (week 34).', 'unitOfMeasure': 'grams', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Truncal Fat Mass (Week 87)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/Somapacitan', 'description': 'Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG001', 'title': 'Somapacitan/Somapacitan', 'description': 'Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG002', 'title': 'Norditropin/Norditropin', 'description': 'Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG003', 'title': 'Norditropin/Somapacitan', 'description': 'Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '-311.85', 'spread': '1771.78', 'groupId': 'OG000'}, {'value': '-196.18', 'spread': '2249.21', 'groupId': 'OG001'}, {'value': '-685.56', 'spread': '2258.93', 'groupId': 'OG002'}, {'value': '364.08', 'spread': '2548.85', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'week -3, week 87', 'description': 'Change in Truncal fat mass was measured from baseline (week -3) until the end of the extension treatment period (week 87).', 'unitOfMeasure': 'grams', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Truncal Lean Body Mass (Week 34)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}, {'value': '116', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}, {'id': 'OG001', 'title': 'Norditropin', 'description': 'Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}, {'id': 'OG002', 'title': 'Somapacitan', 'description': 'Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '402.69', 'spread': '1247.67', 'groupId': 'OG000'}, {'value': '832.77', 'spread': '1409.74', 'groupId': 'OG001'}, {'value': '800.27', 'spread': '1377.75', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week -3, week 34', 'description': 'Change in Truncal lean body mass was measured from baseline (week -3) until the end of the main treatment period (week 34).', 'unitOfMeasure': 'grams', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Truncal Lean Body Mass (Week 87)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/Somapacitan', 'description': 'Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG001', 'title': 'Somapacitan/Somapacitan', 'description': 'Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG002', 'title': 'Norditropin/Norditropin', 'description': 'Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG003', 'title': 'Norditropin/Somapacitan', 'description': 'Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '1197.30', 'spread': '1500.56', 'groupId': 'OG000'}, {'value': '1152.79', 'spread': '1480.06', 'groupId': 'OG001'}, {'value': '975.79', 'spread': '1258.62', 'groupId': 'OG002'}, {'value': '1015.12', 'spread': '1554.88', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'week -3, week 87', 'description': 'Change in Truncal lean body mass was measured from baseline (week -3) until the end of the extension treatment period (week 87).', 'unitOfMeasure': 'grams', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Total Fat Mass (Week 34)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}, {'value': '116', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}, {'id': 'OG001', 'title': 'Norditropin', 'description': 'Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}, {'id': 'OG002', 'title': 'Somapacitan', 'description': 'Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '305.47', 'spread': '2689.06', 'groupId': 'OG000'}, {'value': '-855.71', 'spread': '3167.06', 'groupId': 'OG001'}, {'value': '-85.47', 'spread': '3022.71', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week -3, week 34', 'description': 'Change in Total fat mass was measured from baseline (week -3) until the end of the main treatment period (week 34).', 'unitOfMeasure': 'grams', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Total Fat Mass (Week 87)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/Somapacitan', 'description': 'Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG001', 'title': 'Somapacitan/Somapacitan', 'description': 'Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG002', 'title': 'Norditropin/Norditropin', 'description': 'Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG003', 'title': 'Norditropin/Somapacitan', 'description': 'Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '-540.04', 'spread': '3250.16', 'groupId': 'OG000'}, {'value': '-118.07', 'spread': '3795.36', 'groupId': 'OG001'}, {'value': '-923.01', 'spread': '4099.45', 'groupId': 'OG002'}, {'value': '874.56', 'spread': '4789.34', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week -3, week 87', 'description': 'Change in total fat mass was measured from baseline (week -3) until the end of the extension treatment period (week 87).', 'unitOfMeasure': 'grams', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Visceral Adipose Tissue (Week 34)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}, {'value': '105', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}, {'id': 'OG001', 'title': 'Norditropin', 'description': 'Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}, {'id': 'OG002', 'title': 'Somapacitan', 'description': 'Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.41', 'spread': '13.81', 'groupId': 'OG000'}, {'value': '-9.68', 'spread': '21.37', 'groupId': 'OG001'}, {'value': '-11.61', 'spread': '23.93', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week -3, week 34', 'description': 'Change in Visceral adipose tissue was measured from baseline (week -3) until the end of the main treatment period (week 34).', 'unitOfMeasure': 'centimeter square', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Visceral Adipose Tissue (Week 87)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/Somapacitan', 'description': 'Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG001', 'title': 'Somapacitan/Somapacitan', 'description': 'Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG002', 'title': 'Norditropin/Norditropin', 'description': 'Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG003', 'title': 'Norditropin/Somapacitan', 'description': 'Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '-9.34', 'spread': '25.67', 'groupId': 'OG000'}, {'value': '-6.71', 'spread': '33.07', 'groupId': 'OG001'}, {'value': '-5.17', 'spread': '20.11', 'groupId': 'OG002'}, {'value': '-5.97', 'spread': '28.86', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week -3, week 87', 'description': 'Change in Visceral adipose tissue was measured from baseline (week -3) until the end of the extension treatment period (week 87).', 'unitOfMeasure': 'centimeter square', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Android Fat Mass (Week 34)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}, {'value': '114', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}, {'id': 'OG001', 'title': 'Norditropin', 'description': 'Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}, {'id': 'OG002', 'title': 'Somapacitan', 'description': 'Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '56.32', 'spread': '293.93', 'groupId': 'OG000'}, {'value': '-158.98', 'spread': '325.35', 'groupId': 'OG001'}, {'value': '-81.52', 'spread': '361.62', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week -3, week 34', 'description': 'Change in Android fat mass was measured from baseline (week -3) until the end of the main treatment period (week 34).', 'unitOfMeasure': 'gram', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Android Fat Mass (Week 87)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/Somapacitan', 'description': 'Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG001', 'title': 'Somapacitan/Somapacitan', 'description': 'Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG002', 'title': 'Norditropin/Norditropin', 'description': 'Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG003', 'title': 'Norditropin/Somapacitan', 'description': 'Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '-107.16', 'spread': '367.14', 'groupId': 'OG000'}, {'value': '-39.76', 'spread': '481.66', 'groupId': 'OG001'}, {'value': '-100.76', 'spread': '386.24', 'groupId': 'OG002'}, {'value': '11.52', 'spread': '489.85', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'week -3, week 87', 'description': 'Change in Android fat mass was measured from baseline (week -3) until the end of the extension treatment period (week 87).', 'unitOfMeasure': 'gram', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Gynoid Fat Mass (Week 34)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}, {'value': '114', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}, {'id': 'OG001', 'title': 'Norditropin', 'description': 'Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}, {'id': 'OG002', 'title': 'Somapacitan', 'description': 'Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.35', 'spread': '567.04', 'groupId': 'OG000'}, {'value': '-128.59', 'spread': '471.00', 'groupId': 'OG001'}, {'value': '22.66', 'spread': '510.45', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week -3, week 34', 'description': 'Change in Gynoid fat mass was measured from baseline (week -3) until the end of the main treatment period (week 34).', 'unitOfMeasure': 'gram', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Gynoid Fat Mass (Week 87)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/Somapacitan', 'description': 'Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG001', 'title': 'Somapacitan/Somapacitan', 'description': 'Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG002', 'title': 'Norditropin/Norditropin', 'description': 'Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG003', 'title': 'Norditropin/Somapacitan', 'description': 'Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '-92.00', 'spread': '759.37', 'groupId': 'OG000'}, {'value': '10.23', 'spread': '557.20', 'groupId': 'OG001'}, {'value': '-100.97', 'spread': '620.16', 'groupId': 'OG002'}, {'value': '140.02', 'spread': '790.74', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'week -3, week 87', 'description': 'Change in Gynoid fat mass was measured from baseline (week -3) until the end of the extension treatment period (week 87).', 'unitOfMeasure': 'gram', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Appendicular Skeletal Muscle Mass (Week 34)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}, {'value': '116', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}, {'id': 'OG001', 'title': 'Norditropin', 'description': 'Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}, {'id': 'OG002', 'title': 'Somapacitan', 'description': 'Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '-76.22', 'spread': '1006.58', 'groupId': 'OG000'}, {'value': '482.76', 'spread': '1246.89', 'groupId': 'OG001'}, {'value': '565.21', 'spread': '1011.18', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week -3, week 34', 'description': 'Change in Appendicular skeletal muscle mass was measured from baseline (week -3) until the end of the main treatment period (week 34).', 'unitOfMeasure': 'gram', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Appendicular Skeletal Muscle Mass (Week 87)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/Somapacitan', 'description': 'Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG001', 'title': 'Somapacitan/Somapacitan', 'description': 'Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG002', 'title': 'Norditropin/Norditropin', 'description': 'Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG003', 'title': 'Norditropin/Somapacitan', 'description': 'Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '447.96', 'spread': '1688.08', 'groupId': 'OG000'}, {'value': '538.45', 'spread': '1224.13', 'groupId': 'OG001'}, {'value': '464.75', 'spread': '1513.96', 'groupId': 'OG002'}, {'value': '632.18', 'spread': '1928.68', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'week -3, week 87', 'description': 'Change in Appendicular skeletal muscle mass was measured from baseline (week -3) until the end of the extension treatment period (week 87).', 'unitOfMeasure': 'gram', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Lean Body Mass (Week 34)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}, {'value': '116', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}, {'id': 'OG001', 'title': 'Norditropin', 'description': 'Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}, {'id': 'OG002', 'title': 'Somapacitan', 'description': 'Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '334.43', 'spread': '2048.01', 'groupId': 'OG000'}, {'value': '1359.33', 'spread': '2359.11', 'groupId': 'OG001'}, {'value': '1395.88', 'spread': '2139.32', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week -3, week 34', 'description': 'Change in Lean body mass was measured from baseline (week -3) until the end of the main treatment period (week 34).', 'unitOfMeasure': 'gram', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Lean Body Mass (Week 87)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/Somapacitan', 'description': 'Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG001', 'title': 'Somapacitan/Somapacitan', 'description': 'Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG002', 'title': 'Norditropin/Norditropin', 'description': 'Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG003', 'title': 'Norditropin/Somapacitan', 'description': 'Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '1717.15', 'spread': '2965.23', 'groupId': 'OG000'}, {'value': '1719.87', 'spread': '2515.90', 'groupId': 'OG001'}, {'value': '1464.51', 'spread': '2439.75', 'groupId': 'OG002'}, {'value': '1681.82', 'spread': '3413.61', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'week -3, week 87', 'description': 'Change in Lean body mass was measured from baseline (week -3) until the end of the extension treatment period (week 87).', 'unitOfMeasure': 'gram', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Bone Mineral Content (Week 87)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/Somapacitan', 'description': 'Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG001', 'title': 'Somapacitan/Somapacitan', 'description': 'Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG002', 'title': 'Norditropin/Norditropin', 'description': 'Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG003', 'title': 'Norditropin/Somapacitan', 'description': 'Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '-25.61', 'spread': '93.35', 'groupId': 'OG000'}, {'value': '5.02', 'spread': '113.81', 'groupId': 'OG001'}, {'value': '-10.18', 'spread': '99.18', 'groupId': 'OG002'}, {'value': '32.33', 'spread': '87.86', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'week -3, week 87', 'description': 'Change in Bone mineral content was measured from baseline (week -3) until the end of the extension treatment period (week 87).', 'unitOfMeasure': 'gram', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Bone Mineral Density (Week 87)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/Somapacitan', 'description': 'Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG001', 'title': 'Somapacitan/Somapacitan', 'description': 'Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG002', 'title': 'Norditropin/Norditropin', 'description': 'Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG003', 'title': 'Norditropin/Somapacitan', 'description': 'Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.01', 'spread': '0.04', 'groupId': 'OG000'}, {'value': '-0.00', 'spread': '0.04', 'groupId': 'OG001'}, {'value': '-0.00', 'spread': '0.04', 'groupId': 'OG002'}, {'value': '0.01', 'spread': '0.04', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'week -3, week 87', 'description': 'Change in Bone mineral density was measured from baseline (week -3) until the end of the extension treatment period (week 87).', 'unitOfMeasure': 'grams per square centimeter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in IGF-I SDS (Week 34)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}, {'value': '116', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}, {'id': 'OG001', 'title': 'Norditropin', 'description': 'Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}, {'id': 'OG002', 'title': 'Somapacitan', 'description': 'Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.05', 'spread': '0.59', 'groupId': 'OG000'}, {'value': '2.28', 'spread': '1.32', 'groupId': 'OG001'}, {'value': '2.37', 'spread': '1.33', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week -3, week 34', 'description': 'Change in insulin-like growth factor (IGF-I) standard deviation scores (SDS) was measured from baseline (week -3) until the end of the main treatment period (week 34). A higher score reflects a better outcome.', 'unitOfMeasure': 'Standard deviation score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in IGF-I SDS (Week 87)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/Somapacitan', 'description': 'Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG001', 'title': 'Somapacitan/Somapacitan', 'description': 'Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG002', 'title': 'Norditropin/Norditropin', 'description': 'Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG003', 'title': 'Norditropin/Somapacitan', 'description': 'Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.36', 'spread': '1.55', 'groupId': 'OG000'}, {'value': '2.29', 'spread': '1.39', 'groupId': 'OG001'}, {'value': '2.07', 'spread': '1.12', 'groupId': 'OG002'}, {'value': '2.35', 'spread': '1.54', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week -3, week 87', 'description': 'Change in IGF-I SDS was measured from baseline (week -3) until the end of the extension treatment period (week 87). A higher score reflects a better outcome.', 'unitOfMeasure': 'Standard deviation score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in IGFBP 3 SDS (Week 34)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}, {'value': '116', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}, {'id': 'OG001', 'title': 'Norditropin', 'description': 'Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}, {'id': 'OG002', 'title': 'Somapacitan', 'description': 'Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.12', 'spread': '0.61', 'groupId': 'OG000'}, {'value': '1.44', 'spread': '1.17', 'groupId': 'OG001'}, {'value': '1.56', 'spread': '1.24', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week -3, week 34', 'description': 'Change in insulin like growth factor binding protein 3 (IGFBP 3) SDS was measured from baseline (week -3) until the end of the main treatment period (week 34).', 'unitOfMeasure': 'Standard deviation score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in IGFBP 3 SDS (Week 87)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/Somapacitan', 'description': 'Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG001', 'title': 'Somapacitan/Somapacitan', 'description': 'Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG002', 'title': 'Norditropin/Norditropin', 'description': 'Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG003', 'title': 'Norditropin/Somapacitan', 'description': 'Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.33', 'spread': '1.20', 'groupId': 'OG000'}, {'value': '1.41', 'spread': '1.20', 'groupId': 'OG001'}, {'value': '1.30', 'spread': '1.08', 'groupId': 'OG002'}, {'value': '1.47', 'spread': '1.51', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week -3, week 87', 'description': 'Change in IGFBP 3 SDS was measured from baseline (week -3) until the end of the extension treatment period (week 87).', 'unitOfMeasure': 'Standard deviation score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in TRIM-AGHD (Total and Domain Scores) (Week 34)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}, {'value': '120', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}, {'id': 'OG001', 'title': 'Norditropin', 'description': 'Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}, {'id': 'OG002', 'title': 'Somapacitan', 'description': 'Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}], 'classes': [{'title': 'Energy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}, {'value': '116', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-3.96', 'spread': '25.40', 'groupId': 'OG000'}, {'value': '-13.42', 'spread': '23.73', 'groupId': 'OG001'}, {'value': '-7.81', 'spread': '24.07', 'groupId': 'OG002'}]}]}, {'title': 'Psychological', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}, {'value': '116', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-3.38', 'spread': '12.15', 'groupId': 'OG000'}, {'value': '-8.93', 'spread': '14.21', 'groupId': 'OG001'}, {'value': '-4.63', 'spread': '12.01', 'groupId': 'OG002'}]}]}, {'title': 'Cognitive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}, {'value': '115', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-2.25', 'spread': '18.17', 'groupId': 'OG000'}, {'value': '-7.06', 'spread': '18.47', 'groupId': 'OG001'}, {'value': '-3.92', 'spread': '17.29', 'groupId': 'OG002'}]}]}, {'title': 'Physical', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}, {'value': '115', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-5.88', 'spread': '14.72', 'groupId': 'OG000'}, {'value': '-11.33', 'spread': '19.23', 'groupId': 'OG001'}, {'value': '-7.39', 'spread': '19.25', 'groupId': 'OG002'}]}]}, {'title': 'Total', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}, {'value': '115', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-3.65', 'spread': '12.05', 'groupId': 'OG000'}, {'value': '-9.99', 'spread': '13.64', 'groupId': 'OG001'}, {'value': '-5.71', 'spread': '12.69', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 34', 'description': "Change in treatment-related impact measure - adult growth hormone deficiency (TRIM-AGHD) scores (total and domain scores) was measured from baseline (week 0) until the end of the main treatment period (week 34). The TRIM-AGHD questionnaire measured the impact of GH treatment on the functioning and well-being of AGHD patients. The 4 concepts covered by the questionnaire were physical health, energy levels, cognitive ability and psychological health. TRIM-AGHD has 27 items and a total score as well as domain specific scores can be derived. The total score includes all answers that has been used to calculate each of the 4 subdomains. The score ranged from 0 to 100 for 'individual domains' and for the 'total', where a lower score reflected a better outcome.", 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed = full analysis set (FAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in TRIM-AGHD (Total and Domain Scores) (Week 87)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/Somapacitan', 'description': 'Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG001', 'title': 'Somapacitan/Somapacitan', 'description': 'Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG002', 'title': 'Norditropin/Norditropin', 'description': 'Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG003', 'title': 'Norditropin/Somapacitan', 'description': 'Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}], 'classes': [{'title': 'Energy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-11.73', 'spread': '30.87', 'groupId': 'OG000'}, {'value': '-8.11', 'spread': '25.46', 'groupId': 'OG001'}, {'value': '-23.30', 'spread': '28.03', 'groupId': 'OG002'}, {'value': '-9.13', 'spread': '26.98', 'groupId': 'OG003'}]}]}, {'title': 'Psychological', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-6.97', 'spread': '16.05', 'groupId': 'OG000'}, {'value': '-6.64', 'spread': '14.56', 'groupId': 'OG001'}, {'value': '-15.64', 'spread': '15.36', 'groupId': 'OG002'}, {'value': '-7.35', 'spread': '10.50', 'groupId': 'OG003'}]}]}, {'title': 'Cognitive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-4.88', 'spread': '21.19', 'groupId': 'OG000'}, {'value': '-5.55', 'spread': '18.59', 'groupId': 'OG001'}, {'value': '-14.18', 'spread': '20.29', 'groupId': 'OG002'}, {'value': '-7.71', 'spread': '14.14', 'groupId': 'OG003'}]}]}, {'title': 'Physical', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-11.19', 'spread': '20.13', 'groupId': 'OG000'}, {'value': '-9.57', 'spread': '21.94', 'groupId': 'OG001'}, {'value': '-17.22', 'spread': '27.02', 'groupId': 'OG002'}, {'value': '-13.54', 'spread': '18.02', 'groupId': 'OG003'}]}]}, {'title': 'Total', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-8.28', 'spread': '15.88', 'groupId': 'OG000'}, {'value': '-7.25', 'spread': '14.42', 'groupId': 'OG001'}, {'value': '-17.38', 'spread': '16.77', 'groupId': 'OG002'}, {'value': '-8.67', 'spread': '11.73', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'week 0, week 87', 'description': "Change in TRIM-AGHD (total and domain scores) was measured from baseline (week 0) until the end of the extension treatment period (week 87). The TRIM-AGHD questionnaire measured the impact of GH treatment on the functioning and well-being of AGHD patients. The 4 concepts covered by the questionnaire were physical health, energy levels, cognitive ability and psychological health. TRIM-AGHD has 27 items and a total score as well as domain specific scores can be derived. The total score includes all answers that has been used to calculate each of the 4 subdomains. The score ranged from 0 to 100 for 'individual domains' and for the 'total', where a lower score reflected a better outcome.", 'unitOfMeasure': 'Scores on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed = full analysis set (FAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in SF-36v2 (Summary and Domain Scores) (Week 34)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}, {'value': '120', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}, {'id': 'OG001', 'title': 'Norditropin', 'description': 'Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}, {'id': 'OG002', 'title': 'Somapacitan', 'description': 'Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}], 'classes': [{'title': 'Physical functioning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}, {'value': '117', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.19', 'spread': '6.44', 'groupId': 'OG000'}, {'value': '2.46', 'spread': '7.08', 'groupId': 'OG001'}, {'value': '3.18', 'spread': '7.67', 'groupId': 'OG002'}]}]}, {'title': 'Role limitations due to physical health', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}, {'value': '117', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.49', 'spread': '7.68', 'groupId': 'OG000'}, {'value': '3.95', 'spread': '8.48', 'groupId': 'OG001'}, {'value': '3.14', 'spread': '9.06', 'groupId': 'OG002'}]}]}, {'title': 'Role limitations due to emotional health', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}, {'value': '117', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.29', 'spread': '9.52', 'groupId': 'OG000'}, {'value': '3.50', 'spread': '10.87', 'groupId': 'OG001'}, {'value': '3.06', 'spread': '11.60', 'groupId': 'OG002'}]}]}, {'title': 'Vitality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.21', 'spread': '7.67', 'groupId': 'OG000'}, {'value': '5.26', 'spread': '9.89', 'groupId': 'OG001'}, {'value': '2.38', 'spread': '8.56', 'groupId': 'OG002'}]}]}, {'title': 'Role limitations due to mental health', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.85', 'spread': '9.59', 'groupId': 'OG000'}, {'value': '3.72', 'spread': '10.17', 'groupId': 'OG001'}, {'value': '2.78', 'spread': '9.56', 'groupId': 'OG002'}]}]}, {'title': 'Social functioning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.10', 'spread': '10.43', 'groupId': 'OG000'}, {'value': '3.19', 'spread': '9.80', 'groupId': 'OG001'}, {'value': '2.87', 'spread': '9.69', 'groupId': 'OG002'}]}]}, {'title': 'Bodily pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}, {'value': '117', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.63', 'spread': '8.79', 'groupId': 'OG000'}, {'value': '2.19', 'spread': '9.50', 'groupId': 'OG001'}, {'value': '1.79', 'spread': '9.52', 'groupId': 'OG002'}]}]}, {'title': 'General health', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.50', 'spread': '7.25', 'groupId': 'OG000'}, {'value': '4.47', 'spread': '7.64', 'groupId': 'OG001'}, {'value': '1.85', 'spread': '7.58', 'groupId': 'OG002'}]}]}, {'title': 'Overall physical', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}, {'value': '116', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.01', 'spread': '6.22', 'groupId': 'OG000'}, {'value': '2.87', 'spread': '6.33', 'groupId': 'OG001'}, {'value': '2.40', 'spread': '6.53', 'groupId': 'OG002'}]}]}, {'title': 'Overall mental', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}, {'value': '116', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.28', 'spread': '8.72', 'groupId': 'OG000'}, {'value': '4.09', 'spread': '10.19', 'groupId': 'OG001'}, {'value': '2.70', 'spread': '9.29', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 34', 'description': 'SF-36v2™ questionnaire measured health-related quality of life (HRQoL) on 8 domains (Bodily Pain, General Health, Mental Health, Physical Functioning, Role Emotion, Physical Health, Social Functioning and Vitality) on individual scale ranges. The scores 0-100 (higher scores indicates better HRQoL) from SF-36 were converted to norm-based scores to enable a direct interpretation in relation to distribution of the scores in the 2009 U.S. general population. Mental component summary (MCS) measure is derived from domain scales of vitality, social functioning, role emotional and mental health. Physical component summary (PCS) measure is derived from domain scales of physical functioning, role-physical, bodily pain, and general health. A norm-based score of 50 corresponds to the mean score and 10 corresponds to the standard deviation of the 2009 U.S. general population. A positive change score indicates an improvement since baseline.', 'unitOfMeasure': 'Scores on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed = full analysis set (FAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in SF-36v2 (Summary and Domain Scores) (Week 87)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/Somapacitan', 'description': 'Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG001', 'title': 'Somapacitan/Somapacitan', 'description': 'Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG002', 'title': 'Norditropin/Norditropin', 'description': 'Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG003', 'title': 'Norditropin/Somapacitan', 'description': 'Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}], 'classes': [{'title': 'Physical functioning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.87', 'spread': '8.13', 'groupId': 'OG000'}, {'value': '3.83', 'spread': '7.66', 'groupId': 'OG001'}, {'value': '3.43', 'spread': '6.96', 'groupId': 'OG002'}, {'value': '1.84', 'spread': '8.07', 'groupId': 'OG003'}]}]}, {'title': 'Role limitations due to physical health', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3.31', 'spread': '9.81', 'groupId': 'OG000'}, {'value': '4.16', 'spread': '10.10', 'groupId': 'OG001'}, {'value': '4.65', 'spread': '10.06', 'groupId': 'OG002'}, {'value': '2.45', 'spread': '10.50', 'groupId': 'OG003'}]}]}, {'title': 'Role limitations due to emotional health', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3.46', 'spread': '11.59', 'groupId': 'OG000'}, {'value': '3.46', 'spread': '12.25', 'groupId': 'OG001'}, {'value': '7.30', 'spread': '13.46', 'groupId': 'OG002'}, {'value': '1.13', 'spread': '11.20', 'groupId': 'OG003'}]}]}, {'title': 'Vitality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '6.71', 'spread': '11.01', 'groupId': 'OG000'}, {'value': '4.18', 'spread': '9.30', 'groupId': 'OG001'}, {'value': '8.16', 'spread': '12.77', 'groupId': 'OG002'}, {'value': '4.16', 'spread': '8.88', 'groupId': 'OG003'}]}]}, {'title': 'Role limitations due to mental health', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.80', 'spread': '10.55', 'groupId': 'OG000'}, {'value': '3.66', 'spread': '8.12', 'groupId': 'OG001'}, {'value': '6.12', 'spread': '13.02', 'groupId': 'OG002'}, {'value': '1.70', 'spread': '10.31', 'groupId': 'OG003'}]}]}, {'title': 'Social functioning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3.84', 'spread': '10.36', 'groupId': 'OG000'}, {'value': '3.44', 'spread': '10.29', 'groupId': 'OG001'}, {'value': '4.56', 'spread': '10.34', 'groupId': 'OG002'}, {'value': '0.57', 'spread': '11.26', 'groupId': 'OG003'}]}]}, {'title': 'Bodily pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.41', 'spread': '8.57', 'groupId': 'OG000'}, {'value': '1.47', 'spread': '10.29', 'groupId': 'OG001'}, {'value': '3.51', 'spread': '9.57', 'groupId': 'OG002'}, {'value': '0.30', 'spread': '11.25', 'groupId': 'OG003'}]}]}, {'title': 'General health', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3.46', 'spread': '7.33', 'groupId': 'OG000'}, {'value': '3.32', 'spread': '7.70', 'groupId': 'OG001'}, {'value': '5.66', 'spread': '9.67', 'groupId': 'OG002'}, {'value': '2.20', 'spread': '8.66', 'groupId': 'OG003'}]}]}, {'title': 'Overall physical score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.66', 'spread': '6.91', 'groupId': 'OG000'}, {'value': '2.98', 'spread': '7.24', 'groupId': 'OG001'}, {'value': '3.06', 'spread': '7.07', 'groupId': 'OG002'}, {'value': '1.81', 'spread': '7.72', 'groupId': 'OG003'}]}]}, {'title': 'Overall mental score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4.51', 'spread': '10.39', 'groupId': 'OG000'}, {'value': '3.56', 'spread': '9.06', 'groupId': 'OG001'}, {'value': '7.50', 'spread': '13.59', 'groupId': 'OG002'}, {'value': '1.66', 'spread': '10.18', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'week 0, week 87', 'description': 'SF-36v2™ questionnaire measured health-related quality of life (HRQoL) on 8 domains (Bodily Pain, General Health, Mental Health, Physical Functioning, Role Emotion, Physical Health, Social Functioning and Vitality) on individual scale ranges. The scores 0-100 (higher scores indicates better HRQoL) from SF-36 were converted to norm-based scores to enable a direct interpretation in relation to distribution of the scores in the 2009 U.S. general population. Mental component summary (MCS) measure is derived from domain scales of vitality, social functioning, role emotional and mental health. Physical component summary (PCS) measure is derived from domain scales of physical functioning, role-physical, bodily pain, and general health. A norm-based score of 50 corresponds to the mean score and 10 corresponds to the standard deviation of the 2009 U.S. general population. A positive change score indicates an improvement since baseline.', 'unitOfMeasure': 'Score on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed = full analysis set (FAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'TSQM-9 Scores (Domain Scores) (Week 34)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}, {'value': '120', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}, {'id': 'OG001', 'title': 'Norditropin', 'description': 'Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}, {'id': 'OG002', 'title': 'Somapacitan', 'description': 'Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}], 'classes': [{'title': 'Effectiveness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '49.6', 'spread': '22.2', 'groupId': 'OG000'}, {'value': '67.1', 'spread': '21.8', 'groupId': 'OG001'}, {'value': '56.1', 'spread': '22.5', 'groupId': 'OG002'}]}]}, {'title': 'Convenience', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '74.3', 'spread': '16.9', 'groupId': 'OG000'}, {'value': '73.9', 'spread': '18.7', 'groupId': 'OG001'}, {'value': '77.7', 'spread': '15.3', 'groupId': 'OG002'}]}]}, {'title': 'Global satisfaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '54.0', 'spread': '24.8', 'groupId': 'OG000'}, {'value': '69.0', 'spread': '24.0', 'groupId': 'OG001'}, {'value': '63.1', 'spread': '24.2', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 34', 'description': "Scores from the TSQM-9 scale were calculated at the end of the main treatment period (week 34). The Treatment Satisfaction Questionnaire for Medication - 9 items (TSQM-9) is a generic questionnaire that measures a patients' satisfaction with medication. Items are rated on a 5-point or 7-point scale according to patients' experience with the medication. The items covered are satisfaction with the effect of the medication, convenience and global treatment satisfaction. Each domain is based on 3 questions. The score is calculated in a range from 0 to 100, where a higher score reflects a better outcome. Scores have been summed and then scaled to 0-100.", 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed = FAS. Number analyzed = Number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'TSQM-9 Scores (Domain Scores) (Week 87)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/Somapacitan', 'description': 'Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG001', 'title': 'Somapacitan/Somapacitan', 'description': 'Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG002', 'title': 'Norditropin/Norditropin', 'description': 'Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG003', 'title': 'Norditropin/Somapacitan', 'description': 'Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}], 'classes': [{'title': 'Effectiveness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '59.7', 'spread': '23.1', 'groupId': 'OG000'}, {'value': '65.7', 'spread': '22.4', 'groupId': 'OG001'}, {'value': '69.6', 'spread': '24.0', 'groupId': 'OG002'}, {'value': '70.9', 'spread': '20.9', 'groupId': 'OG003'}]}]}, {'title': 'Convenience', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '75.1', 'spread': '19.1', 'groupId': 'OG000'}, {'value': '80.0', 'spread': '16.5', 'groupId': 'OG001'}, {'value': '72.6', 'spread': '20.0', 'groupId': 'OG002'}, {'value': '79.4', 'spread': '17.1', 'groupId': 'OG003'}]}]}, {'title': 'Global satisfaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '63.2', 'spread': '26.2', 'groupId': 'OG000'}, {'value': '68.1', 'spread': '24.6', 'groupId': 'OG001'}, {'value': '71.7', 'spread': '25.3', 'groupId': 'OG002'}, {'value': '75.1', 'spread': '23.6', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 87', 'description': "Scores from the TSQM-9 scale were calculated at the end of the extension treatment period (week 87). The Treatment Satisfaction Questionnaire for Medication - 9 items (TSQM-9) is a generic questionnaire that measures a patients' satisfaction with medication. Items are rated on a 5-point or 7-point scale according to patients' experience with the medication. The items covered are satisfaction with the effect of the medication, convenience and global treatment satisfaction. Each domain is based on 3 questions. The score is calculated in a range from 0 to 100, where a higher score reflects a better outcome. Scores have been summed and then scaled to 0-100.", 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed = FAS. Number analyzed = Number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Total Cholesterol (Week 34)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}, {'value': '119', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}, {'id': 'OG001', 'title': 'Norditropin', 'description': 'Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}, {'id': 'OG002', 'title': 'Somapacitan', 'description': 'Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.03', 'spread': '0.96', 'groupId': 'OG000'}, {'value': '-0.10', 'spread': '0.91', 'groupId': 'OG001'}, {'value': '-0.09', 'spread': '0.78', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week -3, week 34', 'description': 'Change in Total cholesterol was measured from baseline (week -3) until the end of the main treatment period (week 34).', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analysed = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Total Cholesterol (Week 87)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/Somapacitan', 'description': 'Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG001', 'title': 'Somapacitan/Somapacitan', 'description': 'Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG002', 'title': 'Norditropin/Norditropin', 'description': 'Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG003', 'title': 'Norditropin/Somapacitan', 'description': 'Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.21', 'spread': '0.89', 'groupId': 'OG000'}, {'value': '0.03', 'spread': '0.96', 'groupId': 'OG001'}, {'value': '-0.05', 'spread': '0.94', 'groupId': 'OG002'}, {'value': '-0.33', 'spread': '1.08', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'week -3, week 87', 'description': 'Change in Total cholesterol was measured from baseline (week -3) until the end of the extension treatment period (week 87).', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analysed = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in HDL-cholesterol (Week 34)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}, {'value': '119', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}, {'id': 'OG001', 'title': 'Norditropin', 'description': 'Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}, {'id': 'OG002', 'title': 'Somapacitan', 'description': 'Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.00', 'spread': '0.37', 'groupId': 'OG000'}, {'value': '0.02', 'spread': '0.28', 'groupId': 'OG001'}, {'value': '0.05', 'spread': '0.30', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week -3, week 34', 'description': 'Change in High-density lipoprotein (HDL) cholesterol was measured from baseline (week -3) until the end of the main treatment period (week 34).', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analysed = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in HDL-cholesterol (Week 87)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/Somapacitan', 'description': 'Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG001', 'title': 'Somapacitan/Somapacitan', 'description': 'Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG002', 'title': 'Norditropin/Norditropin', 'description': 'Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG003', 'title': 'Norditropin/Somapacitan', 'description': 'Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.06', 'spread': '0.30', 'groupId': 'OG000'}, {'value': '0.05', 'spread': '0.32', 'groupId': 'OG001'}, {'value': '0.09', 'spread': '0.27', 'groupId': 'OG002'}, {'value': '0.06', 'spread': '0.34', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'week -3, week 87', 'description': 'Change in HDL-cholesterol was measured from baseline (week -3) until the end of the extension treatment period (week 87).', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analysed = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in LDL-cholesterol (Week 34)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}, {'value': '119', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}, {'id': 'OG001', 'title': 'Norditropin', 'description': 'Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}, {'id': 'OG002', 'title': 'Somapacitan', 'description': 'Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.02', 'spread': '0.75', 'groupId': 'OG000'}, {'value': '-0.18', 'spread': '0.72', 'groupId': 'OG001'}, {'value': '-0.13', 'spread': '0.64', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week -3, week 34', 'description': 'Change in Low-density lipoprotein (LDL) cholesterol was measured from baseline (week -3) until the end of the main treatment period (week 34).', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analysed = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in LDL-cholesterol (Week 87)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/Somapacitan', 'description': 'Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG001', 'title': 'Somapacitan/Somapacitan', 'description': 'Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG002', 'title': 'Norditropin/Norditropin', 'description': 'Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG003', 'title': 'Norditropin/Somapacitan', 'description': 'Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.30', 'spread': '0.72', 'groupId': 'OG000'}, {'value': '-0.06', 'spread': '0.81', 'groupId': 'OG001'}, {'value': '-0.15', 'spread': '0.85', 'groupId': 'OG002'}, {'value': '-0.36', 'spread': '0.90', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'week -3, week 87', 'description': 'Change in LDL-cholesterol was measured from baseline (week -3) until the end of the extension treatment period (week 87).', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analysed = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Triglycerides (Week 34)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}, {'value': '119', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}, {'id': 'OG001', 'title': 'Norditropin', 'description': 'Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}, {'id': 'OG002', 'title': 'Somapacitan', 'description': 'Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.01', 'spread': '0.65', 'groupId': 'OG000'}, {'value': '0.13', 'spread': '0.62', 'groupId': 'OG001'}, {'value': '-0.02', 'spread': '0.73', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week -3, week 34', 'description': 'Change in Triglycerides was measured from baseline (week -3) until the end of the main treatment period (week 34).', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analysed = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Triglycerides (Week 87)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/Somapacitan', 'description': 'Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG001', 'title': 'Somapacitan/Somapacitan', 'description': 'Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG002', 'title': 'Norditropin/Norditropin', 'description': 'Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG003', 'title': 'Norditropin/Somapacitan', 'description': 'Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.07', 'spread': '0.48', 'groupId': 'OG000'}, {'value': '0.03', 'spread': '0.76', 'groupId': 'OG001'}, {'value': '0.03', 'spread': '0.56', 'groupId': 'OG002'}, {'value': '-0.08', 'spread': '0.73', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'week -3, week 87', 'description': 'Change in Triglycerides was measured from baseline (week -3) until the end of the extension treatment period (week 87).', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analysed = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Hs-CRP (Week 34)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}, {'value': '116', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}, {'id': 'OG001', 'title': 'Norditropin', 'description': 'Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}, {'id': 'OG002', 'title': 'Somapacitan', 'description': 'Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.405', 'spread': '13.144', 'groupId': 'OG000'}, {'value': '-1.604', 'spread': '13.254', 'groupId': 'OG001'}, {'value': '-0.569', 'spread': '5.616', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week -3, week 34', 'description': 'Change in high-sensitivity C-reactive protein (hs-CRP) was measured from baseline (week -3) until the end of the main treatment period (week 34).', 'unitOfMeasure': 'mg/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analysed = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Hs-CRP (Week 87)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/Somapacitan', 'description': 'Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG001', 'title': 'Somapacitan/Somapacitan', 'description': 'Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG002', 'title': 'Norditropin/Norditropin', 'description': 'Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG003', 'title': 'Norditropin/Somapacitan', 'description': 'Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.325', 'spread': '16.247', 'groupId': 'OG000'}, {'value': '-1.445', 'spread': '3.791', 'groupId': 'OG001'}, {'value': '-0.857', 'spread': '17.491', 'groupId': 'OG002'}, {'value': '-1.257', 'spread': '12.497', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'week -3, week 87', 'description': 'Change in hs-CRP was measured from baseline (week -3) until the end of the extension treatment period (week 87).', 'unitOfMeasure': 'mg/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analysed = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in IL-6 (Week 34)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}, {'id': 'OG001', 'title': 'Norditropin', 'description': 'Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}, {'id': 'OG002', 'title': 'Somapacitan', 'description': 'Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.48', 'spread': '24.84', 'groupId': 'OG000'}, {'value': '0.07', 'spread': '4.01', 'groupId': 'OG001'}, {'value': '0.18', 'spread': '5.78', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week -3, week 34', 'description': 'Change in Interleukin 6 (IL-6) was measured from baseline (week -3) until the end of the main treatment period (week 34).', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analysed = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in IL-6 (Week 87)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/Somapacitan', 'description': 'Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG001', 'title': 'Somapacitan/Somapacitan', 'description': 'Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG002', 'title': 'Norditropin/Norditropin', 'description': 'Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG003', 'title': 'Norditropin/Somapacitan', 'description': 'Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.11', 'spread': '3.30', 'groupId': 'OG000'}, {'value': '0.52', 'spread': '6.19', 'groupId': 'OG001'}, {'value': '0.49', 'spread': '5.12', 'groupId': 'OG002'}, {'value': '1.19', 'spread': '2.92', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'week -3, week 87', 'description': 'Change in IL-6 was measured from baseline (week -3) until the end of the extension treatment period (week 87).', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analysed = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Body Weight (Week 34)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}, {'value': '119', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}, {'id': 'OG001', 'title': 'Norditropin', 'description': 'Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}, {'id': 'OG002', 'title': 'Somapacitan', 'description': 'Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.6', 'spread': '2.9', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '4.0', 'groupId': 'OG001'}, {'value': '1.3', 'spread': '4.2', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week -3, week 34', 'description': 'Change in body weight was measured from baseline (week -3) until the end of the main treatment period (week 34).', 'unitOfMeasure': 'Kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analysed = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Body Weight (Week 87)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/Somapacitan', 'description': 'Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG001', 'title': 'Somapacitan/Somapacitan', 'description': 'Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG002', 'title': 'Norditropin/Norditropin', 'description': 'Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG003', 'title': 'Norditropin/Somapacitan', 'description': 'Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.2', 'spread': '4.4', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '4.8', 'groupId': 'OG001'}, {'value': '0.4', 'spread': '5.2', 'groupId': 'OG002'}, {'value': '2.1', 'spread': '7.0', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'week -3, week 87', 'description': 'Change in body weight was measured from baseline (week -3) until the end of the extension treatment period (week 87).', 'unitOfMeasure': 'Kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analysed = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Waist Circumference (Week 34)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}, {'value': '117', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}, {'id': 'OG001', 'title': 'Norditropin', 'description': 'Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}, {'id': 'OG002', 'title': 'Somapacitan', 'description': 'Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.82', 'spread': '4.50', 'groupId': 'OG000'}, {'value': '-0.66', 'spread': '4.83', 'groupId': 'OG001'}, {'value': '-0.00', 'spread': '4.52', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week -3, week 34', 'description': 'Change in waist circumference was measured from baseline (week -3) until the end of the main treatment period (week 34).', 'unitOfMeasure': 'cm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analysed = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Waist Circumference (Week 87)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/Somapacitan', 'description': 'Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG001', 'title': 'Somapacitan/Somapacitan', 'description': 'Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG002', 'title': 'Norditropin/Norditropin', 'description': 'Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG003', 'title': 'Norditropin/Somapacitan', 'description': 'Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.35', 'spread': '5.62', 'groupId': 'OG000'}, {'value': '0.53', 'spread': '5.17', 'groupId': 'OG001'}, {'value': '-2.26', 'spread': '7.93', 'groupId': 'OG002'}, {'value': '0.74', 'spread': '7.17', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'week -3, week 87', 'description': 'Change in waist circumference was measured from baseline (week -3) until the end of the extension treatment period (week 87).', 'unitOfMeasure': 'cm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analysed = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Number of Adverse Events (Weeks 0-35)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}, {'value': '120', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}, {'id': 'OG001', 'title': 'Norditropin', 'description': 'Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}, {'id': 'OG002', 'title': 'Somapacitan', 'description': 'Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '184', 'groupId': 'OG000'}, {'value': '426', 'groupId': 'OG001'}, {'value': '385', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 0-35', 'description': 'Number of adverse events from baseline (week 0) until the end of week 35 were reported. This endpoint shows number of treatment-emergent adverse events (TEAEs), including the injection site reactions.', 'unitOfMeasure': 'Events', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed = safety analysis set (SAS) which comprised all randomised participants who received at least one dose of trial product.'}, {'type': 'SECONDARY', 'title': 'Number of Adverse Events (Weeks 0-88)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/Somapacitan', 'description': 'Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG001', 'title': 'Somapacitan/Somapacitan', 'description': 'Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG002', 'title': 'Norditropin/Norditropin', 'description': 'Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG003', 'title': 'Norditropin/Somapacitan', 'description': 'Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG004', 'title': 'Norditropin/-', 'description': 'Participants who received Norditropin in the main period of the trial and discontinued after the main period of the study are included here.'}], 'classes': [{'categories': [{'measurements': [{'value': '395', 'groupId': 'OG000'}, {'value': '699', 'groupId': 'OG001'}, {'value': '384', 'groupId': 'OG002'}, {'value': '385', 'groupId': 'OG003'}, {'value': '49', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 0-88', 'description': 'Number of adverse events from baseline (week 0) until the end of week 88 were reported. This endpoint shows the number of TEAEs along with the injection site reactions.', 'unitOfMeasure': 'Events', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed = safety analysis set (SAS) which comprised all randomised participants who received at least one dose of trial product.'}, {'type': 'SECONDARY', 'title': 'Occurrence of Anti-NNC0195-0092 Antibodies (Weeks 0-35)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}, {'value': '120', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}, {'id': 'OG001', 'title': 'Norditropin', 'description': 'Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}, {'id': 'OG002', 'title': 'Somapacitan', 'description': 'Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Weeks 0 to 35', 'description': 'Number of participants with anti-NNC0195-0092 antibodies at week 35 was recorded. The numbers presented in this endpoint are the participants that were found to have positive antibodies.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed = safety analysis set (SAS) which comprised all randomised participants who received at least one dose of trial product.'}, {'type': 'SECONDARY', 'title': 'Occurrence of Anti-NNC0195-0092 Antibodies (Weeks 0-88)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/Somapacitan', 'description': 'Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG001', 'title': 'Somapacitan/Somapacitan', 'description': 'Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG002', 'title': 'Norditropin/Norditropin', 'description': 'Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG003', 'title': 'Norditropin/Somapacitan', 'description': 'Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG004', 'title': 'Norditropin/-', 'description': 'Participants who received Norditropin in the main period of the trial and discontinued after the main period of the study are included here.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Weeks 0 to 88', 'description': 'Number of participants with anti-NNC0195-0092 antibodies at week 88 was recorded. The numbers presented in this endpoint are the participants that were found to have positive antibodies.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed = safety analysis set (SAS) which comprised all randomised participants who received at least one dose of trial product.'}, {'type': 'SECONDARY', 'title': 'Incidence of Technical Complaints During Exposure to Trial Product (Weeks 0-35)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}, {'value': '120', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}, {'id': 'OG001', 'title': 'Norditropin', 'description': 'Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}, {'id': 'OG002', 'title': 'Somapacitan', 'description': 'Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 0 to 35', 'description': 'Incidence of technical complaints were recorded from baseline (week 0) until week 35.', 'unitOfMeasure': 'Technical complaints', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed = safety analysis set (SAS) which comprised all randomised participants who received at least one dose of trial product.'}, {'type': 'SECONDARY', 'title': 'Incidence of Technical Complaints During Exposure to Trial Product (Weeks 0-88)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/Somapacitan', 'description': 'Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG001', 'title': 'Somapacitan/Somapacitan', 'description': 'Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG002', 'title': 'Norditropin/Norditropin', 'description': 'Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG003', 'title': 'Norditropin/Somapacitan', 'description': 'Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 0 to 88', 'description': 'Incidence of technical complaints were recorded from baseline (week 0) until week 88.', 'unitOfMeasure': 'Technical complaints', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed = safety analysis set (SAS) which comprised all randomised participants who received at least one dose of trial product.'}, {'type': 'SECONDARY', 'title': 'Change in Physical Examination During Exposure to Trial Product (Week 35)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}, {'value': '120', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}, {'id': 'OG001', 'title': 'Norditropin', 'description': 'Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}, {'id': 'OG002', 'title': 'Somapacitan', 'description': 'Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}], 'classes': [{'title': 'Head, neck, eyes, nose (Week 0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}, {'value': '120', 'groupId': 'OG002'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '55', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}, {'value': '108', 'groupId': 'OG002'}]}, {'title': 'Abnormal, not clinically significant (NCS)', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}, {'title': 'Abnormal, clinically significant (CS)', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}, {'title': 'Missing', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Head, neck, eyes, nose (Week 35)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '51', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}, {'value': '107', 'groupId': 'OG002'}]}, {'title': 'Abnormal, not clinically significant (NCS)', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}, {'title': 'Abnormal, clinically significant (CS)', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}, {'title': 'Missing', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Respiratory sys. (Week 0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}, {'value': '120', 'groupId': 'OG002'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '61', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}, {'value': '119', 'groupId': 'OG002'}]}, {'title': 'Abnormal, not clinically significant (NCS)', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}, {'title': 'Abnormal, clinically significant (CS)', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': 'Missing', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Respiratory sys. (Week 35)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '56', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}, {'value': '117', 'groupId': 'OG002'}]}, {'title': 'Abnormal, not clinically significant (NCS)', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}, {'title': 'Abnormal, clinically significant (CS)', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': 'Missing', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Cardiovascular sys. (Week 0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}, {'value': '120', 'groupId': 'OG002'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '56', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}, {'value': '116', 'groupId': 'OG002'}]}, {'title': 'Abnormal, not clinically significant (NCS)', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}, {'title': 'Abnormal, clinically significant (CS)', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': 'Missing', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Cardiovascular sys. (Week 35)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '54', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}, {'value': '112', 'groupId': 'OG002'}]}, {'title': 'Abnormal, not clinically significant (NCS)', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}, {'title': 'Abnormal, clinically significant (CS)', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': 'Missing', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Gastrointestinal sys. (Week 0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}, {'value': '120', 'groupId': 'OG002'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '59', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}, {'value': '119', 'groupId': 'OG002'}]}, {'title': 'Abnormal, not clinically significant (NCS)', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}, {'title': 'Abnormal, clinically significant (CS)', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': 'Missing', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Gastrointestinal sys. (Week 35)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '53', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}, {'value': '116', 'groupId': 'OG002'}]}, {'title': 'Abnormal, not clinically significant (NCS)', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}, {'title': 'Abnormal, clinically significant (CS)', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': 'Missing', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Musculoskeletal sys. (Week 0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}, {'value': '120', 'groupId': 'OG002'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '59', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}, {'value': '113', 'groupId': 'OG002'}]}, {'title': 'Abnormal, not clinically significant (NCS)', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}, {'title': 'Abnormal, clinically significant (CS)', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}, {'title': 'Missing', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Musculoskeletal sys. (Week 35)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '54', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}, {'value': '111', 'groupId': 'OG002'}]}, {'title': 'Abnormal, not clinically significant (NCS)', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}, {'title': 'Abnormal, clinically significant (CS)', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}, {'title': 'Missing', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Central & Peripheral nervous sys (Week 0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}, {'value': '120', 'groupId': 'OG002'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '59', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}, {'value': '117', 'groupId': 'OG002'}]}, {'title': 'Abnormal, not clinically significant (NCS)', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}, {'title': 'Abnormal, clinically significant (CS)', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': 'Missing', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Central & Peripheral nervous sys (Week 35)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '55', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}, {'value': '114', 'groupId': 'OG002'}]}, {'title': 'Abnormal, not clinically significant (NCS)', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}, {'title': 'Abnormal, clinically significant (CS)', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': 'Missing', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Skin (Week 0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}, {'value': '120', 'groupId': 'OG002'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '51', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '109', 'groupId': 'OG002'}]}, {'title': 'Abnormal, not clinically significant (NCS)', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}, {'title': 'Abnormal, clinically significant (CS)', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': 'Missing', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Skin (Week 35)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '51', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}, {'value': '102', 'groupId': 'OG002'}]}, {'title': 'Abnormal, not clinically significant (NCS)', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}, {'title': 'Abnormal, clinically significant (CS)', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}, {'title': 'Missing', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Lymph node palpation (Week 0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}, {'value': '120', 'groupId': 'OG002'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '61', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}, {'value': '120', 'groupId': 'OG002'}]}, {'title': 'Abnormal, not clinically significant (NCS)', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': 'Abnormal, clinically significant (CS)', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': 'Missing', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Lymph node palpation (Week 35)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '56', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}]}, {'title': 'Abnormal, not clinically significant (NCS)', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': 'Abnormal, clinically significant (CS)', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': 'Missing', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 0 and week 35', 'description': 'Change in physical examination from baseline (week 0) until the end of the main treatment period (week 35) was reported. Results are presented for the following examinations: 1) Head, neck, eyes and nose 2) Respiratory system (sys.) 3) Cardiovascular sys. 4) Gastrointestinal sys. 5) Musculoskeletal sys. 6) Central \\& Peripheral nervous sys. 7) Skin 8) Lymph node palpation', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product. Number Analyzed = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Physical Examination During Exposure to Trial Product (Week 88)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/Somapacitan', 'description': 'Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG001', 'title': 'Somapacitan/Somapacitan', 'description': 'Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG002', 'title': 'Norditropin/Norditropin', 'description': 'Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG003', 'title': 'Norditropin/Somapacitan', 'description': 'Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG004', 'title': 'Norditropin/-', 'description': 'Participants who received Norditropin in the main period of the trial and discontinued after the main period of the study are included here.'}], 'classes': [{'title': 'Head, neck, eyes, nose (Week 0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '55', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}]}, {'title': 'Abnormal, NCS', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}, {'title': 'Abnormal, CS', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}, {'title': 'Missing', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Head, neck, eyes, nose (Week 88)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '48', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}, {'value': '44', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}, {'title': 'Abnormal, NCS', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}, {'title': 'Abnormal, CS', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}, {'title': 'Missing', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Respiratory sys. (Week 0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '61', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}]}, {'title': 'Abnormal, NCS', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}, {'title': 'Abnormal, CS', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}, {'title': 'Missing', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Respiratory sys. (Week 88)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '54', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}, {'title': 'Abnormal, NCS', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}, {'title': 'Abnormal, CS', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}, {'title': 'Missing', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Cardiovascular sys. (Week 0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '56', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}]}, {'title': 'Abnormal, NCS', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}, {'title': 'Abnormal, CS', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}, {'title': 'Missing', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Cardiovascular sys. (Week 88)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}, {'title': 'Abnormal, NCS', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}, {'title': 'Abnormal, CS', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}, {'title': 'Missing', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Gastrointestinal sys. (Week 0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '59', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}]}, {'title': 'Abnormal, NCS', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}, {'title': 'Abnormal, CS', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}, {'title': 'Missing', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Gastrointestinal sys. (Week 88)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}, {'title': 'Abnormal, NCS', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}, {'title': 'Abnormal, CS', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}, {'title': 'Missing', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Musculoskeletal sys. (Week 0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '59', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}]}, {'title': 'Abnormal, NCS', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}, {'title': 'Abnormal, CS', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}, {'title': 'Missing', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Musculoskeletal sys. (Week 88)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '49', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}, {'value': '46', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}, {'title': 'Abnormal, NCS', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}, {'title': 'Abnormal, CS', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}, {'title': 'Missing', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Central & Peripheral nervous sys. (week 0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '59', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}]}, {'title': 'Abnormal, NCS', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}, {'title': 'Abnormal, CS', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}, {'title': 'Missing', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Central & Peripheral nervous sys. (week 88)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '53', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '45', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}, {'title': 'Abnormal, NCS', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}, {'title': 'Abnormal, CS', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}, {'title': 'Missing', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Skin (Week 0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '51', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}]}, {'title': 'Abnormal, NCS', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}, {'title': 'Abnormal, CS', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}, {'title': 'Missing', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Skin (Week 88)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '49', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '42', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}, {'title': 'Abnormal, NCS', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}, {'title': 'Abnormal, CS', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}, {'title': 'Missing', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Lymph node palpation (week 0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '61', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}]}, {'title': 'Abnormal, NCS', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}, {'title': 'Abnormal, CS', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}, {'title': 'Missing', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Lymph node palpation (week 88)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '53', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}, {'title': 'Abnormal, NCS', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}, {'title': 'Abnormal, CS', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}, {'title': 'Missing', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 0 and week 88', 'description': 'Change in physical examination from baseline (week 0) until the end of the extension period (week 88) was reported. Results are presented for the following examinations: 1) Head, neck, eyes and nose 2) Respiratory system (sys.) 3) Cardiovascular sys. 4) Gastrointestinal sys. 5) Musculoskeletal sys. 6) Central \\& Peripheral nervous sys. 7) Skin 8) Lymph node palpation', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product. Number Analyzed = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Electrocardiogram (ECG) Evaluation During Exposure to Trial Product (Week 35)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}, {'value': '120', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}, {'id': 'OG001', 'title': 'Norditropin', 'description': 'Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}, {'id': 'OG002', 'title': 'Somapacitan', 'description': 'Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}], 'classes': [{'title': 'Week -3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}, {'value': '120', 'groupId': 'OG002'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}]}, {'title': 'Abnormal, NCS', 'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}, {'title': 'Abnormal, CS', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}, {'title': 'Missing', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 35', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}, {'value': '119', 'groupId': 'OG002'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}]}, {'title': 'Abnormal, NCS', 'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}]}, {'title': 'Abnormal, CS', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}, {'title': 'Missing', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week -3 and week 35', 'description': 'Change in Electrocardiogram (ECG) evaluation from baseline (week -3) until the end of the main treatment period (week 35) was reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product. Number Analyzed = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in ECG Evaluation During Exposure to Trial Product (Week 88)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/Somapacitan', 'description': 'Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG001', 'title': 'Somapacitan/Somapacitan', 'description': 'Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG002', 'title': 'Norditropin/Norditropin', 'description': 'Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG003', 'title': 'Norditropin/Somapacitan', 'description': 'Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG004', 'title': 'Norditropin/-', 'description': 'Participants who received Norditropin in the main period of the trial and discontinued after the main period of the study are included here.'}], 'classes': [{'title': 'Week -3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}]}, {'title': 'Abnormal, NCS', 'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}, {'title': 'Abnormal, CS', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}, {'title': 'Missing', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Week 88', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}, {'title': 'Abnormal, NCS', 'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}, {'title': 'Abnormal, CS', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}, {'title': 'Missing', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week -3 and week 88', 'description': 'Change in ECG evaluation from baseline (week 0) until the end of the extension period (Week 88) was reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product. Number Analyzed = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Diastolic Blood Pressure (Week 35)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}, {'id': 'OG001', 'title': 'Norditropin', 'description': 'Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}, {'id': 'OG002', 'title': 'Somapacitan', 'description': 'Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.41', 'spread': '7.75', 'groupId': 'OG000'}, {'value': '-2.07', 'spread': '8.73', 'groupId': 'OG001'}, {'value': '-1.42', 'spread': '8.98', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week -3, week 35', 'description': 'Change in diastolic blood pressure was measured from baseline (week -3) until the end of the main treatment period (week 35).', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Diastolic Blood Pressure (Week 88)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/Somapacitan', 'description': 'Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG001', 'title': 'Somapacitan/Somapacitan', 'description': 'Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG002', 'title': 'Norditropin/Norditropin', 'description': 'Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG003', 'title': 'Norditropin/Somapacitan', 'description': 'Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.48', 'spread': '7.77', 'groupId': 'OG000'}, {'value': '-0.85', 'spread': '9.21', 'groupId': 'OG001'}, {'value': '-0.61', 'spread': '8.71', 'groupId': 'OG002'}, {'value': '-2.10', 'spread': '9.50', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week -3, week 88', 'description': 'Change in diastolic blood pressure was measured from baseline (week -3) until the end of the extension treatment period week 88.', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Systolic Blood Pressure (Week 35)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}, {'id': 'OG001', 'title': 'Norditropin', 'description': 'Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}, {'id': 'OG002', 'title': 'Somapacitan', 'description': 'Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.13', 'spread': '11.35', 'groupId': 'OG000'}, {'value': '-2.81', 'spread': '13.33', 'groupId': 'OG001'}, {'value': '-1.39', 'spread': '12.89', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week -3, week 35', 'description': 'Change in systolic blood pressure was measured from baseline (week -3) until the end of the main treatment period (week 35).', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Systolic Blood Pressure (Week 88)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/Somapacitan', 'description': 'Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG001', 'title': 'Somapacitan/Somapacitan', 'description': 'Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG002', 'title': 'Norditropin/Norditropin', 'description': 'Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG003', 'title': 'Norditropin/Somapacitan', 'description': 'Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.30', 'spread': '12.18', 'groupId': 'OG000'}, {'value': '0.45', 'spread': '13.01', 'groupId': 'OG001'}, {'value': '-1.35', 'spread': '13.07', 'groupId': 'OG002'}, {'value': '-1.83', 'spread': '11.63', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week -3, week 88', 'description': 'Change in systolic blood pressure was measured from baseline (week -3) until the end of the extension treatment period (week 88).', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Pulse (Week 35)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}, {'value': '119', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}, {'id': 'OG001', 'title': 'Norditropin', 'description': 'Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}, {'id': 'OG002', 'title': 'Somapacitan', 'description': 'Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.54', 'spread': '9.43', 'groupId': 'OG000'}, {'value': '2.61', 'spread': '9.74', 'groupId': 'OG001'}, {'value': '1.02', 'spread': '10.20', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week -3, week 35', 'description': 'Change in pulse was measured from baseline (week -3) until the end of the main treatment period (week 35).', 'unitOfMeasure': 'beats/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Pulse (Week 88)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/Somapacitan', 'description': 'Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG001', 'title': 'Somapacitan/Somapacitan', 'description': 'Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG002', 'title': 'Norditropin/Norditropin', 'description': 'Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG003', 'title': 'Norditropin/Somapacitan', 'description': 'Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.78', 'spread': '11.70', 'groupId': 'OG000'}, {'value': '-0.55', 'spread': '10.51', 'groupId': 'OG001'}, {'value': '-0.55', 'spread': '10.32', 'groupId': 'OG002'}, {'value': '0.08', 'spread': '8.75', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week -3, week 88', 'description': 'Change in pulse was measured from baseline (week -3) until the end of the extension treatment period (week 88).', 'unitOfMeasure': 'beats/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Haemoglobin (Week 34)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}, {'value': '119', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}, {'id': 'OG001', 'title': 'Norditropin', 'description': 'Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}, {'id': 'OG002', 'title': 'Somapacitan', 'description': 'Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.87', 'spread': '10.25', 'groupId': 'OG000'}, {'value': '-0.51', 'spread': '8.80', 'groupId': 'OG001'}, {'value': '0.64', 'spread': '8.78', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week -3, week 34', 'description': 'Change in Haemoglobin was measured from baseline (week -3) until the end of the main treatment period (week 34).', 'unitOfMeasure': 'g/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Haemoglobin (Week 87)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/Somapacitan', 'description': 'Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG001', 'title': 'Somapacitan/Somapacitan', 'description': 'Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG002', 'title': 'Norditropin/Norditropin', 'description': 'Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG003', 'title': 'Norditropin/Somapacitan', 'description': 'Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.93', 'spread': '11.36', 'groupId': 'OG000'}, {'value': '2.76', 'spread': '9.54', 'groupId': 'OG001'}, {'value': '-0.40', 'spread': '9.22', 'groupId': 'OG002'}, {'value': '0.86', 'spread': '15.96', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'week -3, week 87', 'description': 'Change in Haemoglobin was measured from baseline (week -3) until the end of the week 87.', 'unitOfMeasure': 'g/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Haematocrit (Week 34)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}, {'value': '119', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}, {'id': 'OG001', 'title': 'Norditropin', 'description': 'Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}, {'id': 'OG002', 'title': 'Somapacitan', 'description': 'Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.5', 'spread': '3.3', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '2.9', 'groupId': 'OG001'}, {'value': '0.1', 'spread': '3.1', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week -3, week 34', 'description': 'Change in Haematocrit was measured from baseline (week -3) until the end of the main treatment period (week 34).', 'unitOfMeasure': '% of red blood cells', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Haematocrit (Week 87)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/Somapacitan', 'description': 'Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG001', 'title': 'Somapacitan/Somapacitan', 'description': 'Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG002', 'title': 'Norditropin/Norditropin', 'description': 'Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG003', 'title': 'Norditropin/Somapacitan', 'description': 'Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.17', 'spread': '3.44', 'groupId': 'OG000'}, {'value': '0.21', 'spread': '3.29', 'groupId': 'OG001'}, {'value': '-0.59', 'spread': '2.78', 'groupId': 'OG002'}, {'value': '-0.48', 'spread': '5.10', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'week -3, week 87', 'description': 'Change in Haematocrit was measured from baseline (week -3) until the end of the week 87.', 'unitOfMeasure': '% of red blood cells', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Erythrocytes (Week 34)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}, {'value': '119', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}, {'id': 'OG001', 'title': 'Norditropin', 'description': 'Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}, {'id': 'OG002', 'title': 'Somapacitan', 'description': 'Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.09', 'spread': '0.33', 'groupId': 'OG000'}, {'value': '0.06', 'spread': '0.29', 'groupId': 'OG001'}, {'value': '0.08', 'spread': '0.32', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week -3, week 34', 'description': 'Change in Erythrocytes was measured from baseline (week -3) until the end of the main treatment period (week 34).', 'unitOfMeasure': 'cells/pL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Erythrocytes (Week 87)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/Somapacitan', 'description': 'Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG001', 'title': 'Somapacitan/Somapacitan', 'description': 'Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG002', 'title': 'Norditropin/Norditropin', 'description': 'Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG003', 'title': 'Norditropin/Somapacitan', 'description': 'Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.09', 'spread': '0.34', 'groupId': 'OG000'}, {'value': '0.12', 'spread': '0.35', 'groupId': 'OG001'}, {'value': '0.01', 'spread': '0.31', 'groupId': 'OG002'}, {'value': '0.05', 'spread': '0.54', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'week -3, week 87', 'description': 'Change in Erythrocytes was measured from baseline (week -3) until the end of the week 87.', 'unitOfMeasure': 'cells/pL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Mean Corpuscular Volume (MCV) (Week 34)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}, {'value': '119', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}, {'id': 'OG001', 'title': 'Norditropin', 'description': 'Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}, {'id': 'OG002', 'title': 'Somapacitan', 'description': 'Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.6', 'spread': '3.3', 'groupId': 'OG000'}, {'value': '-1.8', 'spread': '3.6', 'groupId': 'OG001'}, {'value': '-1.5', 'spread': '3.0', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week -3, week 34', 'description': 'Change in Mean corpuscular volume (MCV) was measured from baseline (week -3) until the end of the main treatment period (week 34).', 'unitOfMeasure': 'fL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Mean Corpuscular Volume (MCV) (Week 87)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/Somapacitan', 'description': 'Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG001', 'title': 'Somapacitan/Somapacitan', 'description': 'Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG002', 'title': 'Norditropin/Norditropin', 'description': 'Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG003', 'title': 'Norditropin/Somapacitan', 'description': 'Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.39', 'spread': '4.27', 'groupId': 'OG000'}, {'value': '-1.80', 'spread': '3.31', 'groupId': 'OG001'}, {'value': '-1.31', 'spread': '3.63', 'groupId': 'OG002'}, {'value': '-1.77', 'spread': '3.66', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'week -3, week 87', 'description': 'Change in Mean corpuscular volume (MCV) was measured from baseline (week -3) until the end of the week 87.', 'unitOfMeasure': 'fL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Mean Corpuscular Haemoglobin Concentration (MCHC) (Week 34)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}, {'value': '119', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}, {'id': 'OG001', 'title': 'Norditropin', 'description': 'Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}, {'id': 'OG002', 'title': 'Somapacitan', 'description': 'Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.1', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.6', 'groupId': 'OG001'}, {'value': '0.1', 'spread': '0.6', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week -3, week 34', 'description': 'Change in Mean corpuscular haemoglobin concentration (MCHC) was measured from baseline (week -3) until the end of the main treatment period (week 34).', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Mean Corpuscular Haemoglobin Concentration (MCHC) (Week 87)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/Somapacitan', 'description': 'Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG001', 'title': 'Somapacitan/Somapacitan', 'description': 'Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG002', 'title': 'Norditropin/Norditropin', 'description': 'Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG003', 'title': 'Norditropin/Somapacitan', 'description': 'Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.36', 'spread': '0.47', 'groupId': 'OG000'}, {'value': '0.29', 'spread': '0.61', 'groupId': 'OG001'}, {'value': '0.23', 'spread': '0.70', 'groupId': 'OG002'}, {'value': '0.35', 'spread': '0.52', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'week -3, week 87', 'description': 'Change in Mean corpuscular haemoglobin concentration (MCHC) was measured from baseline (week -3) until the end of the week 87.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Thrombocytes (Week 34)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}, {'value': '115', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}, {'id': 'OG001', 'title': 'Norditropin', 'description': 'Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}, {'id': 'OG002', 'title': 'Somapacitan', 'description': 'Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.6', 'spread': '37.4', 'groupId': 'OG000'}, {'value': '10.8', 'spread': '37.1', 'groupId': 'OG001'}, {'value': '15.3', 'spread': '35.0', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week -3, week 34', 'description': 'Change in Thrombocytes was measured from baseline (week -3) until the end of the main treatment period (week 34).', 'unitOfMeasure': '10^9 cells/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Thrombocytes (Week 87)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/Somapacitan', 'description': 'Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG001', 'title': 'Somapacitan/Somapacitan', 'description': 'Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG002', 'title': 'Norditropin/Norditropin', 'description': 'Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG003', 'title': 'Norditropin/Somapacitan', 'description': 'Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.2', 'spread': '44.7', 'groupId': 'OG000'}, {'value': '11.0', 'spread': '36.7', 'groupId': 'OG001'}, {'value': '-0.9', 'spread': '31.3', 'groupId': 'OG002'}, {'value': '6.6', 'spread': '53.4', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'week -3, week 87', 'description': 'Change in Thrombocytes was measured from baseline (week -3) until the end of the week 87.', 'unitOfMeasure': '10^9 cells/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Leucocytes (Week 34)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}, {'value': '119', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}, {'id': 'OG001', 'title': 'Norditropin', 'description': 'Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}, {'id': 'OG002', 'title': 'Somapacitan', 'description': 'Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.22', 'spread': '1.57', 'groupId': 'OG000'}, {'value': '-0.05', 'spread': '1.50', 'groupId': 'OG001'}, {'value': '-0.32', 'spread': '1.75', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week -3, week 34', 'description': 'Change in Leucocytes was measured from baseline (week -3) until the end of the main treatment period (week 34).', 'unitOfMeasure': '10^9 cells/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Leucocytes (Week 87)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/Somapacitan', 'description': 'Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG001', 'title': 'Somapacitan/Somapacitan', 'description': 'Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG002', 'title': 'Norditropin/Norditropin', 'description': 'Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG003', 'title': 'Norditropin/Somapacitan', 'description': 'Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.29', 'spread': '1.93', 'groupId': 'OG000'}, {'value': '-0.12', 'spread': '1.94', 'groupId': 'OG001'}, {'value': '-0.14', 'spread': '1.44', 'groupId': 'OG002'}, {'value': '-0.14', 'spread': '2.55', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'week -3, week 87', 'description': 'Change in Leucocytes was measured from baseline (week -3) until the end of the week 87.', 'unitOfMeasure': '10^9 cells/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Alanine Aminotransferase (ALT) (Week 34)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}, {'id': 'OG001', 'title': 'Norditropin', 'description': 'Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}, {'id': 'OG002', 'title': 'Somapacitan', 'description': 'Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.5', 'spread': '24.7', 'groupId': 'OG000'}, {'value': '-1.4', 'spread': '11.9', 'groupId': 'OG001'}, {'value': '-4.4', 'spread': '17.9', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week -3, week 34', 'description': 'Change in ALT was measured from baseline (week -3) until the end of the main treatment period (week 34).', 'unitOfMeasure': 'U/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Alanine Aminotransferase (ALT) (Week 87)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/Somapacitan', 'description': 'Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG001', 'title': 'Somapacitan/Somapacitan', 'description': 'Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG002', 'title': 'Norditropin/Norditropin', 'description': 'Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG003', 'title': 'Norditropin/Somapacitan', 'description': 'Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.1', 'spread': '13.1', 'groupId': 'OG000'}, {'value': '-4.3', 'spread': '16.9', 'groupId': 'OG001'}, {'value': '0.6', 'spread': '12.5', 'groupId': 'OG002'}, {'value': '-3.0', 'spread': '14.6', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'week -3, week 87', 'description': 'Change in ALT was measured from baseline (week -3) until the end of the week 87.', 'unitOfMeasure': 'U/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Albumin (Week 34)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}, {'id': 'OG001', 'title': 'Norditropin', 'description': 'Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}, {'id': 'OG002', 'title': 'Somapacitan', 'description': 'Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.09', 'spread': '3.56', 'groupId': 'OG000'}, {'value': '-0.72', 'spread': '2.81', 'groupId': 'OG001'}, {'value': '-0.42', 'spread': '3.06', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week -3, week 34', 'description': 'Change in Albumin was measured from baseline (week -3) until the end of the main treatment period (week 34).', 'unitOfMeasure': 'g/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Albumin (Week 87)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/Somapacitan', 'description': 'Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG001', 'title': 'Somapacitan/Somapacitan', 'description': 'Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG002', 'title': 'Norditropin/Norditropin', 'description': 'Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG003', 'title': 'Norditropin/Somapacitan', 'description': 'Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.19', 'spread': '3.15', 'groupId': 'OG000'}, {'value': '-0.86', 'spread': '3.12', 'groupId': 'OG001'}, {'value': '-1.12', 'spread': '3.52', 'groupId': 'OG002'}, {'value': '-1.69', 'spread': '3.01', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'week -3, week 87', 'description': 'Change in Albumin was measured from baseline (week -3) until the end of the week 87.', 'unitOfMeasure': 'g/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Alkaline Phosphatase (ALP) (Week 34)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}, {'id': 'OG001', 'title': 'Norditropin', 'description': 'Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}, {'id': 'OG002', 'title': 'Somapacitan', 'description': 'Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.8', 'spread': '16.5', 'groupId': 'OG000'}, {'value': '7.9', 'spread': '24.3', 'groupId': 'OG001'}, {'value': '5.8', 'spread': '14.9', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week -3, week 34', 'description': 'Change in Alkaline phosphatase (ALP) was measured from baseline (week -3) until the end of the main treatment period (week 34).', 'unitOfMeasure': 'U/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Alkaline Phosphatase (AP) (Week 87)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/Somapacitan', 'description': 'Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG001', 'title': 'Somapacitan/Somapacitan', 'description': 'Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG002', 'title': 'Norditropin/Norditropin', 'description': 'Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG003', 'title': 'Norditropin/Somapacitan', 'description': 'Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.1', 'spread': '20.2', 'groupId': 'OG000'}, {'value': '5.4', 'spread': '16.0', 'groupId': 'OG001'}, {'value': '3.3', 'spread': '22.2', 'groupId': 'OG002'}, {'value': '4.2', 'spread': '18.0', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week -3, week 87', 'description': 'Change in Alkaline phosphatase (AP) was measured from baseline (week -3) until the end of the week 87.', 'unitOfMeasure': 'U/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Aspartate Aminotransferase (AST) (Week 34)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}, {'id': 'OG001', 'title': 'Norditropin', 'description': 'Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}, {'id': 'OG002', 'title': 'Somapacitan', 'description': 'Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.96', 'spread': '15.11', 'groupId': 'OG000'}, {'value': '-0.80', 'spread': '9.38', 'groupId': 'OG001'}, {'value': '-2.00', 'spread': '13.97', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week -3, week 34', 'description': 'Change in AST was measured from baseline (week -3) until the end of the main treatment period (week 34).', 'unitOfMeasure': 'U/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Aspartate Aminotransferase (AST) (Week 87)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/Somapacitan', 'description': 'Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG001', 'title': 'Somapacitan/Somapacitan', 'description': 'Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG002', 'title': 'Norditropin/Norditropin', 'description': 'Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG003', 'title': 'Norditropin/Somapacitan', 'description': 'Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.76', 'spread': '24.346', 'groupId': 'OG000'}, {'value': '-2.17', 'spread': '13.98', 'groupId': 'OG001'}, {'value': '-0.43', 'spread': '5.94', 'groupId': 'OG002'}, {'value': '-1.69', 'spread': '12.75', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week -3, week 87', 'description': 'Change in AST was measured from baseline (week -3) until the end of the extension treatment period (week 87).', 'unitOfMeasure': 'U/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Bilirubin (Week 34)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}, {'id': 'OG001', 'title': 'Norditropin', 'description': 'Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}, {'id': 'OG002', 'title': 'Somapacitan', 'description': 'Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.08', 'spread': '4.76', 'groupId': 'OG000'}, {'value': '-0.38', 'spread': '4.10', 'groupId': 'OG001'}, {'value': '-0.41', 'spread': '4.09', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week -3, week 34', 'description': 'Change in Bilirubin was measured from baseline (week -3) until the end of the main treatment period (week 34).', 'unitOfMeasure': 'umol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Bilirubin (Week 87)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/Somapacitan', 'description': 'Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG001', 'title': 'Somapacitan/Somapacitan', 'description': 'Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG002', 'title': 'Norditropin/Norditropin', 'description': 'Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG003', 'title': 'Norditropin/Somapacitan', 'description': 'Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.04', 'spread': '3.77', 'groupId': 'OG000'}, {'value': '0.14', 'spread': '4.45', 'groupId': 'OG001'}, {'value': '0.45', 'spread': '3.24', 'groupId': 'OG002'}, {'value': '-0.33', 'spread': '4.52', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'week -3, week 87', 'description': 'Change in Bilirubin was measured from baseline (week -3) until the end of the extension treatment period (week 87).', 'unitOfMeasure': 'umol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Calcium (Week 34)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}, {'id': 'OG001', 'title': 'Norditropin', 'description': 'Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}, {'id': 'OG002', 'title': 'Somapacitan', 'description': 'Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.00', 'spread': '0.13', 'groupId': 'OG000'}, {'value': '0.04', 'spread': '0.14', 'groupId': 'OG001'}, {'value': '0.03', 'spread': '0.11', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week -3, week 34', 'description': 'Change in Calcium was measured from baseline (week -3) until the end of the main treatment period (week 34).', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Calcium (Week 87)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/Somapacitan', 'description': 'Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG001', 'title': 'Somapacitan/Somapacitan', 'description': 'Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG002', 'title': 'Norditropin/Norditropin', 'description': 'Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG003', 'title': 'Norditropin/Somapacitan', 'description': 'Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.01', 'spread': '0.12', 'groupId': 'OG000'}, {'value': '0.03', 'spread': '0.12', 'groupId': 'OG001'}, {'value': '0.03', 'spread': '0.11', 'groupId': 'OG002'}, {'value': '0.01', 'spread': '0.12', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'week -3, week 87', 'description': 'Change in Calcium was measured from baseline (week -3) until the end of the week 87.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Chloride (Week 34)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}, {'id': 'OG001', 'title': 'Norditropin', 'description': 'Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}, {'id': 'OG002', 'title': 'Somapacitan', 'description': 'Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.1', 'spread': '2.7', 'groupId': 'OG000'}, {'value': '-0.6', 'spread': '2.9', 'groupId': 'OG001'}, {'value': '-0.3', 'spread': '2.9', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week -3, week 34', 'description': 'Change in Chloride was measured from baseline (week -3) until the end of the main treatment period (week 34).', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Chloride (Week 87)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/Somapacitan', 'description': 'Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG001', 'title': 'Somapacitan/Somapacitan', 'description': 'Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG002', 'title': 'Norditropin/Norditropin', 'description': 'Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG003', 'title': 'Norditropin/Somapacitan', 'description': 'Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.8', 'spread': '3.5', 'groupId': 'OG000'}, {'value': '-1.0', 'spread': '3.0', 'groupId': 'OG001'}, {'value': '-1.1', 'spread': '3.2', 'groupId': 'OG002'}, {'value': '-0.6', 'spread': '3.1', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'week -3, week 87', 'description': 'Change in Chloride was measured from baseline (week -3) until the end of the week 87.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Creatinine (Week 34)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}, {'id': 'OG001', 'title': 'Norditropin', 'description': 'Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}, {'id': 'OG002', 'title': 'Somapacitan', 'description': 'Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.9', 'spread': '9.4', 'groupId': 'OG000'}, {'value': '-2.8', 'spread': '10.9', 'groupId': 'OG001'}, {'value': '-2.9', 'spread': '10.6', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week -3, week 34', 'description': 'Change in Creatinine was measured from baseline (week -3) until the end of the main treatment period (week 34).', 'unitOfMeasure': 'umol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Creatinine (Week 87)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/Somapacitan', 'description': 'Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG001', 'title': 'Somapacitan/Somapacitan', 'description': 'Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG002', 'title': 'Norditropin/Norditropin', 'description': 'Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG003', 'title': 'Norditropin/Somapacitan', 'description': 'Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.6', 'spread': '11.9', 'groupId': 'OG000'}, {'value': '-2.5', 'spread': '11.7', 'groupId': 'OG001'}, {'value': '-2.0', 'spread': '9.8', 'groupId': 'OG002'}, {'value': '1.8', 'spread': '41.2', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'week -3, week 87', 'description': 'Change in Creatinine was measured from baseline (week -3) until the end of the week 87.', 'unitOfMeasure': 'umol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Creatine Kinase (Week 34)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}, {'id': 'OG001', 'title': 'Norditropin', 'description': 'Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}, {'id': 'OG002', 'title': 'Somapacitan', 'description': 'Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.0', 'spread': '136.6', 'groupId': 'OG000'}, {'value': '10.9', 'spread': '101.0', 'groupId': 'OG001'}, {'value': '-23.5', 'spread': '355.0', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week -3, week 34', 'description': 'Change in Creatine kinase was measured from baseline (week -3) until the end of the main treatment period (week 34).', 'unitOfMeasure': 'U/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Creatine Kinase (Week 87)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/Somapacitan', 'description': 'Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG001', 'title': 'Somapacitan/Somapacitan', 'description': 'Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG002', 'title': 'Norditropin/Norditropin', 'description': 'Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG003', 'title': 'Norditropin/Somapacitan', 'description': 'Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '228.7', 'spread': '1603.3', 'groupId': 'OG000'}, {'value': '-9.4', 'spread': '411.3', 'groupId': 'OG001'}, {'value': '1.3', 'spread': '89.3', 'groupId': 'OG002'}, {'value': '30.5', 'spread': '125.7', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'week -3, week 87', 'description': 'Change in Creatine kinase was measured from baseline (week -3) until the end of the week 87.', 'unitOfMeasure': 'U/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Gamma-glutamyl Transferase (GGT) (Week 34)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}, {'id': 'OG001', 'title': 'Norditropin', 'description': 'Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}, {'id': 'OG002', 'title': 'Somapacitan', 'description': 'Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.3', 'spread': '66.2', 'groupId': 'OG000'}, {'value': '-5.8', 'spread': '17.0', 'groupId': 'OG001'}, {'value': '-4.2', 'spread': '27.5', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week -3, week 34', 'description': 'Change in GGT was measured from baseline (week -3) until the end of the main treatment period (week 34).', 'unitOfMeasure': 'U/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Gamma-glutamyl Transferase (GGT) (Week 87)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/Somapacitan', 'description': 'Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG001', 'title': 'Somapacitan/Somapacitan', 'description': 'Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG002', 'title': 'Norditropin/Norditropin', 'description': 'Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG003', 'title': 'Norditropin/Somapacitan', 'description': 'Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '19.4', 'spread': '16.4', 'groupId': 'OG000'}, {'value': '29.3', 'spread': '39.3', 'groupId': 'OG001'}, {'value': '25.9', 'spread': '23.8', 'groupId': 'OG002'}, {'value': '20.7', 'spread': '13.9', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'week -3, week 87', 'description': 'Change in GGT was measured from baseline (week -3) until the end of the week 87.', 'unitOfMeasure': 'U/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Phosphate (Inorganic) (Week 34)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}, {'id': 'OG001', 'title': 'Norditropin', 'description': 'Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}, {'id': 'OG002', 'title': 'Somapacitan', 'description': 'Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.038', 'spread': '0.183', 'groupId': 'OG000'}, {'value': '0.155', 'spread': '0.182', 'groupId': 'OG001'}, {'value': '0.181', 'spread': '0.202', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week -3, week 34', 'description': 'Change in Phosphate (inorganic) was measured from baseline (week -3) until the end of the main treatment period (week 34).', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Phosphate (Inorganic)(Week 87)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/Somapacitan', 'description': 'Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG001', 'title': 'Somapacitan/Somapacitan', 'description': 'Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG002', 'title': 'Norditropin/Norditropin', 'description': 'Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG003', 'title': 'Norditropin/Somapacitan', 'description': 'Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.100', 'spread': '0.190', 'groupId': 'OG000'}, {'value': '0.125', 'spread': '0.193', 'groupId': 'OG001'}, {'value': '0.076', 'spread': '0.190', 'groupId': 'OG002'}, {'value': '0.115', 'spread': '0.219', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'week -3, week 87', 'description': 'Change in Phosphate (inorganic) was measured from baseline (week -3) until the end of the week 87.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Potassium (Week 34)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}, {'id': 'OG001', 'title': 'Norditropin', 'description': 'Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}, {'id': 'OG002', 'title': 'Somapacitan', 'description': 'Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.02', 'spread': '0.44', 'groupId': 'OG000'}, {'value': '-0.06', 'spread': '0.39', 'groupId': 'OG001'}, {'value': '0.04', 'spread': '9.42', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week -3, week 34', 'description': 'Change in Potassium was measured from baseline (week -3) until the end of the main treatment period (week 34).', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Potassium (Week 87)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/Somapacitan', 'description': 'Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG001', 'title': 'Somapacitan/Somapacitan', 'description': 'Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG002', 'title': 'Norditropin/Norditropin', 'description': 'Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG003', 'title': 'Norditropin/Somapacitan', 'description': 'Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.06', 'spread': '0.45', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0.44', 'groupId': 'OG001'}, {'value': '-0.00', 'spread': '0.40', 'groupId': 'OG002'}, {'value': '-0.03', 'spread': '0.43', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'week -3, week 87', 'description': 'Change in Potassium was measured from baseline (week -3) until the end of the week 87.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Sodium (Week 34)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}, {'value': '115', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}, {'id': 'OG001', 'title': 'Norditropin', 'description': 'Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}, {'id': 'OG002', 'title': 'Somapacitan', 'description': 'Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.1', 'spread': '2.4', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '2.9', 'groupId': 'OG001'}, {'value': '0.5', 'spread': '2.7', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week -3, week 34', 'description': 'Change in Sodium was measured from baseline (week -3) until the end of the main treatment period (week 34).', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Sodium (Week 87)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/Somapacitan', 'description': 'Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG001', 'title': 'Somapacitan/Somapacitan', 'description': 'Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG002', 'title': 'Norditropin/Norditropin', 'description': 'Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG003', 'title': 'Norditropin/Somapacitan', 'description': 'Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.7', 'spread': '3.35', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '2.92', 'groupId': 'OG001'}, {'value': '-0.3', 'spread': '2.74', 'groupId': 'OG002'}, {'value': '0.5', 'spread': '2.76', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'week -3, week 87', 'description': 'Change in Sodium was measured from baseline (week -3) until the end of the extension treatment period (week 87).', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Total Protein (Week 34)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}, {'id': 'OG001', 'title': 'Norditropin', 'description': 'Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}, {'id': 'OG002', 'title': 'Somapacitan', 'description': 'Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.26', 'spread': '5.48', 'groupId': 'OG000'}, {'value': '-0.97', 'spread': '4.36', 'groupId': 'OG001'}, {'value': '-0.83', 'spread': '4.93', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week -3, week 34', 'description': 'Change in total protein was measured from baseline (week -3) until the end of the main treatment period (week 34).', 'unitOfMeasure': 'g/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Total Protein (Week 87)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/Somapacitan', 'description': 'Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG001', 'title': 'Somapacitan/Somapacitan', 'description': 'Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG002', 'title': 'Norditropin/Norditropin', 'description': 'Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG003', 'title': 'Norditropin/Somapacitan', 'description': 'Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.20', 'spread': '5.17', 'groupId': 'OG000'}, {'value': '-0.74', 'spread': '4.88', 'groupId': 'OG001'}, {'value': '-1.31', 'spread': '4.91', 'groupId': 'OG002'}, {'value': '-1.59', 'spread': '4.37', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'week -3, week 87', 'description': 'Change in total protein was measured from baseline (week -3) until the end of extension treatment period (week 87).', 'unitOfMeasure': 'g/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Urea (Week 34)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}, {'id': 'OG001', 'title': 'Norditropin', 'description': 'Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}, {'id': 'OG002', 'title': 'Somapacitan', 'description': 'Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.17', 'spread': '1.27', 'groupId': 'OG000'}, {'value': '-0.40', 'spread': '1.16', 'groupId': 'OG001'}, {'value': '-0.19', 'spread': '1.24', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week -3, week 34', 'description': 'Change in Urea was measured from baseline (week -3) until the end of the main treatment period (week 34).', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Urea (Week 87)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/Somapacitan', 'description': 'Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG001', 'title': 'Somapacitan/Somapacitan', 'description': 'Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG002', 'title': 'Norditropin/Norditropin', 'description': 'Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG003', 'title': 'Norditropin/Somapacitan', 'description': 'Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.11', 'spread': '1.40', 'groupId': 'OG000'}, {'value': '-0.21', 'spread': '1.28', 'groupId': 'OG001'}, {'value': '-0.26', 'spread': '1.35', 'groupId': 'OG002'}, {'value': '-0.03', 'spread': '2.46', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'week -3, week 87', 'description': 'Change in Urea was measured from baseline (week -3) until the end of the extension treatment period (week 87).', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Uric Acid (Week 34)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}, {'id': 'OG001', 'title': 'Norditropin', 'description': 'Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}, {'id': 'OG002', 'title': 'Somapacitan', 'description': 'Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '-8.228', 'spread': '52.557', 'groupId': 'OG000'}, {'value': '-12.61', 'spread': '50.534', 'groupId': 'OG001'}, {'value': '-21.11', 'spread': '57.594', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week -3, week 34', 'description': 'Change in Uric acid was measured from baseline (week -3) until the end of the main treatment period (week 34).', 'unitOfMeasure': 'umol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Uric Acid (Week 87)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/Somapacitan', 'description': 'Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG001', 'title': 'Somapacitan/Somapacitan', 'description': 'Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG002', 'title': 'Norditropin/Norditropin', 'description': 'Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG003', 'title': 'Norditropin/Somapacitan', 'description': 'Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '-25.22', 'spread': '59.042', 'groupId': 'OG000'}, {'value': '-21.95', 'spread': '58.903', 'groupId': 'OG001'}, {'value': '-18.02', 'spread': '59.716', 'groupId': 'OG002'}, {'value': '-31.31', 'spread': '86.787', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'week -3, week 87', 'description': 'Change in Uric acid was measured from baseline (week -3) until the end of the extension treatment period (week 87).', 'unitOfMeasure': 'umol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Estimated Glomerular Filtration Rate (GFR) Creatinine (CKD-EPI) (Week 34)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}, {'id': 'OG001', 'title': 'Norditropin', 'description': 'Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}, {'id': 'OG002', 'title': 'Somapacitan', 'description': 'Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.34', 'spread': '10.68', 'groupId': 'OG000'}, {'value': '2.77', 'spread': '10.07', 'groupId': 'OG001'}, {'value': '2.57', 'spread': '11.24', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week -3, week 34', 'description': 'Change in Estimated GFR creatinine (CKD-EPI) was measured from baseline (week -3) until the end of the main treatment period (week 34).', 'unitOfMeasure': 'mL/min/1.73m^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Estimated GFR Creatinine (CKD-EPI) (Week 87)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/Somapacitan', 'description': 'Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG001', 'title': 'Somapacitan/Somapacitan', 'description': 'Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG002', 'title': 'Norditropin/Norditropin', 'description': 'Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG003', 'title': 'Norditropin/Somapacitan', 'description': 'Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.36', 'spread': '12.67', 'groupId': 'OG000'}, {'value': '2.38', 'spread': '12.28', 'groupId': 'OG001'}, {'value': '1.44', 'spread': '10.52', 'groupId': 'OG002'}, {'value': '1.67', 'spread': '15.77', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'week -3, week 87', 'description': 'Change in estimated GFR creatinine (CKD-EPI) was measured from baseline (week -3) until the end of the extension treatment period (week 87).', 'unitOfMeasure': 'mL/min/1.73m^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Fasting Plasma Glucose (Week 34)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}, {'value': '117', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}, {'id': 'OG001', 'title': 'Norditropin', 'description': 'Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}, {'id': 'OG002', 'title': 'Somapacitan', 'description': 'Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.01', 'spread': '0.42', 'groupId': 'OG000'}, {'value': '0.12', 'spread': '0.65', 'groupId': 'OG001'}, {'value': '0.00', 'spread': '0.56', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week -3, week 34', 'description': 'Change in Fasting plasma glucosewas measured from baseline (week -3) until the end of the main treatment period (week 34).', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Fasting Plasma Glucose (Week 87)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/Somapacitan', 'description': 'Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG001', 'title': 'Somapacitan/Somapacitan', 'description': 'Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG002', 'title': 'Norditropin/Norditropin', 'description': 'Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG003', 'title': 'Norditropin/Somapacitan', 'description': 'Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.06', 'spread': '0.46', 'groupId': 'OG000'}, {'value': '0.13', 'spread': '0.77', 'groupId': 'OG001'}, {'value': '0.05', 'spread': '0.68', 'groupId': 'OG002'}, {'value': '0.04', 'spread': '0.60', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'week -3, week 87', 'description': 'Change in Fasting plasma glucose was measured from baseline (week -3) until the end of the extension treatment period (week 87).', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Fasting Insulin (Week 34)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}, {'value': '117', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}, {'id': 'OG001', 'title': 'Norditropin', 'description': 'Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}, {'id': 'OG002', 'title': 'Somapacitan', 'description': 'Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '14.563', 'spread': '45.217', 'groupId': 'OG000'}, {'value': '27.580', 'spread': '76.230', 'groupId': 'OG001'}, {'value': '12.778', 'spread': '53.703', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week -3, week 34', 'description': 'Change in Fasting insulin was measured from baseline (week -3) until the end of the main treatment period (week 34).', 'unitOfMeasure': 'pmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Fasting Insulin (Week 87)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/Somapacitan', 'description': 'Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG001', 'title': 'Somapacitan/Somapacitan', 'description': 'Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG002', 'title': 'Norditropin/Norditropin', 'description': 'Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG003', 'title': 'Norditropin/Somapacitan', 'description': 'Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.2', 'spread': '57.31', 'groupId': 'OG000'}, {'value': '-3.7', 'spread': '62.39', 'groupId': 'OG001'}, {'value': '-6.5', 'spread': '53.67', 'groupId': 'OG002'}, {'value': '13.4', 'spread': '54.40', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'week -3, week 87', 'description': 'Change in Fasting insulin was measured from baseline (week -3) until the end of the extension treatment period (week 87).', 'unitOfMeasure': 'pmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Steady State Beta Cell Function (%B) (Week 34)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}, {'value': '113', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}, {'id': 'OG001', 'title': 'Norditropin', 'description': 'Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}, {'id': 'OG002', 'title': 'Somapacitan', 'description': 'Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '27.10', 'spread': '105.45', 'groupId': 'OG000'}, {'value': '36.26', 'spread': '290.00', 'groupId': 'OG001'}, {'value': '54.90', 'spread': '173.14', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week -3, week 34', 'description': 'Change in steady state beta cell function (%B) was measured from baseline (week -3) until the end of the main treatment period (week 34).', 'unitOfMeasure': 'Percentage of beta cell function', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Steady State Beta Cell Function (%B) (Week 87)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}, {'value': '46', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/Somapacitan', 'description': 'Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG001', 'title': 'Somapacitan/Somapacitan', 'description': 'Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG002', 'title': 'Norditropin/Norditropin', 'description': 'Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG003', 'title': 'Norditropin/Somapacitan', 'description': 'Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '21.72', 'spread': '154.22', 'groupId': 'OG000'}, {'value': '-16.54', 'spread': '148.72', 'groupId': 'OG001'}, {'value': '-7.34', 'spread': '97.62', 'groupId': 'OG002'}, {'value': '34.54', 'spread': '161.01', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'week -3, week 87', 'description': 'Change in steady state beta cell function (%B) was measured from baseline (week -3) until the end of the week 87.', 'unitOfMeasure': 'Percentage of beta cell function', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Insulin Resistance (IR %) (Week 34)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}, {'value': '114', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}, {'id': 'OG001', 'title': 'Norditropin', 'description': 'Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}, {'id': 'OG002', 'title': 'Somapacitan', 'description': 'Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.53', 'spread': '1.76', 'groupId': 'OG000'}, {'value': '1.26', 'spread': '3.42', 'groupId': 'OG001'}, {'value': '0.47', 'spread': '2.32', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week -3, week 34', 'description': 'Change in Insulin resistance (IR %) was measured from baseline (week -3) until the end of the main treatment period (week 34).', 'unitOfMeasure': 'Percentage of insulin resistance', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Insulin Resistance (IR %) (Week 87)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/Somapacitan', 'description': 'Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG001', 'title': 'Somapacitan/Somapacitan', 'description': 'Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG002', 'title': 'Norditropin/Norditropin', 'description': 'Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG003', 'title': 'Norditropin/Somapacitan', 'description': 'Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.50', 'spread': '2.17', 'groupId': 'OG000'}, {'value': '-0.06', 'spread': '3.14', 'groupId': 'OG001'}, {'value': '-0.02', 'spread': '1.99', 'groupId': 'OG002'}, {'value': '0.52', 'spread': '2.26', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'week -3, week 87', 'description': 'Change in Insulin resistance (IR %) was measured from baseline (week -3) until the end of the extension treatment period (week 87).', 'unitOfMeasure': 'Percentage of insulin resistance', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Glycated Haemoglobin (HbA1c) (%) (Week 34)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}, {'value': '119', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}, {'id': 'OG001', 'title': 'Norditropin', 'description': 'Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}, {'id': 'OG002', 'title': 'Somapacitan', 'description': 'Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.04', 'spread': '0.37', 'groupId': 'OG000'}, {'value': '0.09', 'spread': '0.26', 'groupId': 'OG001'}, {'value': '0.09', 'spread': '0.31', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week -3, week 34', 'description': 'Change in Glycated haemoglobin (HbA1c) (%) was measured from baseline (week -3) until the end of the main treatment period (week 34).', 'unitOfMeasure': 'Percentage of HbA1c', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Glycated Haemoglobin (HbA1c) (%) (Week 87)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/Somapacitan', 'description': 'Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG001', 'title': 'Somapacitan/Somapacitan', 'description': 'Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG002', 'title': 'Norditropin/Norditropin', 'description': 'Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'OG003', 'title': 'Norditropin/Somapacitan', 'description': 'Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.09', 'spread': '0.26', 'groupId': 'OG000'}, {'value': '0.11', 'spread': '0.37', 'groupId': 'OG001'}, {'value': '0.10', 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phase of the trial.'}, {'id': 'FG002', 'title': 'Somapacitan', 'description': 'Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}, {'id': 'FG003', 'title': 'Placebo/Somapacitan', 'description': 'Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'FG004', 'title': 'Somapacitan/Somapacitan', 'description': 'Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'FG005', 'title': 'Norditropin/Norditropin', 'description': 'Participants who received Norditropin in the main phase were randomised 1:1 to continue with norditropin or switch to somapacitan. Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'FG006', 'title': 'Norditropin/Somapacitan', 'description': 'Participants who received Norditropin in the main phase were randomised 1:1 to continue with Norditropin or switch to somapacitan. Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}], 'periods': [{'title': 'Main Phase (Double-blind Phase)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '61'}, {'groupId': 'FG001', 'numSubjects': '119'}, {'groupId': 'FG002', 'numSubjects': '120'}, {'comment': 'This arm is not applicable for the Main phase.', 'groupId': 'FG003', 'numSubjects': '0'}, {'comment': 'This arm is not applicable for the Main phase.', 'groupId': 'FG004', 'numSubjects': '0'}, {'comment': 'This arm is not applicable for the Main phase.', 'groupId': 'FG005', 'numSubjects': '0'}, {'comment': 'This arm is not applicable for the Main phase.', 'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Full Analysis Set', 'achievements': [{'groupId': 'FG000', 'numSubjects': '61'}, {'groupId': 'FG001', 'numSubjects': '119'}, {'groupId': 'FG002', 'numSubjects': '120'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Safety Analysis Set', 'achievements': [{'groupId': 'FG000', 'numSubjects': '61'}, {'groupId': 'FG001', 'numSubjects': '119'}, {'groupId': 'FG002', 'numSubjects': '120'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '55'}, {'groupId': 'FG001', 'numSubjects': '103'}, {'groupId': 'FG002', 'numSubjects': '114'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Unclassified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}]}, {'title': 'Extension Phase (Open-label Phase)', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'This arm is not applicable for the Extension phase.', 'groupId': 'FG000', 'numSubjects': '0'}, {'comment': 'This arm is not applicable for the Extension phase.', 'groupId': 'FG001', 'numSubjects': '0'}, {'comment': 'This arm is not applicable for the Extension phase.', 'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '55'}, {'groupId': 'FG004', 'numSubjects': '114'}, {'groupId': 'FG005', 'numSubjects': '52'}, {'groupId': 'FG006', 'numSubjects': '51'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '53'}, {'groupId': 'FG004', 'numSubjects': '109'}, {'groupId': 'FG005', 'numSubjects': '47'}, {'groupId': 'FG006', 'numSubjects': '48'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '5'}, {'groupId': 'FG006', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'The trial was conducted at 92 sites in 16 countries: Australia - 8, Germany - 4, India - 5, Japan - 14, Latvia - 1, Lithuania - 2, Malaysia - 3, Poland - 5, Romania - 5, Russian Fed. - 6, South Africa - 3, Sweden - 1, Turkey - 4, Ukraine - 1, United Kingdom - 4, United States - 26.', 'preAssignmentDetails': "The trial had a main phase and an extension phase. Participants were treated for 34 weeks in the main phase (followed by 1 week washout) and for 52 weeks in the extension phase (followed by 1 week washout).300 participants received treatment;1 participant was randomised but didn't receive any treatment and was therefore not included in any analyses"}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'BG000'}, {'value': '119', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}, {'value': '300', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.'}, {'id': 'BG001', 'title': 'Norditropin', 'description': 'Participants received Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.\n\nParticipants were re-randomised to receive somapacitan while other continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension part of the trial.'}, {'id': 'BG002', 'title': 'Somapacitan', 'description': 'Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. Participants continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '45.0', 'spread': '15.7', 'groupId': 'BG000'}, {'value': '45.7', 'spread': '15.3', 'groupId': 'BG001'}, {'value': '44.6', 'spread': '14.3', 'groupId': 'BG002'}, {'value': '45.1', 'spread': '15.0', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}, {'value': '155', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}, {'value': '145', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'Asian', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}, {'value': '86', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '76', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}, {'value': '200', 'groupId': 'BG003'}]}, {'title': 'Other: Hispanic', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'Other: Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Other: Caucasian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Not applicable', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Race', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '57', 'groupId': 'BG000'}, {'value': '109', 'groupId': 'BG001'}, {'value': '114', 'groupId': 'BG002'}, {'value': '280', 'groupId': 'BG003'}]}, {'title': 'Not applicable', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Ethnicity', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-11-27', 'size': 2708002, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-04-03T04:59', 'hasProtocol': True}, {'date': '2017-11-27', 'size': 720134, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-04-03T04:59', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 301}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'dispFirstSubmitDate': '2018-04-06', 'completionDateStruct': {'date': '2018-05-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-03', 'studyFirstSubmitDate': '2014-08-26', 'dispFirstSubmitQcDate': '2018-04-06', 'resultsFirstSubmitDate': '2020-04-03', 'studyFirstSubmitQcDate': '2014-09-02', 'dispFirstPostDateStruct': {'date': '2018-04-09', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2020-11-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-06-23', 'studyFirstPostDateStruct': {'date': '2014-09-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-07-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-04-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Truncal Fat Percentage (Week 34)', 'timeFrame': 'Week -3, week 34', 'description': 'Change in Truncal fat percentage was measured from baseline (week -3) until the end of the main treatment period (week 34).'}], 'secondaryOutcomes': [{'measure': 'Change in Truncal Fat Percentage (Week 87)', 'timeFrame': 'week -3, week 87', 'description': 'Change in Truncal fat percentage was measured from baseline (week -3) until the end of the extension treatment period (week 87).'}, {'measure': 'Change in Truncal Fat Mass (Week 34)', 'timeFrame': 'Week -3, week 34', 'description': 'Change in Truncal fat mass was measured from baseline (week -3) until the end of the main treatment period (week 34).'}, {'measure': 'Change in Truncal Fat Mass (Week 87)', 'timeFrame': 'week -3, week 87', 'description': 'Change in Truncal fat mass was measured from baseline (week -3) until the end of the extension treatment period (week 87).'}, {'measure': 'Change in Truncal Lean Body Mass (Week 34)', 'timeFrame': 'Week -3, week 34', 'description': 'Change in Truncal lean body mass was measured from baseline (week -3) until the end of the main treatment period (week 34).'}, {'measure': 'Change in Truncal Lean Body Mass (Week 87)', 'timeFrame': 'week -3, week 87', 'description': 'Change in Truncal lean body mass was measured from baseline (week -3) until the end of the extension treatment period (week 87).'}, {'measure': 'Change in Total Fat Mass (Week 34)', 'timeFrame': 'Week -3, week 34', 'description': 'Change in Total fat mass was measured from baseline (week -3) until the end of the main treatment period (week 34).'}, {'measure': 'Change in Total Fat Mass (Week 87)', 'timeFrame': 'Week -3, week 87', 'description': 'Change in total fat mass was measured from baseline (week -3) until the end of the extension treatment period (week 87).'}, {'measure': 'Change in Visceral Adipose Tissue (Week 34)', 'timeFrame': 'Week -3, week 34', 'description': 'Change in Visceral adipose tissue was measured from baseline (week -3) until the end of the main treatment period (week 34).'}, {'measure': 'Change in Visceral Adipose Tissue (Week 87)', 'timeFrame': 'Week -3, week 87', 'description': 'Change in Visceral adipose tissue was measured from baseline (week -3) until the end of the extension treatment period (week 87).'}, {'measure': 'Change in Android Fat Mass (Week 34)', 'timeFrame': 'Week -3, week 34', 'description': 'Change in Android fat mass was measured from baseline (week -3) until the end of the main treatment period (week 34).'}, {'measure': 'Change in Android Fat Mass (Week 87)', 'timeFrame': 'week -3, week 87', 'description': 'Change in Android fat mass was measured from baseline (week -3) until the end of the extension treatment period (week 87).'}, {'measure': 'Change in Gynoid Fat Mass (Week 34)', 'timeFrame': 'Week -3, week 34', 'description': 'Change in Gynoid fat mass was measured from baseline (week -3) until the end of the main treatment period (week 34).'}, {'measure': 'Change in Gynoid Fat Mass (Week 87)', 'timeFrame': 'week -3, week 87', 'description': 'Change in Gynoid fat mass was measured from baseline (week -3) until the end of the extension treatment period (week 87).'}, {'measure': 'Change in Appendicular Skeletal Muscle Mass (Week 34)', 'timeFrame': 'Week -3, week 34', 'description': 'Change in Appendicular skeletal muscle mass was measured from baseline (week -3) until the end of the main treatment period (week 34).'}, {'measure': 'Change in Appendicular Skeletal Muscle Mass (Week 87)', 'timeFrame': 'week -3, week 87', 'description': 'Change in Appendicular skeletal muscle mass was measured from baseline (week -3) until the end of the extension treatment period (week 87).'}, {'measure': 'Change in Lean Body Mass (Week 34)', 'timeFrame': 'Week -3, week 34', 'description': 'Change in Lean body mass was measured from baseline (week -3) until the end of the main treatment period (week 34).'}, {'measure': 'Change in Lean Body Mass (Week 87)', 'timeFrame': 'week -3, week 87', 'description': 'Change in Lean body mass was measured from baseline (week -3) until the end of the extension treatment period (week 87).'}, {'measure': 'Change in Bone Mineral Content (Week 87)', 'timeFrame': 'week -3, week 87', 'description': 'Change in Bone mineral content was measured from baseline (week -3) until the end of the extension treatment period (week 87).'}, {'measure': 'Change in Bone Mineral Density (Week 87)', 'timeFrame': 'week -3, week 87', 'description': 'Change in Bone mineral density was measured from baseline (week -3) until the end of the extension treatment period (week 87).'}, {'measure': 'Change in IGF-I SDS (Week 34)', 'timeFrame': 'Week -3, week 34', 'description': 'Change in insulin-like growth factor (IGF-I) standard deviation scores (SDS) was measured from baseline (week -3) until the end of the main treatment period (week 34). A higher score reflects a better outcome.'}, {'measure': 'Change in IGF-I SDS (Week 87)', 'timeFrame': 'Week -3, week 87', 'description': 'Change in IGF-I SDS was measured from baseline (week -3) until the end of the extension treatment period (week 87). A higher score reflects a better outcome.'}, {'measure': 'Change in IGFBP 3 SDS (Week 34)', 'timeFrame': 'Week -3, week 34', 'description': 'Change in insulin like growth factor binding protein 3 (IGFBP 3) SDS was measured from baseline (week -3) until the end of the main treatment period (week 34).'}, {'measure': 'Change in IGFBP 3 SDS (Week 87)', 'timeFrame': 'Week -3, week 87', 'description': 'Change in IGFBP 3 SDS was measured from baseline (week -3) until the end of the extension treatment period (week 87).'}, {'measure': 'Change in TRIM-AGHD (Total and Domain Scores) (Week 34)', 'timeFrame': 'Week 0, week 34', 'description': "Change in treatment-related impact measure - adult growth hormone deficiency (TRIM-AGHD) scores (total and domain scores) was measured from baseline (week 0) until the end of the main treatment period (week 34). The TRIM-AGHD questionnaire measured the impact of GH treatment on the functioning and well-being of AGHD patients. The 4 concepts covered by the questionnaire were physical health, energy levels, cognitive ability and psychological health. TRIM-AGHD has 27 items and a total score as well as domain specific scores can be derived. The total score includes all answers that has been used to calculate each of the 4 subdomains. The score ranged from 0 to 100 for 'individual domains' and for the 'total', where a lower score reflected a better outcome."}, {'measure': 'Change in TRIM-AGHD (Total and Domain Scores) (Week 87)', 'timeFrame': 'week 0, week 87', 'description': "Change in TRIM-AGHD (total and domain scores) was measured from baseline (week 0) until the end of the extension treatment period (week 87). The TRIM-AGHD questionnaire measured the impact of GH treatment on the functioning and well-being of AGHD patients. The 4 concepts covered by the questionnaire were physical health, energy levels, cognitive ability and psychological health. TRIM-AGHD has 27 items and a total score as well as domain specific scores can be derived. The total score includes all answers that has been used to calculate each of the 4 subdomains. The score ranged from 0 to 100 for 'individual domains' and for the 'total', where a lower score reflected a better outcome."}, {'measure': 'Change in SF-36v2 (Summary and Domain Scores) (Week 34)', 'timeFrame': 'Week 0, week 34', 'description': 'SF-36v2™ questionnaire measured health-related quality of life (HRQoL) on 8 domains (Bodily Pain, General Health, Mental Health, Physical Functioning, Role Emotion, Physical Health, Social Functioning and Vitality) on individual scale ranges. The scores 0-100 (higher scores indicates better HRQoL) from SF-36 were converted to norm-based scores to enable a direct interpretation in relation to distribution of the scores in the 2009 U.S. general population. Mental component summary (MCS) measure is derived from domain scales of vitality, social functioning, role emotional and mental health. Physical component summary (PCS) measure is derived from domain scales of physical functioning, role-physical, bodily pain, and general health. A norm-based score of 50 corresponds to the mean score and 10 corresponds to the standard deviation of the 2009 U.S. general population. A positive change score indicates an improvement since baseline.'}, {'measure': 'Change in SF-36v2 (Summary and Domain Scores) (Week 87)', 'timeFrame': 'week 0, week 87', 'description': 'SF-36v2™ questionnaire measured health-related quality of life (HRQoL) on 8 domains (Bodily Pain, General Health, Mental Health, Physical Functioning, Role Emotion, Physical Health, Social Functioning and Vitality) on individual scale ranges. The scores 0-100 (higher scores indicates better HRQoL) from SF-36 were converted to norm-based scores to enable a direct interpretation in relation to distribution of the scores in the 2009 U.S. general population. Mental component summary (MCS) measure is derived from domain scales of vitality, social functioning, role emotional and mental health. Physical component summary (PCS) measure is derived from domain scales of physical functioning, role-physical, bodily pain, and general health. A norm-based score of 50 corresponds to the mean score and 10 corresponds to the standard deviation of the 2009 U.S. general population. A positive change score indicates an improvement since baseline.'}, {'measure': 'TSQM-9 Scores (Domain Scores) (Week 34)', 'timeFrame': 'Week 34', 'description': "Scores from the TSQM-9 scale were calculated at the end of the main treatment period (week 34). The Treatment Satisfaction Questionnaire for Medication - 9 items (TSQM-9) is a generic questionnaire that measures a patients' satisfaction with medication. Items are rated on a 5-point or 7-point scale according to patients' experience with the medication. The items covered are satisfaction with the effect of the medication, convenience and global treatment satisfaction. Each domain is based on 3 questions. The score is calculated in a range from 0 to 100, where a higher score reflects a better outcome. Scores have been summed and then scaled to 0-100."}, {'measure': 'TSQM-9 Scores (Domain Scores) (Week 87)', 'timeFrame': 'Week 87', 'description': "Scores from the TSQM-9 scale were calculated at the end of the extension treatment period (week 87). The Treatment Satisfaction Questionnaire for Medication - 9 items (TSQM-9) is a generic questionnaire that measures a patients' satisfaction with medication. Items are rated on a 5-point or 7-point scale according to patients' experience with the medication. The items covered are satisfaction with the effect of the medication, convenience and global treatment satisfaction. Each domain is based on 3 questions. The score is calculated in a range from 0 to 100, where a higher score reflects a better outcome. Scores have been summed and then scaled to 0-100."}, {'measure': 'Change in Total Cholesterol (Week 34)', 'timeFrame': 'Week -3, week 34', 'description': 'Change in Total cholesterol was measured from baseline (week -3) until the end of the main treatment period (week 34).'}, {'measure': 'Change in Total Cholesterol (Week 87)', 'timeFrame': 'week -3, week 87', 'description': 'Change in Total cholesterol was measured from baseline (week -3) until the end of the extension treatment period (week 87).'}, {'measure': 'Change in HDL-cholesterol (Week 34)', 'timeFrame': 'Week -3, week 34', 'description': 'Change in High-density lipoprotein (HDL) cholesterol was measured from baseline (week -3) until the end of the main treatment period (week 34).'}, {'measure': 'Change in HDL-cholesterol (Week 87)', 'timeFrame': 'week -3, week 87', 'description': 'Change in HDL-cholesterol was measured from baseline (week -3) until the end of the extension treatment period (week 87).'}, {'measure': 'Change in LDL-cholesterol (Week 34)', 'timeFrame': 'Week -3, week 34', 'description': 'Change in Low-density lipoprotein (LDL) cholesterol was measured from baseline (week -3) until the end of the main treatment period (week 34).'}, {'measure': 'Change in LDL-cholesterol (Week 87)', 'timeFrame': 'week -3, week 87', 'description': 'Change in LDL-cholesterol was measured from baseline (week -3) until the end of the extension treatment period (week 87).'}, {'measure': 'Change in Triglycerides (Week 34)', 'timeFrame': 'Week -3, week 34', 'description': 'Change in Triglycerides was measured from baseline (week -3) until the end of the main treatment period (week 34).'}, {'measure': 'Change in Triglycerides (Week 87)', 'timeFrame': 'week -3, week 87', 'description': 'Change in Triglycerides was measured from baseline (week -3) until the end of the extension treatment period (week 87).'}, {'measure': 'Change in Hs-CRP (Week 34)', 'timeFrame': 'Week -3, week 34', 'description': 'Change in high-sensitivity C-reactive protein (hs-CRP) was measured from baseline (week -3) until the end of the main treatment period (week 34).'}, {'measure': 'Change in Hs-CRP (Week 87)', 'timeFrame': 'week -3, week 87', 'description': 'Change in hs-CRP was measured from baseline (week -3) until the end of the extension treatment period (week 87).'}, {'measure': 'Change in IL-6 (Week 34)', 'timeFrame': 'Week -3, week 34', 'description': 'Change in Interleukin 6 (IL-6) was measured from baseline (week -3) until the end of the main treatment period (week 34).'}, {'measure': 'Change in IL-6 (Week 87)', 'timeFrame': 'week -3, week 87', 'description': 'Change in IL-6 was measured from baseline (week -3) until the end of the extension treatment period (week 87).'}, {'measure': 'Change in Body Weight (Week 34)', 'timeFrame': 'Week -3, week 34', 'description': 'Change in body weight was measured from baseline (week -3) until the end of the main treatment period (week 34).'}, {'measure': 'Change in Body Weight (Week 87)', 'timeFrame': 'week -3, week 87', 'description': 'Change in body weight was measured from baseline (week -3) until the end of the extension treatment period (week 87).'}, {'measure': 'Change in Waist Circumference (Week 34)', 'timeFrame': 'Week -3, week 34', 'description': 'Change in waist circumference was measured from baseline (week -3) until the end of the main treatment period (week 34).'}, {'measure': 'Change in Waist Circumference (Week 87)', 'timeFrame': 'week -3, week 87', 'description': 'Change in waist circumference was measured from baseline (week -3) until the end of the extension treatment period (week 87).'}, {'measure': 'Number of Adverse Events (Weeks 0-35)', 'timeFrame': 'Weeks 0-35', 'description': 'Number of adverse events from baseline (week 0) until the end of week 35 were reported. This endpoint shows number of treatment-emergent adverse events (TEAEs), including the injection site reactions.'}, {'measure': 'Number of Adverse Events (Weeks 0-88)', 'timeFrame': 'Weeks 0-88', 'description': 'Number of adverse events from baseline (week 0) until the end of week 88 were reported. This endpoint shows the number of TEAEs along with the injection site reactions.'}, {'measure': 'Occurrence of Anti-NNC0195-0092 Antibodies (Weeks 0-35)', 'timeFrame': 'Weeks 0 to 35', 'description': 'Number of participants with anti-NNC0195-0092 antibodies at week 35 was recorded. The numbers presented in this endpoint are the participants that were found to have positive antibodies.'}, {'measure': 'Occurrence of Anti-NNC0195-0092 Antibodies (Weeks 0-88)', 'timeFrame': 'Weeks 0 to 88', 'description': 'Number of participants with anti-NNC0195-0092 antibodies at week 88 was recorded. The numbers presented in this endpoint are the participants that were found to have positive antibodies.'}, {'measure': 'Incidence of Technical Complaints During Exposure to Trial Product (Weeks 0-35)', 'timeFrame': 'Weeks 0 to 35', 'description': 'Incidence of technical complaints were recorded from baseline (week 0) until week 35.'}, {'measure': 'Incidence of Technical Complaints During Exposure to Trial Product (Weeks 0-88)', 'timeFrame': 'Weeks 0 to 88', 'description': 'Incidence of technical complaints were recorded from baseline (week 0) until week 88.'}, {'measure': 'Change in Physical Examination During Exposure to Trial Product (Week 35)', 'timeFrame': 'Week 0 and week 35', 'description': 'Change in physical examination from baseline (week 0) until the end of the main treatment period (week 35) was reported. Results are presented for the following examinations: 1) Head, neck, eyes and nose 2) Respiratory system (sys.) 3) Cardiovascular sys. 4) Gastrointestinal sys. 5) Musculoskeletal sys. 6) Central \\& Peripheral nervous sys. 7) Skin 8) Lymph node palpation'}, {'measure': 'Change in Physical Examination During Exposure to Trial Product (Week 88)', 'timeFrame': 'Week 0 and week 88', 'description': 'Change in physical examination from baseline (week 0) until the end of the extension period (week 88) was reported. Results are presented for the following examinations: 1) Head, neck, eyes and nose 2) Respiratory system (sys.) 3) Cardiovascular sys. 4) Gastrointestinal sys. 5) Musculoskeletal sys. 6) Central \\& Peripheral nervous sys. 7) Skin 8) Lymph node palpation'}, {'measure': 'Change in Electrocardiogram (ECG) Evaluation During Exposure to Trial Product (Week 35)', 'timeFrame': 'Week -3 and week 35', 'description': 'Change in Electrocardiogram (ECG) evaluation from baseline (week -3) until the end of the main treatment period (week 35) was reported.'}, {'measure': 'Change in ECG Evaluation During Exposure to Trial Product (Week 88)', 'timeFrame': 'Week -3 and week 88', 'description': 'Change in ECG evaluation from baseline (week 0) until the end of the extension period (Week 88) was reported.'}, {'measure': 'Change in Diastolic Blood Pressure (Week 35)', 'timeFrame': 'Week -3, week 35', 'description': 'Change in diastolic blood pressure was measured from baseline (week -3) until the end of the main treatment period (week 35).'}, {'measure': 'Change in Diastolic Blood Pressure (Week 88)', 'timeFrame': 'Week -3, week 88', 'description': 'Change in diastolic blood pressure was measured from baseline (week -3) until the end of the extension treatment period week 88.'}, {'measure': 'Change in Systolic Blood Pressure (Week 35)', 'timeFrame': 'Week -3, week 35', 'description': 'Change in systolic blood pressure was measured from baseline (week -3) until the end of the main treatment period (week 35).'}, {'measure': 'Change in Systolic Blood Pressure (Week 88)', 'timeFrame': 'Week -3, week 88', 'description': 'Change in systolic blood pressure was measured from baseline (week -3) until the end of the extension treatment period (week 88).'}, {'measure': 'Change in Pulse (Week 35)', 'timeFrame': 'Week -3, week 35', 'description': 'Change in pulse was measured from baseline (week -3) until the end of the main treatment period (week 35).'}, {'measure': 'Change in Pulse (Week 88)', 'timeFrame': 'Week -3, week 88', 'description': 'Change in pulse was measured from baseline (week -3) until the end of the extension treatment period (week 88).'}, {'measure': 'Change in Haemoglobin (Week 34)', 'timeFrame': 'Week -3, week 34', 'description': 'Change in Haemoglobin was measured from baseline (week -3) until the end of the main treatment period (week 34).'}, {'measure': 'Change in Haemoglobin (Week 87)', 'timeFrame': 'week -3, week 87', 'description': 'Change in Haemoglobin was measured from baseline (week -3) until the end of the week 87.'}, {'measure': 'Change in Haematocrit (Week 34)', 'timeFrame': 'Week -3, week 34', 'description': 'Change in Haematocrit was measured from baseline (week -3) until the end of the main treatment period (week 34).'}, {'measure': 'Change in Haematocrit (Week 87)', 'timeFrame': 'week -3, week 87', 'description': 'Change in Haematocrit was measured from baseline (week -3) until the end of the week 87.'}, {'measure': 'Change in Erythrocytes (Week 34)', 'timeFrame': 'Week -3, week 34', 'description': 'Change in Erythrocytes was measured from baseline (week -3) until the end of the main treatment period (week 34).'}, {'measure': 'Change in Erythrocytes (Week 87)', 'timeFrame': 'week -3, week 87', 'description': 'Change in Erythrocytes was measured from baseline (week -3) until the end of the week 87.'}, {'measure': 'Change in Mean Corpuscular Volume (MCV) (Week 34)', 'timeFrame': 'Week -3, week 34', 'description': 'Change in Mean corpuscular volume (MCV) was measured from baseline (week -3) until the end of the main treatment period (week 34).'}, {'measure': 'Change in Mean Corpuscular Volume (MCV) (Week 87)', 'timeFrame': 'week -3, week 87', 'description': 'Change in Mean corpuscular volume (MCV) was measured from baseline (week -3) until the end of the week 87.'}, {'measure': 'Change in Mean Corpuscular Haemoglobin Concentration (MCHC) (Week 34)', 'timeFrame': 'Week -3, week 34', 'description': 'Change in Mean corpuscular haemoglobin concentration (MCHC) was measured from baseline (week -3) until the end of the main treatment period (week 34).'}, {'measure': 'Change in Mean Corpuscular Haemoglobin Concentration (MCHC) (Week 87)', 'timeFrame': 'week -3, week 87', 'description': 'Change in Mean corpuscular haemoglobin concentration (MCHC) was measured from baseline (week -3) until the end of the week 87.'}, {'measure': 'Change in Thrombocytes (Week 34)', 'timeFrame': 'Week -3, week 34', 'description': 'Change in Thrombocytes was measured from baseline (week -3) until the end of the main treatment period (week 34).'}, {'measure': 'Change in Thrombocytes (Week 87)', 'timeFrame': 'week -3, week 87', 'description': 'Change in Thrombocytes was measured from baseline (week -3) until the end of the week 87.'}, {'measure': 'Change in Leucocytes (Week 34)', 'timeFrame': 'Week -3, week 34', 'description': 'Change in Leucocytes was measured from baseline (week -3) until the end of the main treatment period (week 34).'}, {'measure': 'Change in Leucocytes (Week 87)', 'timeFrame': 'week -3, week 87', 'description': 'Change in Leucocytes was measured from baseline (week -3) until the end of the week 87.'}, {'measure': 'Change in Alanine Aminotransferase (ALT) (Week 34)', 'timeFrame': 'Week -3, week 34', 'description': 'Change in ALT was measured from baseline (week -3) until the end of the main treatment period (week 34).'}, {'measure': 'Change in Alanine Aminotransferase (ALT) (Week 87)', 'timeFrame': 'week -3, week 87', 'description': 'Change in ALT was measured from baseline (week -3) until the end of the week 87.'}, {'measure': 'Change in Albumin (Week 34)', 'timeFrame': 'Week -3, week 34', 'description': 'Change in Albumin was measured from baseline (week -3) until the end of the main treatment period (week 34).'}, {'measure': 'Change in Albumin (Week 87)', 'timeFrame': 'week -3, week 87', 'description': 'Change in Albumin was measured from baseline (week -3) until the end of the week 87.'}, {'measure': 'Change in Alkaline Phosphatase (ALP) (Week 34)', 'timeFrame': 'Week -3, week 34', 'description': 'Change in Alkaline phosphatase (ALP) was measured from baseline (week -3) until the end of the main treatment period (week 34).'}, {'measure': 'Change in Alkaline Phosphatase (AP) (Week 87)', 'timeFrame': 'Week -3, week 87', 'description': 'Change in Alkaline phosphatase (AP) was measured from baseline (week -3) until the end of the week 87.'}, {'measure': 'Change in Aspartate Aminotransferase (AST) (Week 34)', 'timeFrame': 'Week -3, week 34', 'description': 'Change in AST was measured from baseline (week -3) until the end of the main treatment period (week 34).'}, {'measure': 'Change in Aspartate Aminotransferase (AST) (Week 87)', 'timeFrame': 'Week -3, week 87', 'description': 'Change in AST was measured from baseline (week -3) until the end of the extension treatment period (week 87).'}, {'measure': 'Change in Bilirubin (Week 34)', 'timeFrame': 'Week -3, week 34', 'description': 'Change in Bilirubin was measured from baseline (week -3) until the end of the main treatment period (week 34).'}, {'measure': 'Change in Bilirubin (Week 87)', 'timeFrame': 'week -3, week 87', 'description': 'Change in Bilirubin was measured from baseline (week -3) until the end of the extension treatment period (week 87).'}, {'measure': 'Change in Calcium (Week 34)', 'timeFrame': 'Week -3, week 34', 'description': 'Change in Calcium was measured from baseline (week -3) until the end of the main treatment period (week 34).'}, {'measure': 'Change in Calcium (Week 87)', 'timeFrame': 'week -3, week 87', 'description': 'Change in Calcium was measured from baseline (week -3) until the end of the week 87.'}, {'measure': 'Change in Chloride (Week 34)', 'timeFrame': 'Week -3, week 34', 'description': 'Change in Chloride was measured from baseline (week -3) until the end of the main treatment period (week 34).'}, {'measure': 'Change in Chloride (Week 87)', 'timeFrame': 'week -3, week 87', 'description': 'Change in Chloride was measured from baseline (week -3) until the end of the week 87.'}, {'measure': 'Change in Creatinine (Week 34)', 'timeFrame': 'Week -3, week 34', 'description': 'Change in Creatinine was measured from baseline (week -3) until the end of the main treatment period (week 34).'}, {'measure': 'Change in Creatinine (Week 87)', 'timeFrame': 'week -3, week 87', 'description': 'Change in Creatinine was measured from baseline (week -3) until the end of the week 87.'}, {'measure': 'Change in Creatine Kinase (Week 34)', 'timeFrame': 'Week -3, week 34', 'description': 'Change in Creatine kinase was measured from baseline (week -3) until the end of the main treatment period (week 34).'}, {'measure': 'Change in Creatine Kinase (Week 87)', 'timeFrame': 'week -3, week 87', 'description': 'Change in Creatine kinase was measured from baseline (week -3) until the end of the week 87.'}, {'measure': 'Change in Gamma-glutamyl Transferase (GGT) (Week 34)', 'timeFrame': 'Week -3, week 34', 'description': 'Change in GGT was measured from baseline (week -3) until the end of the main treatment period (week 34).'}, {'measure': 'Change in Gamma-glutamyl Transferase (GGT) (Week 87)', 'timeFrame': 'week -3, week 87', 'description': 'Change in GGT was measured from baseline (week -3) until the end of the week 87.'}, {'measure': 'Change in Phosphate (Inorganic) (Week 34)', 'timeFrame': 'Week -3, week 34', 'description': 'Change in Phosphate (inorganic) was measured from baseline (week -3) until the end of the main treatment period (week 34).'}, {'measure': 'Change in Phosphate (Inorganic)(Week 87)', 'timeFrame': 'week -3, week 87', 'description': 'Change in Phosphate (inorganic) was measured from baseline (week -3) until the end of the week 87.'}, {'measure': 'Change in Potassium (Week 34)', 'timeFrame': 'Week -3, week 34', 'description': 'Change in Potassium was measured from baseline (week -3) until the end of the main treatment period (week 34).'}, {'measure': 'Change in Potassium (Week 87)', 'timeFrame': 'week -3, week 87', 'description': 'Change in Potassium was measured from baseline (week -3) until the end of the week 87.'}, {'measure': 'Change in Sodium (Week 34)', 'timeFrame': 'Week -3, week 34', 'description': 'Change in Sodium was measured from baseline (week -3) until the end of the main treatment period (week 34).'}, {'measure': 'Change in Sodium (Week 87)', 'timeFrame': 'week -3, week 87', 'description': 'Change in Sodium was measured from baseline (week -3) until the end of the extension treatment period (week 87).'}, {'measure': 'Change in Total Protein (Week 34)', 'timeFrame': 'Week -3, week 34', 'description': 'Change in total protein was measured from baseline (week -3) until the end of the main treatment period (week 34).'}, {'measure': 'Change in Total Protein (Week 87)', 'timeFrame': 'week -3, week 87', 'description': 'Change in total protein was measured from baseline (week -3) until the end of extension treatment period (week 87).'}, {'measure': 'Change in Urea (Week 34)', 'timeFrame': 'Week -3, week 34', 'description': 'Change in Urea was measured from baseline (week -3) until the end of the main treatment period (week 34).'}, {'measure': 'Change in Urea (Week 87)', 'timeFrame': 'week -3, week 87', 'description': 'Change in Urea was measured from baseline (week -3) until the end of the extension treatment period (week 87).'}, {'measure': 'Change in Uric Acid (Week 34)', 'timeFrame': 'Week -3, week 34', 'description': 'Change in Uric acid was measured from baseline (week -3) until the end of the main treatment period (week 34).'}, {'measure': 'Change in Uric Acid (Week 87)', 'timeFrame': 'week -3, week 87', 'description': 'Change in Uric acid was measured from baseline (week -3) until the end of the extension treatment period (week 87).'}, {'measure': 'Change in Estimated Glomerular Filtration Rate (GFR) Creatinine (CKD-EPI) (Week 34)', 'timeFrame': 'Week -3, week 34', 'description': 'Change in Estimated GFR creatinine (CKD-EPI) was measured from baseline (week -3) until the end of the main treatment period (week 34).'}, {'measure': 'Change in Estimated GFR Creatinine (CKD-EPI) (Week 87)', 'timeFrame': 'week -3, week 87', 'description': 'Change in estimated GFR creatinine (CKD-EPI) was measured from baseline (week -3) until the end of the extension treatment period (week 87).'}, {'measure': 'Change in Fasting Plasma Glucose (Week 34)', 'timeFrame': 'Week -3, week 34', 'description': 'Change in Fasting plasma glucosewas measured from baseline (week -3) until the end of the main treatment period (week 34).'}, {'measure': 'Change in Fasting Plasma Glucose (Week 87)', 'timeFrame': 'week -3, week 87', 'description': 'Change in Fasting plasma glucose was measured from baseline (week -3) until the end of the extension treatment period (week 87).'}, {'measure': 'Change in Fasting Insulin (Week 34)', 'timeFrame': 'Week -3, week 34', 'description': 'Change in Fasting insulin was measured from baseline (week -3) until the end of the main treatment period (week 34).'}, {'measure': 'Change in Fasting Insulin (Week 87)', 'timeFrame': 'week -3, week 87', 'description': 'Change in Fasting insulin was measured from baseline (week -3) until the end of the extension treatment period (week 87).'}, {'measure': 'Change in Steady State Beta Cell Function (%B) (Week 34)', 'timeFrame': 'Week -3, week 34', 'description': 'Change in steady state beta cell function (%B) was measured from baseline (week -3) until the end of the main treatment period (week 34).'}, {'measure': 'Change in Steady State Beta Cell Function (%B) (Week 87)', 'timeFrame': 'week -3, week 87', 'description': 'Change in steady state beta cell function (%B) was measured from baseline (week -3) until the end of the week 87.'}, {'measure': 'Change in Insulin Resistance (IR %) (Week 34)', 'timeFrame': 'Week -3, week 34', 'description': 'Change in Insulin resistance (IR %) was measured from baseline (week -3) until the end of the main treatment period (week 34).'}, {'measure': 'Change in Insulin Resistance (IR %) (Week 87)', 'timeFrame': 'week -3, week 87', 'description': 'Change in Insulin resistance (IR %) was measured from baseline (week -3) until the end of the extension treatment period (week 87).'}, {'measure': 'Change in Glycated Haemoglobin (HbA1c) (%) (Week 34)', 'timeFrame': 'Week -3, week 34', 'description': 'Change in Glycated haemoglobin (HbA1c) (%) was measured from baseline (week -3) until the end of the main treatment period (week 34).'}, {'measure': 'Change in Glycated Haemoglobin (HbA1c) (%) (Week 87)', 'timeFrame': 'week -3, week 87', 'description': 'Change in Glycated haemoglobin (HbA1c) was measured from baseline (week -3) until the end of the extension treatment period (week 87).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Growth Hormone Disorder', 'Adult Growth Hormone Deficiency']}, 'referencesModule': {'references': [{'pmid': '32022863', 'type': 'RESULT', 'citation': 'Johannsson G, Gordon MB, Hojby Rasmussen M, Hakonsson IH, Karges W, Svaerke C, Tahara S, Takano K, Biller BMK. Once-weekly Somapacitan is Effective and Well Tolerated in Adults with GH Deficiency: A Randomized Phase 3 Trial. J Clin Endocrinol Metab. 2020 Apr 1;105(4):e1358-76. doi: 10.1210/clinem/dgaa049.'}, {'pmid': '39991735', 'type': 'DERIVED', 'citation': 'Otsuka F, Rasmussen MH, Endo T, Svaerke C, Tahara S, Johannsson G. Efficacy in Japanese adults with growth hormone deficiency receiving weekly somapacitan or daily growth hormone: results from phase 3 REAL 1 trial. Front Endocrinol (Lausanne). 2025 Feb 7;16:1534891. doi: 10.3389/fendo.2025.1534891. eCollection 2025.'}, {'pmid': '36380045', 'type': 'DERIVED', 'citation': 'Takahashi Y, Biller BMK, Fukuoka H, Ho KKY, Rasmussen MH, Nedjatian N, Svaerke C, Yuen KCJ, Johannsson G. Weekly somapacitan had no adverse effects on glucose metabolism in adults with growth hormone deficiency. Pituitary. 2023 Feb;26(1):57-72. doi: 10.1007/s11102-022-01283-3. Epub 2022 Nov 15.'}], 'seeAlsoLinks': [{'url': 'http://novonordisk-trials.com', 'label': 'Clinical Trials at Novo Nordisk'}]}, 'descriptionModule': {'briefSummary': 'This study is conducted globally. The purpose is to demonstrate the efficacy of once weekly dosing of NNC0195-0092 (somapacitan) compared to placebo and once-daily dosing of somatropin (human growth hormone, hGH) after 35 weeks of treatment in adults with growth hormone deficiency.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '23 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or female of at least 23 years of age and not more than 79 years of age at the time of signing informed consent\n* Human growth hormone (hGH) treatment naïve or no exposure to hGH or growth hormone (GH) secretagogues for at least 180 days prior to randomisation with any registered or investigational hGH or GH secretagogue product (if only used in connection with stimulation tests for diagnosis of growth hormone deficiency (GHD), subjects can be included)\n* If applicable, hormone replacement therapies for any other hormone deficiencies, adequate and stable for at least 90 days prior to randomisation as judged by the investigator\n* FOR ALL COUNTRIES EXCEPT JAPAN:\n\nConfirmed diagnosis of adult growth hormone deficiency (Subjects must satisfy one of the following criterion and documentation of test results must be available before randomisation (either from subjects' file or new test):\n\n1. Insulin tolerance test (ITT) or glucagon test: a peak GH response of less than 3 ng/mL (3 mcg/L)\n2. Growth hormone releasing hormone (GHRH) + arginine test according to body mass index (BMI): i) BMI less than 25 kg/m\\^2, a peak GH less than 11 ng/mL (11 mcg/L), ii) BMI 25-30 kg/m\\^2, a peak GH less than 8 ng/mL (8 mcg/L), iii) BMI greater than 30 kg/m\\^2, a peak GH less than 4 ng/mL (4 mcg/L)\n3. Three or more pituitary hormone deficiencies and insulin like growth factor - I standard deviation score (IGF-I SDS) less than -2.0 - FOR JAPAN ONLY: Confirmed diagnosis of adult growth hormone deficiency (subjects with adult onset adult growth hormone deficiency (AGHD) need to satisfy at least one of the following criteria, subjects with a history of childhood GHD need to satisfy at least 2 of the following criteria):\n\na. ITT test: a peak GH of less than or equal to 1.8 ng/mL (assay using recombinant GH standard) b. glucagon test: a peak GH of less than or equal to 1.8 ng/mL (assay using recombinant GH standard) c. growth hormone releasing peptide 2 (GHRP-2) tolerance test: a peak GH of less than or equal to 9 ng/mL (assay using recombinant GH standard)\n\nExclusion Criteria:\n\n* Active malignant disease or history of malignancy. Exceptions to this exclusion criterion: - Resection in situ carcinoma of the cervix uteri. Complete eradication of squamous cell or basal cell carcinoma of the skin\n* Subjects with GHD attributed to treatment of intracranial malignant tumours or leukaemia, provided that a recurrence-free survival period of at least 5 years is documented in the subject's file"}, 'identificationModule': {'nctId': 'NCT02229851', 'acronym': 'REAL 1', 'briefTitle': 'Trial to Compare the Efficacy and Safety of NNC0195-0092 (Somapacitan) With Placebo and Norditropin® FlexPro® (Somatropin) in Adults With Growth Hormone Deficiency.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'A Multicentre, Multinational, Randomised, Parallel-group, Placebo-controlled (Double Blind) and Active-controlled (Open) Trial to Compare the Efficacy and Safety of Once Weekly Dosing of NNC0195-0092 (Somapacitan) With Once Weekly Dosing of Placebo and Daily Norditropin® FlexPro® in Adults With Growth Hormone Deficiency for 35 Weeks, Followed by a 53-week Open-label Extension Period', 'orgStudyIdInfo': {'id': 'NN8640-4054'}, 'secondaryIdInfos': [{'id': '2013-002892-16', 'type': 'REGISTRY', 'domain': 'European Medicines Agency'}, {'id': 'U1111-1145-0211', 'type': 'OTHER', 'domain': 'World Health Organization (WHO)'}, {'id': 'JapicCTI-152767', 'type': 'REGISTRY', 'domain': 'JAPIC'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NNC0195-0092 (somapacitan)', 'interventionNames': ['Drug: somapacitan']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Daily hGH', 'interventionNames': ['Drug: somatropin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Switch to NNC0195-0092 (somapacitan) treatment in the extension period.', 'interventionNames': ['Drug: somapacitan', 'Drug: placebo']}], 'interventions': [{'name': 'somapacitan', 'type': 'DRUG', 'otherNames': ['NNC0195-0092'], 'description': "Administered subcutaneously (s.c., under the skin) once weekly for 26 weeks following 8 weeks of titration. Extension of 44 weeks' treatment following 8 weeks of titration.", 'armGroupLabels': ['NNC0195-0092 (somapacitan)', 'Placebo']}, {'name': 'somatropin', 'type': 'DRUG', 'description': "Administered subcutaneously (s.c., under the skin) once daily for 26 weeks following 8 weeks of titration. Re-randomisation to extension of 44 weeks' treatment following 8 weeks of titration.", 'armGroupLabels': ['Daily hGH']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'Administered subcutaneously (s.c., under the skin) once weekly for 26 weeks following 8 weeks of titration.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 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