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Assessing heterogeneity in relative treatment efficacy by age, sex and comorbidity.








Assessing heterogeneity in relative treatment efficacy by age, sex and comorbidity.


Dr David A McAllister


University of Glasgow


Wellcome Trust - Intermediate Clinical Fellowship and Wellcome Beit Award
(201492/Z/16/Z)


Roche - received payment of £550 from Roche pharmaceuticals for giving presentation on the uses of routine healthcare data to Scottish respiratory clinicians.
GSK - collaborated on secondary analysis of clinical trial in patients with COPD. Co-author on submitted article. No financial aspects to this collaboration.
Galecto - received payment of £500 for advising on study design based on analysis of characteristics of patients within a local cohort.


12 February 2018


Less than half of patients with a chronic condition have only a single disease. Most have multiple diseases - or multimorbidity. People with multimorbidity are less likely to receive recommended treatments; Partly because clinical practice guidelines, which make treatment recommendations, rarely provide specific treatment recommendations for people with multimorbidity.
This rarity reflects uncertainty as to whether standard treatment recommendations should apply to multimorbidity. Clinical trials usually resolve such uncertainties, but it is not feasible to conduct trials large enough to examine the most common patterns of multimorbidity, even for the most important treatments. Analysing data from large healthcare databases is a feasible alternative, but such analyses have in several cases led to inaccurate conclusions.
Therefore, individual clinicians have to estimate treatment effectiveness in people with multimorbidity unsupported by guidance or high quality evidence. There is therefore a need to develop novel methods, for determining treatment effectiveness in multimorbidity.
Evidence synthesis (ES), where modellers combine data from multiple sources, is a promising approach. Using ES, results from clinical trials may be combined with other data to estimate treatment effects for particular groups. However, ES has not yet been developed for the problem of multimorbidity and there are a number of additional challenges.
In a project funded by the Wellcome Trust we plan to develop and validate an approach to determine treatment effectiveness in people with multimorbidity. As part of that project we aim to determine whether and how, for different groups of related drug-classes, relative treatment effects differ according to the presence or absence of specific co-existing diseases.
We have identified 201 suitable trials. We will use these to ‘survey' how treatment effects vary according to the presence of co-existing diseases for different types of drug and treatment outcome (eg blood pressure, mortality).
Rather than focusing on individual drugs we will summarise this variation for drug-classes and groupings of related drug classes. We will use statistical models similar to those outlined in the NICE Technical Support Documents for ES.
This work will improve the health of people with multimorbidity. If we find that there is very little variation, it will considerably simplify the challenge of determining treatment effectiveness in multimorbidity. If instead we discover substantial variation, this knowledge may be incorporated into ES, resulting in more robust valid estimates of treatment effectiveness.



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"Description": "1 Year Trial Telmisartan 80 mg Versus Valsartan 160 mg in Hypertensive Type 2 Diabetic Patients With Overt Nephropathy" },{ "PostingID": 2031, "Title": "BI-502.327", "Description": "Telmisartan vs. Valsartan in Patients With Mild to Moderate Hypertension Following a Missed Dose" },{ "PostingID": 2032, "Title": "BI-502.413", "Description": "INNOVATION Study - Telmisartan (Micardis) in Incipient Diabetic Nephropathy" },{ "PostingID": 2034, "Title": "BI-502.392", "Description": "PROBE Investigation of the Safety & Efficacy of Telmisartan (Micardis®) vs Ramipril (Altace®) Using ABPM in HTN" },{ "PostingID": 2035, "Title": "BI-502.397", "Description": "A Prospective, Randomised, Double-blind, Double-dummy, Forced-titration, Multicentre, Parallel Group, One Year Treatment Trial to Compare Telmisartan (MICARDIS) 80 mg Versus Losartan (COZAAR) 100 mg, in Hypertensive Type 2 Diabetic Patients With Overt Nephropathy (AMADEO Study)" },{ "PostingID": 2043, "Title": "BI-205.282", 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Safety of TAK-390MR (60 mg Once-daily [QD] and 90 mg QD) and an Active Comparator, Lansoprazole (30 mg QD) on Healing of Erosive Esophagitis" },{ "PostingID": 2329, "Title": "TAKEDA-T-EE04-086", "Description": "A Phase 3 Study to Evaluate the Safety and Efficacy of Dexlansoprazole MR (60 mg QD and 90 mg QD) Compared to Placebo in Maintenance of Healing in Subjects With Healed Erosive Esophagitis" },{ "PostingID": 2330, "Title": "TAKEDA-T-EE04-087", "Description": "A Phase 3 Study to Evaluate the Safety and Efficacy of Dexlansoprazole MR (60 mg QD and 90 mg QD) Compared to Placebo in Maintenance of Healing in Subjects With Healed Erosive Esophagitis" },{ "PostingID": 2331, "Title": "TAKEDA-T-EE05-135", "Description": "A Phase 3 Study to Evaluate the Safety and Efficacy of TAK-390MR (30 mg QD and 60 mg QD) Compared to Placebo in Maintenance of Healing in Subjects With Healed Erosive Esophagitis" },{ "PostingID": 2332, "Title": "TAKEDA-T-GD04-082", "Description": "A Phase 3 Study to 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"GSK-CIL103657", "Description": "A Randomized, 24-week, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Safety and Tolerability of ARIFLO® (15mg BID) in Patients with Chronic Obstructive Pulmonary Disease (COPD)" },{ "PostingID": 2462, "Title": "GSK-B2C112060", "Description": "A randomized, double-blind, double-dummy, parallel-group, placebo controlled (on inhaled corticosteroid medication), multicenter study to evaluate the efficacy and safety of vilanterol inhalation powder (GW642444) and salmeterol, compared with placebo in the treatment of persistent asthma in adults and adolescents uncontrolled on inhaled corticosteroids" },{ "PostingID": 2481, "Title": "TAKEDA-01-05-TL-491-008", "Description": "A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of TAK-491 in Subjects With Essential Hypertension" },{ "PostingID": 2482, "Title": "TAKEDA-01-05-TL-491-009", "Description": "A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of TAK-491 When Co-administered With Chlorthalidone in Subjects With Essential Hypertension" },{ "PostingID": 2484, "Title": "TAKEDA-01-05-TL-491-010", "Description": "A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of TAK-491 When Co-administered With Amlodipine 5 mg in Subjects With Essential Hypertension" },{ "PostingID": 2485, "Title": "TAKEDA-01-06-TL-491-011", "Description": "A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of TAK-491 in Black Subjects With Essential Hypertension" },{ "PostingID": 2489, "Title": "TAKEDA-01-06-TL-491-016", "Description": "An 8-Month Phase 3, Open-Label Study With a Blinded Reversal Phase to Evaluate the Safety and Tolerability of TAK-491 in Subjects With Essential Hypertension" },{ "PostingID": 2491, "Title": "TAKEDA-01-06-TL-491-019", "Description": "A Double-Blind, Randomized, Placebo-Controlled, 5-Arm Titration Study to Evaluate the Efficacy and Safety of TAK-491 When Compared With Valsartan and Olmesartan in Subjects With Essential Hypertension" },{ "PostingID": 2492, "Title": "TAKEDA-01-06-TL-491-020", "Description": "A Double-Blind, Randomized, Parallel-Group Study to Compare the Efficacy and Safety of TAK-491 With Ramipril in Subjects With Essential Hypertension" },{ "PostingID": 2502, "Title": "TAKEDA-TAK-491_301", "Description": "A Double-Blind, Randomized, Parallel-Group Study to Compare the Efficacy and Safety of TAK-491 With Valsartan in Subjects With Essential Hypertension" },{ "PostingID": 2511, "Title": "BI-1245.36", "Description": "Efficacy and Safety of Empagliflozin (BI 10773) in Patients With Type 2 Diabetes and Renal Impairment" },{ "PostingID": 2513, "Title": "BI-1245.48", "Description": "12 Week Efficacy and Safety Study of Empagliflozin (BI 10773) in Hypertensive Patients With Type 2 Diabetes Mellitus" },{ "PostingID": 2521, "Title": "BI-107.210", "Description": "Study to Compare Prescription Non-Steroidal Anti-Inflammatory Drug (NSAID) Changes, Health Care Utilization, Efficacy and Safety of Meloxicam 7.5 mg Versus Usual Care Administration of Prescription NSAIDs in a Managed Healthcare Setting in Patients With Osteoarthritis" },{ "PostingID": 2567, "Title": "ROCHE-MA17903", "Description": "Double-blind, partially randomized, parallel group, multicenter study to assess the efficacy and safety of 100 mg and 150 mg monthly oral ibandronate in women with postmenopausal osteoporosis having completed the phase III oral ibandronate trial BM16549

Medicine: Ibandronate, Condition: osteoporosis with pathological fracture, Phase: 4, Clinical Study ID: MA17903, Sponsor: Roche" },{ "PostingID": 2606, "Title": "BI-248.671", "Description": "Pramipexole Extended Release Versus Pramipexole Immediate Release for 18 Weeks in Chinese Parkinson's Disease (PD) Patients" },{ "PostingID": 2616, "Title": "BI-502.376", "Description": "Study to Evaluate Efficacy of Micardis® (Telmisartan) and Valsartan in Patients With Mild-to-moderate Hypertension After Missing One Dose Using Ambulatory Blood Pressure Monitoring" },{ "PostingID": 2627, "Title": "BI-205.452", "Description": "Comparison of Tiotropium in the HandiHaler Versus the Respimat in Chronic Obstructive Pulmonary Disease" },{ "PostingID": 2630, "Title": "GSK-AVA102672", "Description": "A 54-week, double-blind, randomized, placebo-controlled, parallel-group study to investigate the effects of rosiglitazone (extended release tablets) as adjunctive therapy to donepezil on cognition and overall clinical response in APOE ε4-stratified subjects with mild to moderate Alzheimer’s disease." },{ "PostingID": 2642, "Title": "ROCHE-NA25220", "Description": "A randomized, double-blind, parallel-group study of safety and the effect on clinical outcome of tocilizumab SC versus placebo SC in combination with traditional disease modifying anti-rheumatic drugs (DMARDs) in patients with moderate to severe active rheumatoid arthritis" },{ "PostingID": 2644, "Title": "ROCHE-WA19926", "Description": "Multi-center, randomized, double-blind, parallel group study of the safety, disease remission & prevention of structural joint damage during treatment with tocilizumab as a monotherapy & in combination with methotrexate versus methotrexate in pts with early moderate to severe rheumatoid arthritis" },{ "PostingID": 2645, "Title": "ROCHE-WA22762", "Description": "A Phase III multicenter, double blind, placebo controlled, parallel group study of the safety and efficacy of a subcutaneous formulation of tocilizumab administered once or twice weekly versus an intravenous administration of tocilizumab administered once every four weeks." },{ "PostingID": 2647, "Title": "ROCHE-WA19924", "Description": "A Multi-center, Randomized, Blinded, Parallel-group Study of the Reduction of Signs and Symptoms During Monotherapy Treatment With Tocilizumab 8 mg/kg Intravenously Versus Adalimumab 40 mg Subcutaneously in Patients With Rheumatoid Arthritis" },{ "PostingID": 2745, "Title": "ASTELLAS-178-CL-049", "Description": "A Randomized, Double-Blind, Parallel Group, Active Controlled, Multi-center Long-term Study to Assess the Safety and Efficacy of the Beta-3 Agonist Mirabegron (YM178) 50 mg qd and 100 mg qd in Subjects with Symptoms of Overactive Bladder." },{ "PostingID": 2746, "Title": "ASTELLAS-178-CL-074", "Description": "A Phase III, Randomized, Double-Blind, Parallel Group, Placebo Controlled, Multicenter Study to Assess the Efficacy and Safety of the Beta-3 Agonist Mirabegron (25 mg qd and 50 mg qd) in Subjects with Symptoms of Overactive bladder." },{ "PostingID": 2747, "Title": "ASTELLAS-178-EC-001", "Description": "A Double-Blind, Randomized, Parallel Group, Multi-Centre Study to Evaluate the Efficacy and Safety of Mirabegron Compared to Solifenacin in Subjects with Overactive Bladder (OAB) Treated with Antimuscarinics and Dissatisfied due to Lack of Efficacy." },{ "PostingID": 2749, "Title": "ASTELLAS-178-CL-047", "Description": "A Phase III, Randomized, Double-Blind, Parallel Group, Placebo Controlled, Multicenter Study to Assess the Efficacy and Safety of Mirabegron in Subjects with Symptoms of Overactive Bladder." },{ "PostingID": 2844, "Title": "LILLY-H3S-MC-GGGK", "Description": "Comparison of Raloxifene Hydrochloride and Placebo in the Treatment of Postmenopausal Women With Osteoporosis" },{ "PostingID": 2930, "Title": "BI-1222.51", "Description": "Co-administration of Olodaterol Respimat® and Tiotropium Handihaler®" },{ "PostingID": 3023, "Title": "LILLY-B3D-MC-GHAC", "Description": "Effects of LY333334 in the Treatment of Postmenopausal Women With Osteoporosis" },{ "PostingID": 3030, "Title": "LILLY-B3D-US-GHBZ", "Description": "Comparison of the Effects of Teriparatide With Those of Alendronate Sodium on Lumbar Spine Bone Mineral Density in Glucocorticoid-Induced Osteoporosis" },{ "PostingID": 3036, "Title": "BI-1199.32", "Description": "Safety and Efficacy of BIBF 1120 at High Dose in Idiopathic Pulmonary Fibrosis Patients" },{ "PostingID": 3037, "Title": "BI-1199.34", "Description": "Safety and Efficacy of BIBF 1120 at High Dose in Idiopathic Pulmonary Fibrosis Patients II" },{ "PostingID": 3039, "Title": "TAKEDA-C02-009", "Description": "A Phase III, Randomized, Multicenter, Allopurinol and Placebo-Controlled Study Assessing the Safety and Efficacy of Oral Febuxostat in Subjects With Gout" },{ "PostingID": 3040, "Title": "TAKEDA-C02-010", "Description": "A Phase 3, Randomized, Multicenter Study Comparing the Safety and Efficacy of Oral Febuxostat Versus Allopurinol in Subjects With Gout" },{ "PostingID": 3041, "Title": "TAKEDA-C02-021", "Description": "A Phase 3, Open-Label, Randomized, Allopurinol-Controlled Study to Assess the Long-Term Safety of Oral Febuxostat in Subjects With Gout" },{ "PostingID": 3042, "Title": "TAKEDA-F-GT06-153", "Description": "A Phase 3, Randomized, Multicenter, Double-Blind, Allopurinol-Controlled Study Assessing the Efficacy and Safety of Oral Febuxostat in Subjects With Gout" },{ "PostingID": 3094, "Title": "TAKEDA-SYR-322_402", "Description": "A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Cardiovascular Outcomes Following Treatment With Alogliptin in Addition to Standard of Care in Subjects With Type 2 Diabetes and Acute Coronary Syndrome" },{ "PostingID": 3387, "Title": "GSK-COR103561", "Description": "A Randomized, Double-Blind, Multi-Center Study Comparing the Effects of Carvedilol Phosphate Modified Release Formulation (COREG- MR) with Metoprolol Succinate (TOPROL XL) on the Lipid Profile in Normolipidemic, or Mildly Dyslipidemic Hypertensive Patients" },{ "PostingID": 3388, "Title": "GSK-COR103560", "Description": "A Randomized, Double-blind, Positive-Controlled, Multicenter Study Comparing the Efficacy of Carvedilol Phosphate Modified Release Formulation (COREG MR) and Metoprolol Succinate Extended Release (TOPROL-XL) on the Reduction of Microalbuminuria in Patients with Hypertension and Microalbuminuria" },{ "PostingID": 3412, "Title": "GSK-FFA115285", "Description": "A randomised, double-blind, double-dummy, placebo controlled multi-centre study to evaluate the efficacy and safety of fluticasone furoate inhalation powder and fluticasone propionate inhalation powder in the treatment of asthma in adults and adolescents not currently treated with inhaled corticosteroids" },{ "PostingID": 3415, "Title": "GSK-FFU109045", "Description": "A Comparison of Fluticasone Furoate Nasal
 Spray versus Oral Fexofenadine in the Treatment of Seasonal
 Allergic Rhinitis" },{ "PostingID": 3510, "Title": "ASTELLAS-905-UC-050", "Description": "A Randomized, Double-blind, Parallel, Placebo-controlled, Phase 4, Multicenter Study to Assess Efficacy and Safety of VESIcare® (Solifenacin Succinate) to Improve Urinary Continence of Subjects After Robotic Assisted Radical Prostatectomy" },{ "PostingID": 3512, "Title": "SANOFI-EFC11628", "Description": "6-Month, Multicenter, Randomized, Open-label, Parallel-group Study Comparing the Efficacy and Safety of a New Formulation of Insulin Glargine and Lantus® both plus Mealtime Insulin in Patients with Type 2 Diabetes Mellitus with a 6-Month Safety Extension Period" },{ "PostingID": 3513, "Title": "SANOFI-EFC11629", "Description": "6-Month, Multicenter, Randomized, Open-label, Parallel-group Study Comparing the Efficacy and Safety of a New Formulation of Insulin Glargine and Lantus® Both in Combination with Oral Antihyperglycemic Drug(s) in Patients with Type 2 Diabetes Mellitus with a 6-Month Safety Extension Period" },{ "PostingID": 3614, "Title": "GSK-LOV111820", "Description": "A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial to Assess the Efficacy and Safety of Lovaza for the Prevention of Recurrent, Symptomatic Atrial Fibrillation" },{ "PostingID": 3771, "Title": "BI-205.301", "Description": "Efficacy and Safety of Tiotropium in Patients With COPD and Concomitant Diagnosis of Asthma" },{ "PostingID": 3773, "Title": "SANOFI-EFC6521", "Description": "A multinational, randomized, double blind, placebo-controlled study to evaluate the efficacy and safety of AVE5026 in the prevention of venous thromboembolism (VTE) in cancer patients at high risk for VTE and who are undergoing chemotherapy" },{ "PostingID": 3793, "Title": "GSK-MEA115588", "Description": "MEA115588 A randomised, double-blind, double-dummy, placebo-controlled, parallel-group, multi-centre study of the efficacy and safety of mepolizumab adjunctive therapy in subjects with severe uncontrolled refractory asthma" },{ "PostingID": 3820, "Title": "LILLY-H9X-MC-GBCF", "Description": "A Phase 2/3, Placebo-Controlled, Efficacy and Safety Study of Once-Weekly, Subcutaneous LY2189265 Compared to Sitagliptin in Patients With Type 2 Diabetes Mellitus on Metformin" },{ "PostingID": 3823, "Title": "LILLY-H9X-MC-GBDA", "Description": "A Randomized, Placebo-Controlled Comparison of the Effects of Two Doses of LY2189265 or Exenatide on Glycemic Control in Patients with Type 2 Diabetes on Stable Doses of Metformin and Pioglitazone (AWARD-1: Assessment of Weekly AdministRation of LY2189265 in Diabetes-1))" },{ "PostingID": 3824, "Title": "LILLY-H9X-MC-GBDC", "Description": "The Impact of LY2189265 versus Metformin on Glycemic Control in Early Type 2 Diabetes Mellitus (AWARD-3: Assessment of Weekly AdministRation of LY2189265 in Diabetes-3)" },{ "PostingID": 3825, "Title": "LILLY-H9X-MC-GBDD", "Description": "The Impact of LY2189265 versus Insulin Glargine in Combination with Insulin Lispro for the Treatment to Target of Type 2 Diabetes Mellitus (AWARD-4: Assessment of Weekly AdministRation of LY2189265 in Diabetes-4))" },{ "PostingID": 3826, "Title": "LILLY-H9X-MC-GBDE", "Description": "A Randomized, Open-Label, Parallel-Arm Study Comparing the Effect of Once-Weekly Dulaglutide with Once-Daily Liraglutide in Patients with Type 2 Diabetes (AWARD 6: Assessment of Weekly AdministRation of LY2189265 in Diabetes-6)" },{ "PostingID": 3841, "Title": "BI-502.316", "Description": "Telmisartan With or Without Hydrochlorothiazide (HCTZ) Compared With Losartan With or Without HCTZ in Mild to Moderate Hypertensive Patients" },{ "PostingID": 3872, "Title": "BI-205.417", "Description": "Evaluation of Tiotropium 5 µg/Day Delivered Via the Respimat® Inhaler Over 48 Weeks in Patients With Severe Persistent Asthma on Top of Usual Care (Study II)" },{ "PostingID": 3873, "Title": "BI-205.416", "Description": "Evaluation of Tiotropium 5 µg/Day Delivered Via the Respimat® Inhaler Over 48 Weeks in Patients With Severe Persistent Asthma on Top of Usual Care (Study I)" },{ "PostingID": 3918, "Title": "UCB-C87085", "Description": "Study to Evaluate Efficacy and Safety of Certolizumab Pegol for Induction of Remission in Patients With Crohn's Disease" },{ "PostingID": 3929, "Title": "TAKEDA-SYR-322_305", "Description": "A Multicenter, Randomized, Double-Blind, Active-Controlled Study to Evaluate the Durability of the Efficacy and Safety of Alogliptin Compared to Glipizide When Used in Combination With Metformin in Subjects With Type 2 Diabetes" },{ "PostingID": 3951, "Title": "GSK-200109", "Description": "A study to compare the addition of umeclidinium bromide (UMEC) to fluticasone furoate (FF)/vilanterol (VI), with placebo plus FF/VI in subjects with Chronic Obstructive Pulmonary Disease (COPD) -Study 1" },{ "PostingID": 3952, "Title": "GSK-200110", "Description": "A study to compare the addition of umeclidinium bromide (UMEC) to fluticasone furoate (FF)/vilanterol (VI), with placebo plus FF/VI in subjects with Chronic Obstructive Pulmonary Disease (COPD) -Study 2" },{ "PostingID": 4024, "Title": "UCB-NO1252", "Description": "Double-blind, Randomized Study Evaluating the Efficacy and Safety of Brivaracetam in Adults With Partial Onset Seizures" },{ "PostingID": 4025, "Title": "UCB-NO1253", "Description": "Double-blind, Randomized Study Evaluating the Efficacy and Safety of Brivaracetam in Adults With Partial Onset Seizures" },{ "PostingID": 4037, "Title": "BI-352.2046", "Description": "Inhaled Corticosteroid Withdrawal in Patients With Chronic Obstructive Pulmonary Disease" },{ "PostingID": 4086, "Title": "NOVARTIS-CENA713D1301", "Description": "A 24-week, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-finding Evaluation of the Efficacy, Safety, and Tolerability of the Once-daily Rivastigmine Transdermal Patch in Patients With Probable Alzheimer's Disease (MMSE 10-20)" },{ "PostingID": 4115, "Title": "GSK-201315", "Description": "A Randomized, Parallel-group, Open-label Study to Evaluate the Efficacy and Safety of Umeclidinium (UMEC) 62.5 mcg compared with Glycopyrronium 44 mcg in Subjects with Chronic Obstructive Pulmonary Disease (COPD)" },{ "PostingID": 4116, "Title": "GSK-201316", "Description": "A Randomized, Blinded, Double-dummy, Parallel-group Study to Evaluate the Efficacy and Safety of Umeclidinium (UMEC) 62.5 mcg compared with Tiotropium 18 mcg in Subjects with Chronic Obstructive Pulmonary Disease (COPD)" },{ "PostingID": 4189, "Title": "NOVARTIS-CZOL446H2310", "Description": "Multinational, multicenter, double-blind, randomized, placebo-controlled, parallel group study assessing the efficacy of intravenous zoledronic acid in preventing subsequent osteoporotic fractures after a hip fracture" },{ "PostingID": 4190, "Title": "NOVARTIS-CZOL446H2301", "Description": "A multicenter, double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of zoledronic acid in the treatment of osteoporosis in postmenopausal women taking cal-cium and vitamin D" },{ "PostingID": 4191, "Title": "NOVARTIS-CZOL446H2301E1", "Description": "A 3-year, Double-blind Extension to CZOL446H2301 to Evaluate the Long-term Safety and Efficacy of Zoledronic Acid in the Treatment of Osteoporosis in Postmenopausal Women Taking Calcium and Vitamin D" },{ "PostingID": 4193, "Title": "NOVARTIS-CZOL446H2409", "Description": "A One-year Partial Double-blinded, Randomized, Multi-center, Multi-national Study to Assess the Effects of Combination Therapy of Annual Zoledronic Acid (5 mg) and Daily Subcutaneous Teriparatide (2mcrg) on Postmenopausal Women With Severe Osteoporosis" },{ "PostingID": 4195, "Title": "NOVARTIS-CZOL446M2309", "Description": "A Two Year Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Fracture Efficacy and Safety of Intravenous Zoledronic Acid 5 mg Annually for the Treatment of Osteoporosis in Men" },{ "PostingID": 4196, "Title": "NOVARTIS-CZOL446O2306", "Description": "Efficacy and Safety of Zoledronic Acid in the Prevention and Treatment of Corticosteroid Induced Osteoporosis" },{ "PostingID": 4224, "Title": "GSK-200165", "Description": "Study 200165, A Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel-Group Study to Compare the Efficacy of a 2-Week Treatment with Fluticasone Propionate Nasal Spray versus Cetirizine in Adult Subjects with Seasonal Allergic Rhinitis (SAR)" },{ "PostingID": 4241, "Title": "GSK-AC4116135", "Description": "A multicenter, randomized, double-blind, parallel-group study to evaluate the efficacy and safety of the addition of umeclidinium bromide (62.5mcg) once-daily to fluticasone propionate/salmeterol (250/50mcg) twice-daily, umeclidinium bromide (125mcg) once-daily to fluticasone propionate/salmeterol (250/50mcg) twice-daily versus placebo to fluticasone propionate/salmeterol (250/50mcg) twice-daily over 12 weeks with COPD" },{ "PostingID": 4273, "Title": "LILLY-H9X-MC-GBDB", "Description": "A Randomized, Open-Label, Parallel-Arm, Noninferiority Comparison of the Effects of Two Doses of LY2189265 and Insulin Galrgine on Glycemic Control in Patients with Type 2 Diabetes on Stable Doses of Metformin and Glimeperide (AWARD-2: Assessment of Weekly AdministRation of LY2189265 in Diabetes - 2)" },{ "PostingID": 4274, "Title": "LILLY-H9X-MC-GBDG", "Description": "A Randomized, Parallel-Arm, Double-Blinded Study Comparing the Effect of Once-Weekly Dulaglutide With Placebo in Patients With Type 2 Diabetes Mellitus on Sulfonylurea Therapy (AWARD-8: Assessment of Weekly AdministRation of LY2189265 in Diabetes - 8)" },{ "PostingID": 4372, "Title": "ASTELLAS-178-CL-048", "Description": "Phase III Study of YM178: A double-blind group comparison study in patients with overactive bladder" },{ "PostingID": 4452, "Title": "LILLY-I1F-MC-RHAZ", "Description": "A Multicenter Study With a Randomized, Double-Blind, Placebo-Controlled Induction Dosing Period Followed by a Randomized Maintenance Dosing Period and a Long- Term Extension Period to Evaluate the Efficacy and Safety of LY2439821 in Patients With Moderate-to-Severe Plaque Psoriasis UNCOVER-1" },{ "PostingID": 4453, "Title": "LILLY-I1F-MC-RHBA", "Description": "A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Comparing the Efficacy and Safety of LY2439821 to Etanercept and Placebo in Patients With Moderate-to-Severe Plaque Psoriasis. UNCOVER-2" },{ "PostingID": 4454, "Title": "LILLY-I1F-MC-RHBC", "Description": "A 12-Week Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Comparing the Efficacy and Safety of LY2439821 to Etanercept and Placebo in Patients With Moderate to Severe Plaque Psoriasis With a Long-Term Extension Period UNCOVER-3" },{ "PostingID": 4467, "Title": "LILLY-H6D-MC-LVGY", "Description": "PHIRST-1: Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Phosphodiesterase Type 5 (PDE5) Inhibitor Tadalafil in the Treatment in Patients With Pulmonary Arterial Hypertension" },{ "PostingID": 4468, "Title": "LILLY-H6D-MC-LVHB", "Description": "A Phase 3, Randomized, Double Blind, Placebo and Tamsulosin Controlled, Parallel Design, Multinational Study to Evaluate the Efficacy and Safety of Tadalafil Once a Day Dosing for 12 Weeks in Asian Men With Signs and Symptoms of Benign Prostatic Hyperplasia" },{ "PostingID": 4469, "Title": "LILLY-H6D-MC-LVHG", "Description": "A Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, 5-Group, Multinational Study to Evaluate the Efficacy, Dose Response, and Safety of Tadalafil Once-a-Day Dosing for 12 Weeks in Men With Signs and Symptoms of Benign Prostatic Hyperplasia" },{ "PostingID": 4470, "Title": "LILLY-H6D-MC-LVHJ", "Description": "A Phase 3, Randomized, Double-Blind,
Placebo-Controlled, Parallel-Design, Multinational Study to Evaluate the Efficacy and Safety of Daily Tadalafil for 12 Weeks in Men with Signs and Symptoms of Benign Prostatic Hyperplasia" },{ "PostingID": 4472, "Title": "LILLY-H6D-MC-LVHR", "Description": "A Randomized, Double-Blind, Placebo-Controlled, Parallel Design, Multinational Study to Evaluate the Efficacy and Safety of Tadalafil 2.5 and 5 mg Once Daily Dosing for 12 Weeks for the Treatment of Erectile Dysfunction and Signs and Symptoms of Benign Prostatic Hyperplasia in Men With Both Erectile Dysfunction and Benign Prostatic Hyperplasia" },{ "PostingID": 4473, "Title": "LILLY-H6D-MC-LVHS", "Description": "A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Design Study to Evaluate the Safety and Efficacy of Daily Tadalafil for 12 Weeks in Men with Signs and Symptoms of Benign Prostatic Hyperplasia on Concomitant Alpha1-Adrenergic Blocker Therapy" },{ "PostingID": 4476, "Title": "LILLY-H6D-MC-LVID", "Description": "A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Global Multicenter Study to Evaluate the Efficacy and Safety of Tadalafil Once Daily Dosing for 12 Weeks in Men With Signs and Symptoms of Benign Prostatic Hyperplasia" },{ "PostingID": 4554, "Title": "NOVARTIS-Q4881g", "Description": "A Phase III, Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-ranging Study to Evaluate the Efficacy and Safety of Xolair® (Omalizumab) in Patients With Chronic Idiopathic Urticaria (CIU)/Chronic Spontaneous Urticaria (CSU) Who Remain Symptomatic Despite Antihistamine Treatment (H1)

Medicine: omalizumab, Condition: Chronic Idiopathic Urticaria (CIU), Phase: 3, Clinical Study ID: Q4881g , Sponsor: Novartis." },{ "PostingID": 4555, "Title": "NOVARTIS-Q4882g", "Description": "A Phase III, Multicenter, Randomized, Double-blind, Dose-ranging, Placebo-controlled Study to Evaluate the Efficacy, Response Duration and Safety of Xolair (Omalizumab) in Patients With Chronic Idiopathic Urticaria (CIU)/Chronic Spontaneous Urticaria Who Remain Symptomatic Despite Antihistamine Treatment (H1)

Medicine: omalizumab, Condition: Chronic Idiopathic Urticaria (CIU), Phase: 3, Clinical Study ID: Q4882g , Sponsor: Novartis." },{ "PostingID": 4558, "Title": "NOVARTIS-CAIN457A2302", "Description": "A Randomized, Double-blind, Placebo Controlled, Multicenter Study of Subcutaneous Secukinumab to Demonstrate Efficacy After Twelve Weeks of Treatment, and to Assess the Safety, Tolerability and Long-term Efficacy up to One Year in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis

Medicine: secukinumab, Condition: Psoriasis, Phase: 3, Clinical Study ID: CAIN457A2302 , Sponsor: Novartis." },{ "PostingID": 4559, "Title": "NOVARTIS-CAIN457A2303", "Description": "A Randomized, Double-blind, Double-dummy, Placebo Controlled, Multicenter Study of Subcutaneous Secukinumab to Demonstrate Efficacy After Twelve Weeks of Treatment, Compared to Placebo and Etanercept, and to Assess the Safety, Tolerability and Long-term Efficacy up to One Year in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis

Medicine: secukinumab , Condition: Psoriasis, Phase: 3, Clinical Study ID: CAIN457A2303 , Sponsor: Novartis." },{ "PostingID": 4561, "Title": "BI-1276.1", "Description": "Safety and Efficacy Study of Empagliflozin and Metformin for 24 Weeks in Treatment Naive Patients With Type 2 Diabetes

Medicine: empagliflozin, Condition: Diabetes Mellitus, Type 2;   Hyperglycemia, Phase: 3, Clinical Study ID:  1276.1, Sponsor: Boehringer Ingelheim." }]

Statistical Analysis Plan


https://bmcmedicine.biomedcentral.com/articles/10.1186/s12916-019-1427-1#article-info

Hanlon, P., Hannigan, L., Rodriguez-Perez, J. et al. Representation of people with comorbidity and multimorbidity in clinical trials of novel drug therapies: an individual-level participant data analysis. BMC Med 17, 201 (2019)

DOI: 10.1186/s12916-019-1427-1