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The main purpose of this study is to assess preliminary efficacy and safety of CFZ533/iscalimab (Cohort A), LYS006 (Cohort B), MAS825 (Cohort C), LOU064/remibrutinib (Cohort D) and VAY736/ianalumab (Cohort E) in patients with moderate to severe hidradenitis suppurativa and to determine if CFZ533, LYS006, MAS825, LOU064 and VAY736 have an adequate clinical profile for further clinical development.
This is a randomized, subject and investigator-blinded, placebo-controlled, multi-center and parallel-group non-confirmatory study to assess the efficacy, safety and tolerability of five investigational drugs, CFZ533 (iscalimab), LYS006, MAS825, LOU064 (remibrutinib) and VAY736 (ianalumab) in subjects with moderate to severe hidradenitis suppurativa.
All participants from Cohorts A, B and C had planned a 16-week treatment period and 12-week safety follow up period. All participants for Cohort D had planned a 16-week treatment period and 4-week safety follow up period.
All participants for Cohort E had planned a 16-week treatment period and a mandatory 16-week safety follow-up period, plus a conditional follow-up period for up to 84 weeks for a total maximum follow up period of 2 years. Cohorts A-D are completed and Cohort E is ongoing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A - CFZ533 600 mg | Experimental | CFZ533 600 mg administered subcutaneous (s.c) weekly for 4 weeks, followed by bi-weekly until Week 15. |
|
| Cohort B - LYS006 20 mg | Experimental | LYS006 20 mg administered orally twice per day until Week 16. |
|
| Cohort A - Placebo to CFZ533 | Placebo Comparator | Placebo administered subcutaneous (s.c) weekly for 4 weeks, followed by bi-weekly until Week 15. |
|
| Cohort B - Placebo to LYS006 | Placebo Comparator | Placebo administered orally twice per day until Week 16. |
|
| Cohort C - MAS825 300 mg | Experimental | MAS825 300 mg administered s.c. bi-weekly for 4 weeks, followed by monthly until Week 13. |
|
| Cohort C - Placebo to MAS825 | Placebo Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CFZ533 | Drug | CFZ533 600 mg administered subcutaneous (s.c) weekly for 4 weeks, followed by bi-weekly until Week 15. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Clinical Response Measured by Simplified Hidradenitis Suppurativa (sHiSCR) | sHiSCR was defined as at least a 50 percent (%) reduction in abscess and inflammatory nodule (AN) counts, and no increase in draining fistula count related to baseline. The primary variable was modeled with the binomial distribution. A neutral non-informative Beta (1/3, 1/3) distribution was used as the prior for the response rate for all treatment groups. Based on the priors and the observed primary outcome, posterior distributions for the response rate for the investigational treatment and pooled placebo groups were computed respectively. At the time of the statistical comparison for cohorts A, B, and C, the placebo data for cohorts D and E were incomplete and therefore excluded. Similarly, during the comparison for cohort D, the placebo data for cohort E was still pending and was not included. | Baseline, Week 16 |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Olympian Clinical Research | Clearwater | Florida | 33609 | United States | ||
| Park Avenue Dermatology PA |
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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The study consisted of a screening period of up to 35 days. After last dose of study treatment patients could enter the post-treatment follow-up.
Participants took part in 36 investigative sites in 11 countries.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort A - CFZ533 600 mg | CFZ533 600 mg administered subcutaneous (s.c) weekly for 4 weeks, followed by bi-weekly until Week 15. |
| FG001 | Cohort A - Placebo to CFZ533 | Placebo administered subcutaneous (s.c) weekly for 4 weeks, followed by bi-weekly until Week 15. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment Epoch |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 24, 2024 | Nov 25, 2025 |
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Placebo administered s.c. bi-weekly for 4 weeks, followed by monthly until Week 13. |
|
| Cohort D - LOU064 25mg | Experimental | LOU064 25 mg administered orally twice per day until Week 16. |
|
| Cohort D - LOU064 100mg | Experimental | LOU064 100 mg administered orally twice per day until Week 16. |
|
| Cohort D - Placebo to LOU064 | Placebo Comparator | Placebo administered orally twice per day until Week 16. |
|
| Cohort E - VAY736 300 mg | Experimental | VAY736 300 mg administered s.c every 4 weeks until Week 13. |
|
| Cohort E - Placebo to VAY736 | Placebo Comparator | Placebo administered s.c every 4 weeks until Week 13. |
|
| Placebo to CFZ533 | Drug | Placebo administered subcutaneous (s.c) weekly for 4 weeks, followed by bi-weekly until Week 15. |
|
| LYS006 | Drug | LYS006 20 mg administered orally twice per day until Week 16. |
|
| Placebo to LYS006 | Drug | Placebo administered orally twice per day until Week 16. |
|
| MAS825 | Drug | MAS825 300 mg administered s.c. bi-weekly for 4 weeks, followed by monthly until Week 13. |
|
| Placebo to MAS825 | Drug | Placebo administered s.c. bi-weekly for 4 weeks, followed by monthly until Week 13. |
|
| LOU064 25mg | Drug | LOU064 25 mg administered orally twice per day until Week 16. |
|
|
| LOU064 100mg | Drug | LOU064 100 mg administered orally twice per day until Week 16. |
|
|
| Placebo to LOU064 | Drug | Placebo administered orally twice per day until Week 16. |
|
| VAY736 | Drug | VAY736 300 mg administered s.c every 4 weeks until Week 13. |
|
|
| Placebo to VAY736 | Drug | Placebo administered s.c every 4 weeks until Week 13. |
|
| Orange Park |
| Florida |
| 32073 |
| United States |
| University Of South Florida | Tampa | Florida | 33612 | United States |
| Advanced Medical Research | Sandy Springs | Georgia | 30328 | United States |
| NorthShore University Health System | Evanston | Illinois | 60201 | United States |
| Dawes Fretzin Clinical Rea Group | Indianapolis | Indiana | 46256 | United States |
| Penn State Milton S Hershey Medical Center | Hershey | Pennsylvania | 17033-0850 | United States |
| Medical University of South Carolina MUSC | Charleston | South Carolina | 29425 | United States |
| Novartis Investigative Site | Graz | 8036 | Austria |
| Novartis Investigative Site | Brussels | 1070 | Belgium |
| Novartis Investigative Site | Prague | Prague 1 | 11000 | Czechia |
| Novartis Investigative Site | Copenhagen | 2400 | Denmark |
| Novartis Investigative Site | Roskilde | 4000 | Denmark |
| Novartis Investigative Site | Antony | 92160 | France |
| Novartis Investigative Site | Lyon | 69003 | France |
| Novartis Investigative Site | Marseille | 13885 | France |
| Novartis Investigative Site | Nice | 06202 | France |
| Novartis Investigative Site | Reims | 51100 | France |
| Novartis Investigative Site | Rouen | 76031 | France |
| Novartis Investigative Site | Bochum | 44791 | Germany |
| Novartis Investigative Site | Frankfurt | 60590 | Germany |
| Novartis Investigative Site | Hamburg | 20246 | Germany |
| Novartis Investigative Site | Schwerin | 19055 | Germany |
| Novartis Investigative Site | Pécs | Baranya | 7623 | Hungary |
| Novartis Investigative Site | Debrecen | Hajdu Bihar Megye | 4032 | Hungary |
| Novartis Investigative Site | Budapest | H-1083 | Hungary |
| Novartis Investigative Site | Szeged | H 6725 | Hungary |
| Novartis Investigative Site | Kopavogur | 201 | Iceland |
| Novartis Investigative Site | Rotterdam | South Holland | 3015 GD | Netherlands |
| Novartis Investigative Site | Groningen | 9713 GZ | Netherlands |
| Novartis Investigative Site | Granada | Andalusia | 18014 | Spain |
| Novartis Investigative Site | Sabadell | Barcelona | 08208 | Spain |
| Novartis Investigative Site | Manises | Valencia | 46940 | Spain |
| Novartis Investigative Site | Barcelona | 08041 | Spain |
| Novartis Investigative Site | Las Palmas GC | 35010 | Spain |
| Novartis Investigative Site | Valencia | 46026 | Spain |
| FG002 | Cohort B - LYS006 20 mg | LYS006 20 mg administered orally twice per day until Week 16. |
| FG003 | Cohort B - Placebo to LYS006 | Placebo administered orally twice per day until Week 16. |
| FG004 | Cohort C - MAS825 300 mg | MAS825 300 mg administered s.c. bi-weekly for 4 weeks, followed by monthly until Week 13. |
| FG005 | Cohort C - Placebo to MAS825 | Placebo administered s.c. bi-weekly for 4 weeks, followed by monthly until Week 13. |
| FG006 | Cohort D - LOU064 25 mg | LOU064 25 mg administered orally twice per day until Week 16. |
| FG007 | Cohort D - LOU064 100 mg | LOU064 100 mg administered orally twice per day until Week 16. |
| FG008 | Cohort D - Placebo to LOU064 | Placebo administered orally twice per day until Week 16. |
| FG009 | Cohort E - VAY736 300 mg | VAY736 300 mg administered s.c every 4 weeks until Week 13. |
| FG010 | Cohort E - Placebo to VAY736 | Placebo administered s.c every 4 weeks until Week 13. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Entered Post-treatment Follow-up |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort A - CFZ533 600 mg | CFZ533 600 mg administered subcutaneous (s.c) weekly for 4 weeks, followed by bi-weekly until Week 15. |
| BG001 | Cohort A - Placebo to CFZ533 | Placebo administered subcutaneous (s.c) weekly for 4 weeks, followed by bi-weekly until Week 15. |
| BG002 | Cohort B - LYS006 20 mg | LYS006 20 mg administered orally twice per day until Week 16. |
| BG003 | Cohort B - Placebo to LYS006 | Placebo administered orally twice per day until Week 16. |
| BG004 | Cohort C - MAS825 300 mg | MAS825 300 mg administered s.c. bi-weekly for 4 weeks, followed by monthly until Week 13. |
| BG005 | Cohort C - Placebo to MAS825 | Placebo administered s.c. bi-weekly for 4 weeks, followed by monthly until Week 13. |
| BG006 | Cohort D - LOU064 25 mg | LOU064 25 mg administered orally twice per day until Week 16. |
| BG007 | Cohort D - LOU064 100 mg | LOU064 100 mg administered orally twice per day until Week 16. |
| BG008 | Cohort D - Placebo to LOU064 | Placebo administered orally twice per day until Week 16. |
| BG009 | Cohort E - VAY736 300 mg | VAY736 300 mg administered s.c every 4 weeks until Week 13. |
| BG010 | Cohort E - Placebo to VAY736 | Placebo administered s.c every 4 weeks until Week 13. |
| BG011 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Achieving Clinical Response Measured by Simplified Hidradenitis Suppurativa (sHiSCR) | sHiSCR was defined as at least a 50 percent (%) reduction in abscess and inflammatory nodule (AN) counts, and no increase in draining fistula count related to baseline. The primary variable was modeled with the binomial distribution. A neutral non-informative Beta (1/3, 1/3) distribution was used as the prior for the response rate for all treatment groups. Based on the priors and the observed primary outcome, posterior distributions for the response rate for the investigational treatment and pooled placebo groups were computed respectively. At the time of the statistical comparison for cohorts A, B, and C, the placebo data for cohorts D and E were incomplete and therefore excluded. Similarly, during the comparison for cohort D, the placebo data for cohort E was still pending and was not included. | The Pharmacodynamic (PD) analysis set included all participants who received any study drug and had no protocol deviations with relevant impact on PD data. | Posted | Count of Participants | Participants | Baseline, Week 16 |
|
|
|
|
Cohorts A, B and C: 28 weeks including 12 weeks follow up period. Cohort D: 20 weeks including 4 weeks follow up period. Cohort E (ongoing): up to 116 weeks including 100 weeks follow up period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort A - CFZ533 600 mg | CFZ533 600 mg administered subcutaneous (s.c) weekly for 4 weeks, followed by bi-weekly until Week 15. | 0 | 29 | 4 | 29 | 23 | 29 |
| EG001 | Cohort B - LYS006 20 mg | LYS006 20 mg administered orally twice per day until Week 16. | 0 | 27 | 2 | 27 | 19 | 27 |
| EG002 | Cohort C - MAS825 300 mg | MAS825 300 mg administered s.c. bi-weekly for 4 weeks, followed by monthly until Week 13. | 0 | 33 | 1 | 33 | 22 | 33 |
| EG003 | Cohort D - LOU064 25 mg | LOU064 25 mg administered orally twice per day until Week 16. | 0 | 33 | 1 | 33 | 26 | 33 |
| EG004 | Cohort D - LOU064 100 mg | LOU064 100 mg administered orally twice per day until Week 16. | 0 | 33 | 1 | 33 | 15 | 33 |
| EG005 | Cohort E - VAY736 300 mg | VAY736 300 mg administered s.c every 4 weeks until Week 13. | 0 | 32 | 1 | 32 | 18 | 32 |
| EG006 | Pooled Placebo (Cohorts A, B, C, D and E) | Placebo to CFZ533, LYS006, MAS825, LOU064 and VAY736. | 0 | 61 | 1 | 61 | 38 | 61 |
| EG007 | Total | Total | 0 | 248 | 11 | 248 | 161 | 248 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Colitis | Gastrointestinal disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Abscess limb | Infections and infestations | MedDRA (27.1) | Systematic Assessment |
| |
| Genital abscess | Infections and infestations | MedDRA (27.1) | Systematic Assessment |
| |
| Testicular abscess | Infections and infestations | MedDRA (27.1) | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA (27.1) | Systematic Assessment |
| |
| Alcohol withdrawal syndrome | Psychiatric disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Ovarian cyst | Reproductive system and breast disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Testicular torsion | Reproductive system and breast disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA (27.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Increased tendency to bruise | Blood and lymphatic system disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Bacteriuria | Infections and infestations | MedDRA (27.1) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (27.1) | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA (27.1) | Systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA (27.1) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (27.1) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (27.1) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (27.1) | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA (27.1) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (27.1) | Systematic Assessment |
| |
| Injection related reaction | Injury, poisoning and procedural complications | MedDRA (27.1) | Systematic Assessment |
| |
| Bacterial test positive | Investigations | MedDRA (27.1) | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA (27.1) | Systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA (27.1) | Systematic Assessment |
| |
| Blood urine present | Investigations | MedDRA (27.1) | Systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA (27.1) | Systematic Assessment |
| |
| Crystal urine present | Investigations | MedDRA (27.1) | Systematic Assessment |
| |
| Nitrite urine present | Investigations | MedDRA (27.1) | Systematic Assessment |
| |
| Urine albumin/creatinine ratio increased | Investigations | MedDRA (27.1) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Hidradenitis | Skin and subcutaneous tissue disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Pain of skin | Skin and subcutaneous tissue disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (27.1) | Systematic Assessment |
|
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | + 1 862 778 8300 | novartis.email@novartis.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 10, 2025 | Nov 25, 2025 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D017497 | Hidradenitis Suppurativa |
| ID | Term |
|---|---|
| D017192 | Skin Diseases, Bacterial |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D012874 | Skin Diseases, Infectious |
| D013492 | Suppuration |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D016575 | Hidradenitis |
| D013543 | Sweat Gland Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000626035 | iscalimab |
| C000722911 | remibrutinib |
| C000656267 | ianalumab |
Not provided
Not provided
Not provided
| Lost to Follow-up |
|
| Withdrawal by Subject |
|
| Male |
|
| Black Or African American |
|
| Other |
|
| Unknown |
|
| White |
|
| Bayesian Analysis |
| Probability (%) diff. in resp. rate >= 0 |
| 97.1 |
| Other |
Bayesian Analysis using a Beta-binomial model |
| Bayesian Analysis | Average difference in response rates | -3.3 | 2-Sided | 90 | -21.9 | 15.9 | 90% credible intervals of the treatment difference are reported as 90% Confidence Interval 2-Sided below. | Other | Bayesian Analysis using a Beta-binomial model |
| Bayesian Analysis | Probability (%) diff. in resp. rate >= 0 | 38.7 | Other | Bayesian Analysis using a Beta-binomial model |
| Bayesian Analysis | Average difference in response rates | 12.2 | 2-Sided | 90 | -7.5 | 31.6 | 90% credible intervals of the treatment difference are reported as 90% Confidence Interval 2-Sided below. | Other | Bayesian Analysis using a Beta-binomial model |
| Bayesian Analysis | Probability (%) diff. in resp. rate >= 0 | 84.7 | Other | Bayesian Analysis using a Beta-binomial model |
| Bayesian Analysis | Average difference in response rates | 37.2 | 2-Sided | 90 | 19.7 | 53.0 | 90% credible intervals of the treatment difference are reported as 90% Confidence Interval 2-Sided below. | Other | Bayesian Analysis using a Beta-binomial model |
| Bayesian Analysis | Probability (%) diff. in resp. rate >= 0 | 99.9 | Other | Bayesian Analysis using a Beta-binomial model |
| Bayesian Analysis | Average difference in response rates | 13.9 | 2-Sided | 90 | -4.2 | 31.9 | 90% credible intervals of the treatment difference are reported as 90% Confidence Interval 2-Sided below. | Other | Bayesian Analysis using a Beta-binomial model |
| Bayesian Analysis | Probability (%) diff. in resp. rate >= 0 | 89.6 | Other | Bayesian Analysis using a Beta-binomial model |
| Bayesian Analysis | Average difference in response rates | 13.4 | 2-Sided | 90 | -4.2 | 31.5 | 90% credible intervals of the treatment difference are reported as 90% Confidence Interval 2-Sided below. | Other | Bayesian Analysis using a Beta-binomial model |
| Bayesian Analysis | Probability (%) diff. in resp. rate >= 0 | 89.0 | Other | Bayesian Analysis using a Beta-binomial model |