Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2015-003564-37 | EudraCT Number |
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Open-label cohort study in adult patients with newly diagnosed or relapsing pemphigus vulgaris, with intra-patient dose-adjustment based on clinical response and BTK occupancy, and with conventional immunosuppressive "rescue treatment", if indicated. The duration of therapy in Part A will be 12 weeks, followed by 12 weeks of follow up. The extension phase, Part B includes 24 weeks of therapy, followed by 4 weeks of follow-up.
Primary Objectives:
To evaluate the safety of PRN1008 in patients with pemphigus vulgaris (PV)
To evaluate the clinical activity of PRN1008 in patients with PV, per criteria in the European Academy of Dermatology and Venereology (EADV) 2014 Pemphigus S2 Guideline (Hertl et al. 2015)
Secondary Objectives
To evaluate the pharmacokinetics (PK) and the pharmacodynamics (PD) of multiple doses of PRN1008 in patients with PV
To evaluate the relationship of PK and PD to each other and to efficacy and safety in this patient population
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PRN1008 | Experimental | Part A: Open-label PRN1008, 12 weeks; 12 weeks follow-up; Part B: Open-label PRN1008, 24 weeks; 4 weeks follow-up |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PRN1008 | Drug | Part A dosing was initiated administering 400 mg BID. Intrapatient dose adjustments (reductions and increases) were permitted based upon tolerability and clinical response with the maximum dose allowed up to 600 mg BID for 12 weeks. Part B initial dosing was 400 mg QD for 2 weeks with dose escalation to 400 mg BID at the discretion of the Investigator for the purposes of investigating dose response and identifying the minimal efficacious dose of rilzabrutinib for 24 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Treatment-emergent Adverse Events | Treatment-emergent adverse events (TEAEs) including clinically significant changes in physical examination, laboratory tests, and vital signs. An AE was defined as any untoward medical occurrence in a participant who received study drug and did not necessarily had to have a causal relationship with the treatment. TEAEs were defined as AEs that developed or worsened or became serious during on-treatment phase that was defined as the time from the start of study drug up to study completion. | Part A: until 24 weeks and Part B: until 28 weeks |
| Percentage of Participants Who Are Able to Achieve Control of Disease Activity (CDA) Within 4 Weeks of Starting PRN1008 Treatment Without the Need for Doses of Prednisone or Prednisolone >0.5 mg/kg | CDA was defined as the time at which new lesions cease to form and established lesions begin to heal. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Able to Achieve Control of Disease Activity (CDA) Without Corticosteroids Within 4 Weeks | CDA was defined as the time at which new lesions cease to form and established lesions begin to heal. | 4 weeks |
| Percentage of Participants Able to Achieve a Complete Response (CR) Without Corticosteroids |
Not provided
Inclusion Criteria:
Male or female patients, aged 18 to 80 years old, with biopsy-proven, mild-moderate PV (PDAI 8 to 45) in Part A and mild to severe PV in Part B (PDAI 8 to 60) that are either:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Premier Specialists | Kogarah | New South Wales | 2217 | Australia | ||
| Sinclair Dermatology |
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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A total of 69 patients were screened for the study (52 patients in Part A and 18* patients in Part B). Of these, 41 unique patients were enrolled in the study (27 patients in Part A and 15* patients in Part B). *One patient who completed Part A of the study and later relapsed was enrolled in Part B.
The study was conducted at 13 centers in 5 countries from 22 January 2016 to 10 January 2020.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Part A | Open-label PRN1008, 12 weeks; 12 weeks follow-up |
| FG001 | Part B | Open-label PRN1008, 24 weeks; 4 weeks follow-up |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Part A: 24 Weeks |
|
| ||||||||||||||||||
| Part B: 28 Weeks |
|
One patient who completed Part A of the study and later relapsed was enrolled in Part B. Therefore baseline results of one patient are repeated in Part B and total patient number is 15.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Part A | Open-label PRN1008, 12 weeks; 12 weeks follow-up |
| BG001 | Part B | Open-label PRN1008, 24 weeks; 4 weeks follow-up |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | One patient who completed Part A of the study and later relapsed was enrolled in Part B. |
| 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 With Treatment-emergent Adverse Events | Treatment-emergent adverse events (TEAEs) including clinically significant changes in physical examination, laboratory tests, and vital signs. An AE was defined as any untoward medical occurrence in a participant who received study drug and did not necessarily had to have a causal relationship with the treatment. TEAEs were defined as AEs that developed or worsened or became serious during on-treatment phase that was defined as the time from the start of study drug up to study completion. | Safety Analysis population: All patients who received at least 1 dose of rilzabrutinib; used for all safety analyses | Posted | Number | percentage of participants | Part A: until 24 weeks and Part B: until 28 weeks |
|
Part A: until 24 weeks and Part B: until 28 weeks
Reported AEs and deaths are TEAEs that developed, worsened, or became serious during the treatment period. Analysis was performed on safety population.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Part A | Open-label PRN1008, 12 weeks; 12 weeks follow-up | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pulmonary sequestration | Congenital, familial and genetic disorders | MedDRA 18.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Trial Transparency Team | Sanofi aventis recherche & développement | 800-633-1610 | 1# | Contact-US@sanofi.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 19, 2019 | Dec 4, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 24, 2020 | Dec 4, 2022 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D010392 | Pemphigus |
| ID | Term |
|---|---|
| D012872 | Skin Diseases, Vesiculobullous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
Not provided
Not provided
Part A with 12 weeks treatment and 12 weeks follow-up. Part B with 24 weeks treatment and 4 weeks follow-up.
Not provided
Not provided
Open Label
Not provided
|
|
CR was defined as complete healing of all lesions and the absence of new lesions. |
| Part A: 12 weeks treatment and Part B: 24 weeks treatment |
| Percentage of Participants Able to Achieve Complete Remission (CR) Without the Need for Doses of Prednisone or Prednisolone of Greater Than 0.5mg/kg | CR was defined as complete healing of all lesions and the absence of new lesions. | Part A: 12 weeks treatment and Part B: 24 weeks treatment |
| Time to Control of Disease Activity (CDA) | CDA was defined as the time at which new lesions cease to form and established lesions begin to heal. Kaplan-Meier estimate median time is reported. | Part A: until 24 weeks and Part B: until 28 weeks |
| Time to End of Consolidation Phase (ECP) | ECP was defined as the time at which no new lesions have developed for minimum of 2 weeks, and approximately 80% of existing lesions have healed. The median time to ECP was based on Kaplan-Meier estimate which considered censoring at end of follow-up for patients who didn't have an event. A +/-3 days window for visits at Week 3 and 5, and +/-7 days window for visits at Week 9, 13, 17, 21, 25. | Part A: until 24 weeks and Part B: until 28 weeks |
| Time to Complete Remission (CR) | CR was defined as complete healing of all lesions and the absence of new lesions. | Part A: until 24 weeks and Part B: until 28 weeks |
| Time to Relapse After PRN1008 Treatment Discontinuation | Relapse was defined as appearance of ≥3 new lesions/month that do not heal spontaneously within 1 week, or by extension of established lesions, in a patient who has achieved disease control. The median time to relapse was based on Kaplan-Meier estimate which considered censoring at end of follow-up for patients who didn't have an event. A +/-3 days window for visits at Week 3 and 5, and +/-7 days window for visits at Week 9, 13, 17, 21, 25. | Part A: until 24 weeks and Part B: until 28 weeks |
| Cumulative Corticosteroid Usage | Cumulative corticosteroid usage | Part A: until 24 weeks and Part B: until 28 weeks |
| Percentage Change From Baseline in Pemphigus Disease Area Index (PDAI) Total Activity Scores | The PDAI questionnaire has 2 components including activity and damage. The activity component consists of skin, scalp and mucosa parts, and the damage component consists of skin and scalp parts. The total activity score was used for the summary of PDAI scores. PDAI total activity score = Total skin activity + Total scalp activity + Total mucosa activity. PDAI Total Activity Score ranged from 0 to 250 points representing disease activity (higher scores mean a worse outcome). Negative change in total activity score from baseline indicates improvement in pemphigus activity. | Part A: until 24 weeks and Part B: until 28 weeks |
| Change From Baseline in Autoimmune Bullous Skin Disorder Intensity Score (ABSIS) Total Activity Score | ABSIS Total Activity Score ranged from 0 to 206 points representing disease activity (higher scores mean a worse outcome). Negative change in total activity score from baseline indicates improvement in pemphigus activity. | Part A: until 24 weeks and Part B: until 28 weeks |
| Change From Baseline in Autoimmune Bullous Diseases Quality of Life (ABQOL) | ABQOL score ranged from 0 to 68 points representing disease activity (higher scores mean a worse outcome). | Part A: until 24 weeks and Part B: until 28 weeks |
| Change From Baseline in Treatment of Autoimmune Bullous Diseases Quality of Life (TABQOL) Scores | TABQOL score ranged from 0 to 68 points representing disease activity (higher scores mean a worse outcome). | Part A: until 24 weeks and Part B: until 28 weeks |
| Change From Baseline in Appetite (SNAQ Score) | Simplified Nutritional Appetite Questionnaire (SNAQ) score ranged from 0 to 20 points representing disease activity (higher scores mean a better outcome). | Part A: until 24 weeks and Part B: until 28 weeks |
| East Melbourne |
| Victoria |
| 3002 |
| Australia |
| Royal Melbourne, Dermatology Office | Melbourne | Victoria | 3050 | Australia |
| Clinical Hospital Osijek | Osijek | 31000 | Croatia |
| Klinichki Bolnicki Centar Zagreb | Zagreb | 10 000 | Croatia |
| Hôpital Avicenne | Bobigny | Siene-Saint Denis | 93009 | France |
| Rouen University Hospital | Rouen | 76038 | France |
| University General Hospital of Ioannina | Ioannina | Ioannina | 45500 | Greece |
| University Hospital of Larissa | Larissa | Thessaly | 41110 | Greece |
| Hospital of Venereal and Skin Diseases A.Syggros | Athens | 16121 | Greece |
| Papageorgiou General Hospital of Thessaloniki | Thessaloniki | 56429 | Greece |
| Chaim Sheba Medical Center | Ramat Gan | 52621 | Israel |
| Tel Aviv Sourasky Medical Center | Tel Aviv | 64239 | Israel |
| NOT COMPLETED |
|
|
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Sex: Female, Male | One patient who completed Part A of the study and later relapsed was enrolled in Part B. | Count of Participants | Participants |
|
| Race (NIH/OMB) | One patient who completed Part A of the study and later relapsed was enrolled in Part B. | Count of Participants | Participants |
|
| OG001 | Part B | Open-label PRN1008, 24 weeks; 4 weeks follow-up |
|
|
| Primary | Percentage of Participants Who Are Able to Achieve Control of Disease Activity (CDA) Within 4 Weeks of Starting PRN1008 Treatment Without the Need for Doses of Prednisone or Prednisolone >0.5 mg/kg | CDA was defined as the time at which new lesions cease to form and established lesions begin to heal. | Intent-to-Treat (ITT) population: All patients who received at least 1 dose of rilzabrutinib | Posted | Number | 95% Confidence Interval | percentage of participants | 4 weeks |
|
|
|
| Secondary | Percentage of Participants Able to Achieve Control of Disease Activity (CDA) Without Corticosteroids Within 4 Weeks | CDA was defined as the time at which new lesions cease to form and established lesions begin to heal. | ITT | Posted | Number | 95% Confidence Interval | percentage of participants | 4 weeks |
|
|
|
| Secondary | Percentage of Participants Able to Achieve a Complete Response (CR) Without Corticosteroids | CR was defined as complete healing of all lesions and the absence of new lesions. | ITT | Posted | Number | percentage of participants | Part A: 12 weeks treatment and Part B: 24 weeks treatment |
|
|
|
| Secondary | Percentage of Participants Able to Achieve Complete Remission (CR) Without the Need for Doses of Prednisone or Prednisolone of Greater Than 0.5mg/kg | CR was defined as complete healing of all lesions and the absence of new lesions. | ITT | Posted | Number | 95% Confidence Interval | percentage of participants | Part A: 12 weeks treatment and Part B: 24 weeks treatment |
|
|
|
| Secondary | Time to Control of Disease Activity (CDA) | CDA was defined as the time at which new lesions cease to form and established lesions begin to heal. Kaplan-Meier estimate median time is reported. | ITT | Posted | Median | 80% Confidence Interval | days | Part A: until 24 weeks and Part B: until 28 weeks |
|
|
|
| Secondary | Time to End of Consolidation Phase (ECP) | ECP was defined as the time at which no new lesions have developed for minimum of 2 weeks, and approximately 80% of existing lesions have healed. The median time to ECP was based on Kaplan-Meier estimate which considered censoring at end of follow-up for patients who didn't have an event. A +/-3 days window for visits at Week 3 and 5, and +/-7 days window for visits at Week 9, 13, 17, 21, 25. | ITT | Posted | Median | 80% Confidence Interval | days | Part A: until 24 weeks and Part B: until 28 weeks |
|
|
|
| Secondary | Time to Complete Remission (CR) | CR was defined as complete healing of all lesions and the absence of new lesions. | ITT | Posted | Median | 80% Confidence Interval | days | Part A: until 24 weeks and Part B: until 28 weeks |
|
|
|
| Secondary | Time to Relapse After PRN1008 Treatment Discontinuation | Relapse was defined as appearance of ≥3 new lesions/month that do not heal spontaneously within 1 week, or by extension of established lesions, in a patient who has achieved disease control. The median time to relapse was based on Kaplan-Meier estimate which considered censoring at end of follow-up for patients who didn't have an event. A +/-3 days window for visits at Week 3 and 5, and +/-7 days window for visits at Week 9, 13, 17, 21, 25. | ITT | Posted | Median | Full Range | days | Part A: until 24 weeks and Part B: until 28 weeks |
|
|
|
| Secondary | Cumulative Corticosteroid Usage | Cumulative corticosteroid usage | ITT | Posted | Mean | Standard Deviation | mg | Part A: until 24 weeks and Part B: until 28 weeks |
|
|
|
| Secondary | Percentage Change From Baseline in Pemphigus Disease Area Index (PDAI) Total Activity Scores | The PDAI questionnaire has 2 components including activity and damage. The activity component consists of skin, scalp and mucosa parts, and the damage component consists of skin and scalp parts. The total activity score was used for the summary of PDAI scores. PDAI total activity score = Total skin activity + Total scalp activity + Total mucosa activity. PDAI Total Activity Score ranged from 0 to 250 points representing disease activity (higher scores mean a worse outcome). Negative change in total activity score from baseline indicates improvement in pemphigus activity. | ITT | Posted | Mean | Standard Deviation | score on a scale | Part A: until 24 weeks and Part B: until 28 weeks |
|
|
|
| Secondary | Change From Baseline in Autoimmune Bullous Skin Disorder Intensity Score (ABSIS) Total Activity Score | ABSIS Total Activity Score ranged from 0 to 206 points representing disease activity (higher scores mean a worse outcome). Negative change in total activity score from baseline indicates improvement in pemphigus activity. | ITT | Posted | Mean | Standard Deviation | score on a scale | Part A: until 24 weeks and Part B: until 28 weeks |
|
|
|
| Secondary | Change From Baseline in Autoimmune Bullous Diseases Quality of Life (ABQOL) | ABQOL score ranged from 0 to 68 points representing disease activity (higher scores mean a worse outcome). | ITT | Posted | Mean | Standard Deviation | score on a scale | Part A: until 24 weeks and Part B: until 28 weeks |
|
|
|
| Secondary | Change From Baseline in Treatment of Autoimmune Bullous Diseases Quality of Life (TABQOL) Scores | TABQOL score ranged from 0 to 68 points representing disease activity (higher scores mean a worse outcome). | ITT | Posted | Mean | Standard Deviation | score on a scale | Part A: until 24 weeks and Part B: until 28 weeks |
|
|
|
| Secondary | Change From Baseline in Appetite (SNAQ Score) | Simplified Nutritional Appetite Questionnaire (SNAQ) score ranged from 0 to 20 points representing disease activity (higher scores mean a better outcome). | ITT | Posted | Mean | Standard Deviation | units on a scale | Part A: until 24 weeks and Part B: until 28 weeks |
|
|
|
| 27 |
| 3 |
| 27 |
| 20 |
| 27 |
| EG001 | Part B | Open-label PRN1008, 24 weeks; 4 weeks follow-up | 0 | 15 | 0 | 15 | 13 | 15 |
| Pancreatic pseudocyst | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Staphylococcal skin infection | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 18.0 | Systematic Assessment |
|
| Peripheral swelling | General disorders | MedDRA 18.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA 18.0 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 18.0 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Change of bowel habit | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Teeth brittle | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Dermatophytosis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| Pharyngitis streptococcal | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| Tracheitis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| Vaginal infection | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| Androgenetic alopecia | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| Erythema nodosum | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| Rash erythematous | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
|
| Lethargy | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
|
| Sciatica | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
|
| Conjunctival haemorrhage | Eye disorders | MedDRA 18.0 | Systematic Assessment |
|
| Eye pain | Eye disorders | MedDRA 18.0 | Systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA 18.0 | Systematic Assessment |
|
| Activated partial thromboplastin time prolonged | Investigations | MedDRA 18.0 | Systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA 18.0 | Systematic Assessment |
|
| Blood glucose increased | Investigations | MedDRA 18.0 | Systematic Assessment |
|
| International normalised ratio increased | Investigations | MedDRA 18.0 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 18.0 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 18.0 | Systematic Assessment |
|
| Ear pain | Ear and labyrinth disorders | MedDRA 18.0 | Systematic Assessment |
|
| Non-alcoholic steatohepatitis | Hepatobiliary disorders | MedDRA 18.0 | Systematic Assessment |
|
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA 18.0 | Systematic Assessment |
|
| Anogenital warts | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | Systematic Assessment |
|
| Terminal insomnia | Psychiatric disorders | MedDRA 18.0 | Systematic Assessment |
|
| Oliguria | Renal and urinary disorders | MedDRA 18.0 | Systematic Assessment |
|
| Amenorrhoea | Reproductive system and breast disorders | MedDRA 18.0 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA 18.0 | Systematic Assessment |
|
| Haematemesis | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
|
The Sponsor supports publication of clinical trial results but may request that investigators temporarily delay or alter publications in order to protect proprietary information. The Sponsor may also require that the results of multicenter studies be published only in their entirety and not as individual site data.
| D007154 | Immune System Diseases |
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| end of follow-up |
|
|
| end of follow-up |
|
|
| end of follow-up |
|
|
| end of follow-up |
|
|
| end of follow-up |
|
|