Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2012-004798-17 | EudraCT Number |
Not provided
Not provided
Study was withdrawn due to scientific and business considerations.
Not provided
Not provided
Not provided
Not provided
Not provided
The primary purpose of the Phase II CLGX818X2102 study is to assess the anti-tumor activity of LGX818 in combination with selected agents.
This is a phase II two part multi-center, open-label study. Part I: LGX818 single agent treatment until progression Part II: Combination treatments of LGX818 + MEK162, or BKM120, or BGJ398, or INC280, or LEE01 to assess the clinical efficacy, to further evaluate the safety of the drug combinations in patients with locally advanced or metastatic BRAF mutant melanoma after relapse on LGX818, and to determine the maximum tolerated dose of the combinations (when not established previously). These drug combinations are selected and assigned to patients based on documentation of molecular resistance mechanism.
Patients with BRAF mutant melanoma treated by LGX818 single agent in other studies can be enrolled directly in Part II of CLGX818X2102 after relapse.
Dose-escalations in the combination arms for which no MTD has been established will be based on the recommendations of a Bayesian logistic regression model guided by an escalation with overdose control criterion.
After careful evaluation of slow enrollment and the BRAF-mutant melanoma treatment landscape, recruitment was permanently halted on 26-Jul-2014.
This recruitment halt was not a consequence of any safety concern and patients who were ongoing in the study continued to be treated as per protocol.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LGX818 single agent | Experimental | Patients had to have written documentation of a BRAFV600 mutation, which was to have been obtained locally on a fresh tumor biopsy (preferred) or on the most recent archival tumor sample available. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LGX818 | Drug | BRAF inhibitor. LGX818 was administered QD orally on a daily schedule (21-day cycles) as a flat-fixed dose and not by body weight or body surface area. LGX818 100 mg capsules and 50 mg capsules. |
| Measure | Description | Time Frame |
|---|---|---|
| Tumor Response (Overall Response Rate) Per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 (Part I & Part II) | Response Evaluation Criteria In Solid Tumors (RECIST) is a set of published rules that define the status of tumors in cancer patients during a specific treatment. The Overall Response Rate was calculated according to the RECIST criteria, as per investigator assessment. Per RECIST guidelines:
| Baseline through study completion (approximately 2 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Dose Limiting Toxicities (DLTs) (Part II) | Incidence of DLTs in Part II of the study was not evaluated due to an inadequate number of patients enrolled in Part II prior to the permanent recruitment halt of this study. | Baseline through study completion (approximately 2 years) |
| Plasma Concentration and Derived Pharmacokinetic Parameters |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Specific exclusion criteria for each treatment arm:
LGX818/MEK162:
History or current evidence of retinal disease History of Gilbert's syndrome.
LGX818/BKM120:
Patients with diabetes mellitus requiring insulin treatment Patient has mood disorders
LGX818/BGJ398:
History and/or current evidence of ectopic mineralization/ calcification Current evidence of corneal disorder/ keratopathy Patients with current evidence of endocrine alteration of calcium/phosphate homeostasis.
History of congenital long QT- syndrome and/or hypokalaemia CTCAE Grade ≥ 3 and/or magnesium levels below the clinically relevant lower limits before study entry.
Ionized (i) calcium (Ca) > ULN Serum inorganic phosphorus (Pi) > ULN
LGX818/LEE011 History of congenital long QT- syndrome and/or hypokalaemia CTCAE Grade ≥ 3 and/or magnesium levels below the clinically relevant lower limits before study entry.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Array BioPharma | 303-381-6604 | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sarah Cannon Research Institute Onc Dept | Nashville | Tennessee | 37203 | United States | ||
| Novartis Investigative Site |
After careful evaluation of slow enrollment and the BRAF-mutant melanoma treatment landscape, recruitment was permanently halted on 26-Jul-2014.
This recruitment halt was not a consequence of any safety concern and patients who were ongoing in the study continued to be treated as per protocol.
The study began on 04-Nov-2013 (First Subject First Visit) to the CLGX818X2102 (LOGIC 1) study. A total of 15 subjects were enrolled. The last subject's last visit occurred on 23-Mar-2015.
Not completed subjects represents subjects that stopped treatment early, due to the corresponding reason.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Part I: LGX818 - Single Agent | Subjects in Part I of the study received LGX818 as a single agent. |
| FG001 | Part II: CLGX818 + MEK162 | As per the original study design, Part II was to have five arms corresponding to the five potential combination treatments; however, only one patient was treated in this part of the study and received LGX818 in combination with MEK162. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Part I: LGX818 |
|
| |||||||||||||||||||||
| Part II: LGX818 + MEK162 |
|
The analysis population for Baseline Demographics is composed of the Full Analysis Set, which consists of all patients who received at least one dose of LGX818.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Part I: LGX818 - Single Agent | Subjects in Part I of the study received LGX818 as a single agent. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of 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 | Tumor Response (Overall Response Rate) Per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 (Part I & Part II) | Response Evaluation Criteria In Solid Tumors (RECIST) is a set of published rules that define the status of tumors in cancer patients during a specific treatment. The Overall Response Rate was calculated according to the RECIST criteria, as per investigator assessment. Per RECIST guidelines:
| This analysis is comprised of the Full Analysis Set, which consists of all patients who received at least one dose of LGX818. | Posted | Number | participants | Baseline through study completion (approximately 2 years) |
|
Adverse Events (AEs), Serious Adverse Events (SAEs), and Non-serious AEs were collected throughout the duration of the study, approximately 2 years. An AE was defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained. This analysis group is the Safety Set, which is all patients from the Full Analysis Set who had at least one post-baseline safety assessment.
Due to slow enrollment, the study was terminated on 26-July-2014, at which time 15 patients were enrolled of Phase I of the study. The last patient last visit date occurred on 23-March-2015.
One patient with documented PD at study Day 146 entered into Part II of the study and received combination treatment of LGX818 450 mg plus MEK162 45 mg for two weeks. The patient experienced disease progression on Day 22 of Part II and discontinued the study.
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 I: LGX818 - Single Agent | Subjects in Part I of the study received LGX818 as a single agent. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypotension | Vascular disorders | MedDRA (16.1) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Flushing | Vascular disorders | MedDRA (16.1) | Non-systematic Assessment |
Recruitment halted on 26-Jul-2014, which led to small numbers of subjects analyzed. This recruitment halt was not a consequence of any safety concern and patients who were ongoing in the study continued to be treated as per protocol.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Array BioPharma, Inc. | 303-381-6604 | clinicaltrials@arraybiopharma.com |
| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided
| ID | Term |
|---|---|
| C000601108 | encorafenib |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
Assessment of pharmacokinetic (PK) parameters and plasma concentration was not done due to an inadequate number of patients enrolled in Part II prior to the permanent recruitment halt of this study. |
| Baseline through study completion (approximately 2 years) |
| Tumor Response (Overall Response Rate) Via Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 (Part I) | Response Evaluation Criteria In Solid Tumors (RECIST) is a set of published rules that define the status of tumors in cancer patients during a specific treatment. The Overall Response Rate was calculated according to the RECIST criteria, as per investigator assessment. Per RECIST guidelines:
| Baseline through completion of Part I of the study (approximately 2 years) |
| Tumor Response (Overall Response Rate) Via Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 (Part II) | Response Evaluation Criteria In Solid Tumors (RECIST) is a set of published rules that define the status of tumors in cancer patients during a specific treatment. The Overall Response Rate was calculated according to the RECIST criteria, as per investigator assessment. Per RECIST guidelines:
One patient with documented PD at study Day 146 entered into Part II of the study and received combination treatment of LGX818 450 mg plus MEK162 45 mg for two weeks. The patient experienced disease progression on Day 22 of Part II and discontinued the study. | Entry to Part II of the study through study completion (approximately 22 days) |
| Molecular Status of Markers Relevant to the RAP/MEK/ERK and PI3K/AKT Pathways | Molecular status was not evaluated due to an inadequate number of patients enrolled in Part II prior to the permanent recruitment halt of this study. | Baseline and at progression with LGX818 single agent treatment |
| East Melbourne |
| Victoria |
| 3002 |
| Australia |
| Novartis Investigative Site | Edmonton | Alberta | T6G 1Z2 | Canada |
| Novartis Investigative Site | Heidelberg | 69120 | Germany |
| Novartis Investigative Site | Barcelona | Catalonia | 08035 | Spain |
| Novartis Investigative Site | Zurich | 8091 | Switzerland |
| Adverse Event |
|
| Disease Progression |
|
| NOT COMPLETED |
|
|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Gender | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Weight | Mean | Standard Deviation | kilograms |
|
| Height | Mean | Standard Deviation | centimeters |
|
| WHO/ ECOG performance status | Categories:
| Number | participants |
|
| Part I: LGX818 - Single Agent |
Subjects in Part I of the study received LGX818 as a single agent. |
| OG001 | Part II: CLGX818 + MEK162 | As per the original study design, Part II was to have five arms corresponding to the five potential combination treatments; however, only one patient was treated in this part of the study and received LGX818 in combination with MEK162. |
|
|
| Secondary | Incidence of Dose Limiting Toxicities (DLTs) (Part II) | Incidence of DLTs in Part II of the study was not evaluated due to an inadequate number of patients enrolled in Part II prior to the permanent recruitment halt of this study. | Posted | Baseline through study completion (approximately 2 years) |
|
|
| Secondary | Plasma Concentration and Derived Pharmacokinetic Parameters | Assessment of pharmacokinetic (PK) parameters and plasma concentration was not done due to an inadequate number of patients enrolled in Part II prior to the permanent recruitment halt of this study. | Posted | Baseline through study completion (approximately 2 years) |
|
|
| Secondary | Tumor Response (Overall Response Rate) Via Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 (Part I) | Response Evaluation Criteria In Solid Tumors (RECIST) is a set of published rules that define the status of tumors in cancer patients during a specific treatment. The Overall Response Rate was calculated according to the RECIST criteria, as per investigator assessment. Per RECIST guidelines:
| This analysis is comprised of the Full Analysis Set, which consists of all patients who received at least one dose of LGX818. | Posted | Number | participants | Baseline through completion of Part I of the study (approximately 2 years) |
|
|
|
| Secondary | Tumor Response (Overall Response Rate) Via Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 (Part II) | Response Evaluation Criteria In Solid Tumors (RECIST) is a set of published rules that define the status of tumors in cancer patients during a specific treatment. The Overall Response Rate was calculated according to the RECIST criteria, as per investigator assessment. Per RECIST guidelines:
One patient with documented PD at study Day 146 entered into Part II of the study and received combination treatment of LGX818 450 mg plus MEK162 45 mg for two weeks. The patient experienced disease progression on Day 22 of Part II and discontinued the study. | This analysis group is comprised of the Full Analysis Set, which consists of all patients who received at least one dose of LGX818. | Posted | Number | participants | Entry to Part II of the study through study completion (approximately 22 days) |
|
|
|
| Secondary | Molecular Status of Markers Relevant to the RAP/MEK/ERK and PI3K/AKT Pathways | Molecular status was not evaluated due to an inadequate number of patients enrolled in Part II prior to the permanent recruitment halt of this study. | Posted | Baseline and at progression with LGX818 single agent treatment |
|
|
| 3 |
| 15 |
| 15 |
| 15 |
| Metastases To Central Nervous System | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (16.1) | Non-systematic Assessment |
|
| Metastatic Pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (16.1) | Non-systematic Assessment |
|
| Atrial Fibrillation | Cardiac disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Coagulopathy | Blood and lymphatic system disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Panic Attack | Psychiatric disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Renal Failure Acute | Renal and urinary disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Urinary Retention | Renal and urinary disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (16.1) | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Melanocytic Naevus | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (16.1) | Non-systematic Assessment |
|
| Skin Papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (16.1) | Non-systematic Assessment |
|
| Acrochordon | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (16.1) | Non-systematic Assessment |
|
| Blepharal Papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (16.1) | Non-systematic Assessment |
|
| Pyogenic Granuloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (16.1) | Non-systematic Assessment |
|
| Seborrhoeic Keratosis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (16.1) | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Asthenia | General disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Oedema Peripheral | General disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Face Oedema | General disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Benign Prostatic Hyperplasia | Reproductive system and breast disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Breast Pain | Reproductive system and breast disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Menstruation Irregular | Reproductive system and breast disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Vaginal Haemorrhage | Reproductive system and breast disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Dyspnoea | Reproductive system and breast disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Procedural Pain | Injury, poisoning and procedural complications | MedDRA (16.1) | Non-systematic Assessment |
|
| Toxicity To Various Agents | Injury, poisoning and procedural complications | MedDRA (16.1) | Non-systematic Assessment |
|
| Gamma-Glutamyltransferase Increased | Investigations | MedDRA (16.1) | Non-systematic Assessment |
|
| Alanine Aminotransferase Increased | Investigations | MedDRA (16.1) | Non-systematic Assessment |
|
| Amylase Increased | Investigations | MedDRA (16.1) | Non-systematic Assessment |
|
| Blood Alkaline Phosphatase Increased | Investigations | MedDRA (16.1) | Non-systematic Assessment |
|
| Blood Cholesterol Increased | Investigations | MedDRA (16.1) | Non-systematic Assessment |
|
| Blood Creatinine Increased | Investigations | MedDRA (16.1) | Non-systematic Assessment |
|
| Electrocardiogram Qt Prolonged | Investigations | MedDRA (16.1) | Non-systematic Assessment |
|
| Haemoglobin Increased | Investigations | MedDRA (16.1) | Non-systematic Assessment |
|
| Lipase Increased | Investigations | MedDRA (16.1) | Non-systematic Assessment |
|
| Weight Decreased | Investigations | MedDRA (16.1) | Non-systematic Assessment |
|
| Atrial Fibrillation | Cardiac disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Long Qt Syndrome | Cardiac disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Leukocytosis | Blood and lymphatic system disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Eosinophilia | Blood and lymphatic system disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Aphasia | Nervous system disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Convulsion | Nervous system disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Hypogeusia | Nervous system disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Neuralgia | Nervous system disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Peripheral Sensorimotor Neuropathy | Nervous system disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| VIIth Nerve Paralysis | Nervous system disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Insomnia | Nervous system disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Cataract | Eye disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Conjunctival Hyperaemia | Eye disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Ophthalmoplegia | Eye disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Vision Blurred | Eye disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Ear Pain | Ear and labyrinth disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Gingival Bleeding | Gastrointestinal disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Haemorrhoidal Haemorrhage | Gastrointestinal disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Inguinal Hernia | Gastrointestinal disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Rectal Haemorrhage | Gastrointestinal disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Tongue Coated | Gastrointestinal disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Hyperkeratosis | Skin and subcutaneous tissue disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Palmar-Plantar Erythrodysaesthesia Syndrome | Skin and subcutaneous tissue disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Dry Skin | Skin and subcutaneous tissue disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Rash Maculo-Papular | Skin and subcutaneous tissue disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Rash Papular | Skin and subcutaneous tissue disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Granuloma Skin | Skin and subcutaneous tissue disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Palmar Erythema | Skin and subcutaneous tissue disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Papule | Skin and subcutaneous tissue disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Rash Macular | Skin and subcutaneous tissue disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Skin Hypertrophy | Skin and subcutaneous tissue disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Muscular Weakness | Musculoskeletal and connective tissue disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Joint Swelling | Musculoskeletal and connective tissue disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Musculoskeletal Chest Pain | Musculoskeletal and connective tissue disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Pain In Extremity | Musculoskeletal and connective tissue disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Anal Abscess | Infections and infestations | MedDRA (16.1) | Non-systematic Assessment |
|
| Folliculitis | Infections and infestations | MedDRA (16.1) | Non-systematic Assessment |
|
| Lower Respiratory Tract Infection | Infections and infestations | MedDRA (16.1) | Non-systematic Assessment |
|
| Oral Candidiasis | Infections and infestations | MedDRA (16.1) | Non-systematic Assessment |
|
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA (16.1) | Non-systematic Assessment |
|
| Urinary Tract Infection | Infections and infestations | MedDRA (16.1) | Non-systematic Assessment |
|
The terms and conditions of the sponsor's agreements with its investigators may vary. However, the sponsor does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of pooled data (i.e.,data from all sites) in the clinical trial.
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| Title | Measurements |
|---|---|
|
| Stable Disease |
|
| Unknown |
|
| Title | Measurements |
|---|---|
|
| Stable Disease |
|
| Unknown |
|