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Study was withdrawn due to scientific and business considerations.
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To evaluate the safety, tolerability and efficacy of LEE011 and LGX818 when administered orally to patients with BRAF mutant melanoma.
In response to developments in the treatment of melanoma, the sponsor reviewed the data from the ongoing study and decided to halt further enrollment of patients in the Phase Ib part of the study. Consequently, the Phase II part of the study was not performed. Early termination of the study was not due to any safety concerns.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase Ib | Experimental | Phase Ib will randomize 18 patients with BRAF mutant melanoma, who are naïve or who have progressed on prior therapy to evaluate the safety and tolerability of the combination of LEE011 and LGX818. |
|
| Phase II arm 1a | Experimental | Phase II arm 1a will randomize 60 patients that are naïve to prior BRAF inhibitor therapy to LGX818+LEE011 to evaluate the effect of adding LEE011 to a BRAFi in this population. |
|
| Phase II arm 1b | Experimental | Phase II arm 1b will randomize 30 patients to LGX818. Single agent anti-tumor activity of LGX818 is comparable to other BRAFi that are either approved or in clinical trials. This single agent anti-tumor activity will be compared to that of the combination (LEE011 + LGX818) in the BRAFi naïve patient population. |
|
| Phase II arm 2 | Experimental | Phase II arm 2 will evaluate a single arm LEE011+LGX818 in 40 patients resistant to prior BRAF inhibitor therapy. Single agent LGX818 has shown limited activity in patients with melanoma who have failed prior BRAF inhibitor treatment; the contribution of LEE011 in this combination will be evaluated. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LEE011 | Drug | LEE011 will be administered orally, once daily for 21 consecutive days followed by a 7-day planned break (28-day cycle). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Phase Ib - Incidence of Dose Limiting Toxicities (DLTs) in Cycle 1 | Dose Limiting Toxicities (DLTs) during the first 28 days of the combination treatment of LEE011 and LGX818. Due to the halt of enrollment, no Maximum Tolerated Dose (MTD) was formally declared during the study. | Cycle 1 (approximately 28 days) |
| Phase II - Progression Free Survival (PFS) | As per RECIST v1.1, PFS is the time from date of randomization/ start of treatment to the date of event defined as the first documented progression or death due to any cause. Due to the halt of enrollment during the Phase Ib part of the study, all analyses related to efficacy were not performed. | Approximately 23 months after enrollment |
| Phase II - Objective Response Rate (ORR) | As per RECIST v1.1, ORR is defined as the proportion of patients with a best overall response of complete response or partial response. Due to the halt of enrollment during the Phase Ib part of the study, all analyses related to efficacy were not performed. | Approximately 23 months after enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Phase I - Number of Subjects Experiencing at Least One Adverse Event (AE). | Approximately 23 months after enrollment | |
| Phase I - Number of Subjects Experiencing at Least One Serious Adverse Event (SAE). | Approximately 23 months after enrollment |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Array BioPharma | 303-381-6604 | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Dept of Oncology | Aurora | Colorado | 80045 | United States | ||
| Karmanos Cancer Institute Dept of Oncology |
In response to developments in the treatment of melanoma, the sponsor reviewed the data from the ongoing study and decided to halt further enrollment of patients in the Phase Ib part of the study. Consequently, the Phase II part of the study was not performed. Early termination of the study was not due to any safety concerns.
Recruitment to CLEE011X2105 began on 10-July-2013. The study concluded on 13-April-2015. Participant Flow data is comprised of the Full Analysis Set (FAS), which is all patients who received at least one dose of LGX818 or LEE011.
Not completed subjects represents subjects that stopped treatment early, due to the corresponding reason.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Phase Ib: LEE011 200 mg + LGX818 300 mg (Cohort) | Ribociclib (LEE011) was provided in capsule form for oral use and was to be taken orally, once a day for 21 consecutive days followed by a 7-day planned break as part of each 28-day cycle of treatment. Encorafenib (LGX818) was to be provided in capsule form for oral use and taken orally, once a day for 28 consecutive days as part of each 28-day cycle of treatment. |
| FG001 | Phase Ib: LEE011 300 mg + LGX818 200 mg (Cohort) | Ribociclib (LEE011) was provided in capsule form for oral use and was to be taken orally, once a day for 21 consecutive days followed by a 7-day planned break as part of each 28-day cycle of treatment. Encorafenib (LGX818) was to be provided in capsule form for oral use and taken orally, once a day for 28 consecutive days as part of each 28-day cycle of treatment. |
| FG002 | Phase Ib: LEE011 400 mg + LGX818 100 mg (Cohort) | Ribociclib (LEE011) was provided in capsule form for oral use and was to be taken orally, once a day for 21 consecutive days followed by a 7-day planned break as part of each 28-day cycle of treatment. Encorafenib (LGX818) was to be provided in capsule form for oral use and taken orally, once a day for 28 consecutive days as part of each 28-day cycle of treatment. |
| FG003 | Phase Ib: LEE011 400 mg + LGX818 200 mg (Cohort) | Ribociclib (LEE011) was provided in capsule form for oral use and was to be taken orally, once a day for 21 consecutive days followed by a 7-day planned break as part of each 28-day cycle of treatment. Encorafenib (LGX818) was to be provided in capsule form for oral use and taken orally, once a day for 28 consecutive days as part of each 28-day cycle of treatment. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Baseline data is comprised of the Full Analysis Set (FAS), which is all patients who received at least one dose of LGX818 or LEE011.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Phase Ib: LEE011 200 mg + LGX818 300 mg (Cohort) | Ribociclib (LEE011) was provided in capsule form for oral use and was to be taken orally, once a day for 21 consecutive days followed by a 7-day planned break as part of each 28-day cycle of treatment. Encorafenib (LGX818) was to be provided in capsule form for oral use and taken orally, once a day for 28 consecutive days as part of each 28-day cycle of treatment. |
| 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 | Phase Ib - Incidence of Dose Limiting Toxicities (DLTs) in Cycle 1 | Dose Limiting Toxicities (DLTs) during the first 28 days of the combination treatment of LEE011 and LGX818. Due to the halt of enrollment, no Maximum Tolerated Dose (MTD) was formally declared during the study. | Analysis group is comprised of the Safety Set (SS), which includes all patients who received at least one dose of LEE011 or LGX818, and have at least one valid post-baseline safety assessment. | Posted | Number | participants with DLTs | Cycle 1 (approximately 28 days) |
|
This study began recruitment on 10-July-2013 and concluded on 13-April-2015. Adverse Events (AEs) were collected throughout the study, approximately 2 years.
An AE is 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.
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 | Phase Ib: LEE011 200 mg + LGX818 300 mg (Cohort) | Ribociclib (LEE011) was provided in capsule form for oral use and was to be taken orally, once a day for 21 consecutive days followed by a 7-day planned break as part of each 28-day cycle of treatment. Encorafenib (LGX818) was to be provided in capsule form for oral use and taken orally, once a day for 28 consecutive days as part of each 28-day cycle of treatment. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
Study recruitment was halted on 07-Aug-2014 during the Phase Ib part of the study. The Phase II part of the study was not performed. Early termination of the study was not due to any safety concerns.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Array BioPharma, Inc. | 303-381-6604 | info@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 |
|---|---|
| C000589651 | ribociclib |
| C000601108 | encorafenib |
Not provided
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|
| LGX818 | Drug | LGX818 will be administered orally, once daily on a continuous dosing schedule (28-day cycle). |
|
|
| Phase Ib/II - Plasma Concentration-time Profiles | Due to the halt of enrollment during the Phase Ib part of the study, all analyses related to plasma concentration time profiles were not performed. | 28-day cycles |
| Phase Ib/II - Overall Response Rate (ORR) | ORR is defined as the proportion of patients with a best overall response of complete response or partial response. Due to the halt of enrollment during the Phase Ib part of the study, this analysis was not performed. | Approximately 23 months after enrollment |
| Phase Ib/II - Progression Free Survival (PFS) | PFS is the time from date of randomization/start of treatment to the date of event defined as the first documented progression or death due to any cause. Due to the halt of enrollment during the Phase Ib part of the study, this analysis was not performed. | Approximately 23 months after enrollment |
| Phase Ib/II - Duration Of Response (DOR) | DOR is calculated as the time from the date of first documented response (complete response (CR) or partial response (PR)) to the first documented date of progression or death due to underlying cancer. Due to the halt of enrollment during the Phase Ib part of the study, this analysis was not performed. | Approximately 23 months after enrollment |
| Phase II - Overall Survival (OS) | OS is defined as the time from date of randomization/start of treatment to date of death due to any cause. If a patient is not known to have died, survival will be censored at the date of last known date patient alive. Due to the halt of enrollment during the Phase Ib part of the study, this analysis was not performed. | Approximately 23 months after enrollment |
| Phase Ib/II - Pharmacokinetic Parameters: AUCtau | Due to the halt of enrollment during the Phase Ib part of the study, all analyses related to pharmacokinetic parameters were not performed. | 28-day cycles |
| Phase Ib/II - Pharmacokinetic Parameters: Cmin | Due to the halt of enrollment during the Phase Ib part of the study, all analyses related to pharmacokinetic parameters were not performed. | 28-day cycles |
| Phase Ib/II - Pharmacokinetic Parameters: Cmax | Due to the halt of enrollment during the Phase Ib part of the study, all analyses related to pharmacokinetic parameters were not performed. | 28-day cycles |
| Phase Ib/II - Pharmacokinetic Parameters: Tmax | Due to the halt of enrollment during the Phase Ib part of the study, all analyses related to pharmacokinetic parameters were not performed. | 28-day cycles |
| Phase Ib/II - Pharmacokinetic Parameters: Racc | Due to the halt of enrollment during the Phase Ib part of the study, all analyses related to pharmacokinetic parameters were not performed. | 28-day cycles |
| Detroit |
| Michigan |
| 48201 |
| United States |
| Memorial Sloan Kettering Cancer Center Dept Oncology | New York | New York | 90033 | United States |
| Oregon Health & Science University Dept. of OHSU (3) | Portland | Oregon | 97239 | United States |
| Vanderbilt University Medical Center SC - Dept of Oncology . | Nashville | Tennessee | 37232 | United States |
| Novartis Investigative Site | Westmead | New South Wales | 2145 | Australia |
| Novartis Investigative Site | Woodville | South Australia | 5011 | Australia |
| Novartis Investigative Site | Montreal | Quebec | H2X 3J4 | Canada |
| Novartis Investigative Site | Utrecht | Netherlands | 3584CX | Netherlands |
| Disease Progression |
|
| Withdrawal by Subject |
|
| BG001 | Phase Ib: LEE011 300 mg + LGX818 200 mg (Cohort) | Ribociclib (LEE011) was provided in capsule form for oral use and was to be taken orally, once a day for 21 consecutive days followed by a 7-day planned break as part of each 28-day cycle of treatment. Encorafenib (LGX818) was to be provided in capsule form for oral use and taken orally, once a day for 28 consecutive days as part of each 28-day cycle of treatment. |
| BG002 | Phase Ib: LEE011 400 mg + LGX818 100 mg (Cohort) | Ribociclib (LEE011) was provided in capsule form for oral use and was to be taken orally, once a day for 21 consecutive days followed by a 7-day planned break as part of each 28-day cycle of treatment. Encorafenib (LGX818) was to be provided in capsule form for oral use and taken orally, once a day for 28 consecutive days as part of each 28-day cycle of treatment. |
| BG003 | Phase Ib: LEE011 400 mg + LGX818 200 mg (Cohort) | Ribociclib (LEE011) was provided in capsule form for oral use and was to be taken orally, once a day for 21 consecutive days followed by a 7-day planned break as part of each 28-day cycle of treatment. Encorafenib (LGX818) was to be provided in capsule form for oral use and taken orally, once a day for 28 consecutive days as part of each 28-day cycle of treatment. |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Weight | Mean | Standard Deviation | kilograms |
|
| WHO/ECOG performance status | Categories:
| Number | participants |
|
| OG001 | Phase Ib: LEE011 300 mg + LGX818 200 mg (Cohort) | Ribociclib (LEE011) was provided in capsule form for oral use and was to be taken orally, once a day for 21 consecutive days followed by a 7-day planned break as part of each 28-day cycle of treatment. Encorafenib (LGX818) was to be provided in capsule form for oral use and taken orally, once a day for 28 consecutive days as part of each 28-day cycle of treatment. |
| OG002 | Phase Ib: LEE011 400 mg + LGX818 100 mg (Cohort) | Ribociclib (LEE011) was provided in capsule form for oral use and was to be taken orally, once a day for 21 consecutive days followed by a 7-day planned break as part of each 28-day cycle of treatment. Encorafenib (LGX818) was to be provided in capsule form for oral use and taken orally, once a day for 28 consecutive days as part of each 28-day cycle of treatment. |
| OG003 | Phase Ib: LEE011 400 mg + LGX818 200 mg (Cohort) | Ribociclib (LEE011) was provided in capsule form for oral use and was to be taken orally, once a day for 21 consecutive days followed by a 7-day planned break as part of each 28-day cycle of treatment. Encorafenib (LGX818) was to be provided in capsule form for oral use and taken orally, once a day for 28 consecutive days as part of each 28-day cycle of treatment. |
|
|
| Primary | Phase II - Progression Free Survival (PFS) | As per RECIST v1.1, PFS is the time from date of randomization/ start of treatment to the date of event defined as the first documented progression or death due to any cause. Due to the halt of enrollment during the Phase Ib part of the study, all analyses related to efficacy were not performed. | This analysis set would have been the Full Analysis (FAS), which included all patients who received at least one dose of encorafenib or ribociclib. | Posted | Approximately 23 months after enrollment |
|
|
| Primary | Phase II - Objective Response Rate (ORR) | As per RECIST v1.1, ORR is defined as the proportion of patients with a best overall response of complete response or partial response. Due to the halt of enrollment during the Phase Ib part of the study, all analyses related to efficacy were not performed. | This analysis set would have been the Full Analysis (FAS), which included all patients who received at least one dose of encorafenib or ribociclib. | Posted | Approximately 23 months after enrollment |
|
|
| Secondary | Phase I - Number of Subjects Experiencing at Least One Adverse Event (AE). | Analysis group is comprised of the Safety Set (SS), which includes all patients who received at least one dose of LEE011 or LGX818, and have at least one valid post-baseline safety assessment. | Posted | Number | participants | Approximately 23 months after enrollment |
|
|
|
| Secondary | Phase I - Number of Subjects Experiencing at Least One Serious Adverse Event (SAE). | Analysis group is comprised of the Safety Set (SS), which is all patients who received at least one dose of LEE011 or LGX818, and have at least one valid post-baseline safety assessment. | Posted | Number | participants | Approximately 23 months after enrollment |
|
|
|
| Secondary | Phase Ib/II - Plasma Concentration-time Profiles | Due to the halt of enrollment during the Phase Ib part of the study, all analyses related to plasma concentration time profiles were not performed. | This analysis group would have been the PK analysis set (PAS), which would have consisted of all patients who had at least one blood sample providing evaluable drug concentration data. | Posted | 28-day cycles |
|
|
| Secondary | Phase Ib/II - Overall Response Rate (ORR) | ORR is defined as the proportion of patients with a best overall response of complete response or partial response. Due to the halt of enrollment during the Phase Ib part of the study, this analysis was not performed. | This analysis set would have been the Full Analysis (FAS), which included all patients who received at least one dose of encorafenib or ribociclib. | Posted | Approximately 23 months after enrollment |
|
|
| Secondary | Phase Ib/II - Progression Free Survival (PFS) | PFS is the time from date of randomization/start of treatment to the date of event defined as the first documented progression or death due to any cause. Due to the halt of enrollment during the Phase Ib part of the study, this analysis was not performed. | This analysis set would have been the Full Analysis (FAS), which included all patients who received at least one dose of encorafenib or ribociclib. | Posted | Approximately 23 months after enrollment |
|
|
| Secondary | Phase Ib/II - Duration Of Response (DOR) | DOR is calculated as the time from the date of first documented response (complete response (CR) or partial response (PR)) to the first documented date of progression or death due to underlying cancer. Due to the halt of enrollment during the Phase Ib part of the study, this analysis was not performed. | This analysis set would have been the Full Analysis (FAS), which included all patients who received at least one dose of encorafenib or ribociclib. | Posted | Approximately 23 months after enrollment |
|
|
| Secondary | Phase II - Overall Survival (OS) | OS is defined as the time from date of randomization/start of treatment to date of death due to any cause. If a patient is not known to have died, survival will be censored at the date of last known date patient alive. Due to the halt of enrollment during the Phase Ib part of the study, this analysis was not performed. | This analysis set would have been the Full Analysis (FAS), which included all patients who received at least one dose of encorafenib or ribociclib. | Posted | Approximately 23 months after enrollment |
|
|
| Secondary | Phase Ib/II - Pharmacokinetic Parameters: AUCtau | Due to the halt of enrollment during the Phase Ib part of the study, all analyses related to pharmacokinetic parameters were not performed. | This analysis group would have been the PK analysis set (PAS), which would have consisted of all patients who had at least one blood sample providing evaluable drug concentration data. | Posted | 28-day cycles |
|
|
| Secondary | Phase Ib/II - Pharmacokinetic Parameters: Cmin | Due to the halt of enrollment during the Phase Ib part of the study, all analyses related to pharmacokinetic parameters were not performed. | This analysis group would have been the PK analysis set (PAS), which would have consisted of all patients who had at least one blood sample providing evaluable drug concentration data. | Posted | 28-day cycles |
|
|
| Secondary | Phase Ib/II - Pharmacokinetic Parameters: Cmax | Due to the halt of enrollment during the Phase Ib part of the study, all analyses related to pharmacokinetic parameters were not performed. | This analysis group would have been the PK analysis set (PAS), which would have consisted of all patients who had at least one blood sample providing evaluable drug concentration data. | Posted | 28-day cycles |
|
|
| Secondary | Phase Ib/II - Pharmacokinetic Parameters: Tmax | Due to the halt of enrollment during the Phase Ib part of the study, all analyses related to pharmacokinetic parameters were not performed. | This analysis group would have been the PK analysis set (PAS), which would have consisted of all patients who had at least one blood sample providing evaluable drug concentration data. | Posted | 28-day cycles |
|
|
| Secondary | Phase Ib/II - Pharmacokinetic Parameters: Racc | Due to the halt of enrollment during the Phase Ib part of the study, all analyses related to pharmacokinetic parameters were not performed. | This analysis group would have been the PK analysis set (PAS), which would have consisted of all patients who had at least one blood sample providing evaluable drug concentration data. | Posted | 28-day cycles |
|
|
| 3 |
| 6 |
| 6 |
| 6 |
| EG001 | Phase Ib: LEE011 300 mg + LGX818 200 mg (Cohort) | Ribociclib (LEE011) was provided in capsule form for oral use and was to be taken orally, once a day for 21 consecutive days followed by a 7-day planned break as part of each 28-day cycle of treatment. Encorafenib (LGX818) was to be provided in capsule form for oral use and taken orally, once a day for 28 consecutive days as part of each 28-day cycle of treatment. | 5 | 12 | 12 | 12 |
| EG002 | Phase Ib: LEE011 400 mg + LGX818 100 mg (Cohort) | Ribociclib (LEE011) was provided in capsule form for oral use and was to be taken orally, once a day for 21 consecutive days followed by a 7-day planned break as part of each 28-day cycle of treatment. Encorafenib (LGX818) was to be provided in capsule form for oral use and taken orally, once a day for 28 consecutive days as part of each 28-day cycle of treatment. | 3 | 6 | 6 | 6 |
| EG003 | Phase Ib: LEE011 400 mg + LGX818 200 mg (Cohort) | Ribociclib (LEE011) was provided in capsule form for oral use and was to be taken orally, once a day for 21 consecutive days followed by a 7-day planned break as part of each 28-day cycle of treatment. Encorafenib (LGX818) was to be provided in capsule form for oral use and taken orally, once a day for 28 consecutive days as part of each 28-day cycle of treatment. | 1 | 4 | 4 | 4 |
| Brain oedema | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
|
| Chest wall abscess | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA | Non-systematic Assessment |
|
| Dermatitis bullous | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
| Failure to thrive | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Memory impairment | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Mental status changes | Psychiatric disorders | MedDRA | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Seizure | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Simple partial seizures | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Spinal cord compression | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Syncope | Vascular disorders | MedDRA | Non-systematic Assessment |
|
| Systemic inflammatory response syndrome | Immune system disorders | MedDRA | Non-systematic Assessment |
|
| Transaminases increased | Hepatobiliary disorders | MedDRA | Non-systematic Assessment |
|
| Urinary tract infection | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
|
| Lymphopenia | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
|
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
|
| Increased tendency to bruise | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA | Non-systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA | Non-systematic Assessment |
|
| Ear pruritus | Ear and labyrinth disorders | MedDRA | Non-systematic Assessment |
|
| Adrenal insufficiency | Endocrine disorders | MedDRA | Non-systematic Assessment |
|
| Cushingoid | Endocrine disorders | MedDRA | Non-systematic Assessment |
|
| Eye pruritus | Eye disorders | MedDRA | Non-systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA | Non-systematic Assessment |
|
| Blepharospasm | Eye disorders | MedDRA | Non-systematic Assessment |
|
| Dry eye | Eye disorders | MedDRA | Non-systematic Assessment |
|
| Eye discharge | Eye disorders | MedDRA | Non-systematic Assessment |
|
| Photophobia | Eye disorders | MedDRA | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Oral pain | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Cheilitis | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Gingival discolouration | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Gingival ulceration | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Glossitis | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Glossodynia | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Retching | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA | Non-systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA | Non-systematic Assessment |
|
| Chills | General disorders | MedDRA | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA | Non-systematic Assessment |
|
| Localised oedema | General disorders | MedDRA | Non-systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA | Non-systematic Assessment |
|
| Peripheral swelling | General disorders | MedDRA | Non-systematic Assessment |
|
| Xerosis | General disorders | MedDRA | Non-systematic Assessment |
|
| Oral candidiasis | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Skin candida | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Conjunctivitis | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Dermatitis infected | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Fungal infection | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Furuncle | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Lower respiratory tract infection | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
|
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
|
| Laceration | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
|
| Muscle strain | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
|
| Post procedural complication | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
|
| Post procedural discharge | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
|
| Skin abrasion | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Sunburn | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA | Non-systematic Assessment |
|
| Electrocardiogram QT prolonged | Investigations | MedDRA | Non-systematic Assessment |
|
| Weight decreased | Investigations | MedDRA | Non-systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA | Non-systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA | Non-systematic Assessment |
|
| Blood sodium decreased | Investigations | MedDRA | Non-systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA | Non-systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA | Non-systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA | Non-systematic Assessment |
|
| Blood glucose increased | Investigations | MedDRA | Non-systematic Assessment |
|
| Blood iron decreased | Investigations | MedDRA | Non-systematic Assessment |
|
| Blood phosphorus decreased | Investigations | MedDRA | Non-systematic Assessment |
|
| Blood potassium decreased | Investigations | MedDRA | Non-systematic Assessment |
|
| Blood thyroid stimulating hormone increased | Investigations | MedDRA | Non-systematic Assessment |
|
| Cardiac murmur | Investigations | MedDRA | Non-systematic Assessment |
|
| Lymphocyte count decreased | Investigations | MedDRA | Non-systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA | Non-systematic Assessment |
|
| Troponin increased | Investigations | MedDRA | Non-systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
|
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
|
| Hypermagnesaemia | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Periarthritis | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Acrochordon | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
|
| Melanocytic naevus | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
|
| Skin papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
|
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
|
| Acanthoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
|
| Infected neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
|
| Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
|
| Seborrhoeic keratosis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Neuralgia | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Balance disorder | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Hyperaesthesia | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Neuropathy peripheral | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Partial seizures | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Peripheral motor neuropathy | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Sciatica | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA | Non-systematic Assessment |
|
| Mood swings | Psychiatric disorders | MedDRA | Non-systematic Assessment |
|
| Anger | Psychiatric disorders | MedDRA | Non-systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA | Non-systematic Assessment |
|
| Irritability | Psychiatric disorders | MedDRA | Non-systematic Assessment |
|
| Mental status changes | Psychiatric disorders | MedDRA | Non-systematic Assessment |
|
| Sleep disorder | Psychiatric disorders | MedDRA | Non-systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
|
| Renal impairment | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
|
| Penile oedema | Reproductive system and breast disorders | MedDRA | Non-systematic Assessment |
|
| Scrotal oedema | Reproductive system and breast disorders | MedDRA | Non-systematic Assessment |
|
| Scrotal pain | Reproductive system and breast disorders | MedDRA | Non-systematic Assessment |
|
| Scrotal swelling | Reproductive system and breast disorders | MedDRA | Non-systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Dry throat | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Upper-airway cough syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
| Hyperkeratosis | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
| Palmoplantar keratoderma | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
| Photosensitivity reaction | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
| Pruritus generalised | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
| Skin sensitisation | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
| Transient acantholytic dermatosis | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
| Actinic keratosis | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
| Cold sweat | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
| Ephelides | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
| Intertrigo | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
| Leukoplakia | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
| Pain of skin | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
| Rash erythematous | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
| Rash papular | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
| Skin hypopigmentation | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
| Vitiligo | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
| Flushing | Vascular disorders | MedDRA | Non-systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA | Non-systematic Assessment |
|
| Embolism | Vascular disorders | MedDRA | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA | 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 |