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This open-label study will assess the safety and efficacy of RO5185426 in previously treated metastatic melanoma patients with brain metastases. Patients will receive RO5185426 at a dose of 960 mg twice daily orally until disease progression or unacceptable toxicity occurs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RO5185426 | Drug | 960 mg b.i.d. orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Adverse Events (AEs) | AE:any unfavorable and unintended sign, symptom, or disease associated with use of study drug, regardless of relation to study drug. Pre-existing conditions that worsened and laboratory or clinical tests that resulted in change in treatment or discontinuation from study drug were reported as AEs. Serious AE: resulted in death, life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was congenital anomaly/birth defect or was medically significant. Grade-1:discomfort but no disruption of normal daily activity. Grade-2:discomfort sufficient to reduce or affect daily activity,no intervention indicated.Grade-3:inability to perform normal daily activity,intervention indicated.Grade-4:immediate threat to life or leading to permanent mental or physical condition that prevented performing normal daily activities.Grade 5: death. Any AE included participants with serious and non-serious AE. | From baseline up to last dose (0.1 to 11.3 months) plus 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR) by Disease Site | Objective response was assessed by the investigator according to Response Evaluation Criteria in Solid Tumours (RECIST) (Version 1.1). CR was defined as disappearance of all target and non-target lesions and no new lesions. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions. Best overall response was calculated separately for brain, other sites (extracranial) and whole body. Percentage of participants with 95 percent (%) Clopper-Pearson confidence interval (CI) are reported. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHUV; Departement d'Oncologie | Lausanne | 1011 | Switzerland | |||
| Universitätsspital Zürich; Dermatologische Klinik |
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| ID | Title | Description |
|---|---|---|
| FG000 | Vemurafenib | Participants received vemurafenib tablets, 960 milligrams (mg), twice daily (BID), orally continuously until disease progression, unacceptable toxicity, withdrawal of consent, death, other reason deemed by investigator or study termination by the Sponsor. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety population: All participants who received at least one dose of study medication.
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| ID | Title | Description |
|---|---|---|
| BG000 | Vemurafenib | Participants received vemurafenib tablets, 960 mg, BID, orally continuously until disease progression, unacceptable toxicity, withdrawal of consent, death, other reason deemed by investigator or study termination by the Sponsor. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 Adverse Events (AEs) | AE:any unfavorable and unintended sign, symptom, or disease associated with use of study drug, regardless of relation to study drug. Pre-existing conditions that worsened and laboratory or clinical tests that resulted in change in treatment or discontinuation from study drug were reported as AEs. Serious AE: resulted in death, life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was congenital anomaly/birth defect or was medically significant. Grade-1:discomfort but no disruption of normal daily activity. Grade-2:discomfort sufficient to reduce or affect daily activity,no intervention indicated.Grade-3:inability to perform normal daily activity,intervention indicated.Grade-4:immediate threat to life or leading to permanent mental or physical condition that prevented performing normal daily activities.Grade 5: death. Any AE included participants with serious and non-serious AE. | Safety Population. | Posted | Number | percentage of participants | From baseline up to last dose (0.1 to 11.3 months) plus 28 days |
From baseline up to last dose (0.1 to 11.3 months) plus 28 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Vemurafenib | Participants received vemurafenib tablets, 960 mg, BID, orally continuously until disease progression, unacceptable toxicity, withdrawal of consent, death, other reason deemed by investigator or study termination by the Sponsor. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hyperkeratosis | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-LaRoche | 800 821-8590 | genentech@druginfo.com |
Not provided
| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| Baseline, Week 4, Week 8 and thereafter every 8th week until progressive disease, unacceptable toxicity, consent withdrawal, death or other reasons deemed by the investigator (up to 16 months) |
| Duration of Response by Disease Site | Duration of response was defined as the time interval between the date of the earliest qualifying response and the date of progressive disease (PD) or death, only for those participants whose best overall response was CR or PR. CR and PR were assessed by investigator according to RECIST version 1.1. CR was defined as disappearance of all target and non-target lesions and no new lesions. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions. PD was defined as at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 millimeter (mm), progression of existing non-target lesions, or presence of new lesions. Duration of response was calculated by Kaplan-Meier estimates separately for brain, other sites (extracranial) and whole body. | Baseline, Week 4, Week 8 and thereafter every 8th week until progressive disease or death (up to 16 months) |
| Time to Response by Disease Site | Time to response was defined as the interval between the date of first treatment and the date of first documentation of CR or PR (whichever occurred first). CR and PR were assessed by investigator according to RECIST version 1.1. CR was defined as disappearance of all target and non-target lesions and no new lesions. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions. Time of response was calculated by Kaplan-Meier estimates separately for brain, other sites (extracranial) and whole body. | Baseline, Week 4, Week 8 and thereafter every 8th week until progressive disease, unacceptable toxicity, consent withdrawal, death or other reasons deemed by the investigator (up to 16 months) |
| Duration of Stable Disease (SD) by Disease Site | Duration of SD was defined as the time between the first documented date of SD and date of PD or death from any cause. SD was defined (according to RECIST version 1.1) as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions. PD was defined as at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions. Duration of SD was calculated by Kaplan-Meier estimates separately for brain, other sites (extracranial) and whole body. | Baseline, Week 4, Week 8 and thereafter every 8th week until progressive disease, unacceptable toxicity, consent withdrawal, death or other reasons deemed by the investigator (up to 16 months) |
| Time to New Lesion by Disease Site | Time to new lesions was defined as the interval between the date of first treatment and the date of first documentation of new lesions. Time to new lesion was calculated by Kaplan-Meier estimates separately for brain, other sites (extracranial) and whole body. | Baseline, Week 4, Week 8 and thereafter every eighth week until progressive disease, unacceptable toxicity, consent withdrawal, death or other reasons deemed by the investigator (up to 16 months) |
| Percentage of Participants With Disease Progression or Death by Disease Site | Disease progression (according to RECIST version 1.1) was defined as at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study or absolute increase and at least 5 mm, progression of existing non-target lesions, or presence of new lesions. Percentage of participants with disease progression by brain, other sites (extracranial) and whole body are reported. | Baseline, Week 4, Week 8 and thereafter every 8th week until progressive disease, unacceptable toxicity, consent withdrawal, death or other reasons deemed by the investigator (up to 16 months) |
| Progression Free Survival (PFS) | PFS was defined as the time interval between the date of the first treatment and the date of progression or death from any cause, whichever occurred first. Disease progression (according to RECIST version 1.1) was defined as at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study or absolute increase and at least 5 mm, progression of existing non-target lesions, or presence of new lesions. PFS was calculated by Kaplan-Meier estimates separately for brain, other sites (extracranial) and whole body. | Baseline, Week 4, Week 8 and thereafter every eighth week until progressive disease, unacceptable toxicity, consent withdrawal, death or other reasons deemed by the investigator (up to 16 months) |
| Percentage of Participants Who Died | Percentage of participants who died due to any reason are reported. | Baseline up to end of the study and every 3 months during follow-up (up to 16 months) |
| Overall Survival (OS) | OS was defined as the time from the date of first treatment to the date of death, regardless of the cause of death. Participants who discontinued the study treatment for any reason other than withdrawal of consent were continued to be followed for survival. The end of study occurred when all participants had been followed for a period of 6 months, had died, withdrawn consent or were lost to follow-up, whichever occurred first. OS was calculated by Kaplan-Meier estimates. | From start of treatment up to end of the study and every 3 months during follow up (up to 16 months) |
| Percentage of Participants With Improvement in Total Daily Dose of Corticosteroids | An improvement in corticosteroid dose was defined as a dose reduction of at least 33% of baseline dose for at least 28 days or stopping use completely. Percentage of participants and 95% Clopper-Pearson CI are reported. | Baseline, every week during the first 8 weeks and every second week thereafter up to last dose (0.1 to 11.3 months) plus 28 days |
| Percentage of Participants With Improvement in Total Daily Dose of Narcotic Pain Analgesic | An improvement in narcotic pain analgesics was defined as a dose reduction of at least 33% of baseline dose for at least 28 days or stopping use completely. | Baseline, every week during the first 8 weeks and every second week thereafter up to last dose (0.1 to 11.3 months) plus 28 days |
| Percentage of Participants With Improvement in Visual Analog Scale (VAS) Assessment of Pain | VAS is a measure of pain intensity. The participant was asked to mark on a 100 mm line where their pain level was on the day they completed the scale. The beginning of the line represented no pain and the end of the line represented maximum pain. Total score ranged from 0 - 100. Reported values are decrease in VAS of greater than (>) 20 mm or >30 mm from baseline. | Baseline; Day 1 of Cycles 2-8 (28-day cycle) and at the end of study visit (up to 16 months) |
| Percentage of Participants With Improvement in Physician's Assessment of Global Performance Status | Physician's Assessment of Global Performance Status was assessed on 7 point scale (1- Very much better, 2-Much better, 3-A little better, 4-No change, 5-A little worse, 6-Much worse, 7- Very much worse). An improvement was classed as a difference from baseline of at least -1 point. Percentage of participants with 95% Clopper-Pearson CI were reported for participants with improvement in Physician's Assessment of Global Performance Status at any visit. | Baseline, Day 1 of every 28-day cycle, at end of study and at the 28-day follow-up visit (up to 16 months) |
| Zurich |
| 8091 |
| Switzerland |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| ID |
|---|
| Title |
|---|
| Description |
|---|
| OG000 | Vemurafenib | Participants received vemurafenib tablets, 960 mg, BID, orally continuously until disease progression, unacceptable toxicity, withdrawal of consent, death, other reason deemed by investigator or study termination by the Sponsor. |
|
|
| Secondary | Percentage of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR) by Disease Site | Objective response was assessed by the investigator according to Response Evaluation Criteria in Solid Tumours (RECIST) (Version 1.1). CR was defined as disappearance of all target and non-target lesions and no new lesions. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions. Best overall response was calculated separately for brain, other sites (extracranial) and whole body. Percentage of participants with 95 percent (%) Clopper-Pearson confidence interval (CI) are reported. | Safety population. Here, 'n' signifies the number of participants with measurable disease at baseline for specified category. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline, Week 4, Week 8 and thereafter every 8th week until progressive disease, unacceptable toxicity, consent withdrawal, death or other reasons deemed by the investigator (up to 16 months) |
|
|
|
| Secondary | Duration of Response by Disease Site | Duration of response was defined as the time interval between the date of the earliest qualifying response and the date of progressive disease (PD) or death, only for those participants whose best overall response was CR or PR. CR and PR were assessed by investigator according to RECIST version 1.1. CR was defined as disappearance of all target and non-target lesions and no new lesions. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions. PD was defined as at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 millimeter (mm), progression of existing non-target lesions, or presence of new lesions. Duration of response was calculated by Kaplan-Meier estimates separately for brain, other sites (extracranial) and whole body. | Safety population. Here, 'n' signifies number of participants with best overall response of CR or PR for specified category. | Posted | Median | 95% Confidence Interval | months | Baseline, Week 4, Week 8 and thereafter every 8th week until progressive disease or death (up to 16 months) |
|
|
|
| Secondary | Time to Response by Disease Site | Time to response was defined as the interval between the date of first treatment and the date of first documentation of CR or PR (whichever occurred first). CR and PR were assessed by investigator according to RECIST version 1.1. CR was defined as disappearance of all target and non-target lesions and no new lesions. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions. Time of response was calculated by Kaplan-Meier estimates separately for brain, other sites (extracranial) and whole body. | Safety population. Here, 'n' signifies number of participants with measurable disease for specified category. | Posted | Median | 95% Confidence Interval | months | Baseline, Week 4, Week 8 and thereafter every 8th week until progressive disease, unacceptable toxicity, consent withdrawal, death or other reasons deemed by the investigator (up to 16 months) |
|
|
|
| Secondary | Duration of Stable Disease (SD) by Disease Site | Duration of SD was defined as the time between the first documented date of SD and date of PD or death from any cause. SD was defined (according to RECIST version 1.1) as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions. PD was defined as at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions. Duration of SD was calculated by Kaplan-Meier estimates separately for brain, other sites (extracranial) and whole body. | Safety Population. Here, 'n' signifies number of participants with measurable disease at baseline for specified category. | Posted | Median | 95% Confidence Interval | months | Baseline, Week 4, Week 8 and thereafter every 8th week until progressive disease, unacceptable toxicity, consent withdrawal, death or other reasons deemed by the investigator (up to 16 months) |
|
|
|
| Secondary | Time to New Lesion by Disease Site | Time to new lesions was defined as the interval between the date of first treatment and the date of first documentation of new lesions. Time to new lesion was calculated by Kaplan-Meier estimates separately for brain, other sites (extracranial) and whole body. | Safety population. Here, 'n' signifies number of participants with measurable disease at baseline for specified category. | Posted | Median | 95% Confidence Interval | months | Baseline, Week 4, Week 8 and thereafter every eighth week until progressive disease, unacceptable toxicity, consent withdrawal, death or other reasons deemed by the investigator (up to 16 months) |
|
|
|
| Secondary | Percentage of Participants With Disease Progression or Death by Disease Site | Disease progression (according to RECIST version 1.1) was defined as at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study or absolute increase and at least 5 mm, progression of existing non-target lesions, or presence of new lesions. Percentage of participants with disease progression by brain, other sites (extracranial) and whole body are reported. | Safety Population. | Posted | Number | percentage of participants | Baseline, Week 4, Week 8 and thereafter every 8th week until progressive disease, unacceptable toxicity, consent withdrawal, death or other reasons deemed by the investigator (up to 16 months) |
|
|
|
| Secondary | Progression Free Survival (PFS) | PFS was defined as the time interval between the date of the first treatment and the date of progression or death from any cause, whichever occurred first. Disease progression (according to RECIST version 1.1) was defined as at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study or absolute increase and at least 5 mm, progression of existing non-target lesions, or presence of new lesions. PFS was calculated by Kaplan-Meier estimates separately for brain, other sites (extracranial) and whole body. | Safety Population. | Posted | Median | 95% Confidence Interval | months | Baseline, Week 4, Week 8 and thereafter every eighth week until progressive disease, unacceptable toxicity, consent withdrawal, death or other reasons deemed by the investigator (up to 16 months) |
|
|
|
| Secondary | Percentage of Participants Who Died | Percentage of participants who died due to any reason are reported. | Safety Population. | Posted | Number | percentage of participants | Baseline up to end of the study and every 3 months during follow-up (up to 16 months) |
|
|
|
| Secondary | Overall Survival (OS) | OS was defined as the time from the date of first treatment to the date of death, regardless of the cause of death. Participants who discontinued the study treatment for any reason other than withdrawal of consent were continued to be followed for survival. The end of study occurred when all participants had been followed for a period of 6 months, had died, withdrawn consent or were lost to follow-up, whichever occurred first. OS was calculated by Kaplan-Meier estimates. | Safety population. | Posted | Median | 95% Confidence Interval | months | From start of treatment up to end of the study and every 3 months during follow up (up to 16 months) |
|
|
|
| Secondary | Percentage of Participants With Improvement in Total Daily Dose of Corticosteroids | An improvement in corticosteroid dose was defined as a dose reduction of at least 33% of baseline dose for at least 28 days or stopping use completely. Percentage of participants and 95% Clopper-Pearson CI are reported. | Safety Population. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline, every week during the first 8 weeks and every second week thereafter up to last dose (0.1 to 11.3 months) plus 28 days |
|
|
|
| Secondary | Percentage of Participants With Improvement in Total Daily Dose of Narcotic Pain Analgesic | An improvement in narcotic pain analgesics was defined as a dose reduction of at least 33% of baseline dose for at least 28 days or stopping use completely. | Safety Population | Posted | Number | percentage of participants | Baseline, every week during the first 8 weeks and every second week thereafter up to last dose (0.1 to 11.3 months) plus 28 days |
|
|
|
| Secondary | Percentage of Participants With Improvement in Visual Analog Scale (VAS) Assessment of Pain | VAS is a measure of pain intensity. The participant was asked to mark on a 100 mm line where their pain level was on the day they completed the scale. The beginning of the line represented no pain and the end of the line represented maximum pain. Total score ranged from 0 - 100. Reported values are decrease in VAS of greater than (>) 20 mm or >30 mm from baseline. | Safety population. Here, 'n' signifies number of participants with available data for specified category. | Posted | Number | percentage of participants | Baseline; Day 1 of Cycles 2-8 (28-day cycle) and at the end of study visit (up to 16 months) |
|
|
|
| Secondary | Percentage of Participants With Improvement in Physician's Assessment of Global Performance Status | Physician's Assessment of Global Performance Status was assessed on 7 point scale (1- Very much better, 2-Much better, 3-A little better, 4-No change, 5-A little worse, 6-Much worse, 7- Very much worse). An improvement was classed as a difference from baseline of at least -1 point. Percentage of participants with 95% Clopper-Pearson CI were reported for participants with improvement in Physician's Assessment of Global Performance Status at any visit. | Safety population. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline, Day 1 of every 28-day cycle, at end of study and at the 28-day follow-up visit (up to 16 months) |
|
|
|
| 14 |
| 24 |
| 22 |
| 24 |
| Epilepsy | Nervous system disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Cerebral disorder | Nervous system disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Ileus | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Erysipelas | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
|
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 13.0 | Non-systematic Assessment |
|
| C-reactive protein increased | Investigations | MedDRA 13.0 | Non-systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Solar dermatitis | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Keratosis pilaris | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Photosensitivity reaction | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Epilepsy | Nervous system disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Ageusia | Nervous system disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Oral candidiasis | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
|
| Folliculitis | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Non-systematic Assessment |
|
| Skin papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Sleep disorder | Psychiatric disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Hearing impaired | Ear and labyrinth disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 13.0 | Non-systematic Assessment |
|
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| 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 |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Whole body (n=23) |
|
| Title | Measurements |
|---|---|
|
| Whole body (n=23) |
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Decrease of >30 mm: Cycle 2 - Day 29 (n=23) |
|
| Decrease of > 20 mm: Cycle 3 - Day 57 (n=20) |
|
| Decrease of >30 mm: Cycle 3 - Day 57 (n=20) |
|
| Decrease of > 20 mm: Cycle 4 - Day 85 (n=18) |
|
| Decrease of >30 mm: Cycle 4 - Day 85 (n=18) |
|
| Decrease of > 20 mm: Cycle 5 - Day 113 (n=13) |
|
| Decrease of >30 mm: Cycle 5 - Day 113 (n=13) |
|
| Decrease of > 20 mm: Cycle 6 - Day 141 (n=10) |
|
| Decrease of > 30 mm: Cycle 6 - Day 141 (n=10) |
|
| Decrease of > 20 mm: Cycle 7 - Day 169 (n=8) |
|
| Decrease of > 30 mm: Cycle 7 - Day 169 (n=8) |
|
| Decrease of > 20 mm: Cycle 8 - Day 197 (n=4) |
|
| Decrease of >30 mm: Cycle 8 - Day 197 (n=4) |
|
| Decrease of > 20 mm: End of Study (n=12) |
|
| Decrease of >30 mm: End of Study (n=12) |
|