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| ID | Type | Description | Link |
|---|---|---|---|
| 2008_012 | Other Identifier | Telerex Study Number |
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This clinical study evaluates the safety, tolerability, pharmacokinetics, and immunogenicity of dalotuzumab (MK-0646) in participants with relapsed or refractory locally advanced or metastatic solid tumors using once weekly and once every other week dose infusion regimens.
The primary study hypothesis is that administration of dalotuzumab as a once weekly and an every other week infusion will be generally safe and well tolerated
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dalotuzumab 5 mg/kg | Experimental | Participants receive dalotuzumab 5 mg/kg by intravenous (IV) infusion once each week for up to 1 year or until participant withdraws consent, experiences an adverse event (AE), progressive disease or major protocol violation, has moved or is lost to follow up. |
|
| Dalotuzumab 10 mg/kg | Experimental | Participants receive dalotuzumab 10 mg/kg by IV infusion once each week for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up. |
|
| Dalotuzumab 15 mg/kg/7.5 mg/kg | Experimental | Participants receive an initial dose of dalotuzumab 15 mg/kg by IV infusion followed by a maintenance dose of dalotuzumab 7.5 mg/kg by IV infusion once every 2 weeks for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dalotuzumab | Biological | IV infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experienced a Dose-limiting Toxicity (DLT) | Toxicity was graded and recorded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. DLTs were defined as the occurrence of any of the following events when judged to be related to the study medication: Grade 4 neutropenia; Grade 3 neutropenia with fever >38.5°C; Grade 4 thrombocytopenia; Grade 3 or Grade 4 non-hematologic toxicity, except alopecia and inadequately treated diarrhea, nausea and vomiting. The number of participants who experienced a DLT is presented. | Cycle 1 (Up to 4 weeks) |
| Number of Participants Who Experienced an Adverse Event (AE) | An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study treatment, whether or not considered related to the use of study treatment. Any worsening (i.e. any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition which was temporally associated with the use of study treatment, was also an AE. The number of participants who experienced at least one AE is presented. | Up to 30 days after last dose of study treatment (Up to 101 days) |
| Number of Participants Who Discontinued Study Treatment Due to an AE | An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study treatment, whether or not considered related to the use of study treatment. Any worsening (i.e. any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition which was temporally associated with the use of study treatment, was also an AE. The number of participants who discontinued study treatment due to an AE is presented. | Up to 71 days |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma Concentration (Cmax) of Dalotuzumab | Cmax was assessed on Week 2 (Day 8) for the Dalotuzumab 5 mg/kg and Dalotuzumab 10 mg/kg treatment groups and on Week 3 (Day 15) for the Dalotuzumab 15 mg/kg/7.5 mg/kg treatment group. | Pre-dose, 0.5 h after start of infusion, end of infusion, 5, 10, 24, 30, 48 and 96 and 168 h post-dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
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| ID | Title | Description |
|---|---|---|
| FG000 | Dalotuzumab 5 mg/kg | Participants receive dalotuzumab 5 mg/kg by intravenous (IV) infusion once each week for up to 1 year or until participant withdraws consent, experiences an adverse event (AE), progressive disease or major protocol violation, has moved or is lost to follow up. |
| FG001 | Dalotuzumab 10 mg/kg | Participants receive dalotuzumab 10 mg/kg by IV infusion once each week for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up. |
| FG002 | Dalotuzumab 15 mg/kg/7.5 mg/kg | Participants receive an initial dose of dalotuzumab 15 mg/kg by IV infusion followed by a maintenance dose of dalotuzumab 7.5 mg/kg by IV infusion once every 2 weeks for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Dalotuzumab 5 mg/kg | Participants receive dalotuzumab 5 mg/kg by IV infusion once each week for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up. |
| BG001 | Dalotuzumab 10 mg/kg |
| 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 | Number of Participants Who Experienced a Dose-limiting Toxicity (DLT) | Toxicity was graded and recorded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. DLTs were defined as the occurrence of any of the following events when judged to be related to the study medication: Grade 4 neutropenia; Grade 3 neutropenia with fever >38.5°C; Grade 4 thrombocytopenia; Grade 3 or Grade 4 non-hematologic toxicity, except alopecia and inadequately treated diarrhea, nausea and vomiting. The number of participants who experienced a DLT is presented. | The population consisted of all participants who received at least one dose of study treatment. | Posted | Number | Participants | Cycle 1 (Up to 4 weeks) |
|
Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
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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 | Dalotuzumab 5 mg/kg | Participants receive dalotuzumab 5 mg/kg by IV infusion once each week for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anorexia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C569480 | dalotuzumab |
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| Area Under the Concentration-Time Curve From Zero to Infinity (AUC0-∞) of Dalotuzumab |
AUC0-∞ was assessed on Week 2 (Day 8) for the Dalotuzumab 5 mg/kg and Dalotuzumab 10 mg/kg treatment groups and on Week 3 (Day 15) for the Dalotuzumab 15 mg/kg/7.5 mg/kg treatment group. |
| Pre-dose, 0.5 h after start of infusion, end of infusion, 5, 10, 24, 30, 48 and 96 and 168 h post-dose |
| Time to Cmax (Tmax) of Dalotuzumab | Tmax was assessed on Week 2 (Day 8) for the Dalotuzumab 5 mg/kg and Dalotuzumab 10 mg/kg treatment groups and on Week 3 (Day 15) for the Dalotuzumab 15 mg/kg/7.5 mg/kg treatment group. | Pre-dose, 0.5 h after start of infusion, end of infusion, 5, 10, 24, 30, 48 and 96 and 168 h post-dose |
| Apparent Terminal Half-life (t1/2) of Dalotuzumab | t1/2 was assessed on Week 2 (Day 8) for the Dalotuzumab 5 mg/kg and Dalotuzumab 10 mg/kg treatment groups and on Week 3 (Day 15) for the Dalotuzumab 15 mg/kg/7.5 mg/kg treatment group. | Pre-dose, 0.5 h after start of infusion, end of infusion, 5, 10, 24, 30, 48 and 96 and 168 h post-dose |
| Clearance (CL) of Dalotuzumab | CL of dalotuzumab was assessed on Week 2 (Day 8) for the Dalotuzumab 5 mg/kg and Dalotuzumab 10 mg/kg treatment groups and on Week 3 (Day 15) for the Dalotuzumab 15 mg/kg/7.5 mg/kg treatment group. | Pre-dose, 0.5 h after start of infusion, end of infusion, 5, 10, 24, 30, 48 and 96 and 168 h post-dose |
| Steady State Volume of Distribution (Vss) of Dalotuzumab | Vss was assessed on Week 2 (Day 8) for the Dalotuzumab 5 mg/kg and Dalotuzumab 10 mg/kg treatment groups and on Week 3 (Day 15) for the Dalotuzumab 15 mg/kg/7.5 mg/kg treatment group. | Pre-dose, 0.5 h after start of infusion, end of infusion, 5, 10, 24, 30, 48 and 96 and 168 h post-dose |
| Number of Participants Who Developed a Human Anti-Humanized Antibody (HAHA) Response to Dalotuzumab | Formation of HAHAs may block efficacy by substantially increasing the clearance of dalotuzumab and limit the possibility of future dalotuzumab therapy. The occurrence of HAHAs in the sera of dalotuzumab treated participants at any of the serum collection times was assessed. | Cycle 1: predose on Days 1, 8, 15, and 22; Cycles 2 and 3: predose on Day 1; 4 weeks after last dose of study drug |
Participants receive dalotuzumab 10 mg/kg by IV infusion once each week for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up. |
| BG002 | Dalotuzumab 15 mg/kg/7.5 mg/kg | Participants receive an initial dose of dalotuzumab 15 mg/kg by IV infusion followed by a maintenance dose of dalotuzumab 7.5 mg/kg by IV infusion once every 2 weeks for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up. |
| BG003 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Dalotuzumab 10 mg/kg | Participants receive dalotuzumab 10 mg/kg by IV infusion once each week for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up. |
| OG002 | Dalotuzumab 15 mg/kg/7.5 mg/kg | Participants receive an initial dose of dalotuzumab 15 mg/kg by IV infusion followed by a maintenance dose of dalotuzumab 7.5 mg/kg by IV infusion once every 2 weeks for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up. |
|
|
| Primary | Number of Participants Who Experienced an Adverse Event (AE) | An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study treatment, whether or not considered related to the use of study treatment. Any worsening (i.e. any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition which was temporally associated with the use of study treatment, was also an AE. The number of participants who experienced at least one AE is presented. | The population consisted of all participants who received at least one dose of study treatment. | Posted | Number | Participants | Up to 30 days after last dose of study treatment (Up to 101 days) |
|
|
|
| Primary | Number of Participants Who Discontinued Study Treatment Due to an AE | An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study treatment, whether or not considered related to the use of study treatment. Any worsening (i.e. any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition which was temporally associated with the use of study treatment, was also an AE. The number of participants who discontinued study treatment due to an AE is presented. | The population consisted of all participants who received at least one dose of study treatment. | Posted | Number | Participants | Up to 71 days |
|
|
|
| Secondary | Maximum Plasma Concentration (Cmax) of Dalotuzumab | Cmax was assessed on Week 2 (Day 8) for the Dalotuzumab 5 mg/kg and Dalotuzumab 10 mg/kg treatment groups and on Week 3 (Day 15) for the Dalotuzumab 15 mg/kg/7.5 mg/kg treatment group. | The population consisted of all participants who had pharmacokinetic (PK) measurements at Baseline and at least once during treatment. | Posted | Geometric Mean | Geometric Coefficient of Variation | µg/mL | Pre-dose, 0.5 h after start of infusion, end of infusion, 5, 10, 24, 30, 48 and 96 and 168 h post-dose |
|
|
|
| Secondary | Area Under the Concentration-Time Curve From Zero to Infinity (AUC0-∞) of Dalotuzumab | AUC0-∞ was assessed on Week 2 (Day 8) for the Dalotuzumab 5 mg/kg and Dalotuzumab 10 mg/kg treatment groups and on Week 3 (Day 15) for the Dalotuzumab 15 mg/kg/7.5 mg/kg treatment group. | The population consisted of all participants who had PK measurements at Baseline and at least once during treatment. | Posted | Geometric Mean | Geometric Coefficient of Variation | mg*h/mL | Pre-dose, 0.5 h after start of infusion, end of infusion, 5, 10, 24, 30, 48 and 96 and 168 h post-dose |
|
|
|
| Secondary | Time to Cmax (Tmax) of Dalotuzumab | Tmax was assessed on Week 2 (Day 8) for the Dalotuzumab 5 mg/kg and Dalotuzumab 10 mg/kg treatment groups and on Week 3 (Day 15) for the Dalotuzumab 15 mg/kg/7.5 mg/kg treatment group. | The population consisted of all participants who had PK measurements at Baseline and at least once during treatment. | Posted | Median | Full Range | h | Pre-dose, 0.5 h after start of infusion, end of infusion, 5, 10, 24, 30, 48 and 96 and 168 h post-dose |
|
|
|
| Secondary | Apparent Terminal Half-life (t1/2) of Dalotuzumab | t1/2 was assessed on Week 2 (Day 8) for the Dalotuzumab 5 mg/kg and Dalotuzumab 10 mg/kg treatment groups and on Week 3 (Day 15) for the Dalotuzumab 15 mg/kg/7.5 mg/kg treatment group. | The population consisted of all participants who had PK measurements at Baseline and at least once during treatment. | Posted | Geometric Mean | Geometric Coefficient of Variation | h | Pre-dose, 0.5 h after start of infusion, end of infusion, 5, 10, 24, 30, 48 and 96 and 168 h post-dose |
|
|
|
| Secondary | Clearance (CL) of Dalotuzumab | CL of dalotuzumab was assessed on Week 2 (Day 8) for the Dalotuzumab 5 mg/kg and Dalotuzumab 10 mg/kg treatment groups and on Week 3 (Day 15) for the Dalotuzumab 15 mg/kg/7.5 mg/kg treatment group. | The population consisted of all participants who had PK measurements at Baseline and at least once during treatment. | Posted | Geometric Mean | Geometric Coefficient of Variation | mL/min/kg | Pre-dose, 0.5 h after start of infusion, end of infusion, 5, 10, 24, 30, 48 and 96 and 168 h post-dose |
|
|
|
| Secondary | Steady State Volume of Distribution (Vss) of Dalotuzumab | Vss was assessed on Week 2 (Day 8) for the Dalotuzumab 5 mg/kg and Dalotuzumab 10 mg/kg treatment groups and on Week 3 (Day 15) for the Dalotuzumab 15 mg/kg/7.5 mg/kg treatment group. | The population consisted of all participants who had PK measurements at Baseline and at least once during treatment. | Posted | Geometric Mean | Geometric Coefficient of Variation | L/kg | Pre-dose, 0.5 h after start of infusion, end of infusion, 5, 10, 24, 30, 48 and 96 and 168 h post-dose |
|
|
|
| Secondary | Number of Participants Who Developed a Human Anti-Humanized Antibody (HAHA) Response to Dalotuzumab | Formation of HAHAs may block efficacy by substantially increasing the clearance of dalotuzumab and limit the possibility of future dalotuzumab therapy. The occurrence of HAHAs in the sera of dalotuzumab treated participants at any of the serum collection times was assessed. | The population consisted of all participants who received at least one dose of study treatment. | Posted | Number | Participants | Cycle 1: predose on Days 1, 8, 15, and 22; Cycles 2 and 3: predose on Day 1; 4 weeks after last dose of study drug |
|
|
|
| 0 |
| 3 |
| 3 |
| 3 |
| EG001 | Dalotuzumab 10 mg/kg | Participants receive dalotuzumab 10 mg/kg by IV infusion once each week for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up. | 1 | 6 | 6 | 6 |
| EG002 | Dalotuzumab 15 mg/kg/7.5 mg/kg | Participants receive an initial dose of dalotuzumab 15 mg/kg by IV infusion followed by a maintenance dose of dalotuzumab 7.5 mg/kg by IV infusion once every 2 weeks for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up. | 0 | 6 | 6 | 6 |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
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| Lymphopenia | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
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| Ear congestion | Ear and labyrinth disorders | MedDRA 12.0 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
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| Dysphagia | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
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| Gingival pain | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
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| Melaena | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 12.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 12.0 | Systematic Assessment |
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| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 12.0 | Systematic Assessment |
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| Drug hypersensitivity | Immune system disorders | MedDRA 12.0 | Systematic Assessment |
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| Influenza | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
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| Activated partial thromboplastin time shortened | Investigations | MedDRA 12.0 | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | MedDRA 12.0 | Systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | MedDRA 12.0 | Systematic Assessment |
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| Blood alkaline phosphatase increased | Investigations | MedDRA 12.0 | Systematic Assessment |
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| Blood glucose increased | Investigations | MedDRA 12.0 | Systematic Assessment |
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| Blood lactate dehydrogenase increased | Investigations | MedDRA 12.0 | Systematic Assessment |
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| Blood urea increased | Investigations | MedDRA 12.0 | Systematic Assessment |
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| Blood urine present | Investigations | MedDRA 12.0 | Systematic Assessment |
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| CD4 lymphocytes decreased | Investigations | MedDRA 12.0 | Systematic Assessment |
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| Gamma-glutamyltransferase increased | Investigations | MedDRA 12.0 | Systematic Assessment |
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| International normalised ratio decreased | Investigations | MedDRA 12.0 | Systematic Assessment |
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| International normalised ratio increased | Investigations | MedDRA 12.0 | Systematic Assessment |
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| Prothrombin time shortened | Investigations | MedDRA 12.0 | Systematic Assessment |
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| Urine analysis abnormal | Investigations | MedDRA 12.0 | Systematic Assessment |
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| Weight decreased | Investigations | MedDRA 12.0 | Systematic Assessment |
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| White blood cell count decreased | Investigations | MedDRA 12.0 | Systematic Assessment |
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| Anorexia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
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| Hypermagnesaemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
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| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
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| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
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| Hypochloraemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
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| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
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| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
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| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
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| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
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| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
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| Ketonuria | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
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| Proteinuria | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
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| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
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| Pharyngeal inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
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| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
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| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
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| Hot flush | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
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The Sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission.