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| ID | Type | Description | Link |
|---|---|---|---|
| I2V-MC-CXAD | Other Identifier | Eli Lilly and Company |
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| Name | Class |
|---|---|
| AstraZeneca | INDUSTRY |
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The main purpose of this study is to evaluate the safety and tolerability of chemokine (C-X-C Motif) receptor 4 (CXCR4) peptide antagonist LY2510924 and durvalumab for phase 1a and 1b in participants with advanced refractory solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 20 mg LY2510924 + 1500 mg Durvalumab | Experimental | 20 milligrams (mg) LY2510924 given subcutaneously (SQ) once daily in combination with 1500 mg durvalumab given intravenously (IV) on Day 1 of each cycle (28 days). |
|
| 30 mg LY2510924 + 1500 mg Durvalumab | Experimental | 30 mg LY2510924 given SQ once daily in combination with 1500 mg durvalumab given IV on Day 1 of each cycle (28 days). |
|
| 40 mg LY2510924 + 1500 mg Durvalumab | Experimental | 40 mg LY2510924 given SQ once daily in combination with 1500 mg durvalumab given IV on Day 1 of each cycle (28 days). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY2510924 | Drug | Administered SQ |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs) | DLT is defined as 1 of the following adverse events(AE) reported during the Phase 1a DLT observation period,if considered to be definitely,probably,or possibly related to either study regimen by the investigator;and fulfills any 1 of the following criterion using(NCI)CTCAE version(v)4.03:Grade4 immune-related AE,Grade4 non-laboratory AE,any CTCAE Grade ≥3 QT prolongation AE,≥Grade3 colitis or noninfectious pneumonitis irrespective of duration,Grade3 immune-related AE(excluding colitis,QT prolongation,or pneumonitis) that does not downgrade to Grade2 within 3 days after onset of event despite optimal medical management including systemic corticosteroids,or does not downgrade to ≤Grade 1 or baseline within 14 days,Grade2 pneumonitis that does not resolve to ≤Grade 1 within 3 days of the initiation of maximal supportive care,including corticosteroid therapy,Grade3 toxicity lasting an extended time despite optimal supportive care and there were also laboratory abnormalities criterion. | Cycle 1 (28 Days) |
| Maximum Tolerated Dose (MTD) of LY2510924 | MTD was determined after the evaluation of Phase 1a portion of the trial. For Phase 1a, any DLT-equivalent toxicities observed in Cycle 2 and beyond were also be considered in dose escalation and determining MTD/recommended Phase 2 dose. See outcome measure number 1 for the DLT criterion. | Cycle 1 (28 Days) |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics: Area Under the Concentration-Time Curve (AUC [0-∞]) of LY2510924 When Co-Administered With Durvalumab | Pharmacokinetics: Area Under the Concentration-Time Curve (AUC [0-∞]) of LY2510924 when Co-Administered with Durvalumab | Cycle 1 Day 1: Predose, 0.5, 2, 4, 6, 8, 24-30 hours; Day 15: Predose, 0.5, 2, 4, 6, 8 hours |
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Inclusion Criteria:
Exclusion Criteria:
Have a serious concomitant systemic disorder including human immunodeficiency virus (HIV), active hepatitis B virus (HBV), active HCV, active autoimmune disorder or disease requiring high dose of steroids
Have had prior therapy with an anti-programmed cell death 1 (PD-1), anti-PD-L1, anti-PD-L2, or anticytotoxic T lymphocyte-associated antigen-4 antibody
Moderate or severe cardiovascular disease
Have symptomatic or uncontrolled brain metastases, spinal cord compression, or leptomeningeal disease requiring concurrent treatment
Have received a live vaccine within 30 days before the first dose of study treatment
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
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| Label | URL |
|---|---|
| Click here for more information about this study: A Study of LY2510924 and Durvalumab in Participants With Solid Tumors | View source |
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This study was conducted in 2 parts. Phase 1a of the study consisted of a dose-escalation assessment and Phase 1b of the study included 2 expansion arms. The study was terminated after the Phase 1a part was complete. A participant completed the study if they completed at least 1 cycle.
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| ID | Title | Description |
|---|---|---|
| FG000 | 20 mg LY2510924 + 1500 mg Durvalumab | 20 milligrams (mg) LY2510924 given subcutaneously (SQ) once daily in combination with 1500 mg durvalumab given intravenously (IV) on Day 1 of each cycle (28 days). |
| FG001 | 30 mg LY2510924 + 1500 mg Durvalumab | 30 mg LY2510924 given SQ once daily in combination with 1500 mg durvalumab given IV on Day 1 of each cycle (28 days). |
| FG002 | 40 mg LY2510924 + 1500 mg Durvalumab | 40 mg LY2510924 given SQ once daily in combination with 1500 mg durvalumab given IV on Day 1 of each cycle (28 days). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All participants who received at least one dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | 20 mg LY2510924 + 1500 mg Durvalumab | 20 milligrams (mg) LY2510924 given subcutaneously (SQ) once daily in combination with 1500 mg durvalumab given intravenously (IV) on Day 1 of each cycle (28 days). |
| BG001 | 30 mg LY2510924 + 1500 mg Durvalumab |
| 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 Dose-Limiting Toxicities (DLTs) | DLT is defined as 1 of the following adverse events(AE) reported during the Phase 1a DLT observation period,if considered to be definitely,probably,or possibly related to either study regimen by the investigator;and fulfills any 1 of the following criterion using(NCI)CTCAE version(v)4.03:Grade4 immune-related AE,Grade4 non-laboratory AE,any CTCAE Grade ≥3 QT prolongation AE,≥Grade3 colitis or noninfectious pneumonitis irrespective of duration,Grade3 immune-related AE(excluding colitis,QT prolongation,or pneumonitis) that does not downgrade to Grade2 within 3 days after onset of event despite optimal medical management including systemic corticosteroids,or does not downgrade to ≤Grade 1 or baseline within 14 days,Grade2 pneumonitis that does not resolve to ≤Grade 1 within 3 days of the initiation of maximal supportive care,including corticosteroid therapy,Grade3 toxicity lasting an extended time despite optimal supportive care and there were also laboratory abnormalities criterion. | All participants who received at least one of dose of study drug. | Posted | Count of Participants | Participants | No | Cycle 1 (28 Days) |
Up To 14 months
All participants who received at least one dose of study drug.
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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 | 20 mg LY2510924 + 1500 mg Durvalumab | 20 milligrams (mg) LY2510924 given subcutaneously (SQ) once daily in combination with 1500 mg durvalumab given intravenously (IV) on Day 1 of each cycle (28 days). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 20.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 20.0 | Systematic Assessment |
The study was terminated after the Phase 1a part was complete.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 | ClinicalTrials.gov@lilly.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 12, 2016 | Jul 10, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 2, 2017 | Jul 10, 2018 | SAP_001.pdf |
| ID | Term |
|---|---|
| C000595455 | LY2510924 |
| C000613593 | durvalumab |
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| Durvalumab | Drug | Administered IV |
|
| Number of Participants With Anti-Durvalumab Antibodies When Administered in Combination With LY2510924 |
Number of participants with treatment-emergent positive Anti-Durvalumab antibodies was summarized by treatment group. |
| Predose Cycle 1 Day 1 through 90 Day Post Treatment Follow Up (Up To 12 Months) |
| Percentage of Participants With Best Overall Response of Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)] | Best overall response of CR or PR was defined using RECIST v 1.1 criteria. CR was defined as the disappearance of all lesions, pathological lymph node reduction in short axis to <10 mm, and normalization of tumor marker levels of non-target lesions. PR was defined as ≥30% decrease in sum of diameter(SOD) of target lesions taking as reference the baseline sum diameter. PD was defined as ≥20% increase in SOD of target lesions and short axes of target lymph nodes, taking as reference the smallest sum of the longest diameters recorded since treatment started and an absolute increase in sum diameter of ≥5 mm; appearance of ≥1 new lesions and/or unequivocal progression of existing non-target lesions. Participants who had no post baseline tumor assessments were considered non-responders and included in the denominator when calculating response rate. Percentage of participants=(number of participants with CR+PR/total number of participants)*100. | Baseline through Measured Progressive Disease or Death (Up To 12 Months) |
| Percentage of Participants With CR, PR, or Stable Disease (SD) (Disease Control Rate [DCR]) | DCR: percentage of participants with CR, PR, or SD using RECIST v 1.1 criteria. CR: disappearance of all lesions, pathological lymph node reduction in short axis to <10 mm, and normalization of tumor marker levels of non-target lesions. PR: ≥30% decrease in sum of diameter (SOD) of target lesions taking as reference baseline sum diameter. PD: ≥20% increase in SOD of target lesions and short axes of target lymph nodes, taking as reference smallest sum of longest diameters recorded since treatment started and an absolute increase in sum diameter ≥5 mm; appearance of ≥1 new lesions and/or unequivocal progression of existing non-target lesions. SD: neither sufficient shrinkage to qualify for PR nor increase to qualify for PD. Participants who had no post baseline tumor assessments were considered non-responders and included in the denominator when calculating response rate. Percentage of participants=(number of participants with CR+PR+SD/total number of participants)*100. | Baseline through Measured Progressive Disease (Up To 12 Months) |
30 mg LY2510924 given SQ once daily in combination with 1500 mg durvalumab given IV on Day 1 of each cycle (28 days). |
| BG002 | 40 mg LY2510924 + 1500 mg Durvalumab | 40 mg LY2510924 given SQ once daily in combination with 1500 mg durvalumab given IV on Day 1 of each cycle (28 days). |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Region of Enrollment | Count of Participants | Participants | No |
|
| ID | Title | Description |
|---|
| OG000 | 20 mg LY2510924 + 1500 mg Durvalumab | 20 milligrams (mg) LY2510924 given subcutaneously (SQ) once daily in combination with 1500 mg durvalumab given intravenously (IV) on Day 1 of each cycle (28 days). |
| OG001 | 30 mg LY2510924 + 1500 mg Durvalumab | 30 mg LY2510924 given SQ once daily in combination with 1500 mg durvalumab given IV on Day 1 of each cycle (28 days). |
| OG002 | 40 mg LY2510924 + 1500 mg Durvalumab | 40 mg LY2510924 given SQ once daily in combination with 1500 mg durvalumab given IV on Day 1 of each cycle (28 days). |
|
|
| Primary | Maximum Tolerated Dose (MTD) of LY2510924 | MTD was determined after the evaluation of Phase 1a portion of the trial. For Phase 1a, any DLT-equivalent toxicities observed in Cycle 2 and beyond were also be considered in dose escalation and determining MTD/recommended Phase 2 dose. See outcome measure number 1 for the DLT criterion. | All phase 1a participants who received at least one dose of study drug. | Posted | Number | milligram (mg) | Cycle 1 (28 Days) |
|
|
|
| Secondary | Pharmacokinetics: Area Under the Concentration-Time Curve (AUC [0-∞]) of LY2510924 When Co-Administered With Durvalumab | Pharmacokinetics: Area Under the Concentration-Time Curve (AUC [0-∞]) of LY2510924 when Co-Administered with Durvalumab | All participants who received at least one dose of study drug. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram*hour /milliliter (ng *h/mL) | Cycle 1 Day 1: Predose, 0.5, 2, 4, 6, 8, 24-30 hours; Day 15: Predose, 0.5, 2, 4, 6, 8 hours |
|
|
|
| Secondary | Number of Participants With Anti-Durvalumab Antibodies When Administered in Combination With LY2510924 | Number of participants with treatment-emergent positive Anti-Durvalumab antibodies was summarized by treatment group. | All participants who received at least one dose of study drug. | Posted | Count of Participants | Participants | No | Predose Cycle 1 Day 1 through 90 Day Post Treatment Follow Up (Up To 12 Months) |
|
|
|
| Secondary | Percentage of Participants With Best Overall Response of Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)] | Best overall response of CR or PR was defined using RECIST v 1.1 criteria. CR was defined as the disappearance of all lesions, pathological lymph node reduction in short axis to <10 mm, and normalization of tumor marker levels of non-target lesions. PR was defined as ≥30% decrease in sum of diameter(SOD) of target lesions taking as reference the baseline sum diameter. PD was defined as ≥20% increase in SOD of target lesions and short axes of target lymph nodes, taking as reference the smallest sum of the longest diameters recorded since treatment started and an absolute increase in sum diameter of ≥5 mm; appearance of ≥1 new lesions and/or unequivocal progression of existing non-target lesions. Participants who had no post baseline tumor assessments were considered non-responders and included in the denominator when calculating response rate. Percentage of participants=(number of participants with CR+PR/total number of participants)*100. | All participants who received at least one dose of study drug. | Posted | Number | percentage of participants | Baseline through Measured Progressive Disease or Death (Up To 12 Months) |
|
|
|
| Secondary | Percentage of Participants With CR, PR, or Stable Disease (SD) (Disease Control Rate [DCR]) | DCR: percentage of participants with CR, PR, or SD using RECIST v 1.1 criteria. CR: disappearance of all lesions, pathological lymph node reduction in short axis to <10 mm, and normalization of tumor marker levels of non-target lesions. PR: ≥30% decrease in sum of diameter (SOD) of target lesions taking as reference baseline sum diameter. PD: ≥20% increase in SOD of target lesions and short axes of target lymph nodes, taking as reference smallest sum of longest diameters recorded since treatment started and an absolute increase in sum diameter ≥5 mm; appearance of ≥1 new lesions and/or unequivocal progression of existing non-target lesions. SD: neither sufficient shrinkage to qualify for PR nor increase to qualify for PD. Participants who had no post baseline tumor assessments were considered non-responders and included in the denominator when calculating response rate. Percentage of participants=(number of participants with CR+PR+SD/total number of participants)*100. | All participants who received at least one dose of study drug. | Posted | Number | percentage of participants | Baseline through Measured Progressive Disease (Up To 12 Months) |
|
|
|
| 2 |
| 3 |
| 0 |
| 3 |
| 3 |
| 3 |
| EG001 | 30 mg LY2510924 + 1500 mg Durvalumab | 30 mg LY2510924 given SQ once daily in combination with 1500 mg durvalumab given IV on Day 1 of each cycle (28 days). | 3 | 3 | 1 | 3 | 3 | 3 |
| EG002 | 40 mg LY2510924 + 1500 mg Durvalumab | 40 mg LY2510924 given SQ once daily in combination with 1500 mg durvalumab given IV on Day 1 of each cycle (28 days). | 1 | 3 | 1 | 3 | 3 | 3 |
| Pancreatic carcinoma metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
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| Metabolic encephalopathy | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
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| Vena cava thrombosis | Vascular disorders | MedDRA 20.0 | Systematic Assessment |
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| Sinus tachycardia | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
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| Tachycardia | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
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| Hyperthyroidism | Endocrine disorders | MedDRA 20.0 | Systematic Assessment |
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| Hypothyroidism | Endocrine disorders | MedDRA 20.0 | Systematic Assessment |
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| Vision blurred | Eye disorders | MedDRA 20.0 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Ascites | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Gastrointestinal pain | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 20.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 20.0 | Systematic Assessment |
|
| Injection site pain | General disorders | MedDRA 20.0 | Systematic Assessment |
|
| Injection site reaction | General disorders | MedDRA 20.0 | Systematic Assessment |
|
| Localised oedema | General disorders | MedDRA 20.0 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 20.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 20.0 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Tooth infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA 20.0 | Systematic Assessment |
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| Blood bilirubin increased | Investigations | MedDRA 20.0 | Systematic Assessment |
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| Blood creatinine increased | Investigations | MedDRA 20.0 | Systematic Assessment |
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| Weight decreased | Investigations | MedDRA 20.0 | Systematic Assessment |
|
| White blood cell count increased | Investigations | MedDRA 20.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
|
| Disturbance in attention | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
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| Tremor | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA 20.0 | Systematic Assessment |
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| Confusional state | Psychiatric disorders | MedDRA 20.0 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 20.0 | Systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA 20.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
|
| Flushing | Vascular disorders | MedDRA 20.0 | Systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA 20.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 20.0 | Systematic Assessment |
|
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| Day 15 |
|
|