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The purpose of this study is to determine the safety and efficacy of oral lenvatinib in participants with medullary thyroid cancer (MTC) or radioiodine (131 I)-refractory/resistant differentiated thyroid cancer (DTC), unresectable differentiated thyroid cancers, stratified by Histology.
This study contained 3 Phases: the Pretreatment Phase, the Treatment Phase, and the Extension Phase. The Pretreatment Phase lasted no longer than 28 days. Informed consent was obtained and protocol eligibility and disease characteristics were established prior to treatment. The Treatment Phase consisted of a Treatment Period and a Follow-up Period. The Treatment Period of the Treatment Phase began at the time that the first participant began study drug administration and ended at the time when all participants enrolled completed 8 cycles of treatment or discontinued study treatment prior to the eighth cycle (ie, time of data cutoff for the primary study analysis [Primary Completion Date]). All participants then entered the Extension Phase. The Extension Phase consisted of a Treatment Period and a Follow-up Period. The Extension Phase began immediately after the Treatment Phase ended and included all participants that were either still receiving treatment or in follow-up. The time of data cutoff for the primary study analysis occurred when all subjects in the study completed 8 cycles of treatment or discontinued study treatment prior to the eighth cycle.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DTC cohort | Experimental | This arm will enroll participants with radioiodine (131 I)-refractory/resistant differentiated thyroid cancer. |
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| MTC cohort | Experimental | This arm will enroll participants with medullary thyroid cancer. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lenvatinib (DTC Cohort) | Drug | 24 mg lenvatinib (two 10 mg tablets and one 4 mg tablet) given orally, once daily, or 10 mg lenvatinib orally twice daily (20 mg total). Out of 58 participants in the DTC cohort, 56 participants received 24 mg lenvatinib once daily and 2 participants received 10 mg lenvatinib twice daily (total 20 mg daily), given continuously in 28-day treatment cycles. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | ORR was the percentage of participants with best overall response (BOR) of complete response (CR) and partial response (PR) based on modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.0 for target lesions using magnetic resonance imaging/computed tomography (MRI/CT) scans, as determined by independent imaging review (IIR). CR was defined as disappearance of all target lesions. PR was defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of the longest diameter. ORR=CR+PR, was presented with 2-sided 95% confidence interval (CI) by the method of Clopper and Pearson. | From date of treatment start until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice to stop study treatment, or up to data cutoff date 11 April 2011, for up to approximately 2 years 5 months |
| Plasma Pharmacokinetics (PK): Steady State Area Under the Plasma Concentration Curve (AUC) | Up to 9 samples per participant were obtained at specific time points. Plasma concentrations of lenvatinib were analyzed using standard analysis methods. Due to the sparse PK sampling in this study, the data were pooled with data from other Phase 1 studies conducted in participants with solid tumors for PK model development and covariate analysis. Individual exposure (steady state AUC) to lenvatinib in MTC and DTC subjects in this study was derived based on the individual predicted steady state AUC from the final PK model. Only data for participants taking 24 mg lenvatinib daily were reported (participants taking 20 mg lenvatinib daily were not included in this data set). | Cycle 1 Day 1 (predose and at 0.5 and 2 hours postdose), Cycle 1 Day 8 (predose), Cycle 2 Day 1 (predose and at 0.5 and 2 hours postdose), and Cycle 3 Day 1 (predose and at 2 hours postdose) (Cycle length= 28 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Free Thyroxine (T4) | Blood samples to measure free T4 were collected at Screening (Baseline), Cycle 1 Day 15 (MTC cohort), Day 1 of Cycles 2 to 20, and Final Visit. Changes in free T4 concentration values from baseline to specific time points were calculated. Only participants with both baseline and relevant visit values were included. | Day 1 or within 72 hours prior to Day 1 of Cycles 2 to 20, and Final Visit, up to data cutoff date 11 April 2011 (Cycle length= 28 days) |
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Inclusion criteria:
Histologically or cytologically confirmed diagnosis of medullary thyroid cancer (MTC) or differentiated thyroid cancer (DTC).
Measurable disease meeting the following criterion:
Evidence of disease progression by RECIST using site assessment of CT/MRI scans within 12 months (+1 month to allow for variances in patient scanning intervals) prior to study entry.
DTC must be 131-I refractory/resistant: never demonstrated 131-I uptake, progression despite 131-I uptake, or cumulative dose of 131-I of greater than 600 millicurie (mCi) (last dose given at least 6 months prior to study entry).
Well controlled blood pressure prior to study entry.
Exclusion criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Little Rock | Arkansas | United States | ||||
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162 participants were screened for entry into the study, from which 45 were screening failures and 117 entered into the study and were treated.
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| ID | Title | Description |
|---|---|---|
| FG000 | DTC Cohort | Participants with radioiodine (131 I)-refractory/resistant differentiated thyroid cancer (DTC) received 24 mg lenvatinib (two 10 mg tablets and one 4 mg tablet) orally, once daily or 10 mg lenvatinib orally twice daily in 28-day treatment cycles. Out of 58 participants in the DTC cohort, 56 participants received 24 mg lenvatinib once daily and 2 participants received 10 mg lenvatinib twice daily (total 20 mg daily), given continuously in 28-day treatment cycles. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Lenvatinib (MTC Cohort) | Drug | 24 mg lenvatinib (two 10 mg tablets and one 4 mg tablet) given orally, once daily given continuously in 28-day treatment cycles. |
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| Change From Baseline in Free Thyroid Stimulating Hormone (TSH) | Blood samples to measure free TSH were collected at Screening (Baseline), Cycle 1 Day 15 (MTC cohort), Day 1 of Cycles 2 to 20, and Final Visit. Changes in free TSH concentration values from baseline to specific time points were calculated. Only participants with both baseline and relevant visit values were included. For any free TSH result that was reported as <0.008 mIU/L, 0.004 mIU/L was used for calculating summary statistics. | Day 1 or within 72 hours prior to Day 1 of Cycles 2 to 20, and Final Visit, up to data cutoff date 11 April 2011 (Cycle length= 28 days) |
| Percent Change From Baseline in Concentrations of Thyroglobulin (DTC Only) | Blood samples to obtain serum were collected at Cycle 1 Day 1 (Baseline), Day 1 of Cycles 2 to 19, Final Visit, and were analyzed for thyroglobulin concentration. Percent changes in thyroglobulin concentration values from baseline to specific time points were calculated. Only participants with both baseline and relevant visit values were included. | Day 1 or within 72 hours prior to Day 1 of Cycles 2 to 19, and Final Visit, up to data cutoff date 11 April 2011 (Cycle length= 28 days) |
| Percent Change From Baseline in Concentrations of Calcitonin (MTC Only) | Blood samples to obtain serum were collected at Cycle 1 Day 1(Baseline), Day 1 of Cycles 2 to 20, Final Visit, and were analyzed for calcitonin concentration. Percent changes in calcitonin concentration values from baseline to specific time points were calculated. Only participants with both baseline and relevant visit values were included. | Day 1 or within 72 hours prior to Day 1 of Cycles 2 to 20, and Final Visit, up to data cutoff date 11 April 2011 (Cycle length= 28 days) |
| Percent Change From Baseline in Concentrations of Carcinoembryonic Antigen (CEA) (MTC Only) | Blood samples were collected at Cycle 1 Day 1(Baseline), Day 1 of Cycles 2 to 20, Final Visit, and were analyzed for CEA concentration. Percent changes in CEA concentration values from baseline to specific time points were calculated. Only participants with both baseline and relevant visit values were included. | Day 1 or within 72 hours prior to Day 1 of Cycles 2 to 20, and Final Visit, up to data cutoff date 11 April 2011 (Cycle length= 28 days) |
| Change From Baseline in Concentrations of Cytochrome C (CytoC) | Blood samples to obtain serum were collected at Cycle 1 Day 1(Baseline), Cycle 1 Day 8, Cycle 2 Days 1,8 &15, Cycles 3 to 9,11,13 Day 1, Final Visit, and analyzed for CytoC concentration. Changes in CytoC concentration values from baseline to specific time points were calculated. Only participants with both baseline and relevant visit values were included. For results reported as below quantifiable level (BQL), zero was used for calculating summary statistics. If more than 50% of the results at a visit were BQL, then only 'n', 'minimum' and 'maximum' were calculated for summary statistics. | Cycle 1 (Day 8), Cycle 2 (Days 1, 8 and 15), Cycles 3, 4, 5, 6, 7, 8, 9, 11, & 13 (Day 1), and Final Visit, up to data cutoff date 11 April 2011 (Cycle length= 28 days) |
| Change From Baseline in Concentrations of M-30 Neo-Antigen | Blood samples to obtain serum were collected at Cycle 1 Day 1(Baseline), Cycle 1 Day 8, Cycle 2 Days 1,8 &15, Cycles 3 to 9,11,13 Day 1, Final Visit, and analyzed for M-30 concentration. Changes in M-30 concentration values from baseline to specific time points were calculated. Only participants with both baseline and relevant visit values were included. For results reported as BQL, zero was used for calculating summary statistics. If more than 50% of the results at a visit were BQL, then only 'n', 'minimum' and 'maximum' were calculated for summary statistics. | Cycle 1 (Day 8), Cycle 2 (Days 1, 8 & 15), Cycles 3, 4, 5, 6, 7, 8, 9, 11 & 13 (Day 1) and Final Visit, up to data cutoff date 11 April 2011 (Cycle length= 28 days) |
| Change From Baseline in Concentrations of Activated Caspase 3/7 (Casp 3/7) | Blood samples to obtain serum were collected at Cycle 1 Day 1 (Baseline), Cycle 1 Day 8, Cycle 2 Days 1, 8, and 15, Cycles 3 to 9, 11, 13 (Day 1), Final Visit, and analyzed for Casp 3/7 concentration. Changes in Casp 3/7 concentration values from baseline to specific time points were calculated. Only participants with both baseline and relevant visit values were included. The concentrations of Casp 3/7 were BQL for most participants at most time points. For results reported as BQL, zero was used for calculating summary statistics. If more than 50% of the results at a visit were BQL, then only 'n', 'minimum' and 'maximum' were calculated for summary statistics. | Cycle 1 (Day 8), Cycle 2 (Days 1, 8, & 15), Cycles 3, 4, 5, 6, 7, 8, 9, 11, & 13 (Day 1) and Final Visit, up to data cutoff date 11 April 2011 (Cycle length= 28 days) |
| Duration of Response (DoR) Assessed as Per Independent Imaging Reviewers (IIR) | DoR was based on IIR was the time from date of the first CR or PR until the date of first documentation of disease progression or date of death, if death occurred prior to disease progression, for the participants who had BOR of CR or PR. Participants without progressive disease or death were censored at the date of last adequate tumor assessment. Duration of response = End Date - Date of first CR or PR + 1 | From date of the first CR or PR until the date of first documentation of disease progression or date of death, assessed up to data cutoff date 11 April 2011 |
| Disease Control Rate (DCR) Assessed as Per IIR | DCR was the percentage of the participants who had BOR of CR, PR, and stable disease (SD) with the minimum duration of SD lasting greater than or equal to 7 weeks, based on assessments by IIR. DCR = CR+PR+SD greater than or equal to 7 weeks | From date of treatment start until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice to stop study treatment, or up to data cutoff date 11 April 2011, for up to approximately 2 years 5 months |
| Clinical Benefit Rate (CBR) Assessed as Per IIR | CBR was the percentage of the participants who had BOR of CR, PR, and SD with the minimum duration of SD lasting greater than or equal to 23 weeks, based on assessments by IIR. CBR = CR+PR+SD greater than or equal to 23 weeks | From date of treatment start until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice to stop study treatment, or up to data cutoff date 11 April 2011, for up to approximately 2 years 5 months |
| Time to Response (TTR) Assessed as Per IIR | TTR was defined as "time from start of treatment to the time when a participant first achieves a response of PR/CR" based on assessments by IIR. TTR was only calculated for participants with confirmed PR or CR. | From date of treatment start until date of first CR or PR, assessed up to data cutoff date 11 April 2011 |
| Progression Free Survival (PFS) Assessed as Per IIR | PFS was defined as the time from the date of treatment start until progressive disease or death from any cause in the absence of progressive disease. Disease progression was defined as at least a 20% increase in the sum of the longest diameter of target lesions (taking as reference the smallest sum on study), recorded since the treatment started or the appearance of 1 or more new lesions as assessed by IIR using RECIST 1.0. The duration of PFS was calculated as end date minus date of first drug plus 1, based on assessments by IIR. PFS was calculated using Kaplan-Meier estimate and presented with 2-sided 95% Cl. | From date of treatment start until date of progressive disease or death from any cause, assessed up to data cutoff date 11 April 2011, for up to approximately 2 years 5 months |
| Overall Survival (OS) | OS was defined as the time from the date of treatment start until death from any cause. The duration of OS was calculated as 'end date minus date of first drug plus 1', based on assessments by IIR. Participants without a reported death or those lost to follow-up were censored at their last known alive date at the database cutoff. OS was calculated using Kaplan-Meier estimate and presented with 2-sided 95% Cl. | From date of treatment start until date of death from any cause, assessed up to data cutoff date 11 April 2011, for up to approximately 2 years 5 months |
| Number of Participants With Non-Serious Adverse Events (AEs) and Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability of Lenvatinib | Safety assessments consisted of monitoring and recording all AEs (serious and non-serious) and SAEs; concomitant medications, regular monitoring of hematology, blood chemistry, and urine values; periodic measurement of vital signs, Eastern Cooperative Oncology Group (ECOG) performance status, New York Heart Association (NYHA) assessments, electrocardiograms (ECGs), echocardiograms; and performance of physical examinations. | For each participant, from the first dose till 30 days after the last dose of study treatment (up to approximately 10 years 4 months) |
| Los Angeles |
| California |
| United States |
| Los Gatos | California | United States |
| Mission Viejo | California | United States |
| Santa Monica | California | United States |
| Torrance | California | United States |
| Aurora | Colorado | United States |
| Orlando | Florida | United States |
| Tampa | Florida | United States |
| Roswell | Georgia | United States |
| Chicago | Illinois | United States |
| Baltimore | Maryland | United States |
| Bethesda | Maryland | United States |
| Boston | Massachusetts | United States |
| Minneapolis | Minnesota | United States |
| Columbia | Missouri | United States |
| Jefferson City | Missouri | United States |
| Lebanon | New Hampshire | United States |
| Montclair | New Jersey | United States |
| Houston | Texas | United States |
| Long Beach | Washington | United States |
| Seattle | Washington | United States |
| Madison | Wisconsin | United States |
| St Leonards | New South Wales | Australia |
| Brisbane | Australia |
| Melbourne | Australia |
| Lyon | France |
| Paris | France |
| Reims | France |
| Villejuif | France |
| Ferrara | Italy |
| Milan | Italy |
| Naples | Italy |
| Pisa | Italy |
| Rome | Italy |
| Siena | Italy |
| Gliwice | Poland |
| Poznan | Poland |
| Cardiff | United Kingdom |
| Glasgow | United Kingdom |
| London | United Kingdom |
| Sutton | United Kingdom |
| FG001 | MTC Cohort | Participants with medullary thyroid cancer (MTC) received 24 mg lenvatinib (two 10 mg tablets and one 4 mg tablet) given orally, once daily continuously in 28-day treatment cycles. |
| COMPLETED |
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| NOT COMPLETED |
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Intent-to-treat population included all participants who received at least one dose of the study drug and was the primary analysis set for efficacy analyses.
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| ID | Title | Description |
|---|---|---|
| BG000 | DTC Cohort | Participants with radioiodine (131 I)-refractory/resistant differentiated thyroid cancer (DTC) received 24 mg lenvatinib (two 10 mg tablets and one 4 mg tablet) orally, once daily or 10 mg lenvatinib orally twice daily in 28-day treatment cycles. Out of 58 participants in the DTC cohort, 56 participants received 24 mg lenvatinib once daily and 2 participants received 10 mg lenvatinib twice daily (total 20 mg daily), given continuously in 28-day treatment cycles. |
| BG001 | MTC Cohort | Participants with medullary thyroid cancer (MTC) received 24 mg lenvatinib (two 10 mg tablets and one 4 mg tablet) given orally, once daily continuously in 28-day treatment cycles. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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 | |||||||||||||||||||||||
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| Primary | Objective Response Rate (ORR) | ORR was the percentage of participants with best overall response (BOR) of complete response (CR) and partial response (PR) based on modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.0 for target lesions using magnetic resonance imaging/computed tomography (MRI/CT) scans, as determined by independent imaging review (IIR). CR was defined as disappearance of all target lesions. PR was defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of the longest diameter. ORR=CR+PR, was presented with 2-sided 95% confidence interval (CI) by the method of Clopper and Pearson. | The Intent to Treat (ITT) Population included all participants who received at least one dose of the study drug and was the primary analysis set used for efficacy analyses. | Posted | Number | 95% Confidence Interval | Percentage of participants | From date of treatment start until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice to stop study treatment, or up to data cutoff date 11 April 2011, for up to approximately 2 years 5 months |
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| Primary | Plasma Pharmacokinetics (PK): Steady State Area Under the Plasma Concentration Curve (AUC) | Up to 9 samples per participant were obtained at specific time points. Plasma concentrations of lenvatinib were analyzed using standard analysis methods. Due to the sparse PK sampling in this study, the data were pooled with data from other Phase 1 studies conducted in participants with solid tumors for PK model development and covariate analysis. Individual exposure (steady state AUC) to lenvatinib in MTC and DTC subjects in this study was derived based on the individual predicted steady state AUC from the final PK model. Only data for participants taking 24 mg lenvatinib daily were reported (participants taking 20 mg lenvatinib daily were not included in this data set). | PK population included all participants who received the 24 mg daily lenvatinib dose and had concentration values above the limit of quantification and non-missing PK sampling/dose time. | Posted | Median | Full Range | ng·h/mL | Cycle 1 Day 1 (predose and at 0.5 and 2 hours postdose), Cycle 1 Day 8 (predose), Cycle 2 Day 1 (predose and at 0.5 and 2 hours postdose), and Cycle 3 Day 1 (predose and at 2 hours postdose) (Cycle length= 28 days) |
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| Secondary | Change From Baseline in Free Thyroxine (T4) | Blood samples to measure free T4 were collected at Screening (Baseline), Cycle 1 Day 15 (MTC cohort), Day 1 of Cycles 2 to 20, and Final Visit. Changes in free T4 concentration values from baseline to specific time points were calculated. Only participants with both baseline and relevant visit values were included. | All participants who received at least 1 dose of study drug. Only participants with both baseline and relevant visit/time point values were included. Data not reported for DTC cohort at Cycle 1 Day 15 and Cycle 20 Day 1 because no participant was evaluable at these time points. | Posted | Mean | Standard Deviation | pmol/L | Day 1 or within 72 hours prior to Day 1 of Cycles 2 to 20, and Final Visit, up to data cutoff date 11 April 2011 (Cycle length= 28 days) |
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| Secondary | Change From Baseline in Free Thyroid Stimulating Hormone (TSH) | Blood samples to measure free TSH were collected at Screening (Baseline), Cycle 1 Day 15 (MTC cohort), Day 1 of Cycles 2 to 20, and Final Visit. Changes in free TSH concentration values from baseline to specific time points were calculated. Only participants with both baseline and relevant visit values were included. For any free TSH result that was reported as <0.008 mIU/L, 0.004 mIU/L was used for calculating summary statistics. | All participants who received at least 1 dose of study drug. For each change from baseline assessment time point, only participants with both baseline and relevant visit/time point values were included. Data not reported for DTC cohort at Cycle 1 Day 15 and Cycle 20 Day 1 because no participant was evaluable at these time points. | Posted | Mean | Standard Deviation | mIU/L | Day 1 or within 72 hours prior to Day 1 of Cycles 2 to 20, and Final Visit, up to data cutoff date 11 April 2011 (Cycle length= 28 days) |
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| Secondary | Percent Change From Baseline in Concentrations of Thyroglobulin (DTC Only) | Blood samples to obtain serum were collected at Cycle 1 Day 1 (Baseline), Day 1 of Cycles 2 to 19, Final Visit, and were analyzed for thyroglobulin concentration. Percent changes in thyroglobulin concentration values from baseline to specific time points were calculated. Only participants with both baseline and relevant visit values were included. | All participants who received at least 1 dose of study drug. For each change from baseline assessment time point, only participants with both baseline and relevant visit/time point values were included. | Posted | Mean | Standard Deviation | percent change | Day 1 or within 72 hours prior to Day 1 of Cycles 2 to 19, and Final Visit, up to data cutoff date 11 April 2011 (Cycle length= 28 days) |
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| Secondary | Percent Change From Baseline in Concentrations of Calcitonin (MTC Only) | Blood samples to obtain serum were collected at Cycle 1 Day 1(Baseline), Day 1 of Cycles 2 to 20, Final Visit, and were analyzed for calcitonin concentration. Percent changes in calcitonin concentration values from baseline to specific time points were calculated. Only participants with both baseline and relevant visit values were included. | All participants who received at least 1 dose of study drug. For each change from baseline assessment time point, only participants with both baseline and relevant visit/time point values were included. | Posted | Mean | Standard Deviation | percent change | Day 1 or within 72 hours prior to Day 1 of Cycles 2 to 20, and Final Visit, up to data cutoff date 11 April 2011 (Cycle length= 28 days) |
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| Secondary | Percent Change From Baseline in Concentrations of Carcinoembryonic Antigen (CEA) (MTC Only) | Blood samples were collected at Cycle 1 Day 1(Baseline), Day 1 of Cycles 2 to 20, Final Visit, and were analyzed for CEA concentration. Percent changes in CEA concentration values from baseline to specific time points were calculated. Only participants with both baseline and relevant visit values were included. | All participants who received at least 1 dose of study drug. For each change from baseline assessment time point, only participants with both baseline and relevant visit/time point values were included. | Posted | Mean | Standard Deviation | percent change | Day 1 or within 72 hours prior to Day 1 of Cycles 2 to 20, and Final Visit, up to data cutoff date 11 April 2011 (Cycle length= 28 days) |
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| Secondary | Change From Baseline in Concentrations of Cytochrome C (CytoC) | Blood samples to obtain serum were collected at Cycle 1 Day 1(Baseline), Cycle 1 Day 8, Cycle 2 Days 1,8 &15, Cycles 3 to 9,11,13 Day 1, Final Visit, and analyzed for CytoC concentration. Changes in CytoC concentration values from baseline to specific time points were calculated. Only participants with both baseline and relevant visit values were included. For results reported as below quantifiable level (BQL), zero was used for calculating summary statistics. If more than 50% of the results at a visit were BQL, then only 'n', 'minimum' and 'maximum' were calculated for summary statistics. | All participants who received at least 1 dose of study drug. Only participants with both baseline and relevant visit/time point values were included. Data not reported for DTC cohort at Cycle 2 Day 1, for MTC cohort at Cycle 2 Day 15, Day 1 of Cycle 11 and 13 because no participant was evaluable at these time points. | Posted | Mean | Standard Deviation | pg/mL | Cycle 1 (Day 8), Cycle 2 (Days 1, 8 and 15), Cycles 3, 4, 5, 6, 7, 8, 9, 11, & 13 (Day 1), and Final Visit, up to data cutoff date 11 April 2011 (Cycle length= 28 days) |
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| Secondary | Change From Baseline in Concentrations of M-30 Neo-Antigen | Blood samples to obtain serum were collected at Cycle 1 Day 1(Baseline), Cycle 1 Day 8, Cycle 2 Days 1,8 &15, Cycles 3 to 9,11,13 Day 1, Final Visit, and analyzed for M-30 concentration. Changes in M-30 concentration values from baseline to specific time points were calculated. Only participants with both baseline and relevant visit values were included. For results reported as BQL, zero was used for calculating summary statistics. If more than 50% of the results at a visit were BQL, then only 'n', 'minimum' and 'maximum' were calculated for summary statistics. | All participants who received at least 1 dose of study drug. Only participants with both baseline and relevant visit/time point values were included. Data not reported for DTC cohort at Cycle 2 Day 1, for MTC cohort at Cycle 2 Day 15, Day 1 of Cycle 11 and 13 because no participant was evaluable at these time points. | Posted | Mean | Standard Deviation | U/L | Cycle 1 (Day 8), Cycle 2 (Days 1, 8 & 15), Cycles 3, 4, 5, 6, 7, 8, 9, 11 & 13 (Day 1) and Final Visit, up to data cutoff date 11 April 2011 (Cycle length= 28 days) |
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| Secondary | Change From Baseline in Concentrations of Activated Caspase 3/7 (Casp 3/7) | Blood samples to obtain serum were collected at Cycle 1 Day 1 (Baseline), Cycle 1 Day 8, Cycle 2 Days 1, 8, and 15, Cycles 3 to 9, 11, 13 (Day 1), Final Visit, and analyzed for Casp 3/7 concentration. Changes in Casp 3/7 concentration values from baseline to specific time points were calculated. Only participants with both baseline and relevant visit values were included. The concentrations of Casp 3/7 were BQL for most participants at most time points. For results reported as BQL, zero was used for calculating summary statistics. If more than 50% of the results at a visit were BQL, then only 'n', 'minimum' and 'maximum' were calculated for summary statistics. | All participants who received at least 1 dose of study drug. Only participants with both baseline and relevant visit/time point values were included. Data not reported for DTC cohort at Cycle 2 Day 1, for MTC cohort at Cycle 2 Day 15, Day 1 of Cycle 11 and 13 because no participant was evaluable at these time points. | Posted | Mean | Standard Deviation | U/W | Cycle 1 (Day 8), Cycle 2 (Days 1, 8, & 15), Cycles 3, 4, 5, 6, 7, 8, 9, 11, & 13 (Day 1) and Final Visit, up to data cutoff date 11 April 2011 (Cycle length= 28 days) |
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| Secondary | Duration of Response (DoR) Assessed as Per Independent Imaging Reviewers (IIR) | DoR was based on IIR was the time from date of the first CR or PR until the date of first documentation of disease progression or date of death, if death occurred prior to disease progression, for the participants who had BOR of CR or PR. Participants without progressive disease or death were censored at the date of last adequate tumor assessment. Duration of response = End Date - Date of first CR or PR + 1 | ITT population. Participants who were evaluable for this given measure at a given time point were included for this assessment. | Posted | Median | 95% Confidence Interval | Months | From date of the first CR or PR until the date of first documentation of disease progression or date of death, assessed up to data cutoff date 11 April 2011 |
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| Secondary | Disease Control Rate (DCR) Assessed as Per IIR | DCR was the percentage of the participants who had BOR of CR, PR, and stable disease (SD) with the minimum duration of SD lasting greater than or equal to 7 weeks, based on assessments by IIR. DCR = CR+PR+SD greater than or equal to 7 weeks | ITT population. Participants who were evaluable for this given measure at a given time point were included for this assessment. | Posted | Number | 95% Confidence Interval | Percentage of participants | From date of treatment start until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice to stop study treatment, or up to data cutoff date 11 April 2011, for up to approximately 2 years 5 months |
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| Secondary | Clinical Benefit Rate (CBR) Assessed as Per IIR | CBR was the percentage of the participants who had BOR of CR, PR, and SD with the minimum duration of SD lasting greater than or equal to 23 weeks, based on assessments by IIR. CBR = CR+PR+SD greater than or equal to 23 weeks | ITT population. Participants who were evaluable for this given measure at a given time point were included for this assessment. | Posted | Number | 95% Confidence Interval | Percentage of participants | From date of treatment start until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice to stop study treatment, or up to data cutoff date 11 April 2011, for up to approximately 2 years 5 months |
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| Secondary | Time to Response (TTR) Assessed as Per IIR | TTR was defined as "time from start of treatment to the time when a participant first achieves a response of PR/CR" based on assessments by IIR. TTR was only calculated for participants with confirmed PR or CR. | The Efficacy Evaluable Population included all participants who received at least one dose of the study treatment, had a baseline and at least one posttreatment tumor response evaluation. Participants who were evaluable for this given measure at a given time point were included for this assessment. | Posted | Median | 95% Confidence Interval | Months | From date of treatment start until date of first CR or PR, assessed up to data cutoff date 11 April 2011 |
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| Secondary | Progression Free Survival (PFS) Assessed as Per IIR | PFS was defined as the time from the date of treatment start until progressive disease or death from any cause in the absence of progressive disease. Disease progression was defined as at least a 20% increase in the sum of the longest diameter of target lesions (taking as reference the smallest sum on study), recorded since the treatment started or the appearance of 1 or more new lesions as assessed by IIR using RECIST 1.0. The duration of PFS was calculated as end date minus date of first drug plus 1, based on assessments by IIR. PFS was calculated using Kaplan-Meier estimate and presented with 2-sided 95% Cl. | ITT population | Posted | Median | 95% Confidence Interval | Months | From date of treatment start until date of progressive disease or death from any cause, assessed up to data cutoff date 11 April 2011, for up to approximately 2 years 5 months |
| ||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | OS was defined as the time from the date of treatment start until death from any cause. The duration of OS was calculated as 'end date minus date of first drug plus 1', based on assessments by IIR. Participants without a reported death or those lost to follow-up were censored at their last known alive date at the database cutoff. OS was calculated using Kaplan-Meier estimate and presented with 2-sided 95% Cl. | ITT population | Posted | Median | 95% Confidence Interval | Months | From date of treatment start until date of death from any cause, assessed up to data cutoff date 11 April 2011, for up to approximately 2 years 5 months |
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Non-Serious Adverse Events (AEs) and Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability of Lenvatinib | Safety assessments consisted of monitoring and recording all AEs (serious and non-serious) and SAEs; concomitant medications, regular monitoring of hematology, blood chemistry, and urine values; periodic measurement of vital signs, Eastern Cooperative Oncology Group (ECOG) performance status, New York Heart Association (NYHA) assessments, electrocardiograms (ECGs), echocardiograms; and performance of physical examinations. | Safety population included all participants who received at least 1 dose of study drug and had at least 1 posttreatment safety assessment. | Posted | Number | Participants | For each participant, from the first dose till 30 days after the last dose of study treatment (up to approximately 10 years 4 months) |
|
For each participant, from the first dose till 30 days after the last dose of study treatment (up to approximately 10 years 4 months)
Not provided
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 | DTC Cohort | Participants with radioiodine (131 I)-refractory/resistant differentiated thyroid cancer (DTC) received 24 mg lenvatinib (two 10 mg tablets and one 4 mg tablet) orally, once daily or 10 mg lenvatinib orally twice daily in 28-day treatment cycles. Out of 58 participants in the DTC cohort, 56 participants received 24 mg lenvatinib once daily and 2 participants received 10 mg lenvatinib twice daily (total 20 mg daily), given continuously in 28-day treatment cycles. | 44 | 58 | 32 | 58 | 58 | 58 |
| EG001 | MTC Cohort | Participants with medullary thyroid cancer (MTC) received 24 mg lenvatinib (two 10 mg tablets and one 4 mg tablet) given orally, once daily continuously in 28-day treatment cycles. | 37 | 59 | 42 | 59 | 59 | 59 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Obstructive airways disorder | Respiratory, thoracic and mediastinal disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Oesophagobronchial fistula | Respiratory, thoracic and mediastinal disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Respiratory arrest | Respiratory, thoracic and mediastinal disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Localised intraabdominal fluid collection | Gastrointestinal disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Oesophageal fistula | Gastrointestinal disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Oesophageal perforation | Gastrointestinal disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Pancreatic pseudocyst | Gastrointestinal disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Hypercalcitoninaemia | Metabolism and nutrition disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA version 18.0 | Systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA version 18.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA version 18.0 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA version 18.0 | Systematic Assessment |
| |
| Pneumonia staphylococcal | Infections and infestations | MedDRA version 18.0 | Systematic Assessment |
| |
| Tuberculosis | Infections and infestations | MedDRA version 18.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Arterial haemorrhage | Vascular disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Left ventricular dysfunction | Cardiac disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Malignant pleural effusion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 18.0 | Systematic Assessment |
| |
| Paraneoplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 18.0 | Systematic Assessment |
| |
| Pharyngeal neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 18.0 | Systematic Assessment |
| |
| Tumour haemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 18.0 | Systematic Assessment |
| |
| Nephropathy | Renal and urinary disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Local swelling | General disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Gallbladder enlargement | Hepatobiliary disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Gallbladder obstruction | Hepatobiliary disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA version 18.0 | Systematic Assessment |
| |
| Echocardiogram abnormal | Investigations | MedDRA version 18.0 | Systematic Assessment |
| |
| Ejection fraction decreased | Investigations | MedDRA version 18.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Osteolysis | Musculoskeletal and connective tissue disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Premature menopause | Reproductive system and breast disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Amenorrhoea | Reproductive system and breast disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Pelvic pain | Reproductive system and breast disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Carotid artery stenosis | Nervous system disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Dyskinesia | Nervous system disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Metabolic encephalopathy | Nervous system disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Polycythaemia | Blood and lymphatic system disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Accidental overdose | Injury, poisoning and procedural complications | MedDRA version 18.0 | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA version 18.0 | Systematic Assessment |
| |
| Thoracic vertebral fracture | Injury, poisoning and procedural complications | MedDRA version 18.0 | Systematic Assessment |
| |
| Diplopia | Eye disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Angioedema | Skin and subcutaneous tissue disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Cardiac failure chronic | Cardiac disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Sinus node dysfunction | Cardiac disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Oesophageal spasm | Gastrointestinal disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Generalised oedema | General disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Abscess neck | Infections and infestations | MedDRA version 18.0 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA version 18.0 | Systematic Assessment |
| |
| Candida sepsis | Infections and infestations | MedDRA version 18.0 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA version 18.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA version 18.0 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA version 18.0 | Systematic Assessment |
| |
| Implant site infection | Infections and infestations | MedDRA version 18.0 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA version 18.0 | Systematic Assessment |
| |
| Lung abscess | Infections and infestations | MedDRA version 18.0 | Systematic Assessment |
| |
| Lung infection pseudomonal | Infections and infestations | MedDRA version 18.0 | Systematic Assessment |
| |
| Periorbital cellulitis | Infections and infestations | MedDRA version 18.0 | Systematic Assessment |
| |
| Pseudomonas infection | Infections and infestations | MedDRA version 18.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA version 18.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA version 18.0 | Systematic Assessment |
| |
| Incisional hernia | Injury, poisoning and procedural complications | MedDRA version 18.0 | Systematic Assessment |
| |
| Pancreatic injury | Injury, poisoning and procedural complications | MedDRA version 18.0 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA version 18.0 | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA version 18.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 18.0 | Systematic Assessment |
| |
| Metastatic pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 18.0 | Systematic Assessment |
| |
| Oncologic complication | Infections and infestations | MedDRA version 18.0 | Systematic Assessment |
| |
| Radiculopathy | Nervous system disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Extrapyramidal disorder | Nervous system disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Paraplegia | Nervous system disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Acquired tracheo-oesophageal fistula | Respiratory, thoracic and mediastinal disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Stridor | Respiratory, thoracic and mediastinal disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Tracheal fistula | Respiratory, thoracic and mediastinal disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Aortic stenosis | Vascular disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Arterial rupture | Vascular disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Cervical radiculopathy | Nervous system disorders | MedDRA version 18.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphopenia | Blood and lymphatic system disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Ear discomfort | Ear and labyrinth disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Lacrimation increased | Eye disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Visual impairment | Eye disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Faeces pale | Gastrointestinal disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Gingival bleeding | Gastrointestinal disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Gingival pain | Gastrointestinal disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Glossitis | Gastrointestinal disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Glossodynia | Gastrointestinal disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Haematochezia | Gastrointestinal disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Oral discomfort | Gastrointestinal disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Temperature intolerance | General disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA version 18.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA version 18.0 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA version 18.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA version 18.0 | Systematic Assessment |
| |
| Laryngitis | Infections and infestations | MedDRA version 18.0 | Systematic Assessment |
| |
| Localised infection | Infections and infestations | MedDRA version 18.0 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA version 18.0 | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA version 18.0 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA version 18.0 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA version 18.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA version 18.0 | Systematic Assessment |
| |
| Tooth abscess | Infections and infestations | MedDRA version 18.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA version 18.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA version 18.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA version 18.0 | Systematic Assessment |
| |
| Activated partial thromboplastin time prolonged | Investigations | MedDRA version 18.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA version 18.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA version 18.0 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA version 18.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA version 18.0 | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA version 18.0 | Systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA version 18.0 | Systematic Assessment |
| |
| Blood thyroid stimulating hormone increased | Investigations | MedDRA version 18.0 | Systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | MedDRA version 18.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA version 18.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Muscle tightness | Musculoskeletal and connective tissue disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Periarthritis | Musculoskeletal and connective tissue disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Hyperaesthesia | Nervous system disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Nasal dryness | Respiratory, thoracic and mediastinal disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Exfoliative rash | Skin and subcutaneous tissue disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Hair texture abnormal | Skin and subcutaneous tissue disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Hyperkeratosis | Skin and subcutaneous tissue disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Rash macular | Skin and subcutaneous tissue disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Rash papular | Skin and subcutaneous tissue disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Skin fissures | Skin and subcutaneous tissue disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Skin induration | Skin and subcutaneous tissue disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Swelling face | Skin and subcutaneous tissue disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Cheilitis | Gastrointestinal disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Tongue disorder | Gastrointestinal disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Local swelling | General disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Seasonal allergy | Immune system disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA version 18.0 | Systematic Assessment |
| |
| Rash pustular | Infections and infestations | MedDRA version 18.0 | Systematic Assessment |
| |
| Vaginal infection | Infections and infestations | MedDRA version 18.0 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA version 18.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA version 18.0 | Systematic Assessment |
| |
| Thermal burn | Injury, poisoning and procedural complications | MedDRA version 18.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA version 18.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA version 18.0 | Systematic Assessment |
| |
| Blood thyroid stimulating hormone decreased | Investigations | MedDRA version 18.0 | Systematic Assessment |
| |
| Blood triglycerides increased | Investigations | MedDRA version 18.0 | Systematic Assessment |
| |
| Blood urea increased | Investigations | MedDRA version 18.0 | Systematic Assessment |
| |
| Blood urine present | Investigations | MedDRA version 18.0 | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA version 18.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA version 18.0 | Systematic Assessment |
| |
| Prothrombin time prolonged | Investigations | MedDRA version 18.0 | Systematic Assessment |
| |
| Dyslipidaemia | Metabolism and nutrition disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Hyperglycaemia | Investigations | MedDRA version 18.0 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Joint stiffness | Musculoskeletal and connective tissue disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 18.0 | Systematic Assessment |
| |
| Burning sensation | Nervous system disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Blister | Skin and subcutaneous tissue disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Sinus headache | Nervous system disorders | MedDRA version 18.0 | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eisai Medical Information | Eisai Inc. | 1-888-274-2378 | esi_oncmedinfo@eisai.com |
| ID | Term |
|---|---|
| D013964 | Thyroid Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D004700 | Endocrine System Diseases |
| D013959 | Thyroid Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C531958 | lenvatinib |
Not provided
Not provided
Not provided
| Male |
|
| OG001 | MTC Cohort | Participants with medullary thyroid cancer (MTC) received 24 mg lenvatinib (two 10 mg tablets and one 4 mg tablet) given orally, once daily continuously in 28-day treatment cycles. |
|
|
|
|
Participants with medullary thyroid cancer (MTC) received 24 mg lenvatinib (two 10 mg tablets and one 4 mg tablet) given orally, once daily continuously in 28-day treatment cycles. |
|
|
|
|
|
|
| OG001 | MTC Cohort | Participants with medullary thyroid cancer (MTC) received 24 mg lenvatinib (two 10 mg tablets and one 4 mg tablet) given orally, once daily continuously in 28-day treatment cycles. |
|
|
| OG001 | MTC Cohort | Participants with medullary thyroid cancer (MTC) received 24 mg lenvatinib (two 10 mg tablets and one 4 mg tablet) given orally, once daily continuously in 28-day treatment cycles. |
|
|
| OG001 | MTC Cohort | Participants with medullary thyroid cancer (MTC) received 24 mg lenvatinib (two 10 mg tablets and one 4 mg tablet) given orally, once daily continuously in 28-day treatment cycles. |
|
|
|
|
|
|
|
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
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|