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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-003668-11 | EudraCT Number |
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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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This study will be conducted to assess the long-term safety of study drug(s) in participants who are enrolled in Eisai-sponsored lenvatinib studies.
This is an open-label extension study to roll-over eligible participants from Eisai-sponsored lenvatinib studies. The participants may roll-over no sooner than the primary completion dates in their parent study or after all study data for the primary outcome measure have been collected for the parent study. The parent study is defined as the Eisai-sponsored lenvatinib clinical study in which the participant was receiving lenvatinib either as monotherapy or as combination therapy or was receiving any other comparator therapy. The participant can be enrolled in the current study for the purpose of long-term safety data collection if all the selection criteria for the current study are met. The intention is that the participant will not be without study drug during the transition from the parent study to the rollover study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A : Lenvatinib | Experimental | The roll-over eligible participants from Eisai-sponsored lenvatinib studies who received lenvatinib monotherapy or who crossed over from a comparator arm to receive lenvatinib monotherapy in their parent study will continue to receive lenvatinib monotherapy. |
|
| Cohort B: Lenvatinib plus Comparator drug | Experimental | The roll-over eligible participants from Eisai-sponsored lenvatinib studies who received lenvatinib combination therapy or who crossed over from a comparator arm to receive lenvatinib combination therapy in their parent study will continue to receive lenvatinib combination therapy. |
|
| Cohort C: Comparator drug | Experimental | The roll-over eligible participants from Eisai-sponsored lenvatinib studies who received comparator treatment in their parent study will continue to receive comparator treatment, with exception of participants receiving placebo. For China only: The roll-over eligible participants from Eisai-sponsored lenvatinib studies who received comparator treatment in their parent study will continue to receive sorafenib, with exception of participants receiving placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| E7080 | Drug | Oral Administration. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Any Treatment-Emergent Serious Adverse Events (TESAEs) | A treatment-emergent adverse events (TEAE) was defined as an adverse event (AE) that emerged during the treatment in the current roll-over study, having been absent prior to the time the participant signed the current roll-over study informed consent form (ICF), or re-emerged during treatment in the current roll-over study after having been present but resolved before signing the ICF or worsened in severity during treatment in the current roll-over study relative to the pre-ICF state, when the AE was continuous. A serious adverse event (SAE) was any untoward medical occurrence that at any dose: resulted in death; life threatening condition; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect or was medically important due to other reasons than the mentioned criteria. | Up to 58.8 months in current study |
| Number of Participants With Any Non-Serious Treatment-Emergent Adverse Events (TEAEs) | A TEAE was defined as an AE that emerged during the treatment in the current roll-over study, having been absent prior to the time the participant signed the current roll-over study in ICF, or re-emerged during treatment in the current roll-over study after having been present but resolved before signing the ICF or worsened in severity during treatment in the current roll-over study relative to the pre-ICF state, when the AE was continuous. A non-serious TEAE was any AE that was not considered a serious adverse event. | Up to 58.8 months in current study |
| Number of Participants With Treatment-Related TEAEs | A TEAE was defined as an AE that emerged during the treatment in the current roll-over study, having been absent prior to the time the participant signed the current roll-over study ICF, or re-emerged during treatment in the current roll-over study after having been present but resolved before signing the ICF or worsened in severity during treatment in the current roll-over study relative to the pre-ICF state, when the AE was continuous. Related TEAE was defined as AE with causal relationship between the study drug and the TEAE. |
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Inclusion Criteria:
It is required for all participants currently participating in other lenvatinib studies to meet the following eligibility criteria.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Harbor UCLA Medical Center | Torrance | California | 90502 | United States | ||
| Northwestern University |
A total of 40 participants were screened and enrolled to receive study treatment in this rollover study. The study was to consist of Cohorts A, B and C; however, no participants met criteria for Cohorts B or C, so no participants were enrolled in these cohorts and hence no data were collected and reported for these cohorts. As pre-specified in statistical analysis plan (SAP), data were collected and reported by regions (China and Rest of World) in this study for all sections.
Participants took part in the study at 28 investigative sites in China, United States, Australia, Belgium, Germany, Italy, South Korea, Netherlands, Poland, Romania, and Thailand from 16 August 2018 to 21 December 2023.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort A, China: Lenvatinib Monotherapy | Participants from China who received lenvatinib monotherapy or who crossed over from a comparator arm to receive lenvatinib monotherapy in their parent study (E7080-C086-108 [NCT03009292], or E7080-C086-308 [NCT02966093]) received lenvatinib dose ranging from 4 milligram (mg) to 24 mg, capsules, orally until progressive disease (PD), unacceptable toxicity, participant's discontinued study, use of nonpermitted concomitant drug, unacceptable noncompliance with the protocol, or lost to follow-up. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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 | Mar 10, 2021 | Dec 13, 2024 |
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| Comparator Drug | Drug | Per parent study. |
|
| Comparator Drug: Sorafenib | Drug | Per parent study. |
|
| Up to 58.8 months in current study |
| Number of Participants With Any TEAE | A TEAE was defined as an AE that emerged during the treatment in the current roll-over study, having been absent prior to the time the participant signed the current roll-over study ICF, or re-emerged during treatment in the current roll-over study after having been present but resolved before signing the ICF or worsened in severity during treatment in the current roll-over study relative to the pre-ICF state, when the AE was continuous. | Up to 58.8 months in current study |
| Chicago |
| Illinois |
| 60611 |
| United States |
| Karmanos Cancer Institute | Detroit | Michigan | 48201 | United States |
| The Alfred Hospital | Melbourne | 3004 | Australia |
| UZ Antwerpen | Edegem | Antwerpen | 2650 | Belgium |
| Cliniques Universitaires Saint-Luc | Brussels | Brussels Capital | 1200 | Belgium |
| Sun Yat-sen University, Cancer Center | Guangzhou | Guangdong | China |
| Affiliated Hospital of Guilin Medical University | Guilin | Guangxi | China |
| Harbin Medical University Cancer Hospital | Haerbin | Heilongjiang | China |
| Henan Cancer Hospital | Zhengzhou | Henan | China |
| Union Hospital Tongji Medical College Huazhong University of Science and Technology | Wuhan | Hubei | China |
| Hunan Cancer Hospital | Changsha | Hunan | China |
| Jiangsu Cancer Hospital | Nanjing | Jiangsu | China |
| Nanjing First Hospital | Nanjing | Jiangsu | China |
| The First Hospital of Jilin University | Changchun | Jilin | China |
| No.10 People of Shanghai | Shanghai | Shanghai Municipality | China |
| West China School of Medicine/West China Hospital, Sichuan University | Chengdu | Sichuan | China |
| Tianjin Medical University Cancer Institute & Hospital | Tianjin | Tianjin Municipality | China |
| Zhejiang Cancer Hospital | Hangzhou | Zhejiang | China |
| Eisai trial site 2 | Essen | 45147 | Germany |
| Eisai trial site 1 | Würzburg | 97080 | Germany |
| Azienda Ospedaliero Universitaria Pisana | Pisa | Tuscany | 56124 | Italy |
| Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis | Amsterdam | North Holland | 1066 CX | Netherlands |
| Centrum Onkologii Instytut im.Marii Sklodowskiej Curie-Oddzial w Gliwicach | Gliwice | 44-101 | Poland |
| Institutul National de Endocrinologie "C. I. Parhon" | Bucharest | 11863 | Romania |
| National Cancer Center | Goyang-si | Gyeonggido | 10408 | South Korea |
| Samsung Medical Center - PPDS | Seoul | 6351 | South Korea |
| Chulalongkorn University | Pathum Wan | Bangkok | 10330 | Thailand |
| FG001 | Cohort A, Rest of the World: Lenvatinib Monotherapy | Participants from rest of the world who received lenvatinib monotherapy or who crossed over from a comparator arm to receive lenvatinib monotherapy in their parent study (E7080-E044-101 [NCT00121719], E7080-A001-109 [NCT02686164], E7080-G000-201 [NCT00784303], E7080-G000-303 [NCT01321554], E7080-C086-108 [NCT03009292], or E7080-C086-308 [NCT02966093]) received lenvatinib dose ranging from 4 mg to 24 mg, capsules, orally until PD, unacceptable toxicity, participant's discontinued study, use of nonpermitted concomitant drug, unacceptable noncompliance with the protocol, or lost to follow-up. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Safety analysis set included the group of participants who received at least 1 dose of study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Cohort A, China: Lenvatinib Monotherapy | Participants from China who received lenvatinib monotherapy or who crossed over from a comparator arm to receive lenvatinib monotherapy in their parent study (E7080-C086-108 [NCT03009292], or E7080-C086-308 [NCT02966093]) received lenvatinib dose ranging from 4 mg to 24 mg, capsules, orally until PD, unacceptable toxicity, participant's discontinued study, use of nonpermitted concomitant drug, unacceptable noncompliance with the protocol, or lost to follow-up. |
| BG001 | Cohort A, Rest of the World: Lenvatinib Monotherapy | Participants from rest of the world who received lenvatinib monotherapy or who crossed over from a comparator arm to receive lenvatinib monotherapy in their parent study (E7080-E044-101 [NCT00121719], E7080-A001-109 [NCT02686164], E7080-G000-201 [NCT00784303], E7080-G000-303 [NCT01321554], E7080-C086-108 [NCT03009292], or E7080-C086-308 [NCT02966093]) received lenvatinib dose ranging from 4 mg to 24 mg, capsules, orally until PD, unacceptable toxicity, participant's discontinued study, use of nonpermitted concomitant drug, unacceptable noncompliance with the protocol, or lost to follow-up. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Any Treatment-Emergent Serious Adverse Events (TESAEs) | A treatment-emergent adverse events (TEAE) was defined as an adverse event (AE) that emerged during the treatment in the current roll-over study, having been absent prior to the time the participant signed the current roll-over study informed consent form (ICF), or re-emerged during treatment in the current roll-over study after having been present but resolved before signing the ICF or worsened in severity during treatment in the current roll-over study relative to the pre-ICF state, when the AE was continuous. A serious adverse event (SAE) was any untoward medical occurrence that at any dose: resulted in death; life threatening condition; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect or was medically important due to other reasons than the mentioned criteria. | Safety analysis set included the group of participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | Up to 58.8 months in current study |
|
|
| |||||||||||||||||||||||||||||
| Primary | Number of Participants With Any Non-Serious Treatment-Emergent Adverse Events (TEAEs) | A TEAE was defined as an AE that emerged during the treatment in the current roll-over study, having been absent prior to the time the participant signed the current roll-over study in ICF, or re-emerged during treatment in the current roll-over study after having been present but resolved before signing the ICF or worsened in severity during treatment in the current roll-over study relative to the pre-ICF state, when the AE was continuous. A non-serious TEAE was any AE that was not considered a serious adverse event. | Safety analysis set included the group of participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | Up to 58.8 months in current study |
| |||||||||||||||||||||||||||||||
| Primary | Number of Participants With Treatment-Related TEAEs | A TEAE was defined as an AE that emerged during the treatment in the current roll-over study, having been absent prior to the time the participant signed the current roll-over study ICF, or re-emerged during treatment in the current roll-over study after having been present but resolved before signing the ICF or worsened in severity during treatment in the current roll-over study relative to the pre-ICF state, when the AE was continuous. Related TEAE was defined as AE with causal relationship between the study drug and the TEAE. | Safety analysis set included the group of participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | Up to 58.8 months in current study |
| |||||||||||||||||||||||||||||||
| Primary | Number of Participants With Any TEAE | A TEAE was defined as an AE that emerged during the treatment in the current roll-over study, having been absent prior to the time the participant signed the current roll-over study ICF, or re-emerged during treatment in the current roll-over study after having been present but resolved before signing the ICF or worsened in severity during treatment in the current roll-over study relative to the pre-ICF state, when the AE was continuous. | Safety analysis set included the group of participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | Up to 58.8 months in current study |
|
Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
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 | Cohort A, China: Lenvatinib Monotherapy | Participants from China who received lenvatinib monotherapy or who crossed over from a comparator arm to receive lenvatinib monotherapy in their parent study (E7080-C086-108 [NCT03009292], or E7080-C086-308 [NCT02966093]) received lenvatinib dose ranging from 4 mg to 24 mg, capsules, orally until PD, unacceptable toxicity, participant's discontinued study, use of nonpermitted concomitant drug, unacceptable noncompliance with the protocol, or lost to follow-up. | 2 | 19 | 7 | 19 | 18 | 19 |
| EG001 | Cohort A, Rest of the World: Lenvatinib Monotherapy | Participants from rest of the world who received lenvatinib monotherapy or who crossed over from a comparator arm to receive lenvatinib monotherapy in their parent study (E7080-E044-101 [NCT00121719], E7080-A001-109 [NCT02686164], E7080-G000-201 [NCT00784303], E7080-G000-303 [NCT01321554], E7080-C086-108 [NCT03009292], or E7080-C086-308 [NCT02966093]) received lenvatinib dose ranging from 4 mg to 24 mg, capsules, orally until PD, unacceptable toxicity, participant's discontinued study, use of nonpermitted concomitant drug, unacceptable noncompliance with the protocol, or lost to follow-up. | 5 | 21 | 14 | 21 | 17 | 21 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Large intestine polyp | Gastrointestinal disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA version 26.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA version 26.0 | Systematic Assessment |
| |
| Pulmonary sepsis | Infections and infestations | MedDRA version 26.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA version 26.0 | Systematic Assessment |
| |
| Post procedural haematoma | Injury, poisoning and procedural complications | MedDRA version 26.0 | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA version 26.0 | Systematic Assessment |
| |
| Hypovolaemia | Metabolism and nutrition disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Malignant pleural effusion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 26.0 | Systematic Assessment |
| |
| Metastases to lung | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 26.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Hydrothorax | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Circulatory collapse | Vascular disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Superficial vein thrombosis | Vascular disorders | MedDRA version 26.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Aphthous ulcer | Gastrointestinal disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Gingival disorder | Gastrointestinal disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Gingival pain | Gastrointestinal disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA version 26.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA version 26.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA version 26.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA version 26.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA version 26.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA version 26.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA version 26.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA version 26.0 | Systematic Assessment |
| |
| Albumin globulin ratio decreased | Investigations | MedDRA version 26.0 | Systematic Assessment |
| |
| Amylase increased | Investigations | MedDRA version 26.0 | Systematic Assessment |
| |
| Apolipoprotein A-I decreased | Investigations | MedDRA version 26.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA version 26.0 | Systematic Assessment |
| |
| Bile acids increased | Investigations | MedDRA version 26.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA version 26.0 | Systematic Assessment |
| |
| Blood bicarbonate decreased | Investigations | MedDRA version 26.0 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA version 26.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA version 26.0 | Systematic Assessment |
| |
| Blood fibrinogen decreased | Investigations | MedDRA version 26.0 | Systematic Assessment |
| |
| Blood thyroid stimulating hormone decreased | Investigations | MedDRA version 26.0 | Systematic Assessment |
| |
| Blood urea increased | Investigations | MedDRA version 26.0 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA version 26.0 | Systematic Assessment |
| |
| Haematocrit decreased | Investigations | MedDRA version 26.0 | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA version 26.0 | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA version 26.0 | Systematic Assessment |
| |
| Low density lipoprotein increased | Investigations | MedDRA version 26.0 | Systematic Assessment |
| |
| Neutrophil count increased | Investigations | MedDRA version 26.0 | Systematic Assessment |
| |
| Platelet count increased | Investigations | MedDRA version 26.0 | Systematic Assessment |
| |
| Platelet-large cell ratio decreased | Investigations | MedDRA version 26.0 | Systematic Assessment |
| |
| Protein total decreased | Investigations | MedDRA version 26.0 | Systematic Assessment |
| |
| Urinary occult blood positive | Investigations | MedDRA version 26.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA version 26.0 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Hyperphosphataemia | Metabolism and nutrition disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Hypochloraemia | Metabolism and nutrition disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Joint effusion | Musculoskeletal and connective tissue disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Periarthritis | Musculoskeletal and connective tissue disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Albuminuria | Renal and urinary disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Vulvovaginal inflammation | Reproductive system and breast disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Hydrothorax | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Varicose vein | Vascular disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA version 26.0 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eisai Medical Information | Eisai Inc. | 1-888-274-2378 | esi_oncmedinfo@eisai.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 28, 2024 | Dec 13, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| C531958 | lenvatinib |
Not provided
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
|
|
|
|