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An open-label phase 2, multicenter study in participants with recurrent malignant glioma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | Cohort 1 assessed participants with recurrent Grade 4 malignant glioma (ie, glioblastoma [GBM]) who were bevacizumab-naive. Participants were planned to be accrued in Cohort 1 and randomized in a 1:1 ratio to receive lenvatinib (experimental) or bevacizumab (active comparator). Cohort 1 - Bevacizumab Cohort 1 - Lenvatinib |
|
| Cohort 2 | Experimental | Cohort 2 assessed participants with recurrent Grade 3 malignant glioma who were bevacizumab-naive. Participants in Cohort 2 were planned to be treated with lenvatinib. |
|
| Cohort 3 | Experimental | Cohort 3 assessed participants with recurrent GBM who had disease progression following prior bevacizumab treatment. Participants in Cohort 3 were planned to be treated with lenvatinib. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lenvatinib | Drug | 24 mg lenvatinib capsules orally, once daily continuously in 28-day cycles until disease progression, development of unacceptable toxicity or withdrawal of consent. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) Rate at Month 6 | PFS at Month 6 was defined as the percentage of participants who remained alive and progression-free at Month 6, based on investigator's assessment. Progression was defined using Response Assessment in Neuro-Oncology (RANO) criteria, as a greater than 25% increase in enhancing lesions despite stable or increasing steroid dose, an increase (significant) in non-enhancing T2-weighted-Fluid-Attenuated Inversion Recovery (T2/FLAIR) lesions that are not attributable to other non-tumor causes, and any new lesions. PFS rate at Month 6 was estimated from Kaplan-Meier (K-M) product-limit estimate of PFS. | At Month 6 from randomization (Cohort 1) or first day of treatment (Cohorts 2 and 3) |
| 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 RANO criteria and investigator's assessment. CR was defined as the disappearance of all enhancing disease (measurable and non-measurable) sustained for at least 4 weeks, no new lesions, and stable or improved non-enhancing (T2/FLAIR) lesions. PR was defined as greater than or equal to 50% decrease, compared to baseline, in the sum of products of perpendicular diameters of all measureable enhancing lesions sustained for at least 4 weeks. No progression of non-measurable disease, no new lesions, stable or improved non-enhancing (T2/FLAIR) lesions on same or lower dose of corticosteroids compared to baseline. For both CR and PR, in the absence of a confirming scan 4 weeks later, this scan was considered only stable disease. Only participants with measureable disease at baseline were included in evaluation of ORR. |
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Inclusion Criteria
Histologically confirmed diagnosis of Grade 3 or 4 malignant glioma.
All subjects who have a first or second recurrence following primary management with surgical resection or biopsy, radiotherapy and up to 2 prior systemic treatments with addition of:
Karnofsky score of 70% or greater.
Adequately controlled blood pressure (BP) with or without antihypertensive medications, defined as BP less than 150/90 mmHg at screening and no change in antihypertensive medications within 1 week prior to the Screening Visit.
Adequate renal function, adequate bone marrow function, adequate blood coagulation function and adequate liver function, as defined in protocol.
No evidence of hemorrhage on the baseline magnetic resonance imaging (MRI) scan other than in those subjects who are stable grade 1.
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eisai Medical Services | Eisai Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tampa | Florida | United States | ||||
The protocol definition of study completion was that the participant had disease progression. Protocol defined reasons for not completing were adverse event, participant choice, lost to follow-up, administrative/other (including withdrawal of consent, pregnancy, study terminated by sponsor or other). Death was not a protocol defined reason for non-completion. Participants were followed for survival until death, except where they withdrew consent, or the Sponsor stopped the survival follow-up.
A total of 173 participants were screened and of those, 152 participants were deemed eligible, and 151 received study treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1 - Bevacizumab | Participants with recurrent Grade 4 malignant glioma (ie, glioblastoma [GBM]) who were bevacizumab-naive; received bevacizumab 10 mg/kg administered intravenously every 2 weeks in 28-day cycles |
| FG001 | Cohort 1 - Lenvatinib | Participants with recurrent Grade 4 malignant glioma (ie, glioblastoma [GBM]) who were bevacizumab-naive; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles |
| FG002 | Cohort 2 - Lenvatinib | Participants with recurrent Grade 3 malignant glioma who were bevacizumab-naive; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles |
| FG003 | Cohort 3 - Lenvatinib | Participants with recurrent GBM who had disease progression following prior bevacizumab treatment; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1 - Bevacizumab | Participants with recurrent Grade 4 malignant glioma (ie, glioblastoma [GBM]) who were bevacizumab-naive; received bevacizumab 10 mg/kg administered intravenously every 2 weeks in 28-day cycles |
| BG001 | Cohort 1 - Lenvatinib |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | 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 RANO criteria and investigator's assessment. CR was defined as the disappearance of all enhancing disease (measurable and non-measurable) sustained for at least 4 weeks, no new lesions, and stable or improved non-enhancing (T2/FLAIR) lesions. PR was defined as greater than or equal to 50% decrease, compared to baseline, in the sum of products of perpendicular diameters of all measureable enhancing lesions sustained for at least 4 weeks. No progression of non-measurable disease, no new lesions, stable or improved non-enhancing (T2/FLAIR) lesions on same or lower dose of corticosteroids compared to baseline. For both CR and PR, in the absence of a confirming scan 4 weeks later, this scan was considered only stable disease. Only participants with measureable disease at baseline were included in evaluation of ORR. | Full Analysis Set included all participants who received at least one dose of study drug | Posted | Number | 95% Confidence Interval | Percentage of participants | From date of randomization (Cohort 1) or first day of treatment (Cohorts 2 and 3) until disease progression, development of unacceptable toxicity, withdrawal of consent or up to data cutoff date of 19 March 2013 (i.e., 2.4 years) |
For each participant, from the first patient first dose till 30 days after the last dose or the cut-off date of 19 March 2013 (ie, 2.4 years)
All participants were followed for survival until death, except where a participant withdrew consent, or the Sponsor stopped the survival follow-up during the extension phase after completion of the primary study analysis. Since death was not a protocol defined reason for non-completion, the all cause mortality data below are not reflected in the Participant Flow section.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort 1 - Bevacizumab | Participants with recurrent Grade 4 malignant glioma (ie, glioblastoma [GBM]) who were bevacizumab-naive; received bevacizumab 10 mg/kg administered intravenously every 2 weeks in 28-day cycles |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial infarction | Cardiac disorders | MeDRA version 16.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MeDRA version 16.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eisai Medical Services | Eisai, Inc. | 1-888-422-4743 | esi_medinfo@eisai.com |
Not provided
| ID | Term |
|---|---|
| D005910 | Glioma |
| ID | Term |
|---|---|
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided
| ID | Term |
|---|---|
| C531958 | lenvatinib |
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
Not provided
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|
| Bevacizumab | Drug | Bevacizumab 10 mg/kg administered intravenously every 2 weeks in 28-day cycles until disease progression, development of unacceptable toxicity or withdrawal of consent. |
|
| From date of randomization (Cohort 1) or first day of treatment (Cohorts 2 and 3) until disease progression, development of unacceptable toxicity, withdrawal of consent or up to data cutoff date of 19 March 2013 (i.e., 2.4 years) |
| Progression Free Survival | PFS was measured as the time from randomization (Cohort 1) or the first day of treatment (Cohorts 2 and 3) until the date of first documentation of disease progression or date of death, if death occurred prior to disease progression, based on investigator's assessment. | From date of randomization (Cohort 1) or first day of treatment (Cohorts 2 and 3) until disease progression, development of unacceptable toxicity, withdrawal of consent or up to data cutoff date of 19 March 2013 (ie, 2.4 years) |
| Overall Survival (OS) | OS was measured as the time from the randomization date (Cohort 1) or the first day of treatment (Cohort 2 and 3) to the date of death from any cause. | From date of randomization (Cohort 1) or first day of treatment (Cohorts 2 and 3) until death due to any cause or up to data cutoff date of 19 March 2013 (ie, 2.4 years) |
| Disease Control Rate (DCR) | 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. Only participants with measurable disease at baseline were included in evaluation of DCR, based on investigator's assessment. | From date of randomization (Cohort 1) or first day of treatment (Cohorts 2 and 3) until disease progression, development of unacceptable toxicity, withdrawal of consent or up to data cutoff date of 19 March 2013 (ie, 2.4 years) |
| Clinical Benefit Rate (CBR) | 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. Only participants with measurable disease at baseline were included in evaluation of CBR, based on investigator's assessment. | From date of randomization (Cohort 1) or first day of treatment (Cohorts 2 and 3) until disease progression, development of unacceptable toxicity, withdrawal of consent or up to data cutoff date of 19 March 2013 (ie, 2.4 years) |
| Number of Participants With Adverse Events (AEs)/Serious Adverse Events (SAEs) as a Measure of Safety | Safety was assessed by monitoring and recording all AEs including all Common Terminology Criteria for Adverse Events (CTCAE) grades (for both increasing and decreasing severity) and SAEs; regular monitoring of hematology, clinical chemistry, and urine values; results of physical examinations, regular measurement of vital signs, and electrocardiograms (ECGs), as detailed in the Schedule of Visits and Procedures. The relationship of AEs to treatment was based on investigator judgment. Details of AEs and SAEs are provided in the reported adverse event section. | For each participant, from the first patient first dose till 30 days after the last dose or the cut-off date of 19 March 2013 (ie, 2.4 years) |
| Boston |
| Massachusetts |
| United States |
| Durham | North Carolina | United States |
| Calgary | Canada |
| Toronto | Canada |
| Participant Choice |
|
| Withdrawal of consent |
|
| Clinical progression/deterioration |
|
Participants with recurrent Grade 4 malignant glioma (ie, glioblastoma [GBM]) who were bevacizumab-naive; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles |
| BG002 | Cohort 2 - Lenvatinib | Participants with recurrent Grade 3 malignant glioma who were bevacizumab-naive; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles |
| BG003 | Cohort 3 - Lenvatinib | Participants with recurrent GBM who had disease progression following prior bevacizumab treatment; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles |
| BG004 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| World Health Organization Grading for Gliomas | Number | Participants |
|
|
|
|
| Secondary | Progression Free Survival | PFS was measured as the time from randomization (Cohort 1) or the first day of treatment (Cohorts 2 and 3) until the date of first documentation of disease progression or date of death, if death occurred prior to disease progression, based on investigator's assessment. | Full Analysis Set - all participants who received at least one dose of study drug | Posted | Median | 95% Confidence Interval | Months | From date of randomization (Cohort 1) or first day of treatment (Cohorts 2 and 3) until disease progression, development of unacceptable toxicity, withdrawal of consent or up to data cutoff date of 19 March 2013 (ie, 2.4 years) |
|
|
|
| Secondary | Overall Survival (OS) | OS was measured as the time from the randomization date (Cohort 1) or the first day of treatment (Cohort 2 and 3) to the date of death from any cause. | Full Analysis Set - all participants who received at least one dose of study drug | Posted | Median | 95% Confidence Interval | Months | From date of randomization (Cohort 1) or first day of treatment (Cohorts 2 and 3) until death due to any cause or up to data cutoff date of 19 March 2013 (ie, 2.4 years) |
|
|
|
| Secondary | Disease Control Rate (DCR) | 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. Only participants with measurable disease at baseline were included in evaluation of DCR, based on investigator's assessment. | Full Analysis Set - all participants who received at least one dose of study drug | Posted | Number | 95% Confidence Interval | Percentage of participants | From date of randomization (Cohort 1) or first day of treatment (Cohorts 2 and 3) until disease progression, development of unacceptable toxicity, withdrawal of consent or up to data cutoff date of 19 March 2013 (ie, 2.4 years) |
|
|
|
| Secondary | Clinical Benefit Rate (CBR) | 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. Only participants with measurable disease at baseline were included in evaluation of CBR, based on investigator's assessment. | Full Analysis Set - all participants who received at least one dose of study drug | Posted | Number | 95% Confidence Interval | Percentage of participants | From date of randomization (Cohort 1) or first day of treatment (Cohorts 2 and 3) until disease progression, development of unacceptable toxicity, withdrawal of consent or up to data cutoff date of 19 March 2013 (ie, 2.4 years) |
|
|
|
| Secondary | Number of Participants With Adverse Events (AEs)/Serious Adverse Events (SAEs) as a Measure of Safety | Safety was assessed by monitoring and recording all AEs including all Common Terminology Criteria for Adverse Events (CTCAE) grades (for both increasing and decreasing severity) and SAEs; regular monitoring of hematology, clinical chemistry, and urine values; results of physical examinations, regular measurement of vital signs, and electrocardiograms (ECGs), as detailed in the Schedule of Visits and Procedures. The relationship of AEs to treatment was based on investigator judgment. Details of AEs and SAEs are provided in the reported adverse event section. | Full Analysis Set - all participants who received at least one dose of study drug | Posted | Number | Participants | For each participant, from the first patient first dose till 30 days after the last dose or the cut-off date of 19 March 2013 (ie, 2.4 years) |
|
|
|
| Primary | Progression Free Survival (PFS) Rate at Month 6 | PFS at Month 6 was defined as the percentage of participants who remained alive and progression-free at Month 6, based on investigator's assessment. Progression was defined using Response Assessment in Neuro-Oncology (RANO) criteria, as a greater than 25% increase in enhancing lesions despite stable or increasing steroid dose, an increase (significant) in non-enhancing T2-weighted-Fluid-Attenuated Inversion Recovery (T2/FLAIR) lesions that are not attributable to other non-tumor causes, and any new lesions. PFS rate at Month 6 was estimated from Kaplan-Meier (K-M) product-limit estimate of PFS. | Full Analysis Set included all participants who received at least one dose of study drug | Posted | Number | 95% Confidence Interval | Percentage of participants | At Month 6 from randomization (Cohort 1) or first day of treatment (Cohorts 2 and 3) |
|
|
|
| 36 |
| 38 |
| 10 |
| 38 |
| 38 |
| 38 |
| EG001 | Cohort 1 - Lenvatinib | Participants with recurrent Grade 4 malignant glioma (ie, glioblastoma [GBM]) who were bevacizumab-naive; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles | 38 | 42 | 22 | 42 | 40 | 42 |
| EG002 | Cohort 2 - Lenvatinib | Participants with recurrent Grade 3 malignant glioma who were bevacizumab-naive; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles | 27 | 39 | 12 | 39 | 39 | 39 |
| EG003 | Cohort 3 - Lenvatinib | Participants with recurrent GBM who had disease progression following prior bevacizumab treatment; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles | 30 | 32 | 15 | 32 | 31 | 32 |
| Tachycardia | Cardiac disorders | MeDRA version 16.0 | Systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | MeDRA version 16.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MeDRA version 16.0 | Systematic Assessment |
|
| Intestinal perforation | Gastrointestinal disorders | MeDRA version 16.0 | Systematic Assessment |
|
| Large intestine perforation | Gastrointestinal disorders | MeDRA version 16.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MeDRA version 16.0 | Systematic Assessment |
|
| Pancreatitis | Gastrointestinal disorders | MeDRA version 16.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MeDRA version 16.0 | Systematic Assessment |
|
| Asthenia | General disorders | MeDRA version 16.0 | Systematic Assessment |
|
| Fatigue | General disorders | MeDRA version 16.0 | Systematic Assessment |
|
| General physical health deterioration | General disorders | MeDRA version 16.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MeDRA version 16.0 | Systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | MeDRA version 16.0 | Systematic Assessment |
|
| Hepatitis acute | Hepatobiliary disorders | MeDRA version 16.0 | Systematic Assessment |
|
| Bacteraemia | Infections and infestations | MeDRA version 16.0 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MeDRA version 16.0 | Systematic Assessment |
|
| Diverticulitis | Infections and infestations | MeDRA version 16.0 | Systematic Assessment |
|
| Perirectal abscess | Infections and infestations | MeDRA version 16.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MeDRA version 16.0 | Systematic Assessment |
|
| Skin infection | Infections and infestations | MeDRA version 16.0 | Systematic Assessment |
|
| Urosepsis | Infections and infestations | MeDRA version 16.0 | Systematic Assessment |
|
| Thermal burn | Injury, poisoning and procedural complications | MeDRA version 16.0 | Systematic Assessment |
|
| Wound dehiscence | Injury, poisoning and procedural complications | MeDRA version 16.0 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MeDRA version 16.0 | Systematic Assessment |
|
| Lipase increased | Investigations | MeDRA version 16.0 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MeDRA version 16.0 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MeDRA version 16.0 | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MeDRA version 16.0 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MeDRA version 16.0 | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MeDRA version 16.0 | Systematic Assessment |
|
| Myopathy | Musculoskeletal and connective tissue disorders | MeDRA version 16.0 | Systematic Assessment |
|
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MeDRA version 16.0 | Systematic Assessment |
|
| Tumour haemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MeDRA version 16.0 | Systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MeDRA version 16.0 | Systematic Assessment |
|
| Cognitive disorder | Nervous system disorders | MeDRA version 16.0 | Systematic Assessment |
|
| Convulsion | Nervous system disorders | MeDRA version 16.0 | Systematic Assessment |
|
| Depressed level of consciousness | Nervous system disorders | MeDRA version 16.0 | Systematic Assessment |
|
| Encephalopathy | Nervous system disorders | MeDRA version 16.0 | Systematic Assessment |
|
| Haemorrhage intracranial | Nervous system disorders | MeDRA version 16.0 | Systematic Assessment |
|
| Haemorrhagic stroke | Nervous system disorders | MeDRA version 16.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MeDRA version 16.0 | Systematic Assessment |
|
| Hemianopia homonymous | Nervous system disorders | MeDRA version 16.0 | Systematic Assessment |
|
| Hemiparesis | Nervous system disorders | MeDRA version 16.0 | Systematic Assessment |
|
| Peripheral motor neuropathy | Nervous system disorders | MeDRA version 16.0 | Systematic Assessment |
|
| Pyramidal tract syndrome | Nervous system disorders | MeDRA version 16.0 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MeDRA version 16.0 | Systematic Assessment |
|
| Subarachnoid haemorrhage | Nervous system disorders | MeDRA version 16.0 | Systematic Assessment |
|
| Agitation | Psychiatric disorders | MeDRA version 16.0 | Systematic Assessment |
|
| Confusional state | Psychiatric disorders | MeDRA version 16.0 | Systematic Assessment |
|
| Delirium | Psychiatric disorders | MeDRA version 16.0 | Systematic Assessment |
|
| Depressed mood | Psychiatric disorders | MeDRA version 16.0 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MeDRA version 16.0 | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MeDRA version 16.0 | Systematic Assessment |
|
| Embolism | Vascular disorders | MeDRA version 16.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MeDRA version 16.0 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MeDRA version 16.0 | Systematic Assessment |
|
| Rectal Hemorrhage | Gastrointestinal disorders | MeDRA version 16.0 | Systematic Assessment |
|
| Ischaemic stroke | Nervous system disorders | MeDRA version 16.0 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MeDRA version 16.0 | Systematic Assessment |
|
| Sinus tachycardia | Cardiac disorders | MeDRA version 16.0 | Systematic Assessment |
|
| Splinter haemorrhages | Cardiac disorders | MeDRA version 16.0 | Systematic Assessment |
|
| Ear discomfort | Ear and labyrinth disorders | MeDRA version 16.0 | Systematic Assessment |
|
| Hypoacusis | Ear and labyrinth disorders | MeDRA version 16.0 | Systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | MeDRA version 16.0 | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MeDRA version 16.0 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MeDRA version 16.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MeDRA version 16.0 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MeDRA version 16.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MeDRA version 16.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MeDRA version 16.0 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MeDRA version 16.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MeDRA version 16.0 | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MeDRA version 16.0 | Systematic Assessment |
|
| Faecal incontinence | Gastrointestinal disorders | MeDRA version 16.0 | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MeDRA version 16.0 | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MeDRA version 16.0 | Systematic Assessment |
|
| Gingival bleeding | Gastrointestinal disorders | MeDRA version 16.0 | Systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MeDRA version 16.0 | Systematic Assessment |
|
| Mouth ulceration | Gastrointestinal disorders | MeDRA version 16.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MeDRA version 16.0 | Systematic Assessment |
|
| Oral pain | Gastrointestinal disorders | MeDRA version 16.0 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MeDRA version 16.0 | Systematic Assessment |
|
| Tongue ulceration | Gastrointestinal disorders | MeDRA version 16.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MeDRA version 16.0 | Systematic Assessment |
|
| Asthenia | General disorders | MeDRA version 16.0 | Systematic Assessment |
|
| Fatigue | General disorders | MeDRA version 16.0 | Systematic Assessment |
|
| Feeling cold | General disorders | MeDRA version 16.0 | Systematic Assessment |
|
| Gait disturbance | General disorders | MeDRA version 16.0 | Systematic Assessment |
|
| Irritability | General disorders | MeDRA version 16.0 | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MeDRA version 16.0 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MeDRA version 16.0 | Systematic Assessment |
|
| Candida infection | Infections and infestations | MeDRA version 16.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MeDRA version 16.0 | Systematic Assessment |
|
| Oral candidiasis | Infections and infestations | MeDRA version 16.0 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MeDRA version 16.0 | Systematic Assessment |
|
| Tooth infection | Infections and infestations | MeDRA version 16.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MeDRA version 16.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MeDRA version 16.0 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MeDRA version 16.0 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MeDRA version 16.0 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MeDRA version 16.0 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MeDRA version 16.0 | Systematic Assessment |
|
| Blood pressure increased | Investigations | MeDRA version 16.0 | Systematic Assessment |
|
| Lipase increased | Investigations | MeDRA version 16.0 | Systematic Assessment |
|
| Platelet count decreased | Investigations | MeDRA version 16.0 | Systematic Assessment |
|
| Weight decreased | Investigations | MeDRA version 16.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MeDRA version 16.0 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MeDRA version 16.0 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MeDRA version 16.0 | Systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MeDRA version 16.0 | Systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | MeDRA version 16.0 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MeDRA version 16.0 | Systematic Assessment |
|
| Hypophosphataemia | Metabolism and nutrition disorders | MeDRA version 16.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MeDRA version 16.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MeDRA version 16.0 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MeDRA version 16.0 | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MeDRA version 16.0 | Systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MeDRA version 16.0 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MeDRA version 16.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MeDRA version 16.0 | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MeDRA version 16.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MeDRA version 16.0 | Systematic Assessment |
|
| Aphasia | Nervous system disorders | MeDRA version 16.0 | Systematic Assessment |
|
| Ataxia | Nervous system disorders | MeDRA version 16.0 | Systematic Assessment |
|
| Balance disorder | Nervous system disorders | MeDRA version 16.0 | Systematic Assessment |
|
| Cognitive disorder | Nervous system disorders | MeDRA version 16.0 | Systematic Assessment |
|
| Convulsion | Nervous system disorders | MeDRA version 16.0 | Systematic Assessment |
|
| Disturbance in attention | Nervous system disorders | MeDRA version 16.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MeDRA version 16.0 | Systematic Assessment |
|
| Dysarthria | Nervous system disorders | MeDRA version 16.0 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MeDRA version 16.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MeDRA version 16.0 | Systematic Assessment |
|
| Hemianopia homonymous | Nervous system disorders | MeDRA version 16.0 | Systematic Assessment |
|
| Hemiparesis | Nervous system disorders | MeDRA version 16.0 | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MeDRA version 16.0 | Systematic Assessment |
|
| Memory impairment | Nervous system disorders | MeDRA version 16.0 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MeDRA version 16.0 | Systematic Assessment |
|
| Partial seizures | Nervous system disorders | MeDRA version 16.0 | Systematic Assessment |
|
| Peripheral motor neuropathy | Nervous system disorders | MeDRA version 16.0 | Systematic Assessment |
|
| Pyramidal tract syndrome | Nervous system disorders | MeDRA version 16.0 | Systematic Assessment |
|
| Tremor | Nervous system disorders | MeDRA version 16.0 | Systematic Assessment |
|
| Agitation | Psychiatric disorders | MeDRA version 16.0 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MeDRA version 16.0 | Systematic Assessment |
|
| Confusional state | Psychiatric disorders | MeDRA version 16.0 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MeDRA version 16.0 | Systematic Assessment |
|
| Flat affect | Psychiatric disorders | MeDRA version 16.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MeDRA version 16.0 | Systematic Assessment |
|
| Mood swings | Psychiatric disorders | MeDRA version 16.0 | Systematic Assessment |
|
| Glycosuria | Renal and urinary disorders | MeDRA version 16.0 | Systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MeDRA version 16.0 | Systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | MeDRA version 16.0 | Systematic Assessment |
|
| Urinary incontinence | Renal and urinary disorders | MeDRA version 16.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MeDRA version 16.0 | Systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MeDRA version 16.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MeDRA version 16.0 | Systematic Assessment |
|
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MeDRA version 16.0 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MeDRA version 16.0 | Systematic Assessment |
|
| Hiccups | Respiratory, thoracic and mediastinal disorders | MeDRA version 16.0 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MeDRA version 16.0 | Systematic Assessment |
|
| Painful respiration | Respiratory, thoracic and mediastinal disorders | MeDRA version 16.0 | Systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | MeDRA version 16.0 | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MeDRA version 16.0 | Systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MeDRA version 16.0 | Systematic Assessment |
|
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MeDRA version 16.0 | Systematic Assessment |
|
| Drug eruption | Skin and subcutaneous tissue disorders | MeDRA version 16.0 | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MeDRA version 16.0 | Systematic Assessment |
|
| Ecchymosis | Skin and subcutaneous tissue disorders | MeDRA version 16.0 | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MeDRA version 16.0 | Systematic Assessment |
|
| Hyperkeratosis | Skin and subcutaneous tissue disorders | MeDRA version 16.0 | Systematic Assessment |
|
| Night sweats | Skin and subcutaneous tissue disorders | MeDRA version 16.0 | Systematic Assessment |
|
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MeDRA version 16.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MeDRA version 16.0 | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MeDRA version 16.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MeDRA version 16.0 | Systematic Assessment |
|
Not provided
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| SAEs |
|