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The purpose of this Phase 1 study is to determine the maximum tolerated dose (MTD) through observation of dose limiting toxicity (DLT), which is in advance defined, in patients with peripheral or cutaneous T-cell lymphoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| E7777 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| denileukin diftitox (E7777) | Biological | E7777 will be administered by intravenous (IV) infusion for 5 days from Day 1 through 5 of each cycle (21 days/cycle) with 8 cycles in maximum for E7777 alone therapy. E7777 dose will be escalated from 6 micro-g/kg/day to 12, 15 and then to 18 in a stepwise fashion. |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Tolerated Dose (MTD) and Recommended Dose (RD) | The MTD was defined as the maximum tolerated dose observed after the evaluation of dose limiting toxicity (DLT) in Cycle 1 with 6 participants. If it was judged that the dose was not tolerated and DLT was confirmed in only 3 participants in the lower dose cohort, 3 other participants were to be added and tolerability was evaluated with 6 participants in total. The RD was to be comprehensively determined based on the MTD and safety data. Participants not evaluable for DLT were defined as participants found to be ineligible or in whom DLT evaluation was impossible due to premature termination for reasons other than toxicities in the judgement of the Sponsor, among those who had received at least one dose of the investigational drug after enrollment. | For each dose, first dose of study drug (Cycle 1 Day 1) to end of Cycle 1 (Day 21) (1 cycle = 3 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Non-Serious Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability of Denileukin Diftitox | Safety assessments consisted of monitoring and recording all AEs and SAEs; regular monitoring of hematology, blood coagulation, blood chemistry, and urinalysis values; periodic measurement of vital signs, body weight, 12-lead electrocardiograms (ECGs), Eastern Cooperative Oncology Group performance status, physical examination findings, and ophthalmological examination findings. TEAEs were defined as an AE that had an onset date, or worsening in severity from baseline (pre-treatment), on or after the first dose of study drug up to the last assessment. Treatment-related TEAEs included TEAEs that were considered by the investigator to be possibly or probably related to study drug. SAEs were defined as any untoward medical occurrence which results in death, was life-threatening, required hospitalization or prolonged hospitalization, resulted in persistent or significant disability/incapacity, or caused a congenital anomaly/birth defect. |
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lnclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tadashi Nakanishi | Eisai Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nagoya | Aichi-ken | Japan | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29363235 | Derived | Ohmachi K, Ando K, Ogura M, Uchida T, Tobinai K, Maruyama D, Namiki M, Nakanishi T. E7777 in Japanese patients with relapsed/refractory peripheral and cutaneous T-cell lymphoma: A phase I study. Cancer Sci. 2018 Mar;109(3):794-802. doi: 10.1111/cas.13513. Epub 2018 Feb 26. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1: 6 ug/kg/Day Denileukin Diftitox | Denileukin diftitox was intravenously (IV) infused for 60 minutes (±10 minutes) daily from Day 1 through Day 5 of each Cycle (1 cycle = 3 weeks). |
| FG001 | Cohort 2: 9 ug/kg/Day Denileukin Diftitox | Denileukin diftitox was IV-infused for 60 minutes (±10 minutes) daily from Day 1 through Day 5 of each Cycle (1 cycle = 3 weeks). |
| FG002 | Cohort 3: 12 ug/kg/Day Denileukin Diftitox | Denileukin diftitox was IV-infused for 60 minutes (±10 minutes) daily from Day 1 through Day 5 of each Cycle (1 cycle = 3 weeks). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety analysis set included all participants who received at least one dose of the study drug with at least one evaluable, post-baseline safety datum.
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1: 6 ug/kg/Day Denileukin Diftitox | Denileukin diftitox was intravenously (IV) infused for 60 minutes (±10 minutes) daily from Day 1 through Day 5 of each Cycle (1 cycle = 3 weeks). |
| BG001 | Cohort 2: 9 ug/kg/Day Denileukin Diftitox |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Maximum Tolerated Dose (MTD) and Recommended Dose (RD) | The MTD was defined as the maximum tolerated dose observed after the evaluation of dose limiting toxicity (DLT) in Cycle 1 with 6 participants. If it was judged that the dose was not tolerated and DLT was confirmed in only 3 participants in the lower dose cohort, 3 other participants were to be added and tolerability was evaluated with 6 participants in total. The RD was to be comprehensively determined based on the MTD and safety data. Participants not evaluable for DLT were defined as participants found to be ineligible or in whom DLT evaluation was impossible due to premature termination for reasons other than toxicities in the judgement of the Sponsor, among those who had received at least one dose of the investigational drug after enrollment. | DLT evaluation analysis set included all participants after excluding, from the Safety Analysis Set, participants who were non-evaluable for DLT. | Posted | Number | ug/kg/day | For each dose, first dose of study drug (Cycle 1 Day 1) to end of Cycle 1 (Day 21) (1 cycle = 3 weeks) |
|
From date of first dose up to 30 days after the last dose of study treatment, up to approximately 4 years 2 months
Treatment-emergent adverse events and serious adverse events were reported. Adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was used and included all participants who received at least one dose of study drug with at least one evaluable, post-baseline safety datum.
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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: 6 ug/kg/Day Denileukin Diftitox | Denileukin diftitox was intravenously (IV) infused for 60 minutes (±10 minutes) daily from Day 1 through Day 5 of each Cycle (1 cycle = 3 weeks). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 18.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | MedDRA 18.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eisai Medical Services Inc. | Eisai Inc. | 1-888-422-4743 | esi_medinfo@eisai.com |
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| ID | Term |
|---|---|
| D016411 | Lymphoma, T-Cell, Peripheral |
| D009369 | Neoplasms |
| D009370 | Neoplasms by Histologic Type |
| D008223 | Lymphoma |
| D008206 | Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| ID | Term |
|---|---|
| D016399 | Lymphoma, T-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
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| ID | Term |
|---|---|
| C078456 | denileukin diftitox |
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|
| From date of first dose up to 30 days after the last dose of study treatment, up to approximately 4 years 2 months |
| Maximum Serum Concentration (Cmax) of Denileukin Diftitox | Cmax was defined as the maximum observed concentration of denileukin diftitox following administration of study treatment on Cycle 1 Day 1 and was obtained directly from the measured serum concentration-time curves. Blood samples were collected before and 30 minutes after the start of infusion and immediately (0 minutes), 30, 60, 90, and 120 minutes after the end of infusion of denileukin diftitox. The samples were analyzed for the amount of denileukin diftitox in the serum using a validated ligand-binding assay with a lower limit of quantitation (LLOQ) of 30 nanograms per milliliter (ng/mL). Serum pharmacokinetic (PK) data were analyzed using a non-compartmental analysis approach to obtain individual participant estimates of Cmax, which was then summarized as the median and full range for all participants and expressed as ng/mL. | Cycle 1 (Day 1) |
| Time to Cmax (Tmax) of Denileukin Diftitox in Serum | Blood samples were collected before and 30 minutes after the start of infusion and immediately (0 minutes), 30, 60, 90, and 120 minutes after the end of infusion of denileukin diftitox. The samples were analyzed for the amount of denileukin diftitox in the serum using a validated ligand-binding assay with a LLOQ of 30 ng/mL. Serum PK data were analyzed using a non-compartmental analysis approach to obtain individual participant estimates of Tmax, which was then summarized as the median and full range for all participants and expressed in minutes. | Cycle 1 (Day 1) |
| Area Under the Serum Concentration-Time Curve From Time 0 to Time of Last Quantifiable Concentration (AUC(0-t)) | Blood samples were collected before and 30 minutes after the start of infusion and immediately (0 minutes), 30, 60, 90, and 120 minutes after the end of infusion of denileukin diftitox. The samples were analyzed for the amount of denileukin diftitox in the serum using a validated ligand-binding assay with a LLOQ of 30 ng/mL. Serum PK data were analyzed using a non-compartmental analysis approach to obtain individual participant estimates of AUC(0-t), which was then summarized as the median and full range for all participants and expressed as nanograms*minutes per milliliter (ng*min/mL). | Cycle 1 (Day 1) |
| Area Under the Serum Concentration-Time Curve From Time 0 to Infinity (AUC(0-inf)) | Blood samples were collected before and 30 minutes after the start of infusion and immediately (0 minutes), 30, 60, 90, and 120 minutes after the end of infusion of denileukin diftitox. The samples were analyzed for the amount of denileukin diftitox in the serum using a validated ligand-binding assay with a LLOQ of 30 ng/mL. Serum PK data were analyzed using a non-compartmental analysis approach to obtain individual participant estimates of AUC(0-inf), which was then summarized as the median and full range for all participants and expressed as ng*min/mL. | Cycle 1 (Day 1) |
| Terminal Phase Rate Constant (λz) | Blood samples were collected before and 30 minutes after the start of infusion and immediately (0 minutes), 30, 60, 90, and 120 minutes after the end of infusion of denileukin diftitox. The samples were analyzed for the amount of denileukin diftitox in the serum using a validated ligand-binding assay with a LLOQ of 30 ng/mL. Serum PK data were analyzed using a non-compartmental analysis approach to obtain individual participant estimates of λz, which was then summarized as the median and full range for all participants and expressed in 1/minutes. | Cycle 1 (Day 1) |
| Terminal Elimination Phase Half-life (t1/2) | Blood samples were collected before and 30 minutes after the start of infusion and immediately (0 minutes), 30, 60, 90, and 120 minutes after the end of infusion of denileukin diftitox. The samples were analyzed for the amount of denileukin diftitox in the serum using a validated ligand-binding assay with a LLOQ of 30 ng/mL. Serum PK data were analyzed using a non-compartmental analysis approach to obtain individual participant estimates of t1/2, which was then summarized as the median and full range for all participants and expressed in minutes. | Cycle 1 (Day 1) |
| Volume of Distribution at Terminal Phase (Vz) | Blood samples were collected before and 30 minutes after the start of infusion and immediately (0 minutes), 30, 60, 90, and 120 minutes after the end of infusion of denileukin diftitox. The samples were analyzed for the amount of denileukin diftitox in the serum using a validated ligand-binding assay with a LLOQ of 30 ng/mL. Serum PK data were analyzed using a non-compartmental analysis approach to obtain individual participant estimates of Vz, which was then summarized as the median and full range for all participants and expressed as milliliters per kilogram (mL/kg). | Cycle 1 (Day 1) |
| Volume of Distribution at Steady State (Vss) | Blood samples were collected before and 30 minutes after the start of infusion and immediately (0 minutes), 30, 60, 90, and 120 minutes after the end of infusion of denileukin diftitox. The samples were analyzed for the amount of denileukin diftitox in the serum using a validated ligand-binding assay with a LLOQ of 30 ng/mL. Serum PK data were analyzed using a non-compartmental analysis approach to obtain individual participant estimates of Vss, which was then summarized as the median and full range for all participants and expressed as mL/kg. | Cycle 1 (Day 1) |
| Total Clearance (CL) | Blood samples were collected before and 30 minutes after the start of infusion and immediately (0 minutes), 30, 60, 90, and 120 minutes after the end of infusion of denileukin diftitox. The samples were analyzed for the amount of denileukin diftitox in the serum using a validated ligand-binding assay with a LLOQ of 30 ng/mL. SerumPK data were analyzed using a non-compartmental analysis approach to obtain individual participant estimates of CL, which was then summarized as the median and full range for all participants and expressed as milliliters/minutes/kilograms (mL/min/kg). | Cycle 1 (Day 1) |
| Recommended Dose | This endpoint was combined with primary outcome measure, MTD | For each dose, first dose of study drug (Cycle 1 Day 1) to end of Cycle 1 (Day 21) (1 cycle = 3 weeks) |
| Kashiwa |
| Chiba |
| Japan |
| Isehara | Kanagawa | Japan |
| Chuo-ku | Tokyo | Japan |
| Participant Choice |
|
| Physician Decision |
|
Denileukin diftitox was IV-infused for 60 minutes (±10 minutes) daily from Day 1 through Day 5 of each Cycle (1 cycle = 3 weeks). |
| BG002 | Cohort 3: 12 ug/kg/Day Denileukin Diftitox | Denileukin diftitox was IV-infused for 60 minutes (±10 minutes) daily from Day 1 through Day 5 of each Cycle (1 cycle = 3 weeks). |
| BG003 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG000 | Denileukin Diftitox | Denileukin diftitox was intravenously (IV) infused for 60 minutes (±10 minutes) daily from Day 1 through Day 5 of each Cycle (1 cycle = 3 weeks). |
|
|
| Secondary | Number of Participants With Non-Serious Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability of Denileukin Diftitox | Safety assessments consisted of monitoring and recording all AEs and SAEs; regular monitoring of hematology, blood coagulation, blood chemistry, and urinalysis values; periodic measurement of vital signs, body weight, 12-lead electrocardiograms (ECGs), Eastern Cooperative Oncology Group performance status, physical examination findings, and ophthalmological examination findings. TEAEs were defined as an AE that had an onset date, or worsening in severity from baseline (pre-treatment), on or after the first dose of study drug up to the last assessment. Treatment-related TEAEs included TEAEs that were considered by the investigator to be possibly or probably related to study drug. SAEs were defined as any untoward medical occurrence which results in death, was life-threatening, required hospitalization or prolonged hospitalization, resulted in persistent or significant disability/incapacity, or caused a congenital anomaly/birth defect. | Safety Analysis Set (SAS) included all participants who received at least one dose of the study drug with at least one evaluable, post-baseline safety datum. | Posted | Number | Participants | From date of first dose up to 30 days after the last dose of study treatment, up to approximately 4 years 2 months |
|
|
|
| Secondary | Maximum Serum Concentration (Cmax) of Denileukin Diftitox | Cmax was defined as the maximum observed concentration of denileukin diftitox following administration of study treatment on Cycle 1 Day 1 and was obtained directly from the measured serum concentration-time curves. Blood samples were collected before and 30 minutes after the start of infusion and immediately (0 minutes), 30, 60, 90, and 120 minutes after the end of infusion of denileukin diftitox. The samples were analyzed for the amount of denileukin diftitox in the serum using a validated ligand-binding assay with a lower limit of quantitation (LLOQ) of 30 nanograms per milliliter (ng/mL). Serum pharmacokinetic (PK) data were analyzed using a non-compartmental analysis approach to obtain individual participant estimates of Cmax, which was then summarized as the median and full range for all participants and expressed as ng/mL. | PK analysis set included all participants in whom at least one PK parameter could be calculated. | Posted | Median | Full Range | ng/mL | Cycle 1 (Day 1) |
|
|
|
| Secondary | Time to Cmax (Tmax) of Denileukin Diftitox in Serum | Blood samples were collected before and 30 minutes after the start of infusion and immediately (0 minutes), 30, 60, 90, and 120 minutes after the end of infusion of denileukin diftitox. The samples were analyzed for the amount of denileukin diftitox in the serum using a validated ligand-binding assay with a LLOQ of 30 ng/mL. Serum PK data were analyzed using a non-compartmental analysis approach to obtain individual participant estimates of Tmax, which was then summarized as the median and full range for all participants and expressed in minutes. | PK analysis set | Posted | Median | Full Range | Minutes | Cycle 1 (Day 1) |
|
|
|
| Secondary | Area Under the Serum Concentration-Time Curve From Time 0 to Time of Last Quantifiable Concentration (AUC(0-t)) | Blood samples were collected before and 30 minutes after the start of infusion and immediately (0 minutes), 30, 60, 90, and 120 minutes after the end of infusion of denileukin diftitox. The samples were analyzed for the amount of denileukin diftitox in the serum using a validated ligand-binding assay with a LLOQ of 30 ng/mL. Serum PK data were analyzed using a non-compartmental analysis approach to obtain individual participant estimates of AUC(0-t), which was then summarized as the median and full range for all participants and expressed as nanograms*minutes per milliliter (ng*min/mL). | PK analysis set | Posted | Median | Full Range | ng*min/mL | Cycle 1 (Day 1) |
|
|
|
| Secondary | Area Under the Serum Concentration-Time Curve From Time 0 to Infinity (AUC(0-inf)) | Blood samples were collected before and 30 minutes after the start of infusion and immediately (0 minutes), 30, 60, 90, and 120 minutes after the end of infusion of denileukin diftitox. The samples were analyzed for the amount of denileukin diftitox in the serum using a validated ligand-binding assay with a LLOQ of 30 ng/mL. Serum PK data were analyzed using a non-compartmental analysis approach to obtain individual participant estimates of AUC(0-inf), which was then summarized as the median and full range for all participants and expressed as ng*min/mL. | PK analysis set | Posted | Median | Full Range | ng*min/mL | Cycle 1 (Day 1) |
|
|
|
| Secondary | Terminal Phase Rate Constant (λz) | Blood samples were collected before and 30 minutes after the start of infusion and immediately (0 minutes), 30, 60, 90, and 120 minutes after the end of infusion of denileukin diftitox. The samples were analyzed for the amount of denileukin diftitox in the serum using a validated ligand-binding assay with a LLOQ of 30 ng/mL. Serum PK data were analyzed using a non-compartmental analysis approach to obtain individual participant estimates of λz, which was then summarized as the median and full range for all participants and expressed in 1/minutes. | PK analysis set | Posted | Median | Full Range | 1/minutes | Cycle 1 (Day 1) |
|
|
|
| Secondary | Terminal Elimination Phase Half-life (t1/2) | Blood samples were collected before and 30 minutes after the start of infusion and immediately (0 minutes), 30, 60, 90, and 120 minutes after the end of infusion of denileukin diftitox. The samples were analyzed for the amount of denileukin diftitox in the serum using a validated ligand-binding assay with a LLOQ of 30 ng/mL. Serum PK data were analyzed using a non-compartmental analysis approach to obtain individual participant estimates of t1/2, which was then summarized as the median and full range for all participants and expressed in minutes. | PK analysis set | Posted | Median | Full Range | Minutes | Cycle 1 (Day 1) |
|
|
|
| Secondary | Volume of Distribution at Terminal Phase (Vz) | Blood samples were collected before and 30 minutes after the start of infusion and immediately (0 minutes), 30, 60, 90, and 120 minutes after the end of infusion of denileukin diftitox. The samples were analyzed for the amount of denileukin diftitox in the serum using a validated ligand-binding assay with a LLOQ of 30 ng/mL. Serum PK data were analyzed using a non-compartmental analysis approach to obtain individual participant estimates of Vz, which was then summarized as the median and full range for all participants and expressed as milliliters per kilogram (mL/kg). | PK analysis set | Posted | Median | Full Range | mL/kg | Cycle 1 (Day 1) |
|
|
|
| Secondary | Volume of Distribution at Steady State (Vss) | Blood samples were collected before and 30 minutes after the start of infusion and immediately (0 minutes), 30, 60, 90, and 120 minutes after the end of infusion of denileukin diftitox. The samples were analyzed for the amount of denileukin diftitox in the serum using a validated ligand-binding assay with a LLOQ of 30 ng/mL. Serum PK data were analyzed using a non-compartmental analysis approach to obtain individual participant estimates of Vss, which was then summarized as the median and full range for all participants and expressed as mL/kg. | PK analysis set | Posted | Median | Full Range | mL/kg | Cycle 1 (Day 1) |
|
|
|
| Secondary | Total Clearance (CL) | Blood samples were collected before and 30 minutes after the start of infusion and immediately (0 minutes), 30, 60, 90, and 120 minutes after the end of infusion of denileukin diftitox. The samples were analyzed for the amount of denileukin diftitox in the serum using a validated ligand-binding assay with a LLOQ of 30 ng/mL. SerumPK data were analyzed using a non-compartmental analysis approach to obtain individual participant estimates of CL, which was then summarized as the median and full range for all participants and expressed as milliliters/minutes/kilograms (mL/min/kg). | PK analysis set | Posted | Median | Full Range | mL/min/kg | Cycle 1 (Day 1) |
|
|
|
| Secondary | Recommended Dose | This endpoint was combined with primary outcome measure, MTD | This endpoint was combined with primary outcome measure, MTD | Posted | For each dose, first dose of study drug (Cycle 1 Day 1) to end of Cycle 1 (Day 21) (1 cycle = 3 weeks) |
|
|
| 1 |
| 3 |
| 1 |
| 3 |
| 3 |
| 3 |
| EG001 | Cohort 2: 9 ug/kg/Day Denileukin Diftitox | Denileukin diftitox was IV-infused for 60 minutes (±10 minutes) daily from Day 1 through Day 5 of each Cycle (1 cycle = 3 weeks). | 0 | 7 | 3 | 7 | 7 | 7 |
| EG002 | Cohort 3: 12 ug/kg/Day Denileukin Diftitox | Denileukin diftitox was IV-infused for 60 minutes (±10 minutes) daily from Day 1 through Day 5 of each Cycle (1 cycle = 3 weeks). | 1 | 3 | 1 | 3 | 3 | 3 |
| Delirium | Psychiatric disorders | MedDRA 18.0 | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Aspartate Aminotransferase increased | Investigations | MedDRA 18.0 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 18.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 18.0 | Systematic Assessment |
|
| Infected skin ulcer | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Hepatic Failure | Hepatobiliary disorders | MedDRA 18.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 18.0 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 18.0 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA 18.0 | Systematic Assessment |
|
| Face Oedema | General disorders | MedDRA 18.0 | Systematic Assessment |
|
| Generalised oedema | General disorders | MedDRA 18.0 | Systematic Assessment |
|
| Infusion site extravasation | General disorders | MedDRA 18.0 | Systematic Assessment |
|
| Injection site swelling | General disorders | MedDRA 18.0 | Systematic Assessment |
|
| Peripheral swelling | General disorders | MedDRA 18.0 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 18.0 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 18.0 | Systematic Assessment |
|
| Lymphocyte count decreased | Investigations | MedDRA 18.0 | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA 18.0 | Systematic Assessment |
|
| Lipase increased | Investigations | MedDRA 18.0 | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA 18.0 | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA 18.0 | Systematic Assessment |
|
| Weight increased | Investigations | MedDRA 18.0 | Systematic Assessment |
|
| Amylase increased | Investigations | MedDRA 18.0 | Systematic Assessment |
|
| Blood cholesterol increased | Investigations | MedDRA 18.0 | Systematic Assessment |
|
| White blood cell decreased | Investigations | MedDRA 18.0 | Systematic Assessment |
|
| Blood albumin decreased | Investigations | MedDRA 18.0 | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA 18.0 | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA 18.0 | Systematic Assessment |
|
| Blood cholinesterase decreased | Investigations | MedDRA 18.0 | Systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA 18.0 | Systematic Assessment |
|
| Blood fibrinogen decreased | Investigations | MedDRA 18.0 | Systematic Assessment |
|
| Blood fibrinogen increased | Investigations | MedDRA 18.0 | Systematic Assessment |
|
| Cytomegalovirus test positive | Investigations | MedDRA 18.0 | Systematic Assessment |
|
| Electrocardiogram QT prolonged | Investigations | MedDRA 18.0 | Systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA 18.0 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 18.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 18.0 | Systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 18.0 | Systematic Assessment |
|
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA 18.0 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 18.0 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 18.0 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 18.0 | Systematic Assessment |
|
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 18.0 | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 18.0 | Systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 18.0 | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 18.0 | Systematic Assessment |
|
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 18.0 | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA 18.0 | Systematic Assessment |
|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 18.0 | Systematic Assessment |
|
| Lymphadenitis | Blood and lymphatic system disorders | MedDRA 18.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| Toxic skin eruption | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| Palmar erythema | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| Bacterial infection | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| Conjunctivitis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| Oral Herpes | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| Otitis externa | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | MedDRA 18.0 | Systematic Assessment |
|
| Renal impairment | Renal and urinary disorders | MedDRA 18.0 | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA 18.0 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 18.0 | Systematic Assessment |
|
| Capillary leak syndrome | Vascular disorders | MedDRA 18.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 18.0 | Systematic Assessment |
|
| Conjunctival oedema | Eye disorders | MedDRA 18.0 | Systematic Assessment |
|
| Eyelid oedema | Eye disorders | MedDRA 18.0 | Systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA 18.0 | Systematic Assessment |
|
| Visual Impairment | Eye disorders | MedDRA 18.0 | Systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA 18.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 18.0 | Systematic Assessment |
|
| Atrial Fibrillation | Cardiac disorders | MedDRA 18.0 | Systematic Assessment |
|
| Sinus tachycardia | Cardiac disorders | MedDRA 18.0 | Systematic Assessment |
|
| Antithrombin III deficiency | Congenital, familial and genetic disorders | MedDRA 18.0 | Systematic Assessment |
|
| Colour Blindness | Congenital, familial and genetic disorders | MedDRA 18.0 | Systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| Central nervous system lesion | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
|
| Purpura | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
Not provided
| D007154 | Immune System Diseases |
| Title | Measurements |
|---|---|
|
| Treatment-emergent SAEs |
|
| Death |
|