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The purpose of this study is to evaluate the objective response rate (ORR) of E7777 in participants with relapsed or refractory peripheral T-cell lymphoma (PTCL) and cutaneous T-cell lymphoma (CTCL).
This is a multicenter, single-arm, open label, Phase 2 to evaluate efficacy, safety, pharmacokinetics and immunogenicity of E7777 in participants with relapsed or refractory PTCL and CTCL.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| E7777 | Experimental | Participants with relapsed or refractory peripheral T-cell lymphoma (PTCL) and cutaneous T-cell lymphoma (CTCL) will receive 9 μg/kg/day of E7777, administered by intravenous drip infusion in 60 minutes (± 10 min) for Days 1 through 5 of each cycle in maximum of 8 cycles. Every cycle consists of 3 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| E7777 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | ORR was defined as the percentage of participants whose best overall response (BOR) was complete response (CR) or partial response (PR) based on independent review of Efficacy and Safety Evaluation Committee. ORR was assessed according to modified response criteria based on the revised response criteria for malignant lymphoma (Cheson, 2007), skin lesion and peripheral blood disease were assessed according to clinical end points and response criteria in mycosis fungoides and Sezary syndrome (Olsen, 2011). CR: Disappearance of all evidence of disease; PR: Regression of measurable disease and no new sites. | From the date of administration of the first dose of the study drug until completion of the study or treatment discontinuation, up to approximately 3 years 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) | PFS: time between the date of administration of the first dose of the study drug and the date of the first documentation of progressive disease (PD) or death due to any cause (whichever occurred first) based on independent review of Efficacy and Safety Evaluation Committee, assessed by modified response criteria based on the revised response criteria for malignant lymphoma (Cheson, 2007), skin lesion and peripheral blood disease assessed according to clinical end points and response criteria in mycosis fungoides and Sezary syndrome (Olsen, 2011). PD: Any new lesion or unequivocally increase of previously involved sites from nadir. PFS was calculated using Kaplan-Meier method. Participants with no baseline assessments, treatment discontinuation without postbaseline tumor assessments, new anticancer treatment started prior to disease progression, death or PD after more than one missed tumor assessments and participants still on treatment without PD as of data cut-off were censored. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eisai Trial Site #1 | Nagoya | Aichi-ken | Japan | |||
| Eisai Trial Site #2 |
A total of 45 participants were enrolled (obtained informed consent and screened), of these 8 were screen failures and 37 were treated.
Participants took part in the study at 20 investigative sites in Japan from 28 March 2016 to 26 April 2019.
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| ID | Title | Description |
|---|---|---|
| FG000 | PTCL: E7777 9 mcg/kg/Day | Participants with relapsed or refractory peripheral T-cell lymphoma (PTCL) received E7777 9 microgram per kilogram per day (mcg/kg/day) as intravenous infusion, once daily from Day 1 through Day 5 in each treatment cycle until discontinuation or Cycle 8 (each Cycle length equal to [=] 3 weeks). |
| FG001 |
| 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 | Feb 19, 2016 | Jun 14, 2021 |
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| From the date of administration of the first dose of the study drug until date of the first documentation of PD or death due to any cause (whichever occurred first) up to approximately 3 years 1 month |
| Duration of Response (DOR) | DOR: Time between date of first documentation of CR or PR and PD or death due to any cause based on independent review of Efficacy and Safety Evaluation Committee, assessed by modified response criteria based on revised response criteria for malignant lymphoma (Cheson,2007),skin lesion and peripheral blood disease by clinical end points and response criteria in mycosis fungoides and Sezary syndrome(Olsen,2011). DOR was assessed in responders who had CR or PR. CR: Disappearance of all evidence of disease; PR: Regression of measurable disease and no new sites. PD: Any new lesion or unequivocally increase of previously involved sites from nadir. DOR was calculated using Kaplan-Meier method. Participants with new anticancer treatment started prior to disease progression, death or PD after more than one missed tumor assessments and participants still on treatment without PD as of data cut-off were censored. | From the date of first documentation of CR or PR until date of the first documentation of PD or death due to any cause (whichever occurred first) up to approximately 3 years 1 month |
| Time to Response (TTR) | TTR was defined as time between the date of administration of the first dose of the study drug and the date of first documentation PR or CR based on independent review of Efficacy and Safety Evaluation Committee. PR or CR were assessed according to modified response criteria based on the revised response criteria for malignant lymphoma (Cheson, 2007), skin lesion and peripheral blood disease were assessed according to clinical end points and response criteria in mycosis fungoides and Sezary syndrome (Olsen, 2011). TTR was only conducted among responders who had experienced CR or PR. CR: Disappearance of all evidence of disease; PR: Regression of measurable disease and no new sites. | From the date of administration of the first dose of the study drug until date of the first documentation of PR or CR or death due to any cause (whichever occurred first) up to approximately 3 years 1 month |
| CR Rate | CR rate was defined as the percentage of participants whose BOR was CR based on independent review of Efficacy and Safety Evaluation Committee. CR was assessed according to modified response criteria based on the revised response criteria for malignant lymphoma (Cheson, 2007), skin lesion and peripheral blood disease were assessed according to clinical end points and response criteria in mycosis fungoides and Sezary syndrome (Olsen, 2011). CR: Disappearance of all evidence of disease. | From the date of administration of the first dose of the study drug until completion of the study or treatment discontinuation, up to approximately 3 years 1 month |
| Overall Survival (OS) | OS was defined as the time between the date of administration of the first dose of the study drug and the date of death due to any cause. Participants who were alive at cut-off were censored. | From date of administration of the first dose of the study drug until the date of death due to any cause up to approximately 3 years 1 month |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | From the date of administration of the first dose of the study drug up to 30 days after the last dose of study drug (approximately up to 3 years 1 month) |
| Cmax: Maximum Observed Serum Concentration for E7777 | Cycle 1 Day 1: 0-240 minutes post-infusion; Cycle 3 and 5 Day 1: 0-120 minutes post-infusion (each Cycle length = 3 weeks) |
| Tmax: Time to Reach the Cmax for E7777 | Cycle 1 Day 1: 0-240 minutes post-infusion; Cycle 3 and 5 Day 1: 0-120 minutes post-infusion (each Cycle length = 3 weeks) |
| AUC(0-t ): Area Under the Serum Concentration-time Curve From Time 0 to the Last Measurable Point for E7777 | Cycle 1 Day 1: 0-240 minutes post-infusion; Cycle 3 and 5 Day 1: 0-120 minutes post-infusion (each Cycle length = 3 weeks) |
| AUC(0-inf): Area Under the Serum Concentration-time Curve From Time 0 to Infinity for E7777 | 11 participants were included in the PK analysis, however AUC(0-inf), could not be estimated for 1 participant due to insufficient data for elimination rate constant. | Cycle 1 Day 1: 0-240 minutes post-infusion; Cycle 3 and 5 Day 1: 0-120 minutes post-infusion (each Cycle length = 3 weeks) |
| Mean Residence Time (MRT) for E7777 | 11 participants were included in the PK analysis, however MRT, could not be estimated for 1 participant due to insufficient data for elimination rate constant. | Cycle 1 Day 1: 0-240 minutes post-infusion; Cycle 3 and 5 Day 1: 0-120 minutes post-infusion (each Cycle length = 3 weeks) |
| t1/2: Terminal Elimination Phase Half-life for E7777 | 11 participants were included in the PK analysis, however t1/2, could not be estimated for 1 participant due to insufficient data for elimination rate constant. | Cycle 1 Day 1: 0-240 minutes post-infusion; Cycle 3 and 5 Day 1: 0-120 minutes post-infusion (each Cycle length = 3 weeks) |
| CL: Total Clearance for E7777 | 11 participants were included in the PK analysis, however CL, could not be estimated for 1 participant due to insufficient data for elimination rate constant. | Cycle 1 Day 1: 0-240 minutes post-infusion; Cycle 3 and 5 Day 1: 0-120 minutes post-infusion (each Cycle length = 3 weeks) |
| Vz: Volume of Distribution at Terminal Phase for E7777 | 11 participants were included in the PK analysis, however Vz, could not be estimated for 1 participant due to insufficient data for elimination rate constant. | Cycle 1 Day 1: 0-240 minutes post-infusion; Cycle 3 and 5 Day 1: 0-120 minutes post-infusion (each Cycle length = 3 weeks) |
| Vss: Volume of Distribution at Steady State for E7777 | 11 participants were included in the PK analysis, however Vss, could not be estimated for 1 participant due to insufficient data for elimination rate constant. | Cycle 1 Day 1: 0-240 minutes post-infusion; Cycle 3 and 5 Day 1: 0-120 minutes post-infusion (each Cycle length = 3 weeks) |
| Rac (Cmax): Accumulation Ratio of Cmax for E7777 | Accumulation Ratio of Cmax was calculated as RAC (Cmax) on Cycle 3 Day 1 divided by RAC (Cmax) on Cycle 1 Day 1, and RAC (Cmax) on Cycle 5 Day 1 divided by RAC (Cmax) on Cycle 1 Day 1. | Cycle 1 Day 1: 0-240 minutes post-infusion; Cycle 3 and 5 Day 1: 0-120 minutes post-infusion (each Cycle length = 3 weeks) |
| Rac (AUC): Accumulation Ratio of AUC for E7777 | Accumulation ratio of AUC was calculated as RAC (AUC) on Cycle 3 Day 1 divided by RAC (AUC) on Cycle 1 Day 1, and RAC (AUC) on Cycle 5 Day 1 divided by RAC (AUC) on Cycle 1 Day 1. | Cycle 1 Day 1: 0-240 minutes post-infusion; Cycle 3 and 5 Day 1: 0-120 minutes post-infusion (each Cycle length = 3 weeks) |
| Number of Participants With Positive Anti-E7777 and Anti-IL-2 Antibodies | Cycles 1, 2, 3, 5, 8: Day 1 pre-dose; at treatment discontinuation or completion (Cycle 8 Day 21) (each Cycle length = 3 weeks) |
| Number of Participants With Positive Neutralizing Activity of Anti-E7777 Antibody | Cycles 1, 2, 3, 5, 8: Day 1 pre-dose; at treatment discontinuation or completion (Cycle 8 Day 21) (each Cycle length = 3 weeks) |
| Nagoya |
| Aichi-ken |
| Japan |
| Eisai Trial Site #1 | Kashiwa | Chiba | Japan |
| Eisai Trial Site #1 | Ōta | Gunma | Japan |
| Eisai Trial Site #1 | Kobe | Hyōgo | Japan |
| Eisai Trial Site #1 | Tsukuba | Ibaraki | Japan |
| Eisai Trial Site #1 | Isehara | Kanagawa | Japan |
| Eisai Trial Site #1 | Sendai | Miyagi | Japan |
| Eisai Trial Site #1 | Kurashiki | Okayama-ken | Japan |
| Eisai Trial Site #1 | Suita | Osaka | Japan |
| Eisai Trial Site #2 | Suita | Osaka | Japan |
| Eisai Trial Site #1 | Hamamatsu | Shizuoka | Japan |
| Eisai Trial Site #1 | Yamagata | Tamagata | Japan |
| Eisai Trial Site #1 | Bunkyo-ku | Tokyo | Japan |
| Eisai Trial Site #1 | Chuo-ku | Tokyo | Japan |
| Eisai Trial Site #1 | Koto-ku | Tokyo | Japan |
| Eisai Trial Site #1 | Fukuoka | Japan |
| Eisai Trial Site #1 | Kagoshima | Japan |
| Eisai Trial Site #1 | Kyoto | Japan |
| Eisai Trial Site #1 | Okayama | Japan |
| CTCL: E7777 9 mcg/kg/Day |
Participants with cutaneous T-cell lymphoma (CTCL) received E7777 9 mcg/kg/day as intravenous infusion, once daily from Day 1 through Day 5 in each treatment cycle until discontinuation or Cycle 8 (each Cycle length = 3 weeks). |
| FG002 | Other: E7777 9 mcg/kg/Day | Participant with extranodal natural killer (NK)/T-cell lymphoma received E7777 9 mcg/kg/day as intravenous infusion, once daily from Day 1 through Day 5 in each treatment cycle until discontinuation or Cycle 8 (each Cycle length = 3 weeks). |
| COMPLETED |
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| NOT COMPLETED |
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The safety analysis set was defined as a group of participants who received at least 1 dose of the study drug with at least 1 evaluable postbaseline safety data.
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| ID | Title | Description |
|---|---|---|
| BG000 | PTCL: E7777 9 mcg/kg/Day | Participants with relapsed or refractory PTCL received E7777 9 mcg/kg/day as intravenous infusion, once daily from Day 1 through Day 5 in each treatment cycle until discontinuation or Cycle 8 (each Cycle length = 3 weeks). |
| BG001 | CTCL: E7777 9 mcg/kg/Day | Participants with CTCL received E7777 9 mcg/kg/day as intravenous infusion, once daily from Day 1 through Day 5 in each treatment cycle until discontinuation or Cycle 8 (each Cycle length = 3 weeks). |
| BG002 | Other: E7777 9 mcg/kg/Day | Participant with extranodal NK/T-cell lymphoma received E7777 9 mcg/kg/day as intravenous infusion, once daily from Day 1 through Day 5 in each treatment cycle until discontinuation or Cycle 8 (each Cycle length = 3 weeks). |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Objective Response Rate (ORR) | ORR was defined as the percentage of participants whose best overall response (BOR) was complete response (CR) or partial response (PR) based on independent review of Efficacy and Safety Evaluation Committee. ORR was assessed according to modified response criteria based on the revised response criteria for malignant lymphoma (Cheson, 2007), skin lesion and peripheral blood disease were assessed according to clinical end points and response criteria in mycosis fungoides and Sezary syndrome (Olsen, 2011). CR: Disappearance of all evidence of disease; PR: Regression of measurable disease and no new sites. | The full analysis set (FAS) was defined as a group of participants who received at least 1 dose of the study drug. | Posted | Number | 95% Confidence Interval | percentage of participants | From the date of administration of the first dose of the study drug until completion of the study or treatment discontinuation, up to approximately 3 years 1 month |
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| Secondary | Progression Free Survival (PFS) | PFS: time between the date of administration of the first dose of the study drug and the date of the first documentation of progressive disease (PD) or death due to any cause (whichever occurred first) based on independent review of Efficacy and Safety Evaluation Committee, assessed by modified response criteria based on the revised response criteria for malignant lymphoma (Cheson, 2007), skin lesion and peripheral blood disease assessed according to clinical end points and response criteria in mycosis fungoides and Sezary syndrome (Olsen, 2011). PD: Any new lesion or unequivocally increase of previously involved sites from nadir. PFS was calculated using Kaplan-Meier method. Participants with no baseline assessments, treatment discontinuation without postbaseline tumor assessments, new anticancer treatment started prior to disease progression, death or PD after more than one missed tumor assessments and participants still on treatment without PD as of data cut-off were censored. | The FAS was defined as a group of participants who received at least 1 dose of the study drug. | Posted | Median | 95% Confidence Interval | months | From the date of administration of the first dose of the study drug until date of the first documentation of PD or death due to any cause (whichever occurred first) up to approximately 3 years 1 month |
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| Secondary | Duration of Response (DOR) | DOR: Time between date of first documentation of CR or PR and PD or death due to any cause based on independent review of Efficacy and Safety Evaluation Committee, assessed by modified response criteria based on revised response criteria for malignant lymphoma (Cheson,2007),skin lesion and peripheral blood disease by clinical end points and response criteria in mycosis fungoides and Sezary syndrome(Olsen,2011). DOR was assessed in responders who had CR or PR. CR: Disappearance of all evidence of disease; PR: Regression of measurable disease and no new sites. PD: Any new lesion or unequivocally increase of previously involved sites from nadir. DOR was calculated using Kaplan-Meier method. Participants with new anticancer treatment started prior to disease progression, death or PD after more than one missed tumor assessments and participants still on treatment without PD as of data cut-off were censored. | The FAS was defined as a group of participants who received at least 1 dose of the study drug. Here "overall number of participants analyzed" signifies responded participants. | Posted | Median | 95% Confidence Interval | months | From the date of first documentation of CR or PR until date of the first documentation of PD or death due to any cause (whichever occurred first) up to approximately 3 years 1 month |
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| Secondary | Time to Response (TTR) | TTR was defined as time between the date of administration of the first dose of the study drug and the date of first documentation PR or CR based on independent review of Efficacy and Safety Evaluation Committee. PR or CR were assessed according to modified response criteria based on the revised response criteria for malignant lymphoma (Cheson, 2007), skin lesion and peripheral blood disease were assessed according to clinical end points and response criteria in mycosis fungoides and Sezary syndrome (Olsen, 2011). TTR was only conducted among responders who had experienced CR or PR. CR: Disappearance of all evidence of disease; PR: Regression of measurable disease and no new sites. | The FAS was defined as a group of participants who received at least 1 dose of the study drug. Here "overall number of participants analyzed" signifies responded participants. | Posted | Median | Full Range | months | From the date of administration of the first dose of the study drug until date of the first documentation of PR or CR or death due to any cause (whichever occurred first) up to approximately 3 years 1 month |
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| Secondary | CR Rate | CR rate was defined as the percentage of participants whose BOR was CR based on independent review of Efficacy and Safety Evaluation Committee. CR was assessed according to modified response criteria based on the revised response criteria for malignant lymphoma (Cheson, 2007), skin lesion and peripheral blood disease were assessed according to clinical end points and response criteria in mycosis fungoides and Sezary syndrome (Olsen, 2011). CR: Disappearance of all evidence of disease. | The FAS was defined as a group of participants who received at least 1 dose of the study drug. | Posted | Number | 95% Confidence Interval | percentage of participants | From the date of administration of the first dose of the study drug until completion of the study or treatment discontinuation, up to approximately 3 years 1 month |
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| Secondary | Overall Survival (OS) | OS was defined as the time between the date of administration of the first dose of the study drug and the date of death due to any cause. Participants who were alive at cut-off were censored. | The FAS was defined as a group of participants who received at least 1 dose of the study drug. | Posted | Median | 95% Confidence Interval | months | From date of administration of the first dose of the study drug until the date of death due to any cause up to approximately 3 years 1 month |
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| Secondary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | The safety analysis set was defined as a group of participants who received at least 1 dose of the study drug with at least 1 evaluable postbaseline safety data. | Posted | Count of Participants | Participants | From the date of administration of the first dose of the study drug up to 30 days after the last dose of study drug (approximately up to 3 years 1 month) |
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| Secondary | Cmax: Maximum Observed Serum Concentration for E7777 | The pharmacokinetic (PK) analysis set was defined as a group of participants who received at least 1 dose of the study drug with at least 1 serum concentration data, and included participants who had been taken frequent blood sampling for non-compartment analysis. PK-evaluable population where data at specified time points was available. | Posted | Mean | Standard Deviation | nanogram per milliliter (ng/mL) | Cycle 1 Day 1: 0-240 minutes post-infusion; Cycle 3 and 5 Day 1: 0-120 minutes post-infusion (each Cycle length = 3 weeks) |
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| Secondary | Tmax: Time to Reach the Cmax for E7777 | The PK analysis set was defined as a group of participants who received at least 1 dose of the study drug with at least 1 serum concentration data, and included participants who had been taken frequent blood sampling for non-compartment analysis. PK-evaluable population where data at specified time points was available. | Posted | Median | Full Range | minutes | Cycle 1 Day 1: 0-240 minutes post-infusion; Cycle 3 and 5 Day 1: 0-120 minutes post-infusion (each Cycle length = 3 weeks) |
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| Secondary | AUC(0-t ): Area Under the Serum Concentration-time Curve From Time 0 to the Last Measurable Point for E7777 | The PK analysis set was defined as a group of participants who received at least 1 dose of the study drug with at least 1 serum concentration data, and included participants who had been taken frequent blood sampling for non-compartment analysis. PK-evaluable population where data at specified time points was available. | Posted | Mean | Standard Deviation | nanogram*minute permilliliter(ng*min/mL) | Cycle 1 Day 1: 0-240 minutes post-infusion; Cycle 3 and 5 Day 1: 0-120 minutes post-infusion (each Cycle length = 3 weeks) |
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| Secondary | AUC(0-inf): Area Under the Serum Concentration-time Curve From Time 0 to Infinity for E7777 | 11 participants were included in the PK analysis, however AUC(0-inf), could not be estimated for 1 participant due to insufficient data for elimination rate constant. | The PK analysis set was defined as a group of participants who received at least 1 dose of the study drug with at least 1 serum concentration data, and included participants who had been taken frequent blood sampling for non-compartment analysis. PK-evaluable population where data at specified time points was available. | Posted | Mean | Standard Deviation | ng*min/m | Cycle 1 Day 1: 0-240 minutes post-infusion; Cycle 3 and 5 Day 1: 0-120 minutes post-infusion (each Cycle length = 3 weeks) |
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| Secondary | Mean Residence Time (MRT) for E7777 | 11 participants were included in the PK analysis, however MRT, could not be estimated for 1 participant due to insufficient data for elimination rate constant. | The PK analysis set was defined as a group of participants who received at least 1 dose of the study drug with at least 1 serum concentration data, and included participants who had been taken frequent blood sampling for non-compartment analysis. PK-evaluable population where data at specified time points was available. | Posted | Mean | Standard Deviation | minutes | Cycle 1 Day 1: 0-240 minutes post-infusion; Cycle 3 and 5 Day 1: 0-120 minutes post-infusion (each Cycle length = 3 weeks) |
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| Secondary | t1/2: Terminal Elimination Phase Half-life for E7777 | 11 participants were included in the PK analysis, however t1/2, could not be estimated for 1 participant due to insufficient data for elimination rate constant. | The PK analysis set was defined as a group of participants who received at least 1 dose of the study drug with at least 1 serum concentration data, and included participants who had been taken frequent blood sampling for non-compartment analysis. PK-evaluable population where data at specified time points was available. | Posted | Mean | Standard Deviation | minutes | Cycle 1 Day 1: 0-240 minutes post-infusion; Cycle 3 and 5 Day 1: 0-120 minutes post-infusion (each Cycle length = 3 weeks) |
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| Secondary | CL: Total Clearance for E7777 | 11 participants were included in the PK analysis, however CL, could not be estimated for 1 participant due to insufficient data for elimination rate constant. | The PK analysis set was defined as a group of participants who received at least 1 dose of the study drug with at least 1 serum concentration data, and included participants who had been taken frequent blood sampling for non-compartment analysis. PK-evaluable population where data at specified time points was available. | Posted | Mean | Standard Deviation | milliter per minute per kilogram | Cycle 1 Day 1: 0-240 minutes post-infusion; Cycle 3 and 5 Day 1: 0-120 minutes post-infusion (each Cycle length = 3 weeks) |
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| Secondary | Vz: Volume of Distribution at Terminal Phase for E7777 | 11 participants were included in the PK analysis, however Vz, could not be estimated for 1 participant due to insufficient data for elimination rate constant. | The PK analysis set was defined as a group of participants who received at least 1 dose of the study drug with at least 1 serum concentration data, and included participants who had been taken frequent blood sampling for non-compartment analysis. PK-evaluable population where data at specified time points was available. | Posted | Mean | Standard Deviation | milliliter per kilogram (mL/kg) | Cycle 1 Day 1: 0-240 minutes post-infusion; Cycle 3 and 5 Day 1: 0-120 minutes post-infusion (each Cycle length = 3 weeks) |
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| Secondary | Vss: Volume of Distribution at Steady State for E7777 | 11 participants were included in the PK analysis, however Vss, could not be estimated for 1 participant due to insufficient data for elimination rate constant. | The PK analysis set was defined as a group of participants who received at least 1 dose of the study drug with at least 1 serum concentration data, and included participants who had been taken frequent blood sampling for non-compartment analysis. PK-evaluable population where data at specified time points was available. | Posted | Mean | Standard Deviation | mL/kg | Cycle 1 Day 1: 0-240 minutes post-infusion; Cycle 3 and 5 Day 1: 0-120 minutes post-infusion (each Cycle length = 3 weeks) |
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| Secondary | Rac (Cmax): Accumulation Ratio of Cmax for E7777 | Accumulation Ratio of Cmax was calculated as RAC (Cmax) on Cycle 3 Day 1 divided by RAC (Cmax) on Cycle 1 Day 1, and RAC (Cmax) on Cycle 5 Day 1 divided by RAC (Cmax) on Cycle 1 Day 1. | PK analysis set: group of participants who received at least 1 dose of study drug with at least 1 serum concentration data, and included participants who had taken frequent blood sampling for non-compartment analysis. Overall number of participants analyzed is number of participants with evaluable data at Cycle 1 Day 1 and at Cycles 3 and 5 Day 1 | Posted | Mean | Standard Deviation | ratio | Cycle 1 Day 1: 0-240 minutes post-infusion; Cycle 3 and 5 Day 1: 0-120 minutes post-infusion (each Cycle length = 3 weeks) |
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| Secondary | Rac (AUC): Accumulation Ratio of AUC for E7777 | Accumulation ratio of AUC was calculated as RAC (AUC) on Cycle 3 Day 1 divided by RAC (AUC) on Cycle 1 Day 1, and RAC (AUC) on Cycle 5 Day 1 divided by RAC (AUC) on Cycle 1 Day 1. | PK analysis set: group of participants who received at least 1 dose of study drug with at least 1 serum concentration data, and included participants who had taken frequent blood sampling for non-compartment analysis. Overall number of participants analyzed is number of participants with evaluable data at Cycle 1 Day 1 and at Cycles 3 and 5 Day 1 | Posted | Mean | Standard Deviation | ratio | Cycle 1 Day 1: 0-240 minutes post-infusion; Cycle 3 and 5 Day 1: 0-120 minutes post-infusion (each Cycle length = 3 weeks) |
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| Secondary | Number of Participants With Positive Anti-E7777 and Anti-IL-2 Antibodies | The pharmacodynamics (PD) analysis set was defined as a group of participants who received at least 1 dose of the study drug with at least 1 each of evaluable pre- and post-baseline PD data. Participants who were evaluable for this measure at given time point were included for the assessment. | Posted | Count of Participants | Participants | Cycles 1, 2, 3, 5, 8: Day 1 pre-dose; at treatment discontinuation or completion (Cycle 8 Day 21) (each Cycle length = 3 weeks) |
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| Secondary | Number of Participants With Positive Neutralizing Activity of Anti-E7777 Antibody | The PD analysis set was defined as a group of participants who received at least 1 dose of the study drug with at least 1 each of evaluable pre- and post-baseline PD data. Participants who were evaluable for this measure at given time point were included for the assessment. | Posted | Count of Participants | Participants | Cycles 1, 2, 3, 5, 8: Day 1 pre-dose; at treatment discontinuation or completion (Cycle 8 Day 21) (each Cycle length = 3 weeks) |
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From the date of administration of the first dose of the study drug up to 30 days after the last dose of study drug (approximately up to 3 years 1 month)
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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 | PTCL: E7777 9 mcg/kg/Day | Participants with relapsed or refractory PTCL received E7777 9 mcg/kg/day as intravenous infusion, once daily from Day 1 through Day 5 in each treatment cycle until discontinuation or Cycle 8 (each Cycle length = 3 weeks). | 0 | 17 | 9 | 17 | 17 | 17 |
| EG001 | CTCL: E7777 9 mcg/kg/Day | Participants with CTCL received E7777 9 mcg/kg/day as intravenous infusion, once daily from Day 1 through Day 5 in each treatment cycle until discontinuation or Cycle 8 (each Cycle length = 3 weeks). | 1 | 19 | 8 | 19 | 19 | 19 |
| EG002 | Other: E7777 9 mcg/kg/Day | Participant with extranodal NK/T-cell lymphoma received E7777 9 mcg/kg/day as intravenous infusion, once daily from Day 1 through Day 5 in each treatment cycle until discontinuation or Cycle 8 (each Cycle length = 3 weeks). | 0 | 1 | 0 | 1 | 1 | 1 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Cytomegalovirus chorioretinitis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 21.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 21.1 | Systematic Assessment |
| |
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | Systematic Assessment |
| |
| Tumour associated fever | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | Systematic Assessment |
| |
| Altered state of consciousness | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Laryngeal haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Capillary leak syndrome | Vascular disorders | MedDRA 21.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Lymphocytosis | Blood and lymphatic system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Thrombocytosis | Blood and lymphatic system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Cardiomegaly | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Supraventricular extrasystoles | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Ventricular arrhythmia | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Hypoacusis | Ear and labyrinth disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Adrenal insufficiency | Endocrine disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Eye pain | Eye disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Conjunctivitis allergic | Eye disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Disorder of orbit | Eye disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Eczema eyelids | Eye disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Photopsia | Eye disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Retinal exudates | Eye disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Gingival pain | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Perianal erythema | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Generalised oedema | General disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Face oedema | General disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Facial pain | General disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Puncture site pain | General disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Vessel puncture site erythema | General disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Contrast media allergy | Immune system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Angular cheilitis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Cytomegalovirus chorioretinitis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Cytomegalovirus infection | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Enterocolitis infectious | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Folliculitis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Genital candidiasis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Gingivitis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Herpes virus infection | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Impetigo | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Parotitis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Skin candida | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Tinea pedis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Wound | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 21.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 21.1 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 21.1 | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA 21.1 | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA 21.1 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 21.1 | Systematic Assessment |
| |
| Amylase increased | Investigations | MedDRA 21.1 | Systematic Assessment |
| |
| Blood cholesterol increased | Investigations | MedDRA 21.1 | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA 21.1 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA 21.1 | Systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA 21.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 21.1 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 21.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 21.1 | Systematic Assessment |
| |
| Blood fibrinogen decreased | Investigations | MedDRA 21.1 | Systematic Assessment |
| |
| Blood urea increased | Investigations | MedDRA 21.1 | Systematic Assessment |
| |
| Brain natriuretic peptide increased | Investigations | MedDRA 21.1 | Systematic Assessment |
| |
| Cytomegalovirus test positive | Investigations | MedDRA 21.1 | Systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | MedDRA 21.1 | Systematic Assessment |
| |
| N-terminal prohormone brain natriuretic peptide increased | Investigations | MedDRA 21.1 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Dyslipidaemia | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Tumour lysis syndrome | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Tumour associated fever | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | Systematic Assessment |
| |
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | Systematic Assessment |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Post herpetic neuralgia | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Hallucination, auditory | Psychiatric disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Prostatic pain | Reproductive system and breast disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Laryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Pharyngeal inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Dermatitis exfoliative generalised | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Skin erosion | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Dermal cyst | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Dermatosis | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Rash generalised | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Skin fissures | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Toxic skin eruption | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Capillary leak syndrome | Vascular disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Vasculitis | Vascular disorders | MedDRA 21.1 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Inquiry Service. | Eisai Co., Ltd. | eisai-chiken_hotline@hhc.eisai.co.jp |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 29, 2019 | Jun 14, 2021 | SAP_001.pdf |
| ID | Term |
|---|---|
| D016411 | Lymphoma, T-Cell, Peripheral |
| D016410 | Lymphoma, T-Cell, Cutaneous |
| ID | Term |
|---|---|
| D016399 | Lymphoma, T-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000717987 | E7777 fusion protein |
Not provided
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| OG001 |
| CTCL: E7777 9 mcg/kg/Day |
Participants with CTCL received E7777 9 mcg/kg/day as intravenous infusion, once daily from Day 1 through Day 5 in each treatment cycle until discontinuation or Cycle 8 (each Cycle length = 3 weeks). |
| OG002 | Other: E7777 9 mcg/kg/Day | Participant with extranodal NK/T-cell lymphoma received E7777 9 mcg/kg/day as intravenous infusion, once daily from Day 1 through Day 5 in each treatment cycle until discontinuation or Cycle 8 (each Cycle length = 3 weeks). |
|
|
| OG001 |
| CTCL: E7777 9 mcg/kg/Day |
Participants with CTCL received E7777 9 mcg/kg/day as intravenous infusion, once daily from Day 1 through Day 5 in each treatment cycle until discontinuation or Cycle 8 (each Cycle length = 3 weeks). |
| OG002 | Other: E7777 9 mcg/kg/Day | Participant with extranodal NK/T-cell lymphoma received E7777 9 mcg/kg/day as intravenous infusion, once daily from Day 1 through Day 5 in each treatment cycle until discontinuation or Cycle 8 (each Cycle length = 3 weeks). |
|
|
| OG002 | Other: E7777 9 mcg/kg/Day | Participant with extranodal NK/T-cell lymphoma received E7777 9 mcg/kg/day as intravenous infusion, once daily from Day 1 through Day 5 in each treatment cycle until discontinuation or Cycle 8 (each Cycle length = 3 weeks). |
|
|
| Other: E7777 9 mcg/kg/Day |
Participant with extranodal NK/T-cell lymphoma received E7777 9 mcg/kg/day as intravenous infusion, once daily from Day 1 through Day 5 in each treatment cycle until discontinuation or Cycle 8 (each Cycle length = 3 weeks). |
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