Trial Outcomes & Findings for Study of E7777 in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma and Cutaneous T-cell Lymphoma (NCT NCT02676778)

NCT ID: NCT02676778

Last Updated: 2021-07-15

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 45 participants
• Primary outcome timeframe: 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
• Results posted on: 2021-07-15

Participant Flow

Participants took part in the study at 20 investigative sites in Japan from 28 March 2016 to 26 April 2019.

A total of 45 participants were enrolled (obtained informed consent and screened), of these 8 were screen failures and 37 were treated.

Participant milestones

Measure	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).	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).	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).
Overall Study STARTED	17	19	1
Overall Study COMPLETED	0	7	0
Overall Study NOT COMPLETED	17	12	1

Reasons for withdrawal

Measure	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).	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).	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).
Overall Study Disease Progression	7	3	1
Overall Study Couldn't Start Cycle After Planned Date	1	1	0
Overall Study Withdrawal by Subject	3	2	0
Overall Study Other	4	3	0
Overall Study Adverse Event	2	3	0

Baseline Characteristics

Study of E7777 in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma and Cutaneous T-cell Lymphoma

Baseline characteristics by cohort

Measure	PTCL: E7777 9 mcg/kg/Day n=17 Participants 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).	CTCL: E7777 9 mcg/kg/Day n=19 Participants 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).	Other: E7777 9 mcg/kg/Day n=1 Participants 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).	Total n=37 Participants Total of all reporting groups
Age, Continuous	66.7 years STANDARD_DEVIATION 9.16 • n=5 Participants	55.3 years STANDARD_DEVIATION 15.09 • n=7 Participants	70.0 years n=5 Participants	60.9 years STANDARD_DEVIATION 13.63 • n=4 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	6 Participants n=7 Participants	1 Participants n=5 Participants	12 Participants n=4 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	13 Participants n=7 Participants	0 Participants n=5 Participants	25 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	17 Participants n=5 Participants	19 Participants n=7 Participants	1 Participants n=5 Participants	37 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race/Ethnicity, Customized Japanese	17 Participants n=5 Participants	19 Participants n=7 Participants	1 Participants n=5 Participants	37 Participants n=4 Participants

PRIMARY outcome

Timeframe: 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

Population: The full analysis set (FAS) was defined as a group of participants who received at least 1 dose of the study drug.

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.

Outcome measures

Measure	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).	PTCL and CTCL Participants: E7777 9 mcg/kg/Day n=17 Participants Participants with relapsed or refractory PTCL and 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).	CTCL: E7777 9 mcg/kg/Day n=19 Participants 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).
Objective Response Rate (ORR)	—	41.2 percentage of participants Interval 18.4 to 67.1	31.6 percentage of participants Interval 12.6 to 56.6

SECONDARY outcome

Timeframe: 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

Population: The FAS was defined as a group of participants who received at least 1 dose of the study drug.

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.

Outcome measures

Measure	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).	PTCL and CTCL Participants: E7777 9 mcg/kg/Day n=17 Participants Participants with relapsed or refractory PTCL and 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).	CTCL: E7777 9 mcg/kg/Day n=19 Participants 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).
Progression Free Survival (PFS)	—	2.14 months Interval 1.05 to 4.47	4.24 months Interval 2.56 to Upper limit of confidence interval could not be estimated due to an insufficient number of events.

SECONDARY outcome

Timeframe: 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

Population: 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.

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.

Outcome measures

Measure	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).	PTCL and CTCL Participants: E7777 9 mcg/kg/Day n=7 Participants Participants with relapsed or refractory PTCL and 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).	CTCL: E7777 9 mcg/kg/Day n=6 Participants 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).
Duration of Response (DOR)	—	3.09 months Interval 0.92 to 4.76	4.83 months Interval 2.66 to Upper limit of confidence interval could not be estimated due to an insufficient number of events.

SECONDARY outcome

Timeframe: 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

Population: 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.

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.

Outcome measures

Measure	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).	PTCL and CTCL Participants: E7777 9 mcg/kg/Day n=7 Participants Participants with relapsed or refractory PTCL and 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).	CTCL: E7777 9 mcg/kg/Day n=6 Participants 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).
Time to Response (TTR)	—	1.28 months Interval 1.0 to 2.1	2.12 months Interval 1.0 to 4.6

SECONDARY outcome

Timeframe: 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

Population: The FAS was defined as a group of participants who received at least 1 dose of the study drug.

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.

Outcome measures

Measure	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).	PTCL and CTCL Participants: E7777 9 mcg/kg/Day n=17 Participants Participants with relapsed or refractory PTCL and 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).	CTCL: E7777 9 mcg/kg/Day n=19 Participants 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).
CR Rate	—	5.9 percentage of participants Interval 0.1 to 28.7	0 percentage of participants Interval 0.0 to 17.6

SECONDARY outcome

Timeframe: 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

Population: The FAS was defined as a group of participants who received at least 1 dose of the study drug.

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.

Outcome measures

Measure	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).	PTCL and CTCL Participants: E7777 9 mcg/kg/Day n=17 Participants Participants with relapsed or refractory PTCL and 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).	CTCL: E7777 9 mcg/kg/Day n=19 Participants 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).
Overall Survival (OS)	—	11.79 months Interval 4.11 to 19.29	31.87 months Interval 16.85 to Upper limit of confidence interval could not be estimated due to an insufficient number of events.

SECONDARY outcome

Timeframe: 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)

Population: 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.

Outcome measures

Measure	Other: E7777 9 mcg/kg/Day n=1 Participants 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).	PTCL and CTCL Participants: E7777 9 mcg/kg/Day n=17 Participants Participants with relapsed or refractory PTCL and 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).	CTCL: E7777 9 mcg/kg/Day n=19 Participants 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).
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) TEAEs	1 Participants	17 Participants	19 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) SAEs	0 Participants	9 Participants	8 Participants

SECONDARY outcome

Timeframe: 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)

Population: 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.

Outcome measures

Measure	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).	PTCL and CTCL Participants: E7777 9 mcg/kg/Day n=11 Participants Participants with relapsed or refractory PTCL and 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).	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).
Cmax: Maximum Observed Serum Concentration for E7777 Cycle 1 Day 1	—	132 nanogram per milliliter (ng/mL) Standard Deviation 43.1	—
Cmax: Maximum Observed Serum Concentration for E7777 Cycle 3 Day 1	—	142 nanogram per milliliter (ng/mL) Standard Deviation NA Standard deviation could not be calculated because only one participant was analysed.	—
Cmax: Maximum Observed Serum Concentration for E7777 Cycle 5 Day 1	—	140 nanogram per milliliter (ng/mL) Standard Deviation NA Standard deviation could not be calculated because only one participant was analysed.	—

SECONDARY outcome

Timeframe: 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)

Population: 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.

Outcome measures

Measure	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).	PTCL and CTCL Participants: E7777 9 mcg/kg/Day n=11 Participants Participants with relapsed or refractory PTCL and 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).	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).
Tmax: Time to Reach the Cmax for E7777 Cycle 1 Day 1	—	63.00 minutes Interval 59.0 to 99.0	—
Tmax: Time to Reach the Cmax for E7777 Cycle 3 Day 1	—	65.00 minutes Full range could not be calculated because only one participant was analysed.	—
Tmax: Time to Reach the Cmax for E7777 Cycle 5 Day 1	—	80.00 minutes Full range could not be calculated because only one participant was analysed.	—

SECONDARY outcome

Timeframe: 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)

Population: 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.

Outcome measures

Measure	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).	PTCL and CTCL Participants: E7777 9 mcg/kg/Day n=11 Participants Participants with relapsed or refractory PTCL and 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).	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).
AUC(0-t ): Area Under the Serum Concentration-time Curve From Time 0 to the Last Measurable Point for E7777 Cycle 1 Day 1	—	17600 nanogram*minute permilliliter(ng*min/mL) Standard Deviation 8040	—
AUC(0-t ): Area Under the Serum Concentration-time Curve From Time 0 to the Last Measurable Point for E7777 Cycle 3 Day 1	—	15800 nanogram*minute permilliliter(ng*min/mL) Standard Deviation NA Standard deviation could not be calculated because only one participant was analysed.	—
AUC(0-t ): Area Under the Serum Concentration-time Curve From Time 0 to the Last Measurable Point for E7777 Cycle 5 Day 1	—	16500 nanogram*minute permilliliter(ng*min/mL) Standard Deviation NA Standard deviation could not be calculated because only one participant was analysed.	—

SECONDARY outcome

Timeframe: 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)

Population: 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.

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.

Outcome measures

Measure	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).	PTCL and CTCL Participants: E7777 9 mcg/kg/Day n=11 Participants Participants with relapsed or refractory PTCL and 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).	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).
AUC(0-inf): Area Under the Serum Concentration-time Curve From Time 0 to Infinity for E7777 Cycle 1 Day 1	—	23000 ng*min/m Standard Deviation 7830	—
AUC(0-inf): Area Under the Serum Concentration-time Curve From Time 0 to Infinity for E7777 Cycle 5 Day 1	—	21400 ng*min/m Standard Deviation NA Standard deviation could not be calculated because only one participant was analysed.	—

SECONDARY outcome

Timeframe: 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)

Population: 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.

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.

Outcome measures

Measure	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).	PTCL and CTCL Participants: E7777 9 mcg/kg/Day n=11 Participants Participants with relapsed or refractory PTCL and 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).	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).
Mean Residence Time (MRT) for E7777 Cycle 1 Day 1	—	136 minutes Standard Deviation 29.2	—
Mean Residence Time (MRT) for E7777 Cycle 5 Day 1	—	105 minutes Standard Deviation NA Standard deviation could not be calculated because only one participant was analysed.	—

SECONDARY outcome

Timeframe: 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)

Population: 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.

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.

Outcome measures

Measure	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).	PTCL and CTCL Participants: E7777 9 mcg/kg/Day n=11 Participants Participants with relapsed or refractory PTCL and 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).	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).
t1/2: Terminal Elimination Phase Half-life for E7777 Cycle 1 Day 1	—	96.0 minutes Standard Deviation 19.6	—
t1/2: Terminal Elimination Phase Half-life for E7777 Cycle 3 Day 1	—	116 minutes Standard Deviation NA Standard deviation could not be calculated because only one participant was analysed.	—
t1/2: Terminal Elimination Phase Half-life for E7777 Cycle 5 Day 1	—	69.2 minutes Standard Deviation NA Standard deviation could not be calculated because only one participant was analysed.	—

SECONDARY outcome

Timeframe: 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)

Population: 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.

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.

Outcome measures

Measure	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).	PTCL and CTCL Participants: E7777 9 mcg/kg/Day n=11 Participants Participants with relapsed or refractory PTCL and 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).	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).
CL: Total Clearance for E7777 Cycle 1 Day 1	—	0.465 milliter per minute per kilogram Standard Deviation 0.250	—
CL: Total Clearance for E7777 Cycle 5 Day 1	—	0.421 milliter per minute per kilogram Standard Deviation NA Standard deviation could not be calculated because only one participant was analysed.	—

SECONDARY outcome

Timeframe: 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)

Population: 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.

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.

Outcome measures

Measure	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).	PTCL and CTCL Participants: E7777 9 mcg/kg/Day n=11 Participants Participants with relapsed or refractory PTCL and 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).	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).
Vz: Volume of Distribution at Terminal Phase for E7777 Cycle 1 Day 1	—	59.0 milliliter per kilogram (mL/kg) Standard Deviation 17.4	—
Vz: Volume of Distribution at Terminal Phase for E7777 Cycle 5 Day 1	—	42.0 milliliter per kilogram (mL/kg) Standard Deviation NA Standard deviation could not be calculated because only one participant was analysed.	—

SECONDARY outcome

Timeframe: 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)

Population: 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.

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.

Outcome measures

Measure	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).	PTCL and CTCL Participants: E7777 9 mcg/kg/Day n=11 Participants Participants with relapsed or refractory PTCL and 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).	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).
Vss: Volume of Distribution at Steady State for E7777 Cycle 1 Day 1	—	57.4 mL/kg Standard Deviation 13.5	—
Vss: Volume of Distribution at Steady State for E7777 Cycle 5 Day 1	—	44.1 mL/kg Standard Deviation NA Standard deviation could not be calculated because only one participant was analysed.	—

SECONDARY outcome

Timeframe: 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)

Population: 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

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.

Outcome measures

Measure	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).	PTCL and CTCL Participants: E7777 9 mcg/kg/Day n=1 Participants Participants with relapsed or refractory PTCL and 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).	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).
Rac (Cmax): Accumulation Ratio of Cmax for E7777 Cycle 3 Day 1	—	0.993 ratio Standard Deviation NA Standard deviation could not be calculated because only one participant was analysed.	—
Rac (Cmax): Accumulation Ratio of Cmax for E7777 Cycle 5 Day 1	—	0.979 ratio Standard Deviation NA Standard deviation could not be calculated because only one participant was analysed.	—

SECONDARY outcome

Timeframe: 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)

Population: 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

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.

Outcome measures

Measure	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).	PTCL and CTCL Participants: E7777 9 mcg/kg/Day n=1 Participants Participants with relapsed or refractory PTCL and 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).	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).
Rac (AUC): Accumulation Ratio of AUC for E7777 Cycle 5 Day 1	—	0.827 ratio Standard Deviation NA Standard deviation could not be calculated because only one participant was analysed.	—

SECONDARY outcome

Timeframe: Cycles 1, 2, 3, 5, 8: Day 1 pre-dose; at treatment discontinuation or completion (Cycle 8 Day 21) (each Cycle length = 3 weeks)

Population: 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.

Outcome measures

Measure	Other: E7777 9 mcg/kg/Day n=1 Participants 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).	PTCL and CTCL Participants: E7777 9 mcg/kg/Day n=17 Participants Participants with relapsed or refractory PTCL and 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).	CTCL: E7777 9 mcg/kg/Day n=19 Participants 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).
Number of Participants With Positive Anti-E7777 and Anti-IL-2 Antibodies Anti-E7777 antibody: Cycle 1 Day 1	1 Participants	11 Participants	13 Participants
Number of Participants With Positive Anti-E7777 and Anti-IL-2 Antibodies Anti-E7777 antibody: Cycle 2 Day 1	0 Participants	5 Participants	11 Participants
Number of Participants With Positive Anti-E7777 and Anti-IL-2 Antibodies Anti-E7777 antibody: Cycle 3 Day 1	—	3 Participants	11 Participants
Number of Participants With Positive Anti-E7777 and Anti-IL-2 Antibodies Anti-E7777 antibody: Cycle 5 Day 1	—	1 Participants	10 Participants
Number of Participants With Positive Anti-E7777 and Anti-IL-2 Antibodies Anti-E7777 antibody: Cycle 8 Day 1	—	—	7 Participants
Number of Participants With Positive Anti-E7777 and Anti-IL-2 Antibodies Anti-E7777 antibody: Discontinuation/Completion	1 Participants	10 Participants	15 Participants
Number of Participants With Positive Anti-E7777 and Anti-IL-2 Antibodies Anti-IL-2 antibody: Cycle 1 Day 1	0 Participants	1 Participants	1 Participants
Number of Participants With Positive Anti-E7777 and Anti-IL-2 Antibodies Anti-IL-2 antibody: Cycle 2 Day 1	0 Participants	2 Participants	4 Participants
Number of Participants With Positive Anti-E7777 and Anti-IL-2 Antibodies Anti-IL-2 antibody: Cycle 3 Day 1	—	2 Participants	11 Participants
Number of Participants With Positive Anti-E7777 and Anti-IL-2 Antibodies Anti-IL-2 antibody: Cycle 5 Day 1	—	1 Participants	10 Participants
Number of Participants With Positive Anti-E7777 and Anti-IL-2 Antibodies Anti-IL-2 antibody: Cycle 8 Day 1	—	—	7 Participants
Number of Participants With Positive Anti-E7777 and Anti-IL-2 Antibodies Anti-IL-2 antibody: Discontinuation/Completion	0 Participants	3 Participants	15 Participants

SECONDARY outcome

Timeframe: Cycles 1, 2, 3, 5, 8: Day 1 pre-dose; at treatment discontinuation or completion (Cycle 8 Day 21) (each Cycle length = 3 weeks)

Population: 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.

Outcome measures

Measure	Other: E7777 9 mcg/kg/Day n=1 Participants 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).	PTCL and CTCL Participants: E7777 9 mcg/kg/Day n=17 Participants Participants with relapsed or refractory PTCL and 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).	CTCL: E7777 9 mcg/kg/Day n=19 Participants 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).
Number of Participants With Positive Neutralizing Activity of Anti-E7777 Antibody Cycle 1 Day 1	0 Participants	0 Participants	0 Participants
Number of Participants With Positive Neutralizing Activity of Anti-E7777 Antibody Cycle 2 Day 1	0 Participants	2 Participants	9 Participants
Number of Participants With Positive Neutralizing Activity of Anti-E7777 Antibody Cycle 3 Day 1	—	2 Participants	11 Participants
Number of Participants With Positive Neutralizing Activity of Anti-E7777 Antibody Cycle 5 Day 1	—	1 Participants	8 Participants
Number of Participants With Positive Neutralizing Activity of Anti-E7777 Antibody Cycle 8 Day 1	—	—	6 Participants
Number of Participants With Positive Neutralizing Activity of Anti-E7777 Antibody Discontinuation/Completion	0 Participants	8 Participants	12 Participants

Adverse Events

PTCL: E7777 9 mcg/kg/Day

Serious events: 9 serious events

Other events: 17 other events

Deaths: 0 deaths

CTCL: E7777 9 mcg/kg/Day

Serious events: 8 serious events

Other events: 19 other events

Deaths: 1 deaths

Other: E7777 9 mcg/kg/Day

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	PTCL: E7777 9 mcg/kg/Day n=17 participants at risk 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).	CTCL: E7777 9 mcg/kg/Day n=19 participants at risk 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).	Other: E7777 9 mcg/kg/Day n=1 participants at risk 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).
Blood and lymphatic system disorders Lymphopenia	0.00% 0/17 • 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)	10.5% 2/19 • 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)	0.00% 0/1 • 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)
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/17 • 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)	5.3% 1/19 • 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)	0.00% 0/1 • 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)
Blood and lymphatic system disorders Thrombocytopenia	5.9% 1/17 • 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)	0.00% 0/19 • 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)	0.00% 0/1 • 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)
General disorders Pyrexia	17.6% 3/17 • 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)	0.00% 0/19 • 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)	0.00% 0/1 • 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)
Hepatobiliary disorders Hepatic function abnormal	0.00% 0/17 • 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)	5.3% 1/19 • 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)	0.00% 0/1 • 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)
Infections and infestations Cytomegalovirus chorioretinitis	5.9% 1/17 • 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)	0.00% 0/19 • 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)	0.00% 0/1 • 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)
Infections and infestations Herpes zoster	0.00% 0/17 • 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)	5.3% 1/19 • 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)	0.00% 0/1 • 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)
Infections and infestations Pneumonia	0.00% 0/17 • 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)	5.3% 1/19 • 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)	0.00% 0/1 • 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)
Investigations Alanine aminotransferase increased	23.5% 4/17 • 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)	5.3% 1/19 • 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)	0.00% 0/1 • 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)
Investigations Aspartate aminotransferase increased	23.5% 4/17 • 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)	5.3% 1/19 • 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)	0.00% 0/1 • 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)
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.00% 0/17 • 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)	5.3% 1/19 • 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)	0.00% 0/1 • 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)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	0.00% 0/17 • 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)	5.3% 1/19 • 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)	0.00% 0/1 • 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)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour associated fever	5.9% 1/17 • 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)	0.00% 0/19 • 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)	0.00% 0/1 • 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)
Nervous system disorders Altered state of consciousness	5.9% 1/17 • 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)	0.00% 0/19 • 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)	0.00% 0/1 • 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)
Nervous system disorders Peripheral sensory neuropathy	5.9% 1/17 • 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)	0.00% 0/19 • 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)	0.00% 0/1 • 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)
Respiratory, thoracic and mediastinal disorders Laryngeal haemorrhage	5.9% 1/17 • 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)	0.00% 0/19 • 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)	0.00% 0/1 • 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)
Skin and subcutaneous tissue disorders Drug eruption	5.9% 1/17 • 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)	0.00% 0/19 • 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)	0.00% 0/1 • 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)
Vascular disorders Capillary leak syndrome	0.00% 0/17 • 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)	21.1% 4/19 • 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)	0.00% 0/1 • 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)

Other adverse events

Measure	PTCL: E7777 9 mcg/kg/Day n=17 participants at risk 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).	CTCL: E7777 9 mcg/kg/Day n=19 participants at risk 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).	Other: E7777 9 mcg/kg/Day n=1 participants at risk 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).
Blood and lymphatic system disorders Lymphopenia	82.4% 14/17 • 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)	57.9% 11/19 • 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)	100.0% 1/1 • 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)
Blood and lymphatic system disorders Thrombocytopenia	52.9% 9/17 • 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)	15.8% 3/19 • 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)	100.0% 1/1 • 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)
Blood and lymphatic system disorders Anaemia	17.6% 3/17 • 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)	10.5% 2/19 • 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)	0.00% 0/1 • 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)
Blood and lymphatic system disorders Leukocytosis	0.00% 0/17 • 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)	21.1% 4/19 • 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)	0.00% 0/1 • 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)
Blood and lymphatic system disorders Leukopenia	23.5% 4/17 • 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)	0.00% 0/19 • 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)	0.00% 0/1 • 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)
Blood and lymphatic system disorders Neutropenia	11.8% 2/17 • 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)	0.00% 0/19 • 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)	0.00% 0/1 • 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)
Blood and lymphatic system disorders Lymphocytosis	5.9% 1/17 • 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)	0.00% 0/19 • 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)	0.00% 0/1 • 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)
Blood and lymphatic system disorders Thrombocytosis	0.00% 0/17 • 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)	5.3% 1/19 • 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)	0.00% 0/1 • 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)
Cardiac disorders Cardiomegaly	5.9% 1/17 • 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)	0.00% 0/19 • 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)	0.00% 0/1 • 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)
Cardiac disorders Sinus bradycardia	5.9% 1/17 • 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)	0.00% 0/19 • 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)	0.00% 0/1 • 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)
Cardiac disorders Sinus tachycardia	5.9% 1/17 • 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)	0.00% 0/19 • 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)	0.00% 0/1 • 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)
Cardiac disorders Supraventricular extrasystoles	5.9% 1/17 • 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)	0.00% 0/19 • 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)	0.00% 0/1 • 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)
Cardiac disorders Ventricular arrhythmia	5.9% 1/17 • 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)	0.00% 0/19 • 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)	0.00% 0/1 • 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)
Ear and labyrinth disorders Hypoacusis	5.9% 1/17 • 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)	0.00% 0/19 • 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)	0.00% 0/1 • 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)
Endocrine disorders Adrenal insufficiency	0.00% 0/17 • 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)	5.3% 1/19 • 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)	0.00% 0/1 • 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)
Endocrine disorders Hypothyroidism	5.9% 1/17 • 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)	0.00% 0/19 • 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)	0.00% 0/1 • 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)
Eye disorders Eye pain	5.9% 1/17 • 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)	5.3% 1/19 • 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)	0.00% 0/1 • 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)
Eye disorders Conjunctivitis allergic	5.9% 1/17 • 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)	0.00% 0/19 • 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)	0.00% 0/1 • 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)
Eye disorders Disorder of orbit	0.00% 0/17 • 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)	5.3% 1/19 • 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)	0.00% 0/1 • 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)
Eye disorders Dry eye	0.00% 0/17 • 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)	5.3% 1/19 • 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)	0.00% 0/1 • 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)
Eye disorders Eczema eyelids	5.9% 1/17 • 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)	0.00% 0/19 • 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)	0.00% 0/1 • 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)
Eye disorders Photopsia	0.00% 0/17 • 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)	5.3% 1/19 • 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)	0.00% 0/1 • 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)
Eye disorders Retinal exudates	0.00% 0/17 • 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)	5.3% 1/19 • 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)	0.00% 0/1 • 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)
Eye disorders Vision blurred	0.00% 0/17 • 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)	5.3% 1/19 • 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)	0.00% 0/1 • 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)
Gastrointestinal disorders Constipation	23.5% 4/17 • 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)	52.6% 10/19 • 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)	0.00% 0/1 • 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)
Gastrointestinal disorders Nausea	29.4% 5/17 • 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)	31.6% 6/19 • 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)	0.00% 0/1 • 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)
Gastrointestinal disorders Vomiting	23.5% 4/17 • 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)	15.8% 3/19 • 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)	0.00% 0/1 • 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)
Gastrointestinal disorders Diarrhoea	11.8% 2/17 • 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)	0.00% 0/19 • 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)	100.0% 1/1 • 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)
Gastrointestinal disorders Stomatitis	11.8% 2/17 • 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)	5.3% 1/19 • 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)	0.00% 0/1 • 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)
Gastrointestinal disorders Abdominal discomfort	0.00% 0/17 • 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)	5.3% 1/19 • 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)	0.00% 0/1 • 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)
Gastrointestinal disorders Abdominal pain upper	0.00% 0/17 • 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)	5.3% 1/19 • 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)	0.00% 0/1 • 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)
Gastrointestinal disorders Ascites	5.9% 1/17 • 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)	0.00% 0/19 • 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)	0.00% 0/1 • 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)
Gastrointestinal disorders Colitis	5.9% 1/17 • 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)	0.00% 0/19 • 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)	0.00% 0/1 • 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)
Gastrointestinal disorders Dyspepsia	0.00% 0/17 • 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)	5.3% 1/19 • 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)	0.00% 0/1 • 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)
Gastrointestinal disorders Dysphagia	5.9% 1/17 • 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)	0.00% 0/19 • 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)	0.00% 0/1 • 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)
Gastrointestinal disorders Gingival pain	5.9% 1/17 • 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)	0.00% 0/19 • 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)	0.00% 0/1 • 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)
Gastrointestinal disorders Haemorrhoids	5.9% 1/17 • 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)	0.00% 0/19 • 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)	0.00% 0/1 • 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)
Gastrointestinal disorders Mouth ulceration	0.00% 0/17 • 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)	5.3% 1/19 • 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)	0.00% 0/1 • 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)
Gastrointestinal disorders Perianal erythema	5.9% 1/17 • 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)	0.00% 0/19 • 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)	0.00% 0/1 • 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)
Gastrointestinal disorders Toothache	0.00% 0/17 • 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)	5.3% 1/19 • 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)	0.00% 0/1 • 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)
General disorders Pyrexia	52.9% 9/17 • 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)	36.8% 7/19 • 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)	100.0% 1/1 • 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)
General disorders Malaise	23.5% 4/17 • 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)	42.1% 8/19 • 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)	0.00% 0/1 • 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)
General disorders Oedema peripheral	29.4% 5/17 • 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)	15.8% 3/19 • 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)	0.00% 0/1 • 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)
General disorders Fatigue	17.6% 3/17 • 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)	5.3% 1/19 • 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)	0.00% 0/1 • 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)
General disorders Generalised oedema	0.00% 0/17 • 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)	15.8% 3/19 • 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)	0.00% 0/1 • 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)
General disorders Face oedema	5.9% 1/17 • 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)	0.00% 0/19 • 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)	0.00% 0/1 • 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)
General disorders Facial pain	0.00% 0/17 • 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)	5.3% 1/19 • 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)	0.00% 0/1 • 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)
General disorders Injection site erythema	0.00% 0/17 • 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)	5.3% 1/19 • 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)	0.00% 0/1 • 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)
General disorders Pain	0.00% 0/17 • 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)	5.3% 1/19 • 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)	0.00% 0/1 • 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)
General disorders Puncture site pain	0.00% 0/17 • 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)	5.3% 1/19 • 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)	0.00% 0/1 • 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)
General disorders Vessel puncture site erythema	5.9% 1/17 • 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)	0.00% 0/19 • 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)	0.00% 0/1 • 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)
Hepatobiliary disorders Hepatic function abnormal	0.00% 0/17 • 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)	5.3% 1/19 • 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)	0.00% 0/1 • 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)
Immune system disorders Contrast media allergy	0.00% 0/17 • 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)	5.3% 1/19 • 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)	0.00% 0/1 • 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)
Immune system disorders Drug hypersensitivity	5.9% 1/17 • 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)	0.00% 0/19 • 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)	0.00% 0/1 • 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)
Infections and infestations Angular cheilitis	5.9% 1/17 • 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)	5.3% 1/19 • 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)	0.00% 0/1 • 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)
Infections and infestations Lung infection	11.8% 2/17 • 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)	0.00% 0/19 • 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)	0.00% 0/1 • 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)
Infections and infestations Cellulitis	5.9% 1/17 • 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)	0.00% 0/19 • 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)	0.00% 0/1 • 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)
Infections and infestations Conjunctivitis	5.9% 1/17 • 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)	0.00% 0/19 • 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)	0.00% 0/1 • 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)
Infections and infestations Cytomegalovirus chorioretinitis	5.9% 1/17 • 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)	0.00% 0/19 • 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)	0.00% 0/1 • 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)
Infections and infestations Cytomegalovirus infection	0.00% 0/17 • 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)	5.3% 1/19 • 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)	0.00% 0/1 • 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)
Infections and infestations Enterocolitis infectious	0.00% 0/17 • 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)	5.3% 1/19 • 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)	0.00% 0/1 • 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)
Infections and infestations Folliculitis	5.9% 1/17 • 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)	0.00% 0/19 • 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)	0.00% 0/1 • 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)
Infections and infestations Gastroenteritis	5.9% 1/17 • 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)	0.00% 0/19 • 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)	0.00% 0/1 • 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)
Infections and infestations Genital candidiasis	0.00% 0/17 • 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)	5.3% 1/19 • 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)	0.00% 0/1 • 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)
Infections and infestations Gingivitis	0.00% 0/17 • 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)	5.3% 1/19 • 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)	0.00% 0/1 • 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)
Infections and infestations Herpes virus infection	0.00% 0/17 • 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)	5.3% 1/19 • 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)	0.00% 0/1 • 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)
Infections and infestations Impetigo	0.00% 0/17 • 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)	5.3% 1/19 • 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)	0.00% 0/1 • 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)
Infections and infestations Nasopharyngitis	5.9% 1/17 • 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)	0.00% 0/19 • 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)	0.00% 0/1 • 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)
Infections and infestations Parotitis	5.9% 1/17 • 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)	0.00% 0/19 • 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)	0.00% 0/1 • 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)
Infections and infestations Pneumonia	5.9% 1/17 • 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)	0.00% 0/19 • 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)	0.00% 0/1 • 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)
Infections and infestations Skin candida	0.00% 0/17 • 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)	5.3% 1/19 • 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)	0.00% 0/1 • 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)
Infections and infestations Skin infection	0.00% 0/17 • 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)	5.3% 1/19 • 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)	0.00% 0/1 • 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)
Infections and infestations Tinea pedis	0.00% 0/17 • 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)	5.3% 1/19 • 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)	0.00% 0/1 • 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)
Infections and infestations Upper respiratory tract infection	5.9% 1/17 • 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)	0.00% 0/19 • 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)	0.00% 0/1 • 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)
Infections and infestations Wound infection	0.00% 0/17 • 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)	5.3% 1/19 • 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)	0.00% 0/1 • 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)
Injury, poisoning and procedural complications Wound	0.00% 0/17 • 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)	5.3% 1/19 • 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)	0.00% 0/1 • 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)
Investigations Aspartate aminotransferase increased	76.5% 13/17 • 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)	78.9% 15/19 • 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)	100.0% 1/1 • 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)
Investigations Alanine aminotransferase increased	76.5% 13/17 • 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)	78.9% 15/19 • 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)	0.00% 0/1 • 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)
Investigations Gamma-glutamyltransferase increased	52.9% 9/17 • 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)	36.8% 7/19 • 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)	100.0% 1/1 • 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)
Investigations Lipase increased	35.3% 6/17 • 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)	21.1% 4/19 • 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)	0.00% 0/1 • 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)
Investigations Weight increased	23.5% 4/17 • 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)	15.8% 3/19 • 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)	0.00% 0/1 • 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)
Investigations Blood alkaline phosphatase increased	11.8% 2/17 • 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)	15.8% 3/19 • 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)	100.0% 1/1 • 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)
Investigations Amylase increased	17.6% 3/17 • 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)	10.5% 2/19 • 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)	0.00% 0/1 • 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)
Investigations Blood cholesterol increased	17.6% 3/17 • 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)	10.5% 2/19 • 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)	0.00% 0/1 • 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)
Investigations Blood lactate dehydrogenase increased	17.6% 3/17 • 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)	0.00% 0/19 • 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)	0.00% 0/1 • 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)
Investigations Blood creatine phosphokinase increased	5.9% 1/17 • 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)	5.3% 1/19 • 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)	0.00% 0/1 • 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)
Investigations C-reactive protein increased	0.00% 0/17 • 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)	5.3% 1/19 • 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)	100.0% 1/1 • 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)
Investigations Weight decreased	11.8% 2/17 • 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)	0.00% 0/19 • 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)	0.00% 0/1 • 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)
Investigations Blood bilirubin increased	5.9% 1/17 • 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)	0.00% 0/19 • 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)	0.00% 0/1 • 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)
Investigations Blood creatinine increased	5.9% 1/17 • 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)	0.00% 0/19 • 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)	0.00% 0/1 • 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)
Investigations Blood fibrinogen decreased	5.9% 1/17 • 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)	0.00% 0/19 • 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)	0.00% 0/1 • 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)
Investigations Blood urea increased	5.9% 1/17 • 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)	0.00% 0/19 • 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)	0.00% 0/1 • 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)
Investigations Brain natriuretic peptide increased	5.9% 1/17 • 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)	0.00% 0/19 • 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)	0.00% 0/1 • 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)
Investigations Cytomegalovirus test positive	5.9% 1/17 • 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)	0.00% 0/19 • 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)	0.00% 0/1 • 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)
Investigations Electrocardiogram QT prolonged	5.9% 1/17 • 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)	0.00% 0/19 • 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)	0.00% 0/1 • 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)
Investigations N-terminal prohormone brain natriuretic peptide increased	5.9% 1/17 • 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)	0.00% 0/19 • 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)	0.00% 0/1 • 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)
Metabolism and nutrition disorders Hypoalbuminaemia	70.6% 12/17 • 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)	73.7% 14/19 • 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)	0.00% 0/1 • 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)
Metabolism and nutrition disorders Decreased appetite	29.4% 5/17 • 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)	26.3% 5/19 • 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)	100.0% 1/1 • 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)
Metabolism and nutrition disorders Hypertriglyceridaemia	29.4% 5/17 • 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)	26.3% 5/19 • 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)	0.00% 0/1 • 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)
Metabolism and nutrition disorders Hyperglycaemia	11.8% 2/17 • 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)	10.5% 2/19 • 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)	0.00% 0/1 • 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)
Metabolism and nutrition disorders Hyponatraemia	17.6% 3/17 • 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)	0.00% 0/19 • 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)	100.0% 1/1 • 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)
Metabolism and nutrition disorders Dehydration	17.6% 3/17 • 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)	0.00% 0/19 • 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)	0.00% 0/1 • 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)
Metabolism and nutrition disorders Hypokalaemia	17.6% 3/17 • 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)	0.00% 0/19 • 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)	0.00% 0/1 • 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)
Metabolism and nutrition disorders Hypophosphataemia	17.6% 3/17 • 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)	0.00% 0/19 • 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)	0.00% 0/1 • 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)
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/17 • 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)	10.5% 2/19 • 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)	0.00% 0/1 • 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)
Metabolism and nutrition disorders Hyperuricaemia	5.9% 1/17 • 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)	5.3% 1/19 • 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)	0.00% 0/1 • 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)
Metabolism and nutrition disorders Dyslipidaemia	0.00% 0/17 • 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)	5.3% 1/19 • 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)	0.00% 0/1 • 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)
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/17 • 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)	5.3% 1/19 • 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)	0.00% 0/1 • 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)
Metabolism and nutrition disorders Tumour lysis syndrome	5.9% 1/17 • 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)	0.00% 0/19 • 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)	0.00% 0/1 • 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)
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/17 • 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)	21.1% 4/19 • 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)	0.00% 0/1 • 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)
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/17 • 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)	10.5% 2/19 • 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)	100.0% 1/1 • 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)
Musculoskeletal and connective tissue disorders Arthralgia	5.9% 1/17 • 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)	5.3% 1/19 • 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)	0.00% 0/1 • 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)
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/17 • 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)	5.3% 1/19 • 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)	0.00% 0/1 • 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)
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	5.9% 1/17 • 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)	0.00% 0/19 • 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)	0.00% 0/1 • 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)
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.00% 0/17 • 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)	5.3% 1/19 • 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)	0.00% 0/1 • 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)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour associated fever	11.8% 2/17 • 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)	0.00% 0/19 • 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)	0.00% 0/1 • 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)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	5.9% 1/17 • 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)	0.00% 0/19 • 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)	0.00% 0/1 • 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)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	5.9% 1/17 • 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)	0.00% 0/19 • 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)	0.00% 0/1 • 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)
Nervous system disorders Dysgeusia	17.6% 3/17 • 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)	0.00% 0/19 • 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)	0.00% 0/1 • 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)
Nervous system disorders Headache	5.9% 1/17 • 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)	10.5% 2/19 • 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)	0.00% 0/1 • 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)
Nervous system disorders Dizziness	0.00% 0/17 • 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)	10.5% 2/19 • 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)	0.00% 0/1 • 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)
Nervous system disorders Peripheral sensory neuropathy	5.9% 1/17 • 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)	0.00% 0/19 • 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)	0.00% 0/1 • 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)
Nervous system disorders Post herpetic neuralgia	0.00% 0/17 • 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)	5.3% 1/19 • 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)	0.00% 0/1 • 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)
Psychiatric disorders Insomnia	17.6% 3/17 • 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)	21.1% 4/19 • 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)	0.00% 0/1 • 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)
Psychiatric disorders Delirium	5.9% 1/17 • 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)	5.3% 1/19 • 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)	0.00% 0/1 • 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)
Psychiatric disorders Hallucination, auditory	5.9% 1/17 • 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)	0.00% 0/19 • 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)	0.00% 0/1 • 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)
Renal and urinary disorders Proteinuria	11.8% 2/17 • 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)	5.3% 1/19 • 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)	100.0% 1/1 • 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)
Renal and urinary disorders Renal impairment	0.00% 0/17 • 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)	5.3% 1/19 • 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)	0.00% 0/1 • 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)
Reproductive system and breast disorders Prostatic pain	0.00% 0/17 • 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)	5.3% 1/19 • 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)	0.00% 0/1 • 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)
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	5.9% 1/17 • 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)	5.3% 1/19 • 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)	0.00% 0/1 • 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)
Respiratory, thoracic and mediastinal disorders Cough	5.9% 1/17 • 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)	0.00% 0/19 • 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)	0.00% 0/1 • 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)
Respiratory, thoracic and mediastinal disorders Hiccups	0.00% 0/17 • 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)	5.3% 1/19 • 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)	0.00% 0/1 • 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)
Respiratory, thoracic and mediastinal disorders Laryngeal pain	5.9% 1/17 • 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)	0.00% 0/19 • 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)	0.00% 0/1 • 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)
Respiratory, thoracic and mediastinal disorders Pharyngeal inflammation	0.00% 0/17 • 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)	5.3% 1/19 • 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)	0.00% 0/1 • 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)
Respiratory, thoracic and mediastinal disorders Upper respiratory tract inflammation	5.9% 1/17 • 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)	0.00% 0/19 • 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)	0.00% 0/1 • 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)
Skin and subcutaneous tissue disorders Dermatitis exfoliative generalised	5.9% 1/17 • 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)	5.3% 1/19 • 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)	0.00% 0/1 • 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)
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/17 • 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)	10.5% 2/19 • 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)	0.00% 0/1 • 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)
Skin and subcutaneous tissue disorders Skin erosion	0.00% 0/17 • 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)	10.5% 2/19 • 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)	0.00% 0/1 • 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)
Skin and subcutaneous tissue disorders Dermal cyst	0.00% 0/17 • 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)	5.3% 1/19 • 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)	0.00% 0/1 • 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)
Skin and subcutaneous tissue disorders Dermatitis contact	0.00% 0/17 • 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)	5.3% 1/19 • 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)	0.00% 0/1 • 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)
Skin and subcutaneous tissue disorders Dermatosis	5.9% 1/17 • 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)	0.00% 0/19 • 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)	0.00% 0/1 • 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)
Skin and subcutaneous tissue disorders Rash	0.00% 0/17 • 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)	0.00% 0/19 • 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)	100.0% 1/1 • 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)
Skin and subcutaneous tissue disorders Rash generalised	5.9% 1/17 • 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)	0.00% 0/19 • 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)	0.00% 0/1 • 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)
Skin and subcutaneous tissue disorders Skin fissures	0.00% 0/17 • 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)	5.3% 1/19 • 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)	0.00% 0/1 • 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)
Skin and subcutaneous tissue disorders Skin ulcer	0.00% 0/17 • 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)	5.3% 1/19 • 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)	0.00% 0/1 • 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)
Skin and subcutaneous tissue disorders Toxic skin eruption	0.00% 0/17 • 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)	5.3% 1/19 • 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)	0.00% 0/1 • 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)
Vascular disorders Hypertension	5.9% 1/17 • 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)	21.1% 4/19 • 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)	0.00% 0/1 • 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)
Vascular disorders Capillary leak syndrome	0.00% 0/17 • 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)	15.8% 3/19 • 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)	0.00% 0/1 • 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)
Vascular disorders Hot flush	0.00% 0/17 • 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)	10.5% 2/19 • 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)	0.00% 0/1 • 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)
Vascular disorders Hypotension	0.00% 0/17 • 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)	5.3% 1/19 • 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)	0.00% 0/1 • 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)
Vascular disorders Vasculitis	5.9% 1/17 • 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)	0.00% 0/19 • 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)	0.00% 0/1 • 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)

Additional Information

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Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place